America-Israel Patent Law

Hey Rocky, Watch Me Pull A Rabbit Out of My Hat (or Maybe a Last-Minute Patent Term Extension) – The Bivalirudin (Angiomax) Saga Continues

 

As noted here and elsewhere, The Medicines Company (TMC) failed to secure a patent term extension (PTE) for US 5,196,404, its patent on bivalirudin, a peptide drug that is used as an anti-coagulant during surgery and marketed by TMC as Angiomax.  The deadline for filing a request for PTE is 60 days after FDA approval, but the FDA and USPTO determined that TMC filed its PTE request for the bivalirudin patent one day late.  Oops.  The patent is set to expire next month, on March 23.

 

But when you have a drug worth several hundred million dollars per year, like Angiomax, you don’t take no for an answer.  So TMC first tried to get the USPTO and the FDA to change their minds, filing a request for reconsideration in 2002.  No dice.  Then the Congressman from TMC’s district introduced legislation that would have provided a fix, but the bill is still languishing on Capitol Hill.  So TMC secured two further patents, US 7,582,727 and US 7,598,343, on what Madison Avenue might call “new and improved” versions of bivalirudin (with a third application still in the pipeline at the USPTO), promptly listed those in the Orange Book, and when Teva filed paragraph IV certifications against those patents, sued Teva for infringement in October and December 2009.  Unfortunately for TMC, since Teva’s ANDA for bivalirudin was filed before the new patents were listed in the Orange Book, there’s no automatic 30-month stay, and the best TMC can hope for right now in that litigation is a preliminary injunction, which may or may not issue before March 23, if it issues at all.

 

The latest round in the saga is that last week TMC filed suit against the USPTO, the FDA, the Department of Health and Human Services, and their various heads.  Two days later TMC filed a motion for summary judgment (Download TMC SJ motion).  TMC’s argument boils down to the following:

 

1.     The FDA faxed its approval letter for Angiomax to TMC after business hours on Friday, December 15, 2000. 

 

2.     The FDA regards after-hours submissions made to the FDA under 35 U.S.C. §156 as having been filed on the next business day.

 

3.     In contrast, the PTO and the FDA regard the after-hours fax to TMC, a communication from the FDA under 35 U.S.C. §156, as having been sent on December 15, i.e. on the day it was sent, rather than December 18, 2000, the next business day.

 

4.     The PTO and FDA should interpret like terms in 35 U.S.C. §156 consistently, and thus, consistent with FDA policy regarding incoming submissions, should regard the FDA’s approval letter as having been sent on December 18, 2000, i.e. the next business day.  If the date of the approval letter was December 18, 2000, then the PTE request, submitted on February 14, 2001, was timely filed.

 

TMC asserts some other points, e.g. in the context of a refusal of request for reconsideration in 2007, the USPTO announced for the first time a new policy of calculating the 60 day deadline as beginning on the date the FDA approval letter was mailed, and not beginning on the next day, as had been done until that point (with the effect being that the PTE request was filed two days late rather than a day late).  But the crux of its argument is that the inconsistency in interpretations of deadlines under the same statutory section is not required by the statute itself, and therefore constitutes arbitrary and capricious agency action.

 

Reading the SJ motion, it’s hard not to feel some sympathy for TMC: it picked up a drug product that other companies didn’t want and brought it to market, at a cost of several hundred million dollars, and then it (or its lawyers) goofed when calculating the deadline for filing the PTE request. 

 

And it does sound ridiculous that the FDA can use a double-standard when it comes to dating incoming submissions from pharma companies (must be received by the end of the business hours to be accorded a filing date of that day) versus outgoing correspondence (given the date on which it is sent, even if sent after-hours). 

 

It also sounds ridiculous that the USPTO has apparently changed its view mid-stream, and now for purposes of calculating the deadline for requesting a PTE says the 60 day window starts on the day the FDA mailed its approval, whereas filing deadlines for claiming priority from patent applications or for filing responses to Office Actions begin the day after filing (e.g. if you file a provisional on January 1, you have until the following January 1, not December 31, to file a non-provisional claiming priority therefrom; a response to an action mailed on February 1 with a three month deadline must be filed by May 1 to avoid incurring extension fees). 

 

None of that, however, changes the fact that TMC (or its lawyers) goofed.  Reading between the lines (I have not checked PACER to see if any of the documents referred to in the SJ motion are available, let alone read them), it seems that TMC only decided to rely on the distinction in the FDA’s practice regarding the dating of incoming versus outgoing correspondence after the mix-up occurred.  True, if TMC had reasoned a priori that the effective date for the FDA’s approval letter was December 18, and that its filing deadline should be calculated as 60 days beginning December 18 inclusive, then it would have determined that the deadline was February 16, a Sunday, and might have pushed its filing up to Friday, February 14.  But TMC doesn’t actually allege that it calculated the date in accordance with the December 18 date; TMC only asserts that now, December 18 is the date that should be used to calculate the PTE filing deadline.  More importantly, when you’re dealing with what is likely to be a big seller for you, you err on the side of caution in calculating the date; and normally, you assume the date something was mailed or faxed is the date stamped on it.  In which case TMC should have calculated the deadline correctly.  So it seems unlikely that TMC itself bought into this “next business day” calculation at the time it filed the PTE request.

 

My own suspicion is that TMC either calculated the deadline as two months, rather than 60 days, beginning on December 15, thus making the deadline February 14; or it calculated the deadline as two months beginning from December 16, making the deadline February 15, 2001, a Saturday, and pushed the filing up to the last business day before the deadline.  It’s not necessarily unreasonable to confuse a 2-month deadline with a 60-day deadline, but the statute does say 60 days, not two months.  And whereas the statute provides the Director with discretion to extend certain deadlines, the deadline for filing a PTE isn’t one of them.

 

TMC’s implied assertion, viz. that it’s unfair to penalize TMC for missing the filing by a single day, also rings hollow.  The law is full of examples where a single day makes all the difference.  If you were born 18 years before election day, you get to vote; but if your 18th birthday falls the day after election day, you don’t get to vote.

 

Nor does TMC make a compelling argument for why the inconsistency in FDA policy regarding dating, if it needs to be resolved, should be resolved as TMC proposes it, viz. that after-hours communications from the FDA should be accorded a date of the next business day.  Why shouldn’t the matter be resolved in the other direction, so that the filing date of a paper would be the day on which it is submitted?  On its face, that seems a more logical approach. 

 

Anyway, whatever sympathy one might have toward TMC’s predicament tends to dissipate in view of the fact that the suit was filed so close to the date of patent expiration, when, evidently, the suit could have been filed almost three years earlier.  According to the SJ motion, TMC filed a request for reconsideration that was rejected by the USPTO in April 2007; in December 2009 it filed a second request for consideration, which was rejected in January 2010, and only then did TMC file suit under the Administrative Procedures Act.  But already in 2007, TMC argued that the FDA’s and PTO’s calculation of the deadline was improper, and should have started from December 18, 2000.  So if TMC had these arguments in hand in 2007, why did it wait over two-and-half years to again request reconsideration and then to sue the PTO, the FDA and HHS? 

 

I don’t know enough about APA proceedings to know if TMC could have sued right away in 2007, or if laches (an equitable argument) could apply in the present case (a case brought at law) due to the delay, but I hope that that’s part of the Federal Government’s response.  

 

The delay in the filing of the suit isn’t just whistling Dixie: there was reliance by third parties on the non-issuance of the PTE.  Teva/Barr/Pliva filed an ANDA with a paragraph III certification regarding the patent in question (i.e. that it won’t sell its product until after the expiration of the patent), not a paragraph IV certification.  Grant of a PTE here will force Teva to revise its ANDA to include a P-IV certification against this patent; or to wait close to another five years to introduce its product, until the extension expires; or to launch its product at risk.  But since the ‘404 patent was listed in the Orange Book at the time the ANDA was originally filed, if the PTE is granted and Teva files a P-IV certification, TMC would be entitled to a 30-month stay when it sues Teva for infringement of the ‘404 patent (unlike the already pending suits on the newly listed patents).  Which presumably is why TMC waited to file suit against the government.

 

Finally, an interesting question to ponder is, what happens if the court doesn’t rule before the patent expires?  Or if it rules against TMC but TMC appeals?  35 U.S.C. §156(e)(2) says,

(2) If the term of a patent for which an application has been submitted under subsection (d)(1) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Director shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension.

 

§156(e)(2) empowers the Director to issue a temporary extension under because the PTO hasn’t yet completed its determination of the eligibility of the patent for the extension.  But that’s not the case here.  Here, the PTO’s position is that, for purposes of §156(d)(1) and (e)(2), TMC didn’t submit an application, because the so-called application was submitted after the deadline and therefore, for purposes of the statute, was not submitted.  There is no provision for the Director to issue an interim extension because there is a dispute over whether or not the PTE application was timely filed.  (§156(d)(5)(B) provides for interim extensions when FDA review is still ongoing.)  But if no interim extension is granted, and on appeal TMC wins, what then?  And if the court preliminarily orders the Director to grant an interim extension, only to eventually rule against TMC, will TMC have to compensate Teva, and the consumers who paid higher prices than they should have while the temporary extension was in place?

 

Against the foregoing discussion, the last line of its SJ motion is almost comical.  It reads, “The Court should also order the PTO to take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings”.  Well, sure.  Wait until the last minute to file suit and then ask that the court ensure your rights aren’t harmed as a result of that late filing – in so doing possible unnecessarily prejudicing third parties and the public.  It’s not quite the classic case of the man who kills his parents, then pleads for mercy before the court because he’s an orphan, but it’s not so far off either.

So by waiting to file its suit, TMC has created a cloud over the status of the ‘404 patent.  TMC is the only beneficiary of the existence of that cloud.  While it’s not as good a position to be in as having the PTE in hand, it’s not a bad position for a company that missed its filing deadline.

Prosecution Laches and Inequitable Conduct: Cancer Research Technology et al. v Barr Laboratories et al.

Cancer Research Technology et al. v Barr Laboratories et al., D-Del, Civ. No. 07-457-SLR, January 26, 2010, Judge Sue L. Robinson.  Download CRT v Barr

 

A fellow patent attorney (who wishes to remain anonymous) called my attention to a recent decision issued by Judge Sue L. Robinson of the Delaware District Court.  I’m not a district court decision junkie: since most patent cases revolve, at least in part, around claim construction, and since under Cybor the Federal Circuit reviews claim construction de novo, I tend to ignore many district court decisions – why bother getting into a claim construction-based case before the Federal Circuit has had its say on claim construction?  This case, however, Cancer Research Technology, et al. v Barr Laboraties et al. (really Schering v Barr) dealt with the question of prosecution history laches and inequitable conduct.  The i.c. part is primarily of interest to people practicing in the pharma and biotech fields, where patent applications are usually filed before extensive laboratory and clinical testing of compounds has been carried out.  The laches part is of greater general interest, although less so under the 20-years-from-filing regime.

 

At issue was US 5,260,291, directed to tetrazine derivatives and their use in treating various cancers.  The patent covers the compound temozolomide, which Schering markets under the name Temodar^® for the treatment of two types of brain cancers, glioblastoma multiforme and refractory anaplastic astrocytoma.  As explained in the ruling, the story started in the early 1980’s, when some researchers at Alston University in England developed some tetrazine derivatives and, in conjunction with UK pharmaceutical company May & Baker, began testing these for use against various cancers.  A priority application was filed in England in 1981; a US application, 06/410656, claiming priority to the UK application was filed in 1982. 

 

A first OA was mailed November 18, 1983, in which the Examiner rejected the application for lack of utility, asserting (on the basis of an MPEP section that has long since been supplanted) that it was necessary for the application to include data showing efficacy of the compounds in humans, but that the application lacked such data.  Rather than file a substantive response, the applicants filed a continuation on March 6, 1984 and let the parent case go abandoned.  In October 1984 the same examiner made the same rejection against the continuation application, and again, the applicants didn’t respond, but instead filed another continuation and let the parent case go abandoned. 

 

Although at various points in time the representatives before the USPTO changed, this pattern of rejection-for-lack-of-utility followed by non-response-file-a-continuation repeated itself.  Again. 

 

And again. 

 

And again. 

 

And again. 

 

All in all, over the course of ten years, the applicant filed ten continuations before it filed a substantive response to the lack-of-utility rejection, in February 1993.  And what was the substance of that substantive response?  That according to a 1986 BPAI decision, Ex Parte Krepelka, the applicants didn’t need to provide data showing efficacy in humans, and the animal test data already present in the application was sufficient.  In response, the examiner mailed a Notice of Allowability, and pointed to a 1987 journal article by one of the inventors that showed that some of the compounds were active against tumors in mice as further evidence of utility. 

 

The ‘291 patent issued in November 1993, 11 years after the first application in the chain had originally been filed, entitled to 17 years of term from grant.  It then lay dormant until 2007, when Barr filed an ANDA and CRT/Schering sued. 

 

At trial Barr stipulated to infringement of the asserted claims, but argued that the patent should be unenforceable due to prosecution history laches, i.e. unreasonable delay in prosecution by the applicants.  Judge Robinson accepted this argument, in the process rejecting CRT’s assertion that it hadn’t substantively responded because the examiners required human trial data, which was unavailable.  Judge Robinson ruled that not only was there no explanation given for the delay, but that the response actually filed in 1993 was based on a 1986 BPAI decision which itself invoked a 1969 CCPA decision.  Thus much earlier in prosecution, the applicants could have presented plausible arguments asserting that human test data was unnecessary, and at least made a reasonable attempt to advance prosecution of the case.  From the evidence adduced at trial, the only reason apparent to Judge Robinson for the prolonged delay was to enable CRT to find a strategic partner with which to commercialize the invention.  That was not a good enough reason.  Thus, said the Judge, the patent is unenforceable for prosecution laches.

 

The groundbreaking part of the decision dealt with the question of intervening rights.  In previous cases of prosecution laches, the defendants had relied on the long delay in prosecution – at a time when US patent applications were kept secret until they actually issued – to develop a business; in the words of the case law, the defendants had “intervening rights”.  CRT/Schering argued that Barr (nor anyone else) had developed such intervening rights here, and therefore Barr was not entitled to the relief sought.  Judge Robinson disagreed: the seminal CAFC cases dealing with prosecution laches, the 2002 and 2005 Symbol Technologies v Lemelson cases, did not impose a requirement for intervening rights to exist in order for a patentee to be guilty of prosecution laches.  Put differently, laches is wholly dependent on the applicant, and has nothing to do with whether or not third parties are in fact adversely affected by the applicant’s delaying tactics.

 

If upheld on appeal, this aspect of the decision could have adverse effects for parties with patents that issued on pre-June 1995 applications and that are thus still in force.  In principle it could also affect patents filed after June 1995, although presumably the fact that it was known to the applicants that those patents would be subject to a 20-years-from-earliest-filing term induced them to avoid delaying the grant of their patents.

 

With regard to inequitable conduct, the decision doesn’t break new ground, but it does serve as a reminder to practitioners in the life sciences to be in touch with the inventors through prosecution and continually remind them of their duty to disclose relevant information – and not necessarily just prior art.  The issue here was that the application specifically identified and claimed about a dozen compounds as being “particularly active” against lymphomas and leukemia, and described those compounds as being “important individual compounds” of the disclosed genus, and even describing three of them as being “of particular importance”. 

 

The rub was that research by at least one of the inventors in the late 1980’s, while the application was still being kept alive at the USPTO, showed that, in fact, some of those compounds weren’t active.  Such inactivity per se wouldn’t have been fatal, had the applicants then scaled back the scope of the claims to cover only the active compounds.  But they didn’t: they pressed on with the broad claims and claims on the now-known-to-be-inactive compounds.  Which meant that the data showing inactivity was highly material to patentability: when an examiner says your claims lack utility, and you have data that shows he’s right, that data is going to be of interest to him. 

 

Turning to the second prong of the i.c. inquiry, intent to deceive the USPTO, Judge Robinson inferred this on the part of the inventor on the basis of the fact that during prosecution of the patent he had published more than 40 papers on tetrazine derivatives, including papers showing the inactivity of some of the compounds, yet didn’t see fit to provide this information directly the USPTO.  She also noted that one of the attorneys involved in prosecuting the case testified that he would have explained to the inventors their duty to disclose, and that in any event the inventor had signed a declaration stating that he was aware of the disclosure requirement. 

 

Having found both high materiality and intent, the finding of i.e. was inevitable.  Whether or not this part of the decision will hold up on appeal will hinge in no small part on the CAFC judges assigned to the case.  Reading the district court decision, it’s not clear that the inventor intended to deceive the USPTO.  There were several changes of attorneys during the long prosecution of the ‘291 patent, both in the U.S. and in England, and it seems likely that the inventor may not have know that patent prosecution was ongoing and even if he did, that he didn’t realize he had a duty to disclose the negative test results to the USPTO. 

 

Irrespective of how the CAFC holds on the inequitable conduct question, it’s clear that practitioners need to stay in contact with the inventors during prosecution, advising them that if newly-gathered data impacts the patentability of the pending claims (e.g. shows that the claimed invention lacks utility, at least across its full breadth), that information may need to be reported to the USPTO.  Then again, more often than not, negative data developed along the way leads to an abandonment of the application or diminution of the scope of the claims, so not it’s not clear that facts analogous to those of the present case will repeat themselves anytime soon.

Proposed Statutory Amendment: Early Publication of Israel Patent Applications

Although in the past I’ve suggested that Israel move to an early publication system, I’m neither the first nor the only person to make this suggestion.  It seems that the great minds at the Justice Ministry (which would better be called the Law Ministry, but that’s for a different post) have been thinking about this for a few years as well, and have now circulated proposed amendments to the statute to deal with the matter; the proposed amendments (in Hebrew) can be downloaded here.  (Most legislation in Israel emanates from the bureaucrats at the Justice Ministry, and while at some point formal publication of proposed legislation occurs, earlier drafts are often circulated before such publication – sort of like pre-prints of scientific papers.) 

 

In addition to establishing publication 18 months from the earliest priority date for all currently pending and future filed patent applications, the proposed amendments would:

-   allow patentees to retroactively recover reasonable royalty damages back to the publication date;

-   result in a single, combined filing-examination-publication fee, instead of separate fees at different stages of the examination;

-     eliminate the possibility of a separate claim for unjust enrichment;

-   preclude certain types of amendments to the application, and

-   force applicants to file an abstract identifying the “essence of the invention” as part of the application. 

 

As will be explained below, I think that certain aspects of the proposed legislation constitute a good start, but on the whole the proposal is in need of more than a little tweaking.  I also think that in some respects it doesn’t go far enough, and without some significant additions will result in a patent system that is biased toward infringers.

 

The MOJ has request comments on the proposed amendments by January 31, 2010.  Comments may be sent by email, in Hebrew or English, to howardpoliner@justice.gov.il or shirleya@justice.gov.il; please refer to proposal no. 803-10-2009-000813 in your email.

 

 

18-Month Publication; Reasonable Royalty Damages for Infringement Prior to Grant

The most dramatic effect of the draft legislation would be the publication of all patent applications filed in Israel 18 months from the earliest priority date or, in the case of PCT national phase applications, within 3 months from national phase entry, at which point the application files would be open to the public.  In exchange for this early publication, upon grant of the patent patentees would be able to sue, retroactively, for infringement of the patent during the period between publication and grant; the remedy for such infringement would be limited to reasonable royalties. 

 

The ability to retroactively obtain damages for infringement during the period of application pendency wouldn’t be complete departure from the current law.  Currently, applications are kept secret until notice of their acceptance has been published.  This is followed by an opposition period; the patent isn’t granted until the opposition period passes without incident or, if an opposition has been filed, when the opposition is rejected.  Applicants have no standing to bring suit for infringement prior to grant, and thus are powerless to collect damages, let alone stop infringement, that occurs during examination.  However, once the patent is granted, patentees can sue retroactively for damages to the date of publication, to the extent that the claims ultimately granted were published prior to the opposition period.   

 

Thus under the proposed amendment, the major changes from the current system would be (a) earlier publication of the application, giving the (eventual) patentee a longer retroactive window in which to collect damages for infringement, but (b) limitation of damages for such pre-grant infringement to a reasonable royalty.   As is currently the case, suit could only be brought once the patent is granted, but thereafter patentees would still be able to obtain prospective enforcement of the patent in the form of injunctions, and would still be able to obtain full damages for infringement that occurred after grant. 

 

 

Reasonable Royalty As Only Remedy = Compulsory License

The reasonable royalty provision of the draft legislation strikes me as a thinly-veiled form of a compulsory license.  If I’m a generic drug manufacturer, it’s worth my while to infringe still-pending claims, even if I think they’re likely to eventually be granted – there’s a significant difference between what I can make selling to the four major Sickness Funds (the Israeli equivalent of HMO’s; by law everyone pays a health tax and must belong to one of the Sickness Funds) and what I would be forced to pay under a reasonable royalty scheme.  Under such circumstances, if I’m a drug innovator, the way for me to ensure that my drug not be sold without my permission would be to delay the grant of marketing approval of the drug until after grant of the patent (because approval of the generic version is contingent upon grant of marketing approval to the innovator).  But as a consumer, I’d prefer that new medicines enter the Israeli market sooner rather than later.  Thus the draft legislation would seem to work at cross-purposes with good public policy.

 

Then again, in the pharma sector at least, this may be a red herring.  It may be that in general, the first patents covering a new drug product have already issued by the time the drug is approved for use, and that it’s more likely that follow-on applications covering formulations, new uses and the like would be the ones affected by a possible reasonable royalties scheme that operates prior to grant.  If that’s so – and I don’t have statistics to confirm whether or not this is the case – then if an earlier patent was still in force, the possibility of an injunction or full damages for infringement of that patent would give copyists proper pause to consider whether or not to infringe (or to work around the earlier patent; as it is, Israel law gives third parties the right to infringe provided such infringement is done for the sake of “improving” the patented invention or “developing a new invention”, and is not done on a commercial scale).

 

It should be noted that on its face, the reasonable royalty provision is substantively the same as the situation in the USA, as set forth in 35 U.S.C. §154(d).  However, with respect to the pharma sector, one can’t draw a clean comparison between the situation in Israel and that in the USA: 

(a)     Pharma patents tend to issue more quickly in the USA than in Israel. 

(b)     The USA has the Waxman-Hatch scheme, which compels innovators to list certain patents in the Orange Book and compels generic manufacturers to give notice when they’re going to challenge a listed patent, giving innovators an opportunity to sue and obtain an injunction or, in many cases, an automatic 30-month stay of FDA review of the generic company’s NDA.  Thus as long as the innovator has at least one Orange-Book listed patent, which is invariably the case early in a product’s lifetime, there is no way for a generic manufacturer to sneak a product through the FDA without the innovator’s knowledge.  In contrast, Israel has no comparable scheme.  

(c)     The USA does not have pre-grant patent oppositions (see discussion below).

Taken together, these factors mean there is a higher likelihood that a new drug product may be approved in Israel before patent protection has been obtained than there is in the USA.  As mentioned above, I don’t know if there are statistics that attest to whether or not most new drugs approved in Israel have some form of patent protection at the time of their approval.  What is clear is that the fact that the reasonable royalty remedy is good enough for the USA does not necessarily mean it is good enough for Israel.

 

In the high-tech arena, I suspect the difficulty would run in the opposite direction: under the proposed reasonable royalty scheme, individuals or small businesses having patentable but easily copied ideas would be at the mercy of bigger, established players.  If the goal of the smaller fry is to license the technology, then without the prospect of full retroactive damages, they will have lost some leverage in their ability to negotiate a good royalty rate.  Also, there is no guarantee that the “reasonable royalty” set by the court would be what the parties would actually have negotiated with the threat of full damages hanging overhead.  If the goal of the small patentees is to make and sell a product, or to sell the technology, their likely recourse would be to forego patent protection altogether, since the statute would now give the big players a compulsory license.  (Open question: if a big player steps in and sells infringing goods in Israel while the application is pending, then is forced to pay a reasonable royalty after the patent issues, are the downstream consumers who bought the infringing goods now immune from suit?  See discussion below re: unjust enrichment.)

 

Foregoing patent protection, however, would only work if the small companies’ products couldn’t be reversed-engineered – assuming small companies actually got as far as manufacturing something.  And without the prospect of patent protection, their leverage in negotiations with more powerful players to whom they might wish to sell the technology would tend toward zero.

 

It’s for the latter reason that I think it might be worthwhile to take a page from the U.S. playbook, and to allow applicants to retain the option of keeping their applications secret, if they haven’t filed corresponding applications (or more broadly, haven’t filed applications directed to substantially the same invention) in other 18-month publication jurisdictions. 

 

Alternatively, imposing the prospect of full damages that would be retroactive to the date of publication, assuming one of the infringed claims was in the published application, would give competitors more reason to carefully consider whether or not to infringe.  Ostensibly, the difficulty with such a scheme is that competitors would be left in legal limbo – which claims, if any, will issue?  In practice, however, this is already what goes on in other countries, evidently without detrimental effect.  In any event, sophisticated copyists are able to make reasonable assessments as to what is and is not patentable in a pending, published application. 

 

A twist on this last idea would be to allow infringers to file a notice with the ILPTO that they are infringing while the application is still being examined, including a detailed explanation of how they are infringing the patent.  This would be coupled with a bank guarantee or other surety to cover the expected reasonable royalties.  Such a notice would preclude the eventual patentee from retroactively collecting full damages after grant of the patent; but the admission by the infringer would preclude the infringer from asserting non-infringement after grant of the patent with respect to the product or process specified in the notice.

 

 

Early Publication of Already-Filed Applications

The proposed amendments would apply retroactively to all still-pending applications, with the goal being publication of all pending-but-as-yet-unpublished within two months of the amendments’ coming into force.  That’s not fair to those applicants who filed in Israel knowing that it does not publish applications early, and who relied on that fact in deciding to file in Israel.  Yes, disclosure is the quid quo pro for the exclusivity conferred by a patent, but the timing of that disclosure is also part of the bargain; publishing already-filed applications against the wishes of the applicants amounts to changing the rules in the middle of the game.  (Publishing such applications now may also create a headache for applicants who filed in Israel and in the USA with a non-publication request, knowing that Israel is a not an 18-month publication country.) 

 

A more prudent approach would be an opt-in for applications filed before the amendments come into force: those applicants with pending applications who want their applications to publish early could request such early publication, otherwise already-filed applications would not publish early.

 

 

Precluding Claims for Unjust Enrichment

Unlike most countries, Israel has a separate statute that enables plaintiffs to recover from third parties who were unjustly enriched at plaintiffs’ expense.  In principle, with respect to intellectual property, the various IP statutes themselves set the types of protections and remedies available for different types of IP, and recourse to a general unjust enrichment statute should not be available.  However, during the 1990’s a trend took hold in Israeli jurisprudence whereby courts applied the general unjust enrichment statute in situations in which parties had chosen not to avail themselves of IP protection, in which such protection was actually precluded by statute (e.g. for unpatentable inventions that were already known), or in which such protection had been obtained (e.g. in the form of a patent) but had since expired. 

 

The potential for a remedy for patent infringement apart from the patent statute has created uncertainty when it comes to assessing one’s rights to exploit another’s invention, and led in one instance to Merck suing for unjust enrichment for infringement that occurred while its patent application was being opposed.  The Merck case was in fact part of the impetus for the presently proposed amendments. 

 

Thus, hand-in-hand with providing applicants with some sort of protection during the period patent pendency, the proposed amendments would bar remedies under any other statutes for the exploitation of inventions (a) which are patentable but which are not protected by a patent in Israel, (b) for which a patent had been granted but had since lapsed or expired, or (c) which are not patentable.  The preclusion would not apply to violations of fiduciary duties arising from other statutes.

 

This proposed change is a welcome one.  It’s pity that the judiciary, which created this particular monster, did not see the error of its ways and see fit to bury its own creation without the need for a legislative fix.

 

Regarding the “open question” from above (viz. if a big player steps in and sells infringing goods in Israel while the application is pending, then is forced to pay a reasonable royalty after the patent issues, are the downstream consumers who bought the infringing goods now immune from suit?), this proposed amendment would evidently bar such recovery.

 

 

Let’s Use This Opportunity to Do Away With Pre-Grant Oppositions

It’s laudable that the proposed amendments would still only vest patentees with the power to bring suit once the patent has issued.  But the proposed amendments don’t go far enough in that they still maintain Israel’s outdated and flawed pre-grant opposition system.  Under this system, any third party can oppose the grant of the patent (without the need to identify the real party in interest).  Under current rules, the mere filing of an opposition will guarantee delay of the grant of the patent by at least two years, unless the opponent withdraws the opposition, and no patent term adjustment is available for this lost time should the applicant prevail and the patent be granted.  Furthermore, the fee for filing an opposition is relatively small, as are the costs imposed by the Commissioner on losing opponents.  Not surprisingly, as a result there are several local companies that serially oppose their competitors’ patent applications. 

 

Notwithstanding the ease of initiating opposition proceedings, in general opponents avoid infringing during those proceedings, as they currently face the prospect of full damages for infringement occurring during the proceedings should the application be upheld and the patent granted.  Removing the prospect of full damages, and replacing it with the proposed compulsory licensing scheme, would not only increase the likelihood of infringement during opposition proceedings, it would actually encourage both the filing of additional oppositions, and the protraction of those opposition proceedings: the longer an opponent can delay the grant of the patent, the longer it can benefit from the low-cost compulsory license at reasonable royalty rates.   

 

One option to avoid this problem, and the one that appears to me to make the most sense, would be to scrap oppositions altogether, and have patents issue upon publication of notice of their allowance.  Israel adopted pre-grant oppositions from the 1949 British Patents Act, but the British abandoned the practice when they revised their statute in 1977, and it’s about time Israel did the same.  (An exception could be made, perhaps, in cases of applications that weren’t published until their allowance, should the ability to maintain an application in secret be preserved under certain conditions.) 

 

Although under my proposal, opposition proceedings would be abolished, cancellation proceedings before the Commissioner would still be available to parties who think a patent has been erroneously granted.  Moreover, given the fact that applications would now be published early, interested parties would have plenty of time to track the progress of applications and decide if cancellation proceedings are warranted.  Furthermore, unlike the post-grant opposition under EPO practice, which must be filed within nine months of grant, cancellation proceedings in Israel can be instituted at any time.

 

(I note that there is some case law from the ILPTO itself suggesting that the burden of proof is somehow different, or even rests on different shoulders, during opposition versus cancellation proceedings, but this notion is specious: in either case, the party opposing the application/patent must put forward a prima facie showing of unpatentability, and once such a showing is made, the applicant/patentee must rebut it.  As there is no statutory presumption of validity under Israel law, and the only presumption of validity is the usual presumption of validity accorded to administrative action, there really is no difference between opposition and cancellation proceedings in this regard.)

 

Should the powers-that-be prove too wimpy to follow the lead of the British, at the very least they could amend the procedural rules for oppositions to make them more streamlined.  Currently, an opponent has three months from the publication of the allowance of the application to file a Notice of Opposition, then another month thereafter to file its Statement of Arguments, and yet more time later to file written evidence; it is in no small part the time periods set forth in these rules that result in the long delay in patent grant effected by opposition proceedings.  Under a system in which the substance of an application is only made public at the end of examination, there is some sense to such a time frame. But in the situation where the application file is open to the public for most of the application’s pendency, as is now proposed, there is no reason why all these steps can’t be combined, e.g. by requiring opponents to file an opposition, including arguments and written evidence, within a few months of the grant of the patent.  In fact, this is just the system in place currently for cancellation actions: the party moving to cancel a patent must file its arguments and written evidence at the time it requests cancellation of the patent.

 

 

Single Fee: Bad Idea

Another feature of the proposed amendments is the introduction of a single fee for patent applications that would cover filing, examination and publication.  This seems to be unwarranted.  Not all applications will be examined, and those that are examined will not necessarily be allowed; why should applicants pay for steps that their applications may never undergo?  The combining of the application and initial publication fee makes some sense, and in practice is what happens today; the only difference under the proposed regimen is that the initial publication would include additional details.  But the separation of application and examination fees, which does not presently occur, also makes sense, as this would allow applicants to decide if they really want to pursue examination.  (Of course, it would deprive the ILPTO of revenue, which is why my proposal is unlikely to be adopted.) 

 

 

Limiting the Ability to Correct Applications?  Limiting the ILPTO’s Ability to Request Marking of Applications?

An interesting feature of Israel patent practice follows from §§ 22 and 23 of the statute, which read as follows (my translation):

 

22.    Any time before the acceptance of the application, the applicant may amend the specification of his application, whether in response to a notice per section 20 [i.e. an office action – DJF] or of his own volition.

 

23.    If amendments of a substantive nature were entered in the application, the Commissioner may conclude that for purposes of sections 4, 5 and 9 [which deal respectively with novelty, inventive step and right of first filer - DJF] (1) if it is possible to distinguish between the amendments and the existing specification, that the date of the amendments is the date on which they were submitted to the ILPTO; (2) if it is not possible to distinguish between the amendments and the existing specification, that the date of the entire application is the date on which the amendments were submitted to the ILPTO.

 

Together, these sections give applicants the right to introduce new matter into their applications by way of amendment after the application has been filed.  To the extent the new matter is distinguishable from the originally filed application, the new matter alone receives the date on which it was filed (and consequently may not be entitled to priority); to the extent the new matter is indistinguishable from the rest of the application, the entire application is accorded the later filing date. 

 

As a result of §23, ILPTO examiners often ask applicants to label portions of their applications with the later filing date.  In practice, such requests are usually made not in situations in which new matter was added after the filing date, but rather in national phase applications where new matter was added at the time the PCT application was filed, and is thus not entitled to the claimed priority date.  Although imposing something of an administrative burden on applicants, the practice is quite useful for third parties parsing the patent, as it readily lets them know what material is entitled to what date.  (Compare this to the situation in the USA where significant effort can go into determining what part of a CIP at the end of a long chain of CIPs is entitled to what filing date.)

 

The proposed amendments would do away with §23.  This in itself seems unremarkable.  As the explanation of the proposed amendment notes, if an applicant wishes to introduce new matter, he is free to file a new application (which will be accorded the later filing date).

 

 

Limiting Applicants’ Ability to Amend or Add Claims?

Presently, an applicant may amend a pending application for any reason, and may amend inter alia by expanding the scope of the claims and by adding claims.  Under the proposed amendment, §22 of the statute would be amended to read,

 

22.    Any time before the acceptance of the application, the applicant may amend the specification of his application, whether in response to a notice per section 20 or of his own volition, for the sake of clarification, removal of a mistake that fell in the specification or for the sake of reducing [the number of] its claims.

 

Several interesting points arise from this proposed amendment.  The first is, just what would be considered “clarification” or “removal of a mistake”.  In particular, would expansion of a previously filed claim to include disclosed but previously unclaimed subject matter be considered “clarification” or “removal of a mistake”?  Or would applicants be stuck with the breadth of the claims they initially filed? 

 

While the proposed additional wording is identical to wording that already appears in §65, which governs the amendment of the specification of an issued patent, recourse to §65 is not helpful in construing proposed amended §22, because §66 states that when amending a granted patent, the scope of the claims may not be expanded.  Thus hitherto, there hasn’t been need to determine if “clarification” or “removal of a mistake” includes expansion of the scope of a previously filed claim, because such expansion was precluded by virtue of §66.  Of course, the argument can be made that if §66 is necessary to tell us that expansion of the scope of the claims in a granted patent is verboten, then such expansion of scope not forbidden under §65.  Nevertheless, the point hasn’t been decided before, and the possibility exists that the Commissioner or the courts could take a restrictive view regarding permissible claim amendments under the proposed amended §22.

 

Another point is that applicants would be statutorily barred from adding claims to their applications.  But barring applicants from expanding the scope of their claims or adding claims, is both shortsighted and impractical.  Anyone with any prosecution experience knows the addition or expansion of claims during prosecution happens all the time, for example to cover disclosed embodiments that weren’t previously specifically claimed, or in order to add dependent claims that cover species previously only covered by a genus claim.  In order to avoid such a draconian limitation on their freedom of action, applicants with the money to so will simply front-load their applications with many claims in order to preserve for themselves the right to in essence file new claims later by “amending” earlier-filed claims.  For such applicants, such front-loading will merely entail a waste of resources.  Applicants with more limited resources will be forced to make choices early in prosecution about which embodiments to protect, in the process possibly foregoing protection for commercially important embodiments. 

 

The question would also arise if under the proposed amendment, national phase applications could be amended at the time of national phase entry to include more claims than were filed in the PCT application.  Indeed, since the effective filing date for national phase applications is the PCT filing date, it would seem the proposed amendment could be construed as prohibiting PCT applicants from amending their claims under PCT Articles 19 or 34 so as to include more claims than originally filed – in contravention of Israel’s obligations under the PCT.

 

So the proposed change to §22 impractical and unwise.  But mostly, it is unwarranted.  §§ 12 and 13 of the statute already provide that the specification must contain an enabling disclosure of the invention, and that the claims must reasonably arise from the description.  Inasmuch as under the proposed amendment package, patent prosecution will now be transparent, there is no reason to force applicants to front-load their applications with every conceivable claim they might want later on.  Applicants should be able to claim anything for which there is support in the specification; interested third parties will be able to follow the progress of the application and assess their infringement and (in)validity positions vis-à-vis those claims long before the claims are granted.

 

 

Third party observations and estoppel provisions?

Since under the proposed amendments third parties will be able to follow the progress of patent applications, the question arises if third parties should be able to comment on those applications while they are still being examined.  U.S. law makes it virtually impossible for third parties to participate in the examination process once an application has been published; in contrast, the EPC allows for anonymous third party comments on pending applications. 

 

Presently there is nothing in the Israel patent statute that explicitly permits or prohibits the participation of third parties, so a third party could assert that in the absence of a prohibition, it is allowed to file observations.  However, since applications are not presently open to the public, practically speaking third parties can’t participate in the ex parte examination process. 

 

This practical consideration will change once it becomes possible to follow the progress of applications through the ILPTO.  When that happens, I can conceive of situations in which I would advise clients to anonymously file observations with the ILPTO, even in the absence of statutory provisions governing the filing of such observations.  Given the ILPTO’s hyper-sensitivity to “the purity of the patents register”, it’s entirely possible that the ILPTO would pay attention to such arguments.  If the ILPTO ignored those arguments, the client could have alternative arguments waiting in the wings for use in inter partes opposition or cancellation proceedings; and because the first set of arguments would have been filed anonymously, no form of estoppel would attach to the client’s ability to present the second set of arguments during the inter partes proceedings.

 

Which is why it would be good to include provisions in the statute that explicitly govern the participation of third parties in the examination process, and that would create estoppel so as to prevent third parties from having more than one bite at the apple.  There are essentially six grounds on which a third party can challenge a patent or pending application: lack of novelty; lack of inventive step; insufficient disclosure; claims which are unclear or do not reasonable arise from the specification; failure of the applicant to comply with its duty of disclosure; and lack of applicant’s standing to apply for the patent (i.e. it was someone else, not the applicant, who was entitled to apply for the patent.)  If a third party wants to challenge a pending application on any of those grounds, it should be allowed to do so, but it should then be estopped from later challenging the application or issued patent on a ground earlier raised (provided that the applicant did not amend its claims in response in order to moot the objection).  So during prosecution if a third party wants to assert that a pending claim lacks novelty or inventive step, and the ILPTO determines that the claim is novel and inventive, that third party should be statutorily estopped from raising a lack of novelty of lack of inventive step challenge later, even on the basis of different prior art.

 

 

Requirement to Include an Abstract – “Essence of the Invention”

Presently applicants are not required by statute or regulation to provide an abstract of the invention. Rather, at present §26(b)(5) says that when the Commissioner publishes notice of acceptance of the application, he shall include “A description of the essence of the invention, in the view of the Commissioner”.  As discussed here a few months ago, the Commissioner recently tried to shift to applicants the onus of providing an abstract; at the time, I posited that the Commissioner was not empowered to impose such a requirement.

 

The proposed amendments would enshrine the Commissioner’s requirement in the statute by adding §13(c), which would read,

 

13(c).    The applicant shall attach to the specification a brief description of the essence of the invention in his application. 

 

As explained in my earlier post, unwary applicants could find themselves sacrificing claim scope by complying with such a requirement, since the term “essence of the invention” is the same term used in §49 of the statute, which is the section that establishes that the patentee has the right to prevent others from exploiting an invention for which a patent has been granted, “whether in the manner defined in the claims or in a similar manner that includes, in view of what is defined in the claims, the essence of the invention that is the subject of the patent”.  Thus, in cases where literal infringement cannot be shown, the patentee needs to demonstrate infringement of “the essence of the invention”.  Applicants would therefore be remiss to put statements into the record that could be used to restrict the scope of this “essence of the invention”.  Unfortunately, proposed §13(c) would force applicants to do just this.  As with the restrictions on the number and amendments of claims, such a requirement would thus unfairly force applicants ab initio to potentially limit the scope of the protection to which they are entitled.

 

The addition of §13(c) need not undermine §49.  For example, at the same time §13(c) is added, §27 could be amended to read as follows:

 

The description of the essence of the invention as published under §16A(a)(5) or §26(b)(5) shall not be used by a court or the Commissioner as evidentiary material when they come to interpret the specification or in any other way establish the scope of the protection conferred by the patent in any legal proceeding.

 

Alternatively, the words “essence of the invention” could simply be removed from proposed §13(c), so that it would instead read, for example, The applicant shall attach to the specification a brief description of the invention disclosed in his application.

 

Let’s Confuse Everyone - Update On Excess Claims Fees for Israel Patent Applications: New Regulations Published; Unclear if Excess Claims May be Cancelled Prior to Examination to Avoid Fees, or if Excess Claims Fees are Due in National Phase Application

As noted in an earlier posting, on December 1, 2009, the Knesset’s Constitution, Statute and Law Committee approved the imposition of a fee of 500 shekels (approximately $130 at present exchange rates) for each claim in excess of 50.  Now, you’d think that even the Knesset and the Justice Ministry (which drafted the actual wording of the update) could get something as simple as this right, but noooooo – they had to word it in a way that sows confusion.  To wit:

 

Notice of the amended regulations was published in the official state publication journal (the equivalent of the Federal Register in the USA) on December 24, 2009; the new regulations will take effect 30 days from publication, viz. on January 23, 2010.  The amended regulations (namely the Second Schedule), in relevant part, read as follows:

 

Second Schedule

(A) 1. Upon submission of an application for patent per §11(a) of the statute, 1021 NIS

   1A.   Fee for submission of each claim in a patent application beginning with the 51st claim, 500 NIS * * *

 

This brings us to our first problem: while the revised regulations say that the fee for the first 50 claims for an application filed under §11(a) of the Patents Law is due upon filing of the application (a position necessitated by §15 of the statute, which says that an application will not be accorded a filing date until the filing fee has been paid), and that the fee for each claim in excess of 50 is 500 shekels, the amended regulations do not say when the fee for each excess claim is due.  If the excess claims fees are due upon filing, then applicants will need to carefully consider how many claims to file.  But if the payment of excess claims fees can be deferred until later, why not file a gazillion claims and then decide how to proceed once you’ve seen how things are progressing in the corresponding cases in Europe and the USA?

 

In a letter sent out on January 7, 2010, the Commissioner apparently tried to clarify this point: “The obligation to pay the fee [for excess claims] commences at the time of the filing of the patent application or at the time the specification is amended to include more than 50 claims.  Such an amendment is predicated upon payment of the appropriate fee.”  This implies that as soon as an application is filed with excess claims, the excess claims fees are due, even though the amended regulation does not state this. 

 

However, the Commissioner’s letter goes on to state that “failure to pay the fee for claims 51 and up will result in delay of examination of the application until the fee is paid”, implying that the excess claims fees themselves are not due upon filing, but only when the applicant actually wants examination to proceed.  Hence, writes the Commissioner, the language of the pre-examination letter that is sent to applicants shortly before substantive examination commences “will be updated…to remind the patent applicant community to pay the entirety of the fee due before the application comes up for examination.” 

 

Thus, the Commissioner’s latter statements imply that applicants who file applications with more than 50 claims but do not pay the excess claims fees at the time of filing, then cancel the excess claims prior to the commencement of substantive examination, will not be required to pay the excess claims fees, ever (unless they re-insert the excess claims later). 

 

Nothing like taking what should be a straightforward amendment and making it unnecessarily complicated.  Presumably this matter will be clarified in the near future; personally, it seems to me that if the excess claims are cancelled prior to examination, an applicant shouldn’t have to pay for them, as the ILPTO hasn’t had to expend any extra resources examining the extra claims.  (By the same token, if the excess claims were already allow by the USA or the EPO, and the applicant request allowance under §17(c), I don’t see why the applicant should have to pay excess claims fees, as the Israel examiner isn’t going to have to do any real work anyway.)

 

Now for the second bit of confusion: it is unclear if the new regulations apply to the national phase of PCT applications filed in Israel.  How’s that?  Well, amended part (A)1 of the Second Schedule, which refers to the filing fee for the first fifty claims, refers to applications filed under §11(a) of the statute.  But national phase applications are filed under §48(d), not §11(a).  Thus part (A)(1) clearly does not apply to national phase applications. 

 

Moreover, part (A)7 of the Second Schedule, which sets the fee for the filing of national phase applications filed under §48(d), was not amended accordingly to refer to the first fifty claims.  The failure to amend part (A)7 could thus be taken as indicating that excess claims fees are not to be imposed on national phase applications. 

 

On the other hand, new part (A)1A does not refer to a particular section of the statute, and simply sets a “Fee for submission of each claim in a patent application beginning with the 51st claim”.  Part (A)1A could thus be viewed as setting excess claims fees for national phase applications as well – although if that’s the case, why amend (A)1 at all?  And why number this statement (A)1A rather than place it elsewhere, where it will be clear it’s applicable to both regular and national phase applications? 

 

I have no doubt the ILPTO will adopt the view that excess claims fees are due for national phase applications.  Any national phase applicants who would like to test this by filing an application with 51 claims and then fight the ILPTO over the charge for the 51st claim are invited to contact me – I would be willing to fight the ILPTO on this point pro bono.

 

On the bright side, there’s one point that doesn’t seem to be confusing: it appears from the Commissioner’s letter that the ILPTO will allow applicants who originally paid for excess claims to cancel some of those excess claims and substitute them with others.  Thank goodness for small favors.

We don’t care. We don’t have to. We’re the USPTO.

I was born and grew up in the USA, and although I’ve lived in Israel for most of my adult life, I’ll always be an American.  Living abroad has, however, given me a different perspective on the USA, which, despite its great size and diversity of people and places, is sometimes astoundingly provincial in its outlook.

 

I was reminded of this recently when I heard a patent horror story from an Israeli patent agent I know, whom I’ll call “JB”.  A priority deadline for one of JB’s clients fell during the middle of Succot.  Succot is a week-long Jewish holiday, what I think is termed “Tabernacles” by King James’ translators.  (You can read about some Succot-related patents, using a variant English spelling of the word, here.)  Religiously observant Jews don’t work during Succot, and in deference to the sensibilities of the religiously-observant public – and a good a collective bargaining agreement obtained by the country’s only union – government offices are closed for the week. 

 

Since the ILPTO was closed on the one-year anniversary of the priority filing, JB looked up PCT Rule 80.5, which says, quite sensibly, that if the PCT Receiving Office is closed when some document (like the PCT application itself) is due, that paper can be filed on the next day that that Receiving Office is open.  So JB filed the PCT application at the Israel RO on the next day the ILPTO was open.

 

Fast-forward 18 months.  It’s national phase filing time for 30-month countries, an exciting time in any patent attorney’s life.  JB has his US associate file a national phase application at the USPTO.  The USPTO took JB’s client’s money (no surprise there), gave the application a national phase entry date and an effective filing date of the date the PCT application was filed (no surprise there either), and then informed JB that the application wouldn’t be accorded the priority claim because the PCT application was filed more than one year after the priority application had been filed (near-heart-attack-inducing surprise for JB; although neither he nor the U.S. associate noticed the problem until the inventor herself inspected the filing receipt and wondered what had happened to the priority claim).

 

If only JB had looked at MPEP 1893.03(c) before he filed the PCT application.  Had he done so, he would have seen where it’s written in black and white that notwithstanding PCT Rules, PCT applications that were filed more than 12 months after the priority application were filed will not be accorded the priority date, period.  In other words, if you’re a foreigner and your local PCT Receiving Office was closed on the one-year anniversary, tough. 

 

In fairness, I should mention that MPEP 1893.03(c) does provide one exception to this 12-month rule.  If the priority application was a U.S. application (provisional or non-) and the PCT Receiving Office is the USPTO, then if your one-year date falls on a day when the USPTO is closed, you get an extension until the next business day.  Nice to see some consideration extended toward U.S.-based applicants over foreign ones.

 

It’s not clear to me if the USPTO’s stance breaches the national treatment requirements of the various patent treaties.  In one sense it doesn’t: a foreign national who wants to file at the US Receiving Office would receive the same treatment as US national filing at the USRO, and would be entitled the same extension under the same conditions.  The fly in that ointment is that under the PCT, a foreign national can’t file at the USRO (unless he has dual citizenship, but that’s usually not the case).

 

That the good ol’ U.S. of A. should expect foreigners to conform their filing practices to U.S. policy upon entering national phase (e.g. having to pay extra for multiply dependent claims or for claims in excess of 20) isn’t surprising, and isn’t discriminatory.  Here, though, the USPTO expects foreigners to comport with U.S. law even in respect of their PCT filings.  But the point of the PCT and how it dovetails with the Paris convention is to ensure that, at least for purposes of getting PCT applications on file, applicants don’t need to worry about the details of the laws of other PCT member countries.  Once the Receiving Office has accorded the application a filing date and recognized a priority claim, that should be the end of the matter.  The USPTO’s stance completely undermines the rationale behind the PCT, and in essence forces PCT applicants to act as if they are filing national applications in 140+ countries at the end of the priority year, as if the PCT didn’t exist and the U.S.A. wasn’t a signatory to the PCT. 

 

The USPTO’s stance also leads to some interesting hypotheticals.  For example, Yom Kippur is the holiest day on the Jewish calendar, and falls in in September or October, sometimes on a Monday.  The USPTO is closed on Columbus Day, which falls on a Monday in October.  That means that from time to time, Yom Kippur and Columbus day coincide, in which case papers due at the USPTO and papers due at the ILPTO on that day get an automatic one-day extension to the next day.  What would happen, then, if someone’s priority deadline fell on such a Monday, and they filed a PCT on the next day claiming priority to a US provisional application – but they filed the PCT at the Israel RO rather than the USRO?  Would the USA now regard the PCT application as being entitled to the claimed priority?

 

I should mention that the USPTO claims that its view is based on the statute itself (see 35 U.S.C. §119(e)(1) and (3)) – sort of, “Don’t blame us, blame Congress.”  I’m sure that applicants from outside the USA will be consoled by the fact that it’s the legislature and not the USPTO itself that’s hosing them.  I can just picture the look relief on JB’s client’s face when JB told him, “Don’t worry, it’s not a mere civil servant who made life hard for you, it was Senator X himself!”

 

Some of you (assuming anyone’s reading this) may say, “But under 35 U.S.C. §102(b), the applicants don’t need to claim foreign priority – they get a one year grace period from prior art anyway.”  That’s true…if the difference between the PCT filing date and the convention deadline is only a few days, and the applicant didn’t publish the invention during the first few days after filing the priority application.  But even if that’s the case, if the priority application is a U.S. provisional application, then loss of the priority claim means loss of the §102(e) date afforded by that provisional.  That’s bad news if the application is later involved in an interference.  The applicant also loses a year off his §102(b) date.

 

This isn’t the first time US patent law has taken an unforgiving stance with respect to non-U.S.-based patent applicants.  In a 2007 decision, Boston Scientific SciMed v Medtronic Vascular, the CAFC said a patentee was not entitled to a priority claim where the priority application had been filed at the EPO in the name of the employer, without first obtaining an assignment from all of the employee inventors.  The CAFC reasoned that under U.S. law, the right to claim priority under §119 is a personal right, and therefore a U.S. application is only entitled to foreign priority if the foreign application was filed by the inventor “or on his behalf”.  In many countries, however, Israel included, by law employee inventions are owned by the employer absent an agreement to the contrary.  The CAFC’s SciMed decision did not address the question of whether the operation of such a legal rule would be sufficient to fulfill the “on his behalf” component of the statute.

 

Ironically, Israel has traditionally been accommodating toward U.S. provincialism in the realm of patent filing.  Sunday is a work day in Israel, and the ILPTO is open for business.  But several times a year, American lawyers assume that a deadline that falls on Sunday in Israel is pushed off to Monday, just like in the U.S.A., and inform their Israel associates of the filing deadline on Monday.  Usually, if the lawyer presents a good enough story explaining that the error was made in good faith, the ILPTO will recognize the filing as having been timely made.  Should the ILPTO rethink its position?  Perhaps it should, as it seems there’s a time-bomb out there for many Israeli applicants: the ILPTO is closed on Fridays, and as result, over the years many applicants have undoubtedly filed PCT applications on Sunday with a priority date that fell one year and two days earlier, thinking they would be entitled to their priority date.  (Such applicants would be advised to go back and check their USPTO filing receipts.)  It’s hard not to feel that if the USPTO is going to treat Israeli patent applicants roughly in this way, the ILPTO should return the favor, only with respect to U.S.-based applicants.

 

Back in the seventies, before the breakup of Ma Bell, Lily Tomlin created a character named Ernestine, an annoying telephone company employee, who Ms. Tomlin used to great effect to parody AT&T.  Ernestine’s most memorable line, perhaps, was “We don’t care.  We don’t have to.  We’re the phone company.”  When it comes to patents, “We don’t care.  We don’t have to.  We’re the U.S.A.” continues to be the message the United States sends to the rest of the world.  Which is a shame, at least with regard to priority dates for PCT applications.  At least in that context, it wouldn’t hurt for the United States to admit that other countries sometimes work on different schedules, and to grant priority claims where the PCT Receiving Office was closed on the day the priority year was up.

Excess Claims Fees for Israel Patent Applications

Hitherto, Israel has charged a single fee for patent applications, irrespective of application length or the number of claims.  Two weeks ago, the Commissioner sent out a letter informing the patent practitioner community that on December 1, 2009, the Knesset’s Constitution, Statute and Law Committee approved the imposition of a fee of 500 shekels (approximately $130 at present exchange rates) for each claim in excess of 50.  As of December 22, 2009, official notice of this change had not been published in the official state publication journal (the equivalent of the Federal Register in the USA), but such publication is expected soon; the new regulation is expected to take effect 30 days from publication. 

 

In the same vein, this week the ILPTO circulated an updated list of official fees that will take effect January 1, 2010.  Most fees have been revised upward by a few percentage points.  For example, the filing fee for a new patent application will rise about 2.5%, from 1162 shekels to 1191 shekels.  The new list makes no mention of excess claims fees (as it shouldn’t, since such fees will not take effect January 1), nor does it even mention that fees for excess claims will soon be imposed.

Presumably, (a) the new regulation governing excess claims fees will not have retroactive effect for applications having 51 or more claims that were filed prior to the regulation’s coming into force, and (b) applications which as of the publication date of the new regulation have fewer than 51 claims, but which are amended to include more than 50 claims between the publication date and the coming into force of the regulation, will not be subject to excess claims fees, although the latter is an open question.  Similarly, it is unclear if in the future, excess claims fees will apply to applications already on file with more than 50 claims, in cases in which some of the excess claims are cancelled and replaced with new claims.  For those applications where many claims could be filed but for some reason haven’t been filed, it may be prudent to add such claims now, so as to avoid having to pay fees for them in the future.

As a practical matter, the combined filing and publication fees for a new application will remain about 1200 shekels.  Consequently, in those cases where an applicant feels a necessity to file 53 or more claims, from an official fees standpoint it will be less costly to file two applications each containing up to 50 claims than to file a single application containing 53 or more claims.  In thinking about how to approach such situations, there spring to mind a number of options for minimizing applicants’ costs while preserving their ability to maximize their claim coverage.  I won’t detail those here.  Suffice it to say that the decision regarding how to approach such cases should be made in consultation with competent Israel patent counsel.

Monty Python and The Israel Patents Database

Fans of Monty Python may recall the “Dead Bishop on the Landing” sketch, which included an exchange that went something like this:

 

“What’s for dessert?”

 

“We got rat pudding, rat pie, rat cake, rat sorbet, and strawberry tart.”

 

“Does it have any rat in it?

 

“Well, it does have some rat in it.”

 

“How much?”

 

“Oh, three or four.  Rather a lot, really.”

 

“Alright, I’ll have one piece of strawberry tart without so much rat in it.”

 

Last week I mentioned that the Israel PTO patents database is a relatively new tool available to the public.  This week I discovered that it does contains some errors. 

 

More than three or four.  Quite a few errors, actually. 

 

For example, according to WIPO’s own publicly-available database, PCT/US2003/000012, entitled “Devices and Methods for Heart Valve Treatment” and filed in the name of Myocor, Inc. on January 8, 2003, published as WO 2003/059209 on July 24, 2003.  But a search for PCT/US2003/000012 in the ILTPO database yields two Israel applications, IL 164219 and IL 164428, neither of which was filed in the name of or subsequently assigned to Myocor.  Conversely, a search for WO 2003/059209 yields no Israel applications, and likewise and a search for applicant “Myocor” turns up empty.  

 

IL 164219 was filed in the name of Bone Care International Inc., and is entitled “Method for Treating and Preventing Hypathyroidism” (the last word of the title being an obvious typographical error).  According to the ILPTO database, the PCT publication number for this national phase application is WO 2003/088976, published October 30, 2003; but WIPO’s own database says that this PCT publication number corresponds to application number PCT/US2003/012013, “Method for Treating and Preventing Hyperparathyroidism”, filed April 17, 2003.  Consistent with the incorrect information in the ILPTO database, a search for application number PCT/US2003/012013 in the ILPTO database yields no results, thus indicating to the searcher that there is no national phase application in Israel; but a search for WO 2003/088976 directs the user to IL 164219.  Interestingly, when one clicks on the “show the WIPO publication” link for IL 164219, one is actually sent to the WIPO page for Myocor’s WO 2003/059209. 

 

As to IL 164428, according to the ILPTO database this application (which is abandoned) is entitled “Computer-implemented system and method for measuring and improving manufacturing processes and maximizing product research and development speed and efficiency”, and corresponds to WO 2003/060812, published July 24, 2003.  But according to WIPO, the PCT application number for that publication is PCT/US2003/001272, filed January 15, 2003.  The ILPTO database has no record for a national phase entry for that PCT application number.

 

This isn’t an isolated instance.  For example, the same problem exists when searching the ILPTO database for national phase applications corresponding to PCT/US2003/000013 (two national phase applications to two different entities listed), PCT/US2003/000017 (ditto), PCT/US2003/000022 (ditto), and PCT/US2003/000018 (three national phase applications to three different entities listed).  That means out of the eleven PCT applications ranging from PCT/US2003/000012 to 000022, at least five are incorrectly linked with the corresponding Israel applications.  “Rather a lot, really.”  I’d rather have a database that doesn’t have so many errors in it, or at least not such a high incidence of errors.

 

That there are errors in the ILPTO database is not surprising - all databases of a sufficiently large size are bound to contain some errors (look for 12:01 Tuesday to post in the future regarding some humorous errors in the USPTO’s searchable patent database).  I think that, for this reason, most patent searchers and patent practitioners recommend utilizing more than one database when searching, on the assumption that multiple sources are more likely to lead to the uncovering of errors or omissions.  Nevertheless, the number of errors in the ILPTO’s database seems to be surprisingly large, to the point that it appears there may be a systemic problem with the database.  Kind of makes you wonder how the ILTPO got approval in September to become a PCT search authority, but that’s for a future post.

In any case, there is a qualitative diffrence between an isolated error in a commercial database, which has no legal ramifications, and what may be a systemic error in an officially-maintained database that ostensibly reflects the legal status of a pending patent application. Significant reduction of such errors is critical if Israel is to really move to paperless patent prosecution

In any case, there is a qualitative diffrence between an isolated error in a commercial database, which has no legal ramifications, and what may be a systemic error in an officially-maintained database that ostensibly reflects the legal status of a pending patent application. Significant reduction of such errors is critical if Israel is to really move to paperless patent prosecution.

 

It's Not That Easy Being A Green Patent Office

About a year ago, the Israel PTO introduced an online patent database, in both Hebrew and English.  The database enables the public to look up applications by publication number, priority application number, attorney docket number and PCT application or publication number.  It also identifies related applications, such as divisionals. 

 

For people who are accustomed to using PAIR or epoline, the Israel database leaves much to be desired: while the current application status, and the specification, drawings and allowed claims are available online as pdf files, the file history is not, and must still be ordered for a fee from the ILPTO.  And the documents that are available are only available for online viewing (or any other public inspection) after the application has been allowed, not during examination.  

 

Nevertheless, in comparison to what preceded it – viz., nothing – the introduction of the online database was a positive step forward, and one hopes that early publication of Israel patent applications and online file histories will become available sooner rather than later.

 

The introduction of the online database was part of a longer-term move to paperless file histories, the implementation of which began earlier.  For example, several years ago the ILPTO began accepting (and in some cases requiring) submission of prior art documents in electronic format, and more recently the ILPTO began requiring electronic submission of abstracts. 

 

In keeping with this, and figuring I might save some trees, I recently submitted national phase application to the ILPTO as a searchable pdf file on a CD.  A few weeks later, I received a call from one of the administrative staff members, who told me that I needed to file a paper copy as well.  The gist of the conversation was as follows (I kid you not):

 

“Why do I need to submit a paper copy?” 

 

“Well, we need a paper copy so we can scan it to pdf format.”

 

“I already gave you the file in pdf format.”

 

“Yeah, but we don’t know how to upload that into our system so you’re going to have to send us a paper copy”.

 

It turns out that this wasn’t an isolated incident.  A colleague told me that when he tried to file an application as a pdf file rather than paper, he went through the same thing.

 

Fast forward to earlier today, when the Commissioner published his Circular no. 76, in which he announced that, hot on the heels of the USPTO announcing a “green” patent initiative, the ILPTO would be begin classifying certain patent applications as “green” and moving them to head of the examination line.  In the words of the Commissioner,

 

“Green applications are applications in which the invention described therein, for which a patent is requested, helps improve the environment, among other ways in that it prevents the causes of global warming [or] reduces air or water pollution [or] advances non-polluting agriculture…”

 

Based on that description, I’m not sure I’ve got a handle on what constitutes a “green” patent application (heck, looking at the statute and regulations, I’m not sure the Commissioner is even allowed to make up such a new classification), but in order to gain a better understanding I’ve already filed an application that claims “A method for reducing paper usage in Israel and the concomitant use of water, a scarce commodity in Israel, in paper production, comprising allowing an applicant for a patent in Israel to submit his application in electronic form, without requiring him to submit a paper copy of the application”.  In view of my own experience described above, such a claim is clearly novel; and inasmuch a electronic filing was already well-known from EFS several years earlier, but not yet adopted in Israel, I think I’ve got a good non-obvious argument as well. 

 

If the Commissioner grants my application, I promise to grant the ILPTO a royalty-free license to practice my invention.

Submission of English-Language Patent Applications in Israel

While the Jews have had continuous ties to the Land of Israel for over 3000 years, for most of that time they have not ruled over the area.  The modern State of Israel has only been around since 1948; the British ruled from 1917-1948, and immediately preceding that there was the Ottoman Empire.  The British put some of their own law in place, but kept a fair amount of Turkish law as well, and upon the establishment of the State of Israel, existing British and Turkish law was maintained until it was supplanted by Israeli legislation.  Today, most of the laws in Israel are the result of enactment by the Knesset (Israel’s parliament), but here and there some British or Turkish law still applies.  One area in which this is the case is the official language. 

 

A 1922 British proclamation decreed that English, Hebrew and Arabic would be the official languages in Mandatory Palestine, with preference given to English in certain respects.  Although the preference for English has long since been abolished, the proclamation itself has never been retracted, and thus, strictly speaking, English remains an official language.  As a practical matter, this is generally not the case: trying to register your home or obtain a driver’s license by applying in English is not recommended, unless you don’t really want to own that home or be allowed to drive. 

 

One long-standing exception to this practice has been the Patent Office, which will accept applications filed in Hebrew, Arabic or English, with over 99.9% of the applications being filed in English.  Most of the correspondence with the Israel PTO is conducted in English as well – it’s not uncommon for local patent agents to simply cut-and-paste English-language comments and explanations received from foreign associates into responses filed at the ILPTO.  Likewise, the Patents Journal (the local equivalent of the USPTO Gazette) is published in both Hebrew and English, with a representative claim being published only in English.  Obviously, the ability to file in English helps keep the cost of patenting in Israel low in comparison to those countries that require translations.

 

From time to time there have been attempts to amend the law so as to declare Hebrew the only official language.  Friday’s Hebrew-language Makkor Rishon newspaper reported a Knesset committee recently rejected an attempt to introduce such a bill; this should lay the matter to rest for at least a few years, and filing of English-language patent applications in Israel should continue apace.  Nevertheless, it’s interesting to contemplate the effects, if any, of such legislation would be on Israel patent practice.  While it is tempting to think that this will necessarily be a boon to translators and an entirely unnecessary burden on applicants, it’s not clear that that’s the case, certainly not with respect to national phase applications. 

 

The patent statute itself does not explicitly state in what language an application needs to be filed, and in fact the word “Hebrew” does not appear anywhere in the statute.  §11(a) of the statute simply says that “A patent application shall be submitted to the Office in the manner and form that will be established, accompanied by the fee that will be established…”; the “to be established” means by way of regulation promulgated by the relevant ministry.  Regulation 11(3) establishes that the margin for documents submitted to the ILPTO must be 3-4 cm on the right for documents written in Hebrew or Arabic and 3-4 cm on the left for documents written in English – implying that submission of English-language documents is permissible.  (The regulations also require submission of both English and Hebrew-language versions of the title of the invention.)  On the other hand, at several places the regulations explicitly refer to “an official language”, thus clearly placing themselves within the confines of what is defined in other legislation as an official language.  So on the basis of §11, while at present it can be argued that one may submit documents to the ILPTO in English as a matter of right, it could also be argued that a separate law that establishes a narrower list of official languages that does not include English would override this right. 

 

§17(c) of the statute (discussed previously here and here) states that if one wishes to piggy-back upon the allowance of a corresponding foreign application, one must necessarily provide a translation of the claims of the corresponding allowed claims “in the language in which the application was submitted in Israel”.  This implies that more than one language is a permissible filing language in Israel.  If viewed as specific legislation, §17(c) would trump more general legislation establishing Hebrew as the only official language.  However, §17(c) could also be read as applying within the bounds of the languages that constitute official languages, and therefore circumscribed by any general legislation that excludes English from this list. 

 

One section that is quite clear is §48D of the statute, which deals with national phase filings of PCT applications.  §48D states that the applicant must submit a copy of the PCT application to the ILPTO, and that if the PCT application was filed in a language other than English, an English-language translation of the entire application must be submitted as part of the national phase entry.  No requirement for a Hebrew-language copy of the application is recited.  As this section is specific legislation, it would presumably prevail, even in the face of general legislation limiting the official language to Hebrew, and thus, unless rescinded by the Knesset, national phase applicants would still have a right as a matter of law to file their applications in Israel in English.   Such rescission is unlikely, given the apparent dearth of MKs that read, let alone read this blog, and the resultant surfeit of MKs who remain blissfully ignorant of the English-language national phase application requirement.

Israeli Progressiveness, Israeli Self-Flagellation

Anyone who has been even marginally associated with patent world in the last few years is aware of the severe backlog in patent examination at the USPTO.  The Director of the USPTO under the previous administration tried to remedy this by forcing through rule packages that would have made it difficult for even the most worthy applicants to gain allowance of their patent applications.  The rules were challenged by Dr. Tafas, a solo inventor, and by SmithKline Beecham, one of the world’s largest pharmaceutical companies, in Federal District Court in the Eastern District of Virginia.  In April 2008, the district court struck down the rules as exceeding the USPTO’s authority, ruling that the rules were substantive rather than procedural. 

 

Two days ago, at the behest of the parties, an en banc Court of Appeals for the Federal Circuit dismissed the appeal of the case, vacating an earlier appellate panel decision but leaving the District Court decision in place.  The result is that not only are the new rules out the window, but also, as a practical matter, the USPTO Director will be unable to try to pull the same stunt in future, unless Congress grants the Director substantive rule-making power.

 

The jury is still out on the current USPTO Director, David Kappos, who took over the job a few months ago, but his willingness to dismiss the rules packages that prompted the Tafas suit is promising, and so far he seems willing and able to think outside the box (insofar as possible in the context of a large government office saddled with government employees and government employment rules). 

 

When it comes to the examination backlog, thinking outside the box is undoubtedly what is required.  As Professors Michael Abramowicz and John Duffy note in a recent article, the basic problem is the underlying assumption that every patent office needs to substantively examine each patent application that comes its way.  As national economies become increasingly intertwined, and more companies file more patent applications in more countries, that assumption becomes impractical; even large countries cannot justify the large expenditure of resources to examine every application thoroughly and quickly.  Most of the article is devoted to setting forth a model which, according to the authors, would enable the job of patent examination to be outsourced to the private sector.  Before doing so, however, the authors also note that worksharing among patent offices is another potentially viable solution for increasing global patent examination efficiency.

 

In this connection, the authors point to Israel as being progressive.  Israel is a substantive examination country, or at least it tries to be.  But Israel, while technologically advanced, is a small country, and cannot devote the resources necessary to thoroughly yet timely examining all the patent applications filed at the ILPTO.  That it has neighbors whose idea of friendly relations is blowing up civilian buses or firing missiles at day-care centers further depletes the resources available for activities like patent examination.  So since the 1980’s, Israel has allowed applicants to piggy-back the examination of an Israel patent application on the grant of a corresponding patent in certain foreign jurisdictions, principally the USA and the EPO.  Although initially adopted as a procedural rule by the ILPTO, in 1995 this practice was codified into law as §17(c) of the Patents Law.  Over the years, the Commissioner has made it even easier to utilize §17(c), by deeming a Notice of Allowance (rather than the actual ministerial act of the patent grant, which can occur months later) or a favorable PCT examination report to be sufficient grounds for implementing §17(c).

 

From the ILPTO’s perspective, §17(c) practice works.  §17(c) is widely utilized by applicants seeking to lower global patent prosecution costs; and with the hiring of dozens of new examiners in the last several years, the examination backlog at the ILPTO has been reduced.

 

I used to think of §17(c) as simply a way for Israel to externalize the cost of examination, placing the burden on the EPO and USPTO and then reaping the fruits of their labors.  But as Abramowicz and Duffy note, if enough patent offices raise their quality of examination to mutually acceptable levels, worksharing among national offices can facilitate a reduction in the duplication of efforts, resulting in overall greater global efficiency in patent examination.  Perhaps, now that Israel has been authorized to become a PCT search and examination authority, Israel will be able to carry its fair share of the global patent examination load; I may discuss this a bit in a future post.  In any event, as long as there are other patent offices conducting sufficiently good examination, there is no reason not to rely on the results of those examinations.  And, as a famous twelve-step self-help program notes, the first step on the road to recovery is admitting you have a problem.  At least Israel was willing to admit it couldn’t handle the examination workload, and that the solution was not to stop granting patents (as the USPTO under the previous Director tried to do with its now-defunct rules package and “quality = reject, reject, reject” mantra).

 

What does this have to do with the self-flagellation in the title of this post?  Well, there seems to be a certain segment of the Israeli population that believes that Israel can’t possibly do things as well other developed countries.  In the patent examination context, this means that they will poo-poo the ability of the ILPTO properly examine cases.  Thus, for example, in an Israel Supreme Court decision from around 20 years ago, the Court said, “In Israel, as opposed to the United States, the examination of an application and the grant of a patent are no guarantee that the patent is valid (§37 of the statute).  The examination performed by the Patents Commissioner in accordance with §17 of the statute is not done in a diligent and thorough manner”. 

 

I mention all this because of a discussion I had a few months ago with one of Israel’s leading IP litigators, who asserted that (a) patents examined by the Israel PTO shouldn’t be accorded any deference, because the ILPTO is incompetent, but (b) patents granted through the 17(c) process should be afforded even less deference because they weren’t substantively examined by the ILPTO. 

 

It’s rather disconcerting when the country’s highest court takes such a dim view of the work of its patent office – particularly when it turns out that at least some of the local examiners do at least as good if not a better job of examination than their counterparts in the U.S.A.  It’s even more disconcerting when local litigators seize on outdated court statements like the one above to besmirch the local examination process per se, and to try to undermine the validity of all granted patents on the grounds that Israeli examination as a whole is deficient – especially if they’re going to ignore improvements in local examination and draw comparisons to U.S. examination, which these days is as spotty as Israeli examination.  (Applications in Israel are for the most part filed in English; but I’m not sure which patent office, the USPTO or the ILPTO, has a higher percentage of native English speakers in its examining corps.)

 

But in my view it’s absolutely unconscionable, not to mention logically inconsistent, for local litigators to assert, on the one hand, that the ILPTO is itself incapable of conducting good examination, and to assert, on the other hand, that patents granted via the §17(c) procedure should be afforded even less deference than those granted after substantive examination by the ILPTO.  If the ILPTO is incompetent in comparison to certain other patent offices – a suspect assumption – then we are no worse off by relying on the findings of those offices in making patentability determinations. 

I take some comfort in observing that, unsurprisingly, the ILPTO has rejected the notion that a patent granted under §17(c) is necessarily weaker than one substantively examined by a local examiner.  The Commissioner has had plenty of opportunity to observe the operation of both his own corps of examiners as well as the products of other examination systems, and is well-positioned to assess which patent-granting regimes are the best ones.  Nevertheless, my litigator acquaintance’s assertion that §17(c)-granted patents are weaker than those examined by the ostensibly weak Israeli examining corps continues to disturb me.  It is a thinly-veiled way of saying that there are no valid patents, and I am sure he will advance this argument before the courts when it suits his purposes.  If this position is ever adopted by the courts, it will mean victory for the Luddites and be a blow to Israeli innovation.  And an even more egregious example of Israeli self-flagellation.