America-Israel Patent Law

USPTO Issues Mea Culpa: Some Patent Application Information Made Available Too Early (And Not Through Wikileaks)

This morning, during my daily check of correspondence from the USPTO on private PAIR, I found a fascinating letter, the text of which is reprinted below.  Turns out that the USPTO goofed, and enabled some patent application data to become publicly available on November 11 when that data wasn’t supposed to become available until November 18.  The data wasn’t actually posted on PAIR; it was posted on a third party web site, then removed on November 15 and reposted on November 18, when it also became available on PAIR. 

As the USPTO notes, the number of applications affected by the error is likely quite small, and the effect will be limited to corresponding applications filed outside the USA from November 11 through November 17 without a priority claim to the erroneously disclosed application.  Personally, I’m curious if ANY foreign applications were or will be adversely affected by the premature disclosure. 

What is impressive is that the USPTO came clean regarding its mistake relatively quickly: it seems that it only took about two weeks from the time the USPTO discovered the mistake to the time it mailed letters to all 6015 affected applicants, including the Thanksgiving hiatus.  (A random sampling of the PAIR records for several of those applications indicates that all the letters were mailed November 30.)  The USPTO could have stayed silent about this; had it not said anything, this story might have stayed buried for a long time, if not permanently.  Hat tip to Commissioner David Kappos and his staff for this one.

The text of the letter sent to affected applicants is as follows:

Notice of Erroneous Early Release of Patent Application Information on November 11, 2010

On November 11, 2010, the United States Patent and Trademark Office (USPTO), unintentionally and as a result of a processing error, made available to subscribers of patent application data the patent application publications that were not scheduled to publish under 35 U.S.C. 122(b) until November 18, 2010. The USPTO's subscription service allows a member of the public to obtain copies of all patents or application publications from the USPTO on the date of grant or publication for a fee. One subscriber who had access to the early-published data made these premature patent application publications available on its free Web service, known as Free Patents Online, on November 11, 2010 - one week prior to the scheduled publication date. At the USPTO's request, the subscriber removed access to the patent application publications dated November 18, 2010 on November 15, 2010 until November 18, 2010. While the premature release of application information on November 11, 2010, is not considered a publication of such applications under 35 U.S.c. 122(b), the USPTO acknowledges that there are potential international ramifications in certain very limited circumstances such as where an applicant whose application information was released early did not file a foreign application within the Paris Convention priority period but did file in a foreign country between November 11, 2010 and November 18,2010.

The USPTO did not post the publications on its Web site until November 18,2010, and it did not provide access to the public Patent Application Information Retrieval (PAIR) System based on the early release of the publication data. Moreover, the USPTO did not record in its records that a publication occurred until November 18, 2010. Copies of, and access to, any of the affected applications described in this document were not provided by the USPTO under 37 CFR 1.14 based on the error described in this document. The USPTO regrets this error and is instituting controls to prevent similar processing errors in the future.

Inquiries regarding this matter may be directed to Mark Polutta, Senior Legal Advisor, Office of Patent Legal Administration at (571) 272-7709 or via email addressed to [email protected].

 

A Thanksgiving Present from the Israel PTO: Proposed New Expedited Examination Program To Make Examination in Israel More Attractive

Although the notion of a meal of thanks is well enshrined in Jewish tradition, Thanksgiving is a distinctly American holiday.  Nevertheless, over the weekend the Israel PTO gave Israel patent applicants something to (hopefully) be thankful for.

Seasoned U.S. patent practitioners will recall a time when an applicant who wished to have his application examined on an expedited basis could file a “petition to make special” on several grounds.  In 2006 this practice was changed, so that the only remaining grounds for filing a petition to make special are the inventor’s age or health or under the Patent Prosecution Highway.  See MPEP 708.02.  Otherwise, the petition to make special program was supplanted by the accelerated examination program (MPEP 708.02(a)).  While the latter program has been more successful than its predecessor in speeding up the examination of subject applications, its requirements are much more onerous, as the applicant must conduct a rigorous prior art search before filing and essentially prepare the first Office Action for the Examiner.  

The comparable program in Israel can be found in Regulation 35(a) of the Patents Regulations, which enables applicants having good reason to petition the Commissioner to expedite the examination of his application.  Typically such requests are based on concerns about possible infringement by a competitor and/or the imminent launch by the applicant of a product intended to covered by the claims of the patent application. 

The Israel PTO has now announced that as of January 1, 2011, applicants who have filed an application in Israel and who plan file foreign applications claiming priority from that Israel application may request expedited examination on this basis alone.  The catch is that as part of the request, applicants must file a declaration stating that the Israel application is “the first one filed on the invention”; presumably what the ILPTO means is that the Israel application is the first one filed anywhere in a Paris Convention country on the claimed invention.  In exchange, the ILPTO promises to deliver a “comprehensive” examination report within three months of the approval of the request for expedited examination.  Unfortunately, the report will be delivered in Hebrew, although apparently if the applicant so requests, the ILPTO will prepare an English version of the examination report for consideration by the PCT search authority per PCT Rule 4.12. 

If, as expected, Israel and the USA sign a Patent Prosecution Highway (PPH) agreement, then the newly-announced policy for expedited examination would make the use of the PPH easier for Israeli applicants, since they would be able to file first in Israel and obtain an examination report during the priority year.  Presently the combined filing and initial publication for an Israel patent application is 1194 shekels (about 330 dollars), and the fee for requesting expedited examination is 685 shekels (about 185 dollars).  For applicants wishing to obtain a U.S. patent quickly, this is small price to pay to be able to take advantage of the PPH, especially compared to the cost of accelerated examination when search and attorney fees are taken into account.  It will also be less costly and faster than utilizing the PCT-PPH route by first filing a provisional application, then using the EPO as the PCT search authority. 

Moreover, it does not appear that applicants wishing to take advantage of this new form of expedited examination in Israel would be precluded from filing the same application as a U.S. provisional application on the same day or shortly after the application is filed in Israel (provided that their invention is not a defense technology-related invention, the foreign filing of which is statutorily prohibited). 

The big question is whether or not the ILPTO is really capable of providing a “comprehensive” examination report in every case of expedited examination.  As I noted in a previous post, some Israeli examiners do a first-rate job, finding the most relevant art and clearly explaining its applicability to the patentability of all pending claims; but other examiners don’t find the best art, and/or mis-apply the prior art they do find, and/or do a poor job of explaining how the art applies to the pending claims, and/or don’t explain how the art applies to each and every claim.  If the ILPTO has developed a system for ensuring that all its examiners can provide first-rate examination reports, then this weekend’s announcement is a welcome one.

Jewish Law in CAFC Jurisprudence: Cancer Research Technology et al. v Barr Laboratories et al.

There’s a term in Jewish law called “migo”.  Inter alia, this term is used to denote a situation in which a witness is believed because, although his testimony is not as complete or convincing as might be desired, if he were going to lie, he could have come up with a far better fib.  So it was interesting to see a CAFC decision last week in which the Court employed similar logic in reversing a District Court with regard to inequitable conduct. 

The case in question is Cancer Research Technologies v Barr Laboratories.  I posted about the Delaware District Court’s decision in this case last January: in the context of ANDA litigation, Barr stipulated to the validity and infringement of the asserted claims of CRT’s US 5,260,291, but argued that the patent was unenforceable for both prosecution laches and inequitable conduct.  The former argument was based on the fact that over a period of ten years, the applicant had repeatedly obtained extensions and filed continuations without substantively advancing prosecution; only after the entrance into the picture of a deep-pocketed partner, Schering, having the wherewithal to bring a candidate compound through clinical trials, did the applicant proceed in 1993 to respond to the Examiner in a substantive way.  The latter argument centered on the fact that although one of the inventors had published multiple articles describing negative test results for the claimed compounds, he had not seen fit to provide those results to the USPTO. 

The district court found for Barr on both counts.  On the laches prong, the court ruled that since CRT’s 1993 response was based on 1986 case law, CRT could have replied substantively much earlier in prosecution; that the only reason for delay was CRT’s attempt to find a strategic partner to help commercialize the drug; and that this was not a sufficiently good reason to delay prosecution.  In reaching this conclusion, the District Court rejected CRT’s claim that under Supreme Court and CAFC case law, a party asserting a prosecution laches defense must show that during the period of prosecution delay, the defendant had begun to work the invention or made preparations to do so, i.e. the defendant had secured “intervening rights”.  On the inequitable conduct side, the District Court ruled that test results showing that some of the compounds identified in the application as being “particularly active” were actually inactive were highly material to patentability, and that the withholding of such results from the USPTO, in particular when the inventor had published them elsewhere, implied intent to deceive the USPTO. 

Last week, in a 2-1 decision, the CAFC reversed on both grounds.  Regarding laches, the majority (Judges Newman and Lourie) held that Supreme Court precedent established that “intervening rights” were a necessary component of a laches defense, and that those intervening rights must be established by the defendant during the period of prosecution delay.  Since Barr had not made preparations for copying the API during the period of prosecution delay, Barr had not obtained “intervening rights”, and thus could not avail itself of the laches defense. 

Writing in dissent, Judge Prost asserted that the proper test for prosecution laches was a totality of the circumstances test, not a test requiring proof of the accused infringer being prejudiced during the period of delay.  This, said Judge Prost, was not what Supreme Court or CAFC precedent required:

“By requiring this particularized prejudice, the majority sidesteps the real harm at issue in this case.  The Supreme Court has explicitly recognized that delaying a patentee’s monopoly period harms the public by delaying its free use of the patented invention. Woodbridge, 263 U.S. at 48-49.  Here, the applicant first filed the patent application disclosing temozolomide in 1982.  By stalling prosecution for its own business purposes for nearly a decade, Cancer Research obtained a patent which does not expire until 2014--almost thirty-two years after the first application in this chain was filed.  The majority downplays the public prejudice caused by this delay, 2 Maj. Op. at 12-13; however, Cancer Research’s conduct has prejudiced the public by extending its patent monopoly over temozolomide.  Indeed, Congress has specifically recognized the public’s interest in obtaining affordable prescription drugs by enacting a regulatory scheme to expedite the availability of generic drugs."

The problem with Judge Prost’s dissent is twofold.  First, in assessing laches, she would rely on an alleged harm to an amorphous public.  But it’s not clear that the court’s focus should stray beyond the scope of the actual litigants before the court to consider effects of the prosecution delay on the general public.  Whereas a litigant can explain to the court the particular harm he has suffered as a result of the prosecution delay, assessing harm to the general public, which usually is not directly represented before the court, can be an iffy proposition.  (That’s part of the reason there are rules on standing and justiciability.)  The “accused-infringer-must-have-aquired-intervening-rights-during-the-period-of-delay” rule set forth by the majority circumscribes the court’s purview of the laches argument to the litigants before it. 

Second, even if one were to accept that the rationale Judge Prost proffers for the laches doctrine – namely that “by delaying [the public’s] free use of the patented invention”, the patentee has harmed the public, and should therefore be penalized by having his patent treated as unenforceable – is applicable in principle in all cases, nevertheless that rationale only applies if there actually is a commercial product for the accused infringer to make and for the public to benefit from.  That’s not the case here.  Judge Prost completely misses the point, fully (and unsurprisingly) appreciated by Judges Newman and Lourie, that in this case, without a patent, there never would have been a new drug, period, let alone a new drug that generic copyists could make at low price later on.  

Put differently, the patentee’s prosecution delay engendered no delay of the public’s use of the patented invention, because without the patent there wouldn’t have been any use at all: the molecule would still be sitting on a shelf somewhere.  The laches doctrine shouldn't be applied where, as here, there is no prejudice to the public at large or competitors in particular, let alone where the public benefit from the patent flows directly from the fact that there was prosecution delay. 

Nevertheless, one wonders if the majority’s test isn’t too restrictive, and if the majority could have fashioned a test that would enable competitors to prevail on a prosecution laches defense even when they did not obtain “intervening rights” during the period of prosecution delay.  But discussion of that thought is deferred to a later post. 

As to inequitable conduct, the majority ruled that although data showing some claimed compounds to be inactive were material to patentability, the District Court erred in relying solely on the non-disclosure of that data to the PTO to infer intent on the part of the inventor to deceive the PTO.  The error was that

“materiality and intent are separate requirements, and intent to deceive cannot be found based on materiality alone…A court cannot simply infer that an applicant ‘should have known’ the materiality of withheld information and thus intended to deceive the PTO because the applicant knew of the information and the information is material. A district court must find some other evidence that indicates that the applicant appreciated the information’s materiality…In this case, evidence that Stevens co-authored articles that contradict the disclosure of the ’291 patent specification does not alone establish that Stevens with-held those studies intending to deceive the PTO.” 

Furthermore, said the panel, intent to deceive must be the single most reasonable inference that can be drawn from the evidence adduced.  Here, the panel found that

“While publication to the scientific community is not the same as disclosure to the PTO and does not foreclose a finding of deceptive intent…the prompt publication of data in multiple articles over the entire course of prosecution is inconsistent with finding that intent to deceive is the single most reason-able inference to draw from the evidence in this case…” 

That sounds an awful lot like “migo”: if the inventor wanted to pull a fast one on the PTO, why on earth would he have published several articles showing that certain compounds were inactive?  He should have just kept his data secret.  His public disclosure of that data, even if not to the PTO, does not evince deceptive intent.

The panel also noted that the inventor did not withhold from the PTO only information about the inactivity of certain compounds; rather, “the withheld information includes both positive and negative data regarding the claimed tetrazine derivatives”.  Thus, concluded the majority, “an equally reasonable inference to draw from the evidence is that Stevens viewed publication of all the data as important to his career as a scientist but did not appreciate their potential importance to the patentability of the tetrazine derivatives patent claims.”  Without a finding of intent to deceive, there was no basis for finding inequitable conduct, and the district court’s decision was reversed in this regard as well.

In dissent, Judge Prost asserted that had the withheld information been before the PTO, the scope of the claims would have been affected, a fact that even the majority would acknowledge; that the majority erred in requiring separate evidence for materiality and intent; that “the evidence presented at trial separately supports the district court’s findings on both prongs”; and that “when combined with the district court’s credibility findings regarding Dr. Stevens’s ‘explanation’ for his failure to disclose, is absolutely sufficient to support the conclusion that highly material evidence was withheld from the PTO with intent to deceive.”  As to the most reasonable inference to be drawn from the evidence, the judge believed, apparently on procedural grounds, that it was not for the appellate court to second-guess the district court in this regard: “We should not draw inferences that the district court has already excluded based on its own credibility findings with respect to Stevens’s explanations for the withholding.”

When discussing the district court case, I stated that the fate of the inequitable conduct finding would “hinge in no small part of the CAFC judges assigned to this case”.  It is hoped that the CAFC’s forthcoming en banc decision in Therasense will make inequitable conduct outcomes more judge-independent, by relegating this defense to cases in which there is actual fraud on the PTO.

Will Israel be Joining the U.S. Patent Prosecution Highway? (And If So, Does It Really Matter?)

Over the last several years, the USPTO has entered into a number of bilateral agreements under the rubric of what it calls “The Patent Prosecution Highway” (PPH).  The general idea is to reduce the overall examination workload at participating patent offices.  For example, if someone first files an application at the UK patent office and obtains a favorable examination report there, he may use that favorable report as a basis for expediting examination of a U.S. application that claims priority from the UK application.  Under the PPH, rather than waiting in the examination queue in accordance with its filing date, the U.S. application will be moved near the front of the line.  Although the USPTO will still conduct its own examination of a PPH-advanced application, anecdotal evidence suggests that US examiners will be more likely to find allowable claims in PPH applications than non-PPH applications. 

Unfortunately, in its bilateral form, the PPH is of somewhat limited utility.  For starters, participation in the PPH in its bilateral form has somewhat onerous requirements that render the vast majority of applications PPH-ineligible.  This is partly due to the fact that PPH in its bilateral form is based on the somewhat anachronistic model that a citizen of country A will file first in country A and then later file in country B, claiming Paris convention priority from the application in country A. 

Furthermore, while in theory PPH agreements are bi-directional, in practice this is may not be so when one patent office conducts examination more quickly than the other.  To illustrate, although a favorable examination report in a first-filed U.S. application can be used to advance prosecution in the UK, this is unlikely to happen, both because the UKPO conducts examination more quickly than the USPTO, and because most US applicants are likely to enter the UK via the EPO. 

In any event, other offices with which the USPTO has established bilateral PPH agreements are the EPO and the patent offices of Japan, Korea, Australia, Austria, Canada, Finland, Germany, Hungary, Russia, Singapore and Spain.

Where the PPH is really useful is in the context of the PCT.  The US has PCT-PPH agreements with Austria, Japan, Korea, Russia, Spain and the EPO.  Whereas a US-based applicant whose UK application claims priority from a US provisional cannot avail himself of a favorable UK examination report to get his US non-provisional fast-tracked under the PPH, if that applicant files a PCT application claiming priority from his US provisional, has his search done at, say, the EPO or KIPO, and receives a favorable WOISA or IPRP, he can use WOISA or IPRP as basis for entering the PPH.  Moreover, according to Carol Bidwell of WIPO, figures to date indicate that US applications filed under the PCT-PPH program have an extremely high allowance rate, and are allowed very quickly.  Obviously, this makes PCT-PPH a very attractive option for applicants who want US examination to proceed quickly.

Last year the Israel PTO announced that it was being given the opportunity to become a PCT search authority.  In past posts I have argued that although the extending of this opportunity is nice feather in the ILPTO’s cap, the real goal should be to become a PCT search authority recognized by the USPTO. Because the ILPTO will likely charge significantly less than the EPO or the USPTO for PCT searches, becoming a US-recognized PCT search authority could result in an influx of search fees to the ILPTO, while lowering the cost of the PCT process for US- and Israel-based applicants.

Rumor now has it that the ILPTO and USPTO have agreed for the ILPTO to join the PPH; I’ll believe this when I see it, i.e. when an official announcement is made by the ILPTO and/or the USPTO themselves.  Even if the rumor is true, it’s unclear that Israel’s joining the PPH would have much immediate impact.  Straight-up bilateral PPH would only benefit those Israeli applicants who first file in Israel, then file in the USA claiming priority from the Israel application, then receive a favorable examination report from the ILPTO before the USPTO issues a first OA.  That’s a set of circumstances that simply won’t apply to most Israeli applicants.  Conversely, for US applicants who file in Israel, the issuance of a Notice of Allowance in the USA will often occur before examination is completed in Israel, and may serve as the basis for allowance of the Israel application under 17(c) of the Israel patent statute.  Why invoke the PPH to merely expedite examination when you can gain allowance straight away?

Furthermore, in many cases, the signing of a PPH agreement with the USA would not provide Israeli applicants with any benefits beyond what they already enjoy.  This is because, presently, Israeli applicants can take advantage of the PCT-PPH system: many, if not most, Israeli applicants file U.S. provisional applications as their first filings, then file a PCT claiming priority from the provisional.  Since Israelis must use the USPTO or EPO for PCT search and examination, a favorable WOISA or IPRP at the EPO will facilitate use of the PPH upon entry into the national phase in the USA. 

What would be good about the signing of a PPH agreement is that it would constitute a first step toward becoming a PCT-PPH search authority.  Obviously, even if Israel soon joins the PPH, and even if Israel becomes a PCT search authority (a development expected sometime in 2011), the ILPTO will need to prove its mettle as a PCT search authority before the US will be willing to recognize it as a PCT-PPH office.  But if the ILPTO can eventually join the ranks of PCT-PPH patent offices, that would be a boon for both the ILPTO and US-based applicants. 

Another Fine Mess: What do IBM, Boehringer Ingelheim and Amgen Have In Common?

A few weeks ago I posted about the Commissioner of Patents getting very publicly raked over the coals by a legislator for having unilaterally decided a few years earlier to cease paper publication of the Patents Journal by the Government Press Office (GPO), as required by statute, and to instead only publish the Journal on the ILPTO’s website, all the while continuing to collect the publication fees set by law.  The incident occurred in the context of a committee hearing in the Knesset in which the topic of discussion was a statutory amendment that would enshrine the practice prospectively and ex post facto give legal force to the online publication that had already taken place.  Although the committee decided to put off further discussion until later, I noted at that time that (a) the failure to engage in paper publication cast a cloud over the validity of several thousand patents, but (b) for that very reason the Knesset would enact the proposed legislation to retroactively fix the situation. 

Perhaps unsurprisingly, it only took a few days for some cash-hungry lawyers and some potential plaintiffs to find each other and to file suit against the Commissioner, seeking to have the suit declared a class action.  After all, a single thousand-shekel publication fee paid by an individual applicant is hardly worth fighting over, but if several million shekels in official fees paid by thousands of applicants are at stake, a win would be a windfall for the lawyers, and the plaintiffs might even see a few shekels themselves.  The reasoning evinced in the complaint is seriously flawed, but that’s the topic for a later post. 

In the interim, the ILPTO got the message: on October 31, 2010, it published Patent Journals Nos. 2/2010, 3/2010 and 4/2010, but this time it made sure to have the GPO simultaneously print a copy of each Journal, so that there was simultaneously publication online AND in “Reshumot”, the official state publication organ.  No doubt about it, these three Patents Journals are definitely kosher.  

Today’s post focuses on some of the many patents the status of which is presently in question, and which are in need of a legislative fix.

Exhibit A is a group of patents belonging to IBM.  The four patents in question, IL 151545, IL 153888, IL 157506, and IL 159655 all lapsed in 2007-2008 for failure to pay maintenance fees.  When IBM discovered the oversight, it filed requests to reinstate the patents, in August and October 2009.  Notice of the requests to reinstate were published in the Patents Journal online on the ILPTO website, but paper copies weren’t published.  In the absence of opposition, all four patents were reinstated.  Or were they?  The statute requires that notices of requests to reinstate be published in “Reshumot” by the GPO.  Since formally such publication never took place, it can be argued that technically these four patents still haven’t been reinstated and are therefore presently unenforceable.

Actually, in this particular case, it gets even better: it’s not clear that any of the four patents were actually granted.  The original publication per §26 of the statute of notices that the applications had been allowed by the ILPTO also took place on the ILPTO’s website, without a corresponding paper publication in “Reshumot”.  Since publication in Reshumot is a sine qua non of the patent grant process, it can be argued that technically these patents are still merely applications awaiting publication in Reshumot.  If that’s the case, then IBM should probably ask for a refund of the fees it paid to reinstate the “patents”…

Of course, at worst for IBM, the ILPTO could now publish a paper version of the Patents Journal that would list these four patents.  While that would represent several years lost from the life of the patents, the patents would still be in force.  As will presently be explained, that option isn’t available for our next exhibit.

Exhibit B is IL 95691.  This patent covers tiotropium bromide monohydrate.  That’s the active ingredient in Boehringer Ingelheim’s product Spiriva®, a drug for treating chronic obstructive pulmonary disease.  Spiriva had worldwide sales of over 2 billion Euros in 2009.  The patent was filed on September 14, 1990, but the drug wasn’t approved by the local health authorities until 2004, making the patent eligible for a patent term extension (PTE).  Boehringer timely applied for a PTE, and in March 2010 the ILPTO published notice of intent to grant the extension; the PTE was ostensibly granted several months later in the absence of any opposition thereto. 

But here too, the publication of the notice of intent to grant the PTE occurred only on the ILPTO website, not in the GPO-published, cellulose-based “Reshumot”.  Technically, then, the Commissioner wasn’t authorized to grant the PTE, the “granted” PTE is a nullity, notice of the intent to grant still awaits paper publication in “Reshumot”, and only thereafter can the Commissioner grant the PTE.  

Now we come to the real problem: without a valid PTE, this patent expired in September 2010.  And under the current statute, the Commissioner is neither empowered to grant interim PTEs prior to expiration of the patent (in contrast to the situation in the USA), nor is he authorized to grant a PTE after the expiration of the patent.  In other words, without amendment of the statute to retroactively give legal force to the online publication, this patent is dead.  I don’t know what the local market for Spiriva is, but if it’s doing 2B Euros annually it has to be worth at least a few million here in Israel.

Exhibit C is IL 95572.  This patent covers etanercept, a version of the alpha- and beta-receptors of tumor necrosis that is the active ingredient in Immunex’s (Amgen’s) Enbrel®.  Enbrel, which is indicated for various types of arthritis, had sales of nearly 3.5 billion dollars in 2009.  Enbrel was approved by the Israel Ministry of Health in 2000.  Unfortunately for Immunex/Amgen, although the patent application was filed in 1990, the ILPTO didn’t allow the application until 2008, at which point it was published in the Patents Journal.  Online.  Without a paper publication in “Reshumot”.  So again, technically, the grant of this patent is a nullity, and Immunex needs to await paper publication before it can get its patent.  The only problem with that is that the 20-year term for this “patent” ended in April 2010.  Moreover, this “patent” was eligible for a PTE, and ostensibly received such a PTE, but again, the notice of intent to grant the PTE was only published online, not in “Reshumot”.  So, as in the case of Spiriva, the patent for the API for Enbrel is no longer in force, the Commissioner can’t grant a PTE, and the only hope for getting patent protection at this point is for a retroactively effective amendment to the statute.  The good news for Immunex/Amgen is that since this is a biologic drug rather than a traditional small molecule, it may be a while before generic competition is in a position to receive Israel Health Ministry approval. 

It’s unclear to me why the Knesset committee chose to stall action on this amendment last month.  If, as it seems it may be, the committee chairman, David Rotem, is either trying to capriciously flex his legislative muscle or simply nursing a bruised ego, the present situation is reminiscent of a Laurel & Hardy film.  I stand by my prediction that the Knesset will enact the necessary amendment to fix this problem.  The Commissioner’s motives in this case were the right ones: online publication is a faster and far more efficient way to disseminate the notices that hitherto have been published in “Reshumot”.  True, he should have lobbied the Knesset to make the change first, or at least seen to it that at least one paper copy of the Journal would be published by the time the Journal went online.  Nevertheless, the fact that he didn’t get the statute changed first is no excuse for committee chairman to keep the necessary amendment holed up in committee.  Such failure to act would be folly.  Ultimately, no one has been harmed by the online-only publication.  To the contrary: the filing of oppositions to patent applications has continued apace, indicating that the notice function of publication is being met.  Israel patents continue to be indexed in international patent databases, such as the EPO’s Inpadoc and Derwent’s WPI.  It’s inconceivable that the thousands of patent applicants stand to lose their patents because of Knesset inaction.