America-Israel Patent Law

Update – February 19, 2010 – Are Real Patent Term Extensions and Real Data Exclusivity Provisions on the Way for Israel?

Today I found this story in English online version of Haaretz and this one in the Hebrew-language Globes (the English version is here), which confirm my suspicions about the putative changes in Israel’s patent and data exclusivity laws.  In exchange for these changes, the USA will reportedly now support Israel’s entry to the OECD and will also remove Israel from its “priority watch list”.

 

One aspect of the story that intrigues me is the impetus for the change being Israel’s desire to join the OECD.  Specifically, opening up Israel’s legal services market doesn’t appear to be one of the demands being made for Israel’s acceptance into the organization.  That’s a pity, because without such opening the consumers of those services will continue to pay more than they need to.

 

I should explain.  At present, Israel has a statutorily created bar association, and to practice law in Israel you have to be a member of the bar association (unlike, say, New York, where admittance to practice is contingent upon paying a fee to the Office of Courts Administration but not upon bar association membership).  In a throwback to the guilds of the middle ages, ILBA rules state that an Israeli lawyer cannot be a partner with anyone who isn’t also a member of the ILBA.   Ostensibly this is to protect the purity of the profession (because we all know lawyers as a group have a lily-white reputation) by ensuring that all lawyers practicing in Israel adhere to the same code of ethics, but it’s really just a protectionist measure.  This rule is the one of the primary reasons why there are no multinational firms with offices in Tel-Aviv: were the Israelis to partner with lawyers from outside Israel, the Israelis would be subject to disciplinary action and possible disbarment.

 

Another primary reason for the lack of a multinational presence is taxation: foreign firms are scared that if they have partners in Israel, those firms’ entire profits will be subject to Israeli taxation.

 

The result is that Israelis needing foreign legal services often end up paying more than they ought to for those services: their local attorneys often act as middlemen who drive up the price, and the local legal services market is itself somewhat insulated from the pressures of competition from without.  (In some cases local firms have created strategic alliances with foreign firms, but that’s not the same as being integrated into a single unit.)

It’s time for Israel to amend its laws to facilitate partnering with foreign lawyers.  The OECD should be demanding such reform as part of the price of admission.

Are Real Patent Term Extensions and Real Data Exclusivity Provisions on the Way for Israel?

Earlier today, the two o’clock news on the state-owned Voice of Israel carried a brief story stating that a joint committee of the Foreign Ministry, the Finance Ministry, the Justice Ministry and the Health Ministry announced that Israel will accede to the demands of several countries, principally the USA, and extend the life of “patents for producing medicines”.  According the story, until now Israel has allowed local companies to produce drugs before the patents on those drugs expired in other countries (basically a true statement – see elaboration below).  The Minister of Industry and Trade was reported as saying that this will pave the way for Israel to join the OECD.  The story also reported that Israel has agreed to change the way drugs receive approval.  (If you understand Hebrew, you can download the broadcast and start listening at the 2:44 mark Download 14 00). 

 

The story is sketchy, and in a few minutes of searching the major new websites in Israel I haven’t yet found anything with more details, nor have I been able to reach people who may have first-hand knowledge of what was discussed and concluded.  No doubt more details will emerge in the next day.  However, it’s not difficult to guess the issues that will purportedly be addressed: patent term extensions (PTE) for pharmaceuticals and exclusivity for the data supplied by innovative pharma companies to the Health Ministry when requesting approval of their new drugs.

 

Israel’s current PTE legislation is extremely restrictive, conditioning the grant of a PTE on the grant of PTEs for corresponding patents in certain other countries (e.g. no PTE in the USA = no PTE in Israel), and similarly limiting the duration of those PTEs to the duration of the earliest-expiring PTE one of those certain countries and/or to the earliest grant of marketing approval for the patent-protected drug in one of those countries.  The upshot is that, as reported correctly in the new story, patent protection in Israel often expires before it expires in other western countries, enabling local generic manufacturers to begin to manufacture and stockpile products for sale abroad before their generic counterparts in those countries can do the same.  Thus Israeli generic drug companies can have product ready to sell in those countries as soon as patent and any other legal prohibitions on such sale have lapsed. 

 

Similarly, Israel’s data protection scheme prevents generics from being approved for local sale for a period of up to five years, but the period in question may be shorter, depending on when the product was first approved elsewhere.  More importantly, the statute doesn’t prohibit local generic drug companies from relying on innovators’ data for purposes of getting export licenses from the Health Ministry.  This is the other part of the puzzle that enables the local generic industry to be ready to step in quickly once the sale of generics becomes permissible in another country.

 

These are the two points on which the U.S. has long been pressuring Israel (see, for example, the last several “Special 301” reports of the United States Trade Representative, which because of these two points have put Israel on the “Priority Watch List” alongside countries like China, Russia, Argentina, Chile, Pakistan, India, Thailand and Venezuela), so presumably these are the points that the ministries plan to address. 

 

Among the many aspects of the new report that aren’t clear to me (aside from the obvious questions, Why is the Minister of Industry and Trade commenting on this matter if his own ministry wasn’t involved in the discussions? And why wasn’t his ministry involved in the discussions?), the most significant one is, what’s changed since the legislation was enacted that’s going to allow that legislation to be changed now?  So far, in both the patent term extension and data exclusivity provisions, the local generic industry has gotten pretty much what it wants, despite heavy lobbying from the Israeli equivalent of PhRMA and at least one large innovator company.  That’s no surprise: Israel’s largest private-sector employer is a generic drug company (guess who?).  That’s a lot of jobs, a lot of taxes being paid, and most importantly, a lot of votes. 

 

When the question of data exclusivity was being debated in the first half of the decade (the legislation was finally adopted in late 2005), the generic industry’s main argument was that imposing data exclusivity would simply give an advantage to competitors in countries like India that lack such legislation, and would necessitate the moving of Israel jobs overseas.  A similar argument was made with respect to the patent term extension provisions when these were being adopted.  I don’t see that argument changing now. 

 

Perhaps the ministries don’t really plan to do anything, or they plan to make changes thata will effectively still give the local generic industry what it wants, which is why above I said that these are the issues that will purportedly be addressed.  Or maybe this time the Knesset will call the industry’s bluff and enact stricter legislation, figuring that manufacturing of drugs for export constitutes a small portion of the local generic industry’s activities, and that not many jobs, if any will be lost.  (I don’t have the figures to confirm whether or not that’s really the case). 

 

It any event, it will be interesting to see how this plays out.  I’ll blog more on this as more information becomes available.

Civil Servant Gone Wild: The Israel Commissioner of Patents’ End-Run on The Patent Statute

Ok, I know that if made into a video, the subject of this post won’t sell as many copies as Girls Gone Wild, nor are its effects as wide-ranging as, say, Jon Dudas’ lame (and, mercifully, now late) attempts to circumvent the rule-making process in the USA.  But for those of us who practice patent law in this neck of the woods, the Commissioner has displayed a remarkably cavalier attitude toward the very statute that creates the position he now occupies. 

 

First, there was the announcement by the Commissioner that if an examiner has determined that an application contains claimed directed to more than one invention, then that applicant must file a divisional application along with its response to the examiner.  Divisionals filed after the deadline for response will only be accepted upon payment of an extension fee for each month of “lateness” in filing.  The Commissioner asserted that this policy was dictated by the statute, but it’s not clear that the statute really supports him on this point – and indeed, in the 40 or so years prior to the Commissioner’s announcement that the statute had been in force, none of his predecessors adopted this view.  However, since the cost of an extension is only about $16/month, it will almost always be cheaper for an applicant to wait and see if it wants to file a divisional, and then pay the extension fees, than to pay a lawyer to challenge the Commissioner’s view.

 

The next month, as discussed previously in this blog, the Commissioner imposed a requirement to submit an abstract, thus foisting on the applicant a requirement that the statute imposes on the Commissioner himself.

 

Then we had the now-you-see-it, now-you-don’t case of Australia as a country upon which one could piggy-back under §17(c) of the statute to gain allowance of a corresponding Israel application.  In December 2008 the Commissioner announced that he was taking Australia off the list because experience had shown it to be unreliable (i.e. Australian examinations weren’t very good); in September 2009, he reinstated Australia, without providing reasons.  While the statute empowers the Commissioner to list and de-list foreign patent offices in this manner, it presumes he makes such determinations based on objective criteria of the quality of foreign examination.  Here, the quick change of heart, without accompanying reasons, raised eyebrows.  In retrospect, it appears that the change of heart was motivated not by a substantive change in the situation but by politics, as part of the Commissioner’s efforts to get Israel recognized as a PCT search authority.

 

Next came more extensive reporting requirements under §18 of the statute (the rough equivalent of IDS practice in the USA).  §18 empowers the Commissioner to ask an applicant to provide a list of documents cited during the examination of corresponding applications elsewhere, or which are known to the applicant to be relevant to patentabilty, as well as copies of those documents.  The related Rule 36(1) says that pursuant to §18, before beginning examination, the Commissioner will send a letter to the applicant asking that he provide these documents.  Rule 36(2) says that when an applicant responds to such a request, he may include copies of his arguments submitted in response in the foreign jurisdiction(s).  Note that this is purely at the Applicant’s discretion. 

 

But in January of this year, the Commissioner announced that henceforth, applicants would be required to include copies of those answers, insofar as they relate to novelty and inventive step, and that failure to include such arguments would be regarded as failure to respond to the request under §18.  Nevermind that the statute itself does not empower the Commissioner to request copies of arguments filed abroad.  Or that in the cases of Europe and the USA, those documents will almost always be freely available over the internet, and that ILPTO examiners are already adept at finding those corresponding documents.  Better to act ultra vires and impose unnecessary reporting requirements on applicants than to have Israel examiners engage in a few extra mouse clicks.

 

Next up, limits on the number of independent claims.  About two weeks ago the Commissioner circulated another notice, this one informing people that the ILPTO would only accept two independent claims “of each type”, viz. one or independent claims on a product, one or two for a process for making the product, one or two for an apparatus for making the product, and one or two for using the product.  Ostensibly the Commissioner was merely reminding the public of long-standing ILPTO practice, as most recently enunciated in a 2004 decision of this same Commissioner.  However, there really is no basis in law for the arbitrary limitation of the number of independent claims; and in point of fact, I’ve personally prosecuted applications with numerous independent “Swiss” claims, which belies the assertion that this really represents long-standing ILPTO practice.

 

Finally, we come to this week’s gem.  Rather than paraphrase the Commissioner, I translate here his entire missive:

 

Commissioner’s Circular No. MN81

 

15 February 2010, 1 Adar 5770

 

To:    The Community of Applicants, Patent Agents and Lawyers

From:    Dr. Meir Noam, Commissioner of Patents, Designs and Trademarks

Re:   Division of Patent Applications

 

The purpose of this Circular is to inform the public of the interpretation given by the Patent Office to §24(a) of the Patents Statute, 1968 – 5728 [NOTE: this is a typo – the statute was passed in 1967; it is the Rules that were adopted in 1968 and reflect this in their title.  But that’s small potatoes in the present context - DJF].

 

1. §24(a) states the following: “As long as the application has not been accepted [i.e., opened to the public for inspection following completion of substantive examination – similar to publication in the USPTO Gazette in the pre-18-month publication days – DJF], the applicant may demand that it be divided into individual applications.”

 

2. This section is given to two interpretations: one, that the parent application, and it alone, may be divided until the date of acceptance; the other, that the parent, and any application divided therefrom, may be divided until each one has been accepted.

 

3. The Office hereby serves notice that the interpretation which shall be adopted is that it is the parent case, and it alone, that may be divided until the date of acceptance, and this, inter alia, because of the need to conclude examination proceedings in a reasonable time and because of considerations of legal certainty for the general public.

 

4. This circular shall take effect as of the date of its publication on the Patent Office’s web site.

 

There are several difficulties with this circular.  For starters, if one is already going to distinguish between a parent application and a divisional in terms of the ability to further divide, then there are actually three possibilities, not just two as stated in the Circular:

 

A.     Both the parent and divisional can be divided, the parent until its acceptance and the divisional until its acceptance.

B.     Both the parent and divisional can be divided, but the deadline for dividing in both cases is the date of acceptance of the parent application.

C.     Only the parent case can be divided, and the deadline for doing so is its acceptance date.

 

While the Commissioner is trying to rule out A, it’s not clear from the Circular if he’s settled on B or C as the solution.  (One wonders if in drafting this Circular he received assistance from some of the people at the USPTO who drafted the now-defunct claims and continuation rules, which after their publication required various clarifications of the ambiguities inherent therein.)

 

The bigger problem is that the statute simply doesn’t say what the Commissioner says it says.  Other than giving a divisional the same filing date and priority claims as the parent case, the statute does not distinguish between a divisional and any other application; once a divisional has been filed, the statute treats it as an application like any other, including for purposes of §24(a).  Were the Commissioner’s view correct, then the statute would throughout need to distinguish between divisional and parent applications.  But it doesn’t.

 

This can be seen most acutely by comparing §24(a) to §24(b), which states “If an application contains more than one invention, the Commissioner may, as long as he has not accepted the application, order the applicant to divide his application”.  The applicant then divides his application in accordance with §24(a).  Now suppose that I timely file a divisional, then the parent case issues, and now the examiner says my still-pending divisional claims encompass two inventions.  According to one notice already mentioned above, that constitutes an order to divide the application under §24(b).  Yet according to the latest circular, I CAN'T divide the application at that point, since under §24(a) a divisional, if it can be further divided at all, can only be divided until its parent case has been accepted (“application” in §24(a) referring to the first-filed case in the series) and in this scenario I’m already past that stage. 

 

So in this scenario I respond in either one of two ways.  I could say, Mr. Examiner, you’re no longer empowered to issue an order under §24(b) – you missed the deadline to tell me to divide the application, since the parent case was already accepted, and “application” in §24(b) refers to the same parent application as does §24(a).  Or I could respond, Mr. Examiner, you’re empowered to tell me to divide the application, since the terms “application” and “accept”, respectively, in §24(a) and §24(b) mean different things, but now you’ve given an order with which I can’t comply, since §24(a) prohibits me from dividing my application after its parent has already been accepted. 

 

The second answer makes no sense.  Why would the statute use similar phrasing in §24(a) and §24(b), yet have that phrasing mean completely different things in the two contexts?  And why would the statute empower the Commissioner to order an applicant to do something that the statute in the immediately preceding line prohibits? 

 

But the first answer makes no sense either: inasmuch as §8 stipulates that a patent shall be granted on only one invention, clearly the Commissioner must be able to tell applicants to divide their applications whenever he finds that an application is directed to more than one invention.  

In addition to the logical inconsistencies with the Commissioner’s position, it’s also interesting to note that in the over 40 years since adoption of the statute, not once has any previous commissioner or any court ruled that the time limit for filing a divisional of a divisional is the publication date of the parent case, let alone that filing a divisional of a divisional is verboten.  And given the large number of pre-grant patent oppositions filed in Israel, if indeed the filing of a divisional of a divisional was impermissible under the statute, surely someone would have cited this as grounds to oppose the grant of a divisional-of-a-divisional.  But that hasn’t happened either.  How reassuring to know that after 40-some years, this Commissioner has finally gotten it right.  And that he will no doubt have to entertain some opposition or revocation actions against divisionals-of-divisionals on the grounds that they were improperly filed.  (One wonders if he’ll be willing to refund, with interest, all the examination, publication and renewal fees paid by those applicants over the years for those divisionals-of-divisionals that he maintains the ILPTO should never have accepted in the first place.)

 

Finally, we have paragraph 4 of the circular.  This paragraph isn’t problematic so much as telling.  When one enacts a new policy that changes the status quo, that policy needs a starting date.  But if we’re talking about statutory interpretation, jurisprudential theory says that that interpretation has always been the correct one.  If indeed §24(a) says that one can’t file a divisional of a divisional, or that one can but the time limit for doing so is the publication of the grandparent case, then §24(a) has said this since it was adopted and came into force in 1967.  We don’t need to be told the proper interpretation of this section this in 2010, let alone be told when this interpretation will come into force. 

 

Thus the inclusion in the Circular of a paragraph announcing a starting date is a sort of Freudian slip.  This inclusion suggests several things.  It suggests that the Commissioner doesn’t believe what he wrote.  It suggests that that he knows full well that divisionals-of-divisionals are permissible, and that the deadline for filing a divisional from an existing divisional application is the acceptance date of the existing divisional, not of the grandparent case.  And it suggests that that he knows the issue of “interpretation” is merely a fig-leaf meant to mask his disregard for the plain meaning of the statute, and for the democratic process.  I’m not fooled. 

 

I am, however, insulted.  There may be arguments to be made for and against allowing divisionals of divisionals (though I can’t really come up with a good argument against; the fact that the EPO isn’t fond of them means they’re probably a good idea).  But hitherto Israel has allowed them, and the statute that permits such filings remains unchanged.  If anyone feels that the policy embodied in the statute should be changed, they are free to make their arguments in the public sphere and to lobby the Knesset to change the statute.  It is not the place of an unelected bureaucrat, whose position is an administrative and quasi-judicial one, to usurp the prerogatives of the public and the public’s elected representatives, and to arrogate for himself the role of policy-maker.  That Dr. Noam acts as if he may do so constitutes a slap in the face to the Israeli public.

 

Then again, maybe the Commissioner just views this as good business: after convincing the powers-that-be to allow the ILPTO to undertake a significant hiring increase in the last several years, and following a significant drop in the number of new applications filed in Israel in 2009, the Commissioner may be looking for ways to increase the ILPTO’s workload, so all those examiners don’t sit there twiddling their thumbs.  But if that’s the case, why require applicants to do the examiners’ work for them by providing examination reports and responses from abroad?

 

Unlike the Commissioner’s other forays into ultra vires land, I believe that this one has a reasonable chance of being directly challenged.  It’s not inconceivable that a pharmaceutical company will have a third-generation divisional application that it wants to get on file; or perhaps an adverse party will challenge an application or a patent on the grounds that it is a third-generation divisional. 

On the other hand, maybe here too Dr. Noam will side-step the bullet.  Most pharma patents in Israel are handled by a few large offices, who will be more than happy to advise their clients that all divisionals need to be filed before the parent case is accepted – a position that just happens to align with those offices’ interests in cash flow.

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.