America-Israel Patent Law

Snatching Defeat From the Jaws of Victory

As reported in the previous post, the Knesset’s Constitution, Statute and Law Committee met on January 22 to discuss the bill to enable 18-month publication of Israel patent applications.  Reports from someone in attendance (sadly, yours truly couldn’t be there, although that didn’t stop the official minutes from stating that I was in attendance) were that progress continued to be slow, with discussion focusing on what information and documents would become publicly available at 18 months and how that information would be accessible – would the entire file history become available online, as in the USA and Europe, or would only certain pieces of information be available online, with persons interested in the contents of the files needing to either come to the ILPTO to inspect the files or ordering copies of their contents? 

However, the most entertaining (or, depending on your point of view, sad) part was apparently one trade group’s approach backfiring with respect to the question of third party submissions.  In particular, while the wording of the draft legislation isn’t absolutely clear about what kinds of communications third parties would be allowed to have with examiners concerning pending applications, the Justice Ministry’s view is that the amendment would permit third parties to bring to the attention of examiners information that the applicant already had an obligation to disclose, without additional comments from the third party itself.  

According to both the minutes and eyewitness account, the issue was brought up by one of the trade groups opposed to broad third-party involvement, despite the fact that the proceedings had not yet reached the point of discussing this issue.  Not only did this this approach fail to convince the committee chairman of the correctness of the narrow-involvement position, but it actually piqued the chairman’s interest in allowing broader third-party submissions, while effectively precluding the Justice Ministry from arguing the case for narrow involvement.  The issue has not yet been settled, but it seems that in this case, the group’s hired guns scored what the British would call an own goal (or, in Yankee-speak, shot themselves in the foot).

According to the committee’s web page, the committee is scheduled to resume its deliberations on this bill on February 13 and 26.

Salvador Dali Visits the Knesset

A few minutes from now, the Knesset’s Constitution, Statute and Law Committee will continue its consideration of the bill to enable 18-month publication of patent applications. The Committee’s first hearing on this bill took place on December 7, and consisted primarily of grandiose, grandstanding statements by socialist-leaning members of Knesset (who generally made statements about “social justice” which weren’t germane to the issue of 18-month publication) and lawyers for innovator and generic pharmaceutical companies (who also included irrelevant statements), although there were also a few statements from ostensibly neutral people, viz. representatives of the Israel Bar Association (an organization to which all lawyers in Israel must belong) and a volunteer group called the Association of Patent Attorneys in Israel. A colleague who works in-house for the local branch of a global innovator drug company characterized the proceedings as “surreal”.

Very little headway on the substantive provisions was made at the first meeting; presumably such headway will be made today, accompanied by fireworks as the local generic drug industry (which has been lobbying heavily to amend this bill so as to strip the statute of teeth) attempts to impose its will. If the past is any indication, no other industries or even individuals are interested in the goings-on regarding this bill, which is a shame, since, as a law school professor of mine put it, politics is played by those who show up.

A fuller accounting of the bill and the proceedings will follow in future post. However, there is one subtle aspect in which the December 7 proceedings were more surreal than my colleague may have appreciated. That has to with the way in which Supreme Court decisions are used in political discourse in Israel. Specifically, it’s not unusual for politicians to point to statements by the Israel Supreme Court as providing moral grounding for their proposals. (Perhaps in a future post I’ll go into what I see as the sociology of this phenomenon, but in a nutshell it related in part to the fact that the same court sits as the land’s highest appellate court as well as a court of first instance in certain administrative or constitutional law proceedings.) This was certainly the case at the December 7 hearings, in which several of the speakers pointed to statements by the ILSC regarding the need to balance incentives to innovate with the public’s need for cheap drugs.

What I found ironic was that one of the recent Supreme Court cases that contains language to similar effect (Unipharm v Smithkline Beecham, Civil Appeal No. 8802/06) itself support its position by quoting an earlier Supreme Court decision (Civil Appeal By Leave 5768/94, the so-called “AShIR decision”) that the present bill seeks to overturn. AShIR is a 1998 decision in which, under a theory of unjust enrichment based in Israel’s Unjust Enrichment statute, the Court recognized intellectual property rights in certain manufactured goods for which statutory IP rights (patent or design) were not available, either because the manufacturers did not seek such rights, such rights had been obtained but expired, or the items were already known and therefore not susceptible of patent or design protection. The bill currently under consideration would preclude suits such as AShIR from being brought again in the future.

If you’re going to quote someone in support of your position, you probably shouldn’t simultaneously be trying to undermine that person with the very legislation for which you seek support. But memories in the Knesset don’t seem to be very persistent.

If Pigs Had Wings or, Is The Israeli Generic Drug Industry About to Ambush the Patent Statute? Proposals Waiting in the Wings of the 18-Month Publication Bill

The previous post analyzed the bill for 18-month publication that will be discussed in committee at the Knesset on December 7, and explained how one of the provisions in the bill, which would enable third-party comments on pending application, is problematic. One point I didn’t mention is that in the USA, third parties are statutorily barred from communicating with the USPTO about pending applications. See MPEP 1134 and 1134.01.

The inclusion in the bill of a provision explicitly allowing third party comments on pending applications, while maintaining pre-grant oppositions, is consistent with behind-the-scenes lobbying by the local generic drug industry. But it may just be the tip of iceberg: rumor has it that that industry wants to use the 18-month publication bill to make a host of other changes in local practice, all of which would work to the detriment of patent applicants – i.e., those parties that actually invent things, instead of free-riding on others’ investments, which is the generics’ modus operandi. The changes would adversely affect not only the innovator pharma companies that develop new life-saving medicines, but patent applicants in all fields of endeavor. [Update: the relevant Knesset Committee's web site now contains a marked-up version of the bill, including comments from the committee's legal advisor regarding the generics' wish list.]

Specifically, the generics want to (a) preclude applicants from amending their applications once those applications have published; (b) be granted rights to practice inventions that are disclosed but not claimed in the published application, and only claimed after publication (and eventually granted in the patent); and (c) be able to force early examination of others’ patent applications. I will discuss each of these in turn.

No Amendment After Publication: as discussed in an earlier post, the draft version of the bill included such an amendment, but it was removed in the bill that passed a first reading in the Knesset. To anyone who has ever engaged in patent drafting and/or prosecution, the idea that one should be precluded from amending one’s claims during prosecution is ludicrous. If you’re a reader who doesn’t fall into that category – and unfortunately, no members of Knesset, to the best of my knowledge, have ever applied for a patent, which is why the generics can try to get away with something like this – I’ll try to explain.

The patent system is meant to encourage innovation, but even when an inventor has perfect knowledge and is a soothsayer, a patent is one of the most difficult legal documents to draft properly. Not only does the invention itself have to meet the substantive requirements that it be useful, novel and non-obvious, but the patent application must meet the procedural requirement of enabling others in the field of endeavor to practice the invention. The application has to provide support for whatever is eventually claimed. And the application is frozen in time, as the addition of new matter is after filing is prohibited. In short, the deck is stacked against the applicant from the outset – here in Israel even more so than elsewhere, due to the existence of pre-grant oppositions.

And because inventors do not have perfect knowledge and are not oracles, drafting a patent application is a lot like driving down the highway with a blindfold on: you may have some idea where you want to go but you don’t what curves lie ahead. Usually, at the time a company has to file a patent application, it has incomplete information regarding what the marketplace will look or what embodiments of the invention it plans to commercialize. Often, the applicant does not have in hand all the data it needs to establish why its invention is non-obvious in view of the prior art. Or it may have tried its best to find relevant prior art but still missed something. And budgetary limitations may cause an applicant to restrict the number of claims it initially includes in its patent application, either because of constraints on attorney time or because of fees for excess claims (such as Israel’s imposition two years ago of a 500 shekel fee for each claim over 50).

So the applicant does its best to prepare and file a patent application that describes as many aspects and variations of its invention that it can, while excluding from the scope of the invention the prior art of which the applicant is aware. But the applicant may (and usually does) nevertheless find it necessary to amend its claims after filing, for example in order to overcome previously unknown prior art found by the examiner, or to better claim an embodiment that in view of clinical test results or market research obtained after filing appears more likely to be the commercial embodiment than the one that was considered the most likely commercial embodiment when the application was filed.

To prevent an applicant from amending claims once the application has been published is the epitome of putting form over substance. In most cases, such a stricture would deprive patent applicants of the ability to obtain meaningful protection for their inventions. In some cases, it would result in inventions being maintained as trade secrets, rather than risk disclosing the invention only to be denied commercially meaningful patent claims due to formal strictures on claim amendments. And in the case of medicines, the inability to amend claims would undoubtedly lead to potentially useful medicines never being developed, because without adequate patent protection, no one will invest the hundreds of millions of dollars necessary to obtain FDA or EMA approval.

Intervening Rights: if they don’t succeed in preventing claim amendments, the generic manufacturers want the right to practice any invention that is disclosed but unclaimed in the published patent application, should the unclaimed material eventually be claimed in the patent. That would apparently work in two ways:

(a) Suppose that I file a patent application disclosing an invention that contains elements A, B and C, and optionally D and E. My published claims recite ABCD. If the generic drug companies have their way, a competitor will be able to begin work on ABC, since I haven’t claimed it. When I then broaden my claims during prosecution, so that my issued patent includes a claim on ABC, my competitor will still be free to practice ABC, even if my claim on ABC is valid.

(b) Conversely, the competitor starts to work on ABCDE. During prosecution I amend the claims so that the patent issues with claims on ABCD and ABCDE. I sue for infringement. It’s found that ABCD is invalid over the prior art, but ABCDE is valid. I still lose: since ABCDE wasn’t among my originally published claims, my competitor now has an intervening right to practice ABCD.

Like the proposal to limit claim amendments, this proposal would put form over substance, punishing an inventor for a set of claims that he didn’t realize at the time claimed more or less than he was entitled to claim. Creating intervening rights based on published patent applications would undermine the public policy behind the patent system, which says that an inventor is entitled to a patent on anything useful, new and non-obvious that he’s invented and adequately described in his patent application.

The generic companies apparently assert that they need these intervening rights because otherwise they’ll be stuck on the sidelines, waiting to see what claims the application eventually gets. But that’s specious. Aside from the stupidity inherent in making patent policy for everyone based on the interests of one narrowly-focused industry – and in Israel’s case, an industry that is based entirely on the idea of reaping the rewards of others’ efforts – the fact (to which any veteran patent attorney can attest) is that third parties, including generic drug companies, can make reasonable determinations as to what valid claims can and can’t arise from a particular patent application. But don’t take my word for it. As Unipharm, one of the local generic companies, proudly says on its web site:

“In the current pharmaceutical-IP environment where major pharmaceutical companies are protecting their product with multiple patents, Unipharm has the capabilities of accurately evaluating a product's patent protection suit [sic] and to act accordingly: either to stay off the market until the patents expire, to try to go around the still valid patents or to try to invalidate the patent and launch a generic version as soon as legally possible.”

The world’s leading patent systems allow an applicant to amend his claims during prosecution to include anything supported by the specification, whether or not that claim was present in the application as originally filed or published. They recognize that allowing such amendment is imperative if the patent system is to serve the ends to which it was created, and that there’s no good public policy reason to restrict an inventor’s protection to that which he claimed in a published application. There’s no reason for Israel to deviate from this. Unless it wants to be in the same category as such invention powerhouses as Venezuela.

Third Party Requesting of Examination: The generics also want to amend the law to allow third party requests for expedited examination of others’ patent applications. In U.S. terms, they want to be able to file requests to make special in others’ patent applications. Their argument is that the indeterminacy inherent in the delay between publication and patent grant leaves them in an untenable legal limbo, and that the big, bad innovative drug companies game the system, using multiple patent filings and prolongation of ex parte patent prosecution to keep a sword hanging over the generics’ heads.

Now, I’m the first to agree that in an ideal world, inventors would at the outset be able to conceive of the exact commercial embodiments of their inventions. They’d be able to write perfect patent applications that describe and claim exactly the inventions to which they’re entitled over the prior art – not an inch more and not an inch less. The day that patent applications were filed, they would immediately be allowed, because there would be no backlogs at any of the world’s patent offices. Competitors would know exactly what they can and can’t do in view of the immediately-granted patent, because there would be no ambiguity in any claim language.

And if pigs had wings they could fly.

In other words, the generics’ tale is a good yarn, but it doesn’t stand up to scrutiny. Ours is not an ideal world. Patent applications are rarely perfectly written, and they’re never examined on the day they’re filed. Inventors and their associated small businesses usually need time and money to develop and commercialize their inventions, but they have to file patent applications before they can seek funds. In the pharmaceutical industry, patent applications have to be filed years before clinical testing begins, let alone a new drug is approved for use, and this is true regardless of whether the company is one of the industry giants or a start-up.

In short, both patent applicants and their competitors are inconvenienced by the fact that the patent system is designed and operated by people, not omniscient beings. But that’s life. What entitles generic drug companies to now receive special treatment so that they won’t be inconvenienced? Indeed, as shown by the quote from Unipharm’s web site, they’re not really inconvenienced, since they can assess what claims their competitors can validly obtain and what claims they can’t.

Moreover, Israel is a country in which private property is respected. We don’t allow one individual to tell another how and when to spend his money. But that’s just what the generic companies’ proposal would do: since patent prosecution involves an expenditure of an applicant’s resources, the proposal would allow party A to force B into spending his resources, at A’s convenience.

In fact, inventors often rely on the fact that there will be a delay between filing and examination of patent applications: as mentioned above, the post-filing, pre-examination period provides additional time to develop results demonstrating non-obviousness or to hone in on a commercially significant embodiment of the invention.

To illustrate how ridiculous, and how self-serving, the third party request proposal is, let’s look at some numbers. According to ILPTO database, in 2007 and 2008 respectively, Pfizer filed 104 and 62 patent applications in Israel; Eli Lilly’s figures for the same years were 49 and 37, respectively. (The numbers are significantly lower, and likely incomplete, for 2009 and 2010.) Now suppose that the fee for filing a third-party request is set at 1500 shekels (presently about $400), which is a relatively high fee by ILPTO standards – it’s higher than the patent filing fee as well as the fees for opposing or seeking to revoke a patent. What’s to stop one of the local generic drug companies from filing such a request against every application filed by a particular innovator drug company? According to these numbers, even in a year with lots of patent filings, it would only take about $60,000 to force early examination of every Pfizer and every Lilly application. Moreover, were all the generics band together, they would easily have the resources to force early examination of every patent application filed by an innovator company. But those companies will certainly have prioritized their research efforts differently, and no doubt are relying in part on the natural delay in the examination queue to develop results necessary to either support some of those applications or to allow them to decide to discontinue prosecution.

There’s also the problem that by forcing the unnatural allocation of examination resources on a large scale toward the applications of certain large companies, the examination corps will spend most of its time examining those companies’ applications, at the expense of examination of the applications of smaller companies (who are not yet known and won’t necessarily attract others’ attention) for whom patent grants are critical in securing funding.

Bad Ideas From Self-Serving Players: As I’ve said previously in this blog, I’m a fan of generic drugs. But I’m also a fan of new drug development. And I’m a fan of the development of new technology generally. Those new developments rely on patents. The proposals put forward by the generic drug industry and discussed in this and the previous post are the sorts of things that could only be raised by parties that don’t rely on patents for their livelihoods. Which should come as no surprise, since according to the ILPTO database, those generic drug companies whose primary or exclusive business base is Israel have negligible patent portfolios. For instance, according to the database, in its 36 years of existence Unipharm has filed four patent applications. Two of those were abandoned during prosecution and one of the granted ones was abandoned before its 20-year term. Another company, Trima, has in its nearly 50-year history filed one application.

The generics’ proposals are hyprocritical and self-serving. For years these companies have been whining because Israel doesn’t have early publication of patent applications. Now that the state seems poised to adopt early publication, the generics say they’ll somehow prejudiced because they don’t know what claims will issue, and therefore applicants should be limited in their ability to amend, and the generics should get intervening rights based on the published application, and they should be able to request that someone else’s application be examined out of turn.

The EPO has been doing early publication since its inception, yet the EPO neither precludes applicants from broadening their claims, nor grants intervening rights to third parties on the basis of the published application (although some EPO countries do grant provisional rights to the applicant based on the published application), nor allows third parties to request examination of a competitor’s patent application. The USA has been publishing applications for over 10 years now, it lets applicant broaden claims during prosecution, it doesn't grant intervening rights on the basis of the non-claimed material in published applications, and it doesn’t let third parties even communicate about pending applications, let alone request examination of another’s application.

The Israeli generic drug companies have thrived under the present patent regime. They have nothing to complain about. They don’t need 18-month publication, nor do they need any of the additional changes they would now to like to see wrought in the system. If the generics don’t like the idea of early publication, they should lobby against it. But it’s disingenuous for them to lobby for early publication, then argue that they will somehow be prejudiced by the very thing they asked for, and to demand additional entitlements. What did they do to deserve such a windfall? These proposals are greed, pure and simple, that will serve no one but the generic companies themselves, at the expense of all the others (including players far afield from the pharmaceutical industry) who do the hard work of inventing and developing new technologies.

The USTR's Rite of Spring

Igor Stravinsky’s The Rite of Spring describes, in musically graphic terms, the sacrificing of a young maiden as part of a pagan ritual.  In recent years, the United States Trade Representative has taken to engaging in its own rite of spring, namely publishing its “Special 301 Report”.  This report purportedly addresses “the adequacy and effectiveness of U.S. trading partners’ protection of intellectual property rights (IPR)”.  In fact, that description of the report, taken from the USTR website, is something of a misnomer, as the bulk of the report focuses on what the USTR considers to be the inadequacy and ineffectiveness of its trading partners’ protection of IP rights: of the 77 countries reviewed, over half – 42 – wound up on one of the three lists of countries that don’t measure up to the USTR’s standards.  

As has become an annual part of the USTR’s ritual, Israel once again has found itself on the “Priority Watch List”, i.e. among the worst of the worst, like China.  Which for several reasons makes people who follow the Israel IP scene pause to wonder what political agenda was behind this year’s Special 301 Report, and why yet again Israel merited being the USTR’s sacrificial maiden.  

First, categorizing Israel with China is absurd.  Ignore for the moment that population-wise China is about 200 times larger than Israel, and that its GDP likewise dwarfs Israel’s.  Among the major issues with China are the widespread production of counterfeit goods and theft of trade secrets.  But there’s nothing to compare when it comes to Israel.  Regarding counterfeits, even proportionally to Israel’s size, the problem of counterfeit of goods in Israel nowhere near approaches that in China.  That’s in large part because Israel has statutory measures granting IP rights, and the executive and judicial bodies in Israel work with the rights holders to enforce those rights.  Contrast that with China, where, if statutory protections even exist, the authorities often turn a blind eye to the goings-on.  China manufactures and exports goods bearing counterfeit marks, but if those goods show up Israel, the mark owner can have them seized; Customs will sua sponte hold such goods at the port; and once seized, the fakes will eventually be destroyed, with someone from the infringing side being made to bear the costs.  Similarly, Israel has trade secret legislation, which likewise can be and is enforced.  

In fact, the USTR deems Israel’s level of protection in these areas to be sufficient.  So if Israel provides what the USTR considers to be adequate protection and enforcement on the counterfeit and trade secret theft front, what’s the USTR’s beef with Israel?  Purportedly inadequate legislation in three areas, two of them tied explicitly to pharmaceuticals: data exclusivity, patent term extension calculation, and early (18-month) publication of patent applications.  

 This brings to the fore the second puzzling aspect of the USTR’s categorization of Israel: Israel already has data exclusivity and patent term extension provisions.  It’s just that the USTR decided the protections already in place aren’t quite good enough.  That issue was actually addressed last year, when the U.S. Secretary of Commerce and the Israel Minister of Industry and Trade reached an agreement, and the USTR seemed prepared to divest Israel of its “habitual offender” status.  As reported in earlier posts (here and here), in accordance with that agreement, changes would be made to Israel’s existing data exclusivity legislation (the period of exclusivity would be lengthened from five to six-and-half years, although the legislation would still not be an impediment to Israeli drug exporters), and to its existing patent term extension (PTE) legislation (the process for obtaining PTEs and calculating PTE would be simplified, and a mechanism for filing PTE requests before receipt of MOH approval or grant of the patent would be enabled).  Furthermore, Israel patent applications, which hitherto were opened to the public only upon completion of substantive examination by the ILPTO, would be opened 18 months after the priority date.  (In fact, as reported here, a draft bill to this effect had already been circulated for comment before the agreement was signed.)  It was agreed that the legislative changes would be made quickly, and once they were made, Israel would be dropped not only from the “priority watch list” but also from the “watch list” (which lists not the worst of the worst but the merely bad). 

What the USTR may or may not have taken into account when making that last stipulation was the snail’s pace of the Israel legislative process.  Even if that was an oversight, it doesn’t make the USTR’s position any less disingenuous.  It’s not like Israel hasn’t moved at all on these things, or that the Minister out-and-out lied.  To the contrary: as the USTR well knows, there is movement, and a good faith effort is being made to push all the pieces of legislation forward.  In some cases, the delay has been due to as mundane an issue as the government ministries responsible for drafting the legislation being short-staffed.  That makes Israel an “IP offender” on the order of China? 

Moreover, the USTR didn’t tell the Israelis was that the USTR itself would further slow the amendment process, by insisting on reviewing and approving drafts of legislation.  (Why the Israeli bodies charged with drafting that legislation acceded to the USTR’s request is both puzzling and disconcerting.)  So while legislation on all three fronts is slowly making its way through the system, that’s not good enough for the USTR, which cited the failure to enact the promised reforms – the “failure” to which the USTR is partly to blame – as the primary reason for putting Israel back on the priority watch list.  As Arlo Guthrie might say, you got a lot of damn gall. 

It’s also more than a little hypocritical for the USTR to be impatient with Israel.  The Israeli legislation isn’t moving along any more slowly than “patent reform” in the USA, which has been percolating in Congress in one form or another since 2005, and only now appears to be on the cusp of being adopted.  And unlike the changes Congress seems set to adopt, Israel’s changes probably won’t gut its patent system, as Senator Leahy seems hell-bent on doing in the USA. 

The Special 301 also "encourages" Israel to adopt statutory damages for copyright infringement.  Hello, McFly?  Someone at the USTR ought to learn Hebrew: Israel copyright law has had statutory damages for an awfully long time, including in the 2007 revision of the Copyright Act.  Actually, they don't even need to learn Hebrew: learning how to use the internet would be sufficient, since WIPO Lex actually contains an English text of that statute, and section 56 says in plain English that a copyright holder is entitled to up to 100,000 shekels for damages, without the need for proof.  So before the USTR criticizes Israel for not having what it deems to be 21st century IP laws, the USTR itself might try joining the 21st century.

By publishing this report, and continuing to equate Israel with China because Israel’s data protection and patent term extension schemes aren’t quite what the USTR wants, the USTR only undermines its position in the eyes of Israeli policy makers and those who follow IP law.

A Purim Post

 

Belloq: Dr. Jones. Again we see there is nothing you can possess which I cannot take away.

--Raiders of the Lost Ark of the Covenant, 1982

 

“Of course we should keep the Panama Canal, we stole it fair and square.”

--attributed to U.S. Senate candidate S.E. Hayakawa, 1976 

 

Sunday will mark the holiday of Purim, in which Jews commemorate escape from annihilation – and obliteration of their enemies – in Persia long ago.  One of the themes of Purim is nahafoch hu, which can be idiomatically translated, roughly, as “the tables are turned”.  In that vein, and Purim being a festive and joyous holiday, I thought the news item at right from the February 21 edition of the Jerusalem Post was worth sharing.  (You can click on the image for a larger version; the html version of the article can be found here, but I don’t know how long it will continue to be available for free).  I’m not going to comment, but for those readers who aren’t familiar with the Israeli pharmaceutical scene and can’t figure out why the article brought the above quotes to mind, I’ll mention that the particular pharmaceutical company named in the article doesn’t have any patents.  As they say in Hebrew, hameivin yavin, or as they say in Yiddish, farshtey?

Physician's Lament: Let's Give Away New Drugs For Free

In October I wrote about the paragraph IV challenge to Eli Lilly’s anti-lung cancer drug Alimta^®, royalties from which had paid in full for a new $280 million chemistry building at Princeton University, the patentee.  In November, Princeton and Lilly prevailed at the district court, and in December the Princeton Alumni magazine carried a story about the university’s victory.  This prompted a letter from an alumnus – a physician by trade – bemoaning the P-IV lawsuit instituted by Princeton and Lilly, and the resulting “additional five years” of exclusivity, beyond the original patent term expiry in 2011, from which Princeton and Lilly would now benefit.  “It is likely that the standard seven-year period of patent protection has been enough to cover the development cost of the drug”, he wrote, asserting that while the university had benefited immensely from the drug, the deferment of the entry date for generic competition until 2016 would harm low-income patients who could not afford the $2800 per dose price tag.  “It is disheartening to see the University harming low-income patients and contributing to the high cost of American health care in this way”, he concluded.

 

Now, this may sound surprising coming from a patent attorney who spends a fair amount of his time protecting new molecules, but I’m a big fan of generic drugs.  You won’t catch me buying a name-brand version of ibuprofen, my pain-killer of choice.  However, I’m also a big believer in new drug development, and that costs big bucks.  And frankly, if it’s a choice between erring on the side of giving an innovator a longer period of exclusivity than necessary for its new life-saving drug – with a concomitantly high price for the drug – versus never having that drug reach the market because sufficient exclusivity wasn’t available, I’d rather have the innovator benefit from a few extra years of exclusivity.  So between that and some factual errors in his letter, I couldn’t let Dr. Herr’s remarks go without comment.  I reprint below (with some hyperlinks inserted) the long version of a letter I sent to the Princeton alumni magazine; my understanding is that a much-edited 275-word version will appear in the print edition of the magazine a few weeks hence.

As a patent attorney who has worked on both sides of the innovator/generic drug company divide, I was disappointed to see the position espoused by a health care professional with regard to the economics of innovative drugs like Alimta^® (David Herr ‘65, letters, January 19, 2011).

The FDA, acting as the public’s guardian, requires that new drugs meet stringent safety and efficacy standards.  The overwhelming cost of new drug development lies in the hundreds of millions of dollars spent in clinical trials to demonstrate compliance with those standards.  Furthermore, for every new drug candidate that receives FDA approval, dozens more fail somewhere during clinical trials, and hundreds more never even make it out of the laboratory.  Those many failures are funded by the few successes.  Put bluntly, if you want new drugs tomorrow, you’re going to have to foot part of bill today, because without a reasonable expectation of profit, no company is going to invest the kind of money required to develop new drug candidates.  So while Alimta^®, now approaching seven years on the market, may or may not have already paid for its own development, giving it away to generic competition at this time, as Dr. Herr seems to suggest be done, would doubtless harm the development of the next cancer-curing drug. 

Indeed, that Alimta is an anti-cancer drug already makes it exceptional.  According the only peer-reviewed study published on the subject (Grabowski, Nature Reviews Drug Discovery, Vol. 7 (June 2008) pp. 479-488), a new drug needs about 13-16 years of market exclusivity following its launch in order to justify its development.  Such market exclusivity is presently pegged to patents, which since 1995 have been limited temporally to 20 years from filing, with a possible extension of up to five years for delays in launch due to the FDA approval process.  But meeting FDA requirements for drugs for the treatment of cancer and chronic diseases like Alzheimer’s takes longer than it does for other types of drugs. 

Alimta^® itself is a case in point: the first patent application on the active ingredient was filed in 1989 and eventually granted as US 5,344,932 in August 1994 (not 2004, as stated by Dr. Herr), giving rise to an August 2011 expiration date.  However, FDA approval for the drug only came nine-and-a-half years later, in February 2004 – fourteen-and-a-half years after the filing of the initial patent application.  Without the possibility of a patent term extension to compensate for slow FDA approval (which extension was ultimately granted, until 2016), it is doubtful that Alimta^® would have reached the market; without the profits generated by Alimta^® over the next five years (for example, if another generic drug company were to successfully challenge the patent during that time), other promising new drugs may die in the pipeline.

Incidentally, neither the grant of a patent nor a patent term extension is a guarantee that the innovator will have market exclusivity for that optimal 13-16 year period.  Under the current system, which ties new drug exclusivity to patents, litigation over the validity of those patents is de rigueur; generic drug companies will usually be considered remiss if they don’t challenge an innovator’s patents.  And for reasons I won’t go into here, the deck is currently stacked against the innovators when it comes to patent validity challenges.  What bears mention is that making the timing of entry of generic competition dependent on the outcome litigation creates unpredictably for both innovators and generics manufacturers.  The potential for the untimely loss of market exclusivity due to the loss of a patent thus becomes part of the pricing calculus for innovators.  For this and other reasons, it would probably better to move to a set-term-from-FDA-approval regimen for determining market exclusivity; I discussed this a few months ago in a blog post written in response to an earlier PAW article about the Alimta^® litigation.

Returning to Dr. Herr’s letter, it is heart-wrenching to see someone suffer from a terminal disease solely because they can’t afford the treatment.  But would Dr. Herr prefer that in 30 years’ time his progeny have no more choices for life-saving therapies than are currently available, because in his own lifetime he gave away today’s profit-generating drugs and thus undermined future drug development?

There is, of course, a place for generic drugs in this system: after the 13-16 year window of exclusivity that makes new drug development financially worthwhile.  Not only does the arrival of generic competition cause the price of drugs in the U.S. to plummet precipitously, making those medications affordable for nearly everyone, but without the threat of generic competition, innovator companies would have less incentive to develop new drugs.  

Finally, in the global scheme, the construction of a new chemistry building at Princeton using royalties from Alimta^® is also a good thing.  The old Frick building was well past its prime was I was there in the late 1980’s; at least a few of the many students who will be trained in the new building will over the course of their careers contribute to humanity by participating in new drug development, or by developing generic versions of older drugs.

Daniel Feigelson '90

Rehovot, Israel

Getting the Best Medicines to Market, Not Just the Medicines with the Best Patents

Yesterday the latest copy of my college alumni magazine arrived.  The magazine included an article on the campus’ new chemistry building, built at a cost of about 280 million dollars, and funded entirely by royalties from U.S. patent no. 5,344,932.   That patent covers pemetrexed, the active ingredient in Eli Lilly’s Alimta^® anti-lung cancer drug, which first received FDA approval in 2004.  

Aside from making me wistful for my college years – it turns out that youth really is wasted on the young – and envious of the students who will have the opportunity to do labwork in this stunning new edifice (instead of toiling in the bowels of a 1930’s-era labyrinth, as did yours truly), what struck me was the accompanying article on the litigation around the ‘932 patent.  Or rather, my nonchalance with respect thereto.  

Specifically, my wife thought it interesting that my alma mater is suing Israel-based Teva, its subsidiary Barr and APP Pharmaceuticals for infringing the ‘932 patent.  I was unperturbed.  “Hon, this kind of litigation is routine with drug patents.  I’d be shocked if the generic drug manufacturers didn’t challenge the validity of the patent and there wasn’t a lawsuit.”  Only after making the remark did it strike me how utterly bizarre it is not only that Orange Book listings, paragraph IV certifications and the resulting lawsuits, and reverse payment settlements are the norm, but just how inured those of us who practice in this area of the legal world have become to this situation. 

The incident drove home, not for the first time, the picture painted by Robert Armitage in a presentation he gave last May at the American Intellectual Property Law Association’s spring meeting in New York.  Mr. Armitage is Senior Vice President and Chief General Counsel of Eli Lilly, and his talk focused on the fact that under the Waxman-Hatch system, the new drugs that get developed are those with the best patent protection; these are not necessarily the drugs for which there is the greatest need.  The following summary is my own restatement of Mr. Armitage’s talk, but I strongly urge readers to read his entire paper, which may be downloaded here, with the gracious permission of Mr. Armitage.

The talk began by looking at the motivations and goals surrounding the enactment of the Hatch-Waxman amendment in 1984.  New drug development, including the requisite clinical testing and the physician education and marketing necessary to get new drugs prescribed, is inherently a high-risk investment.  Consequently, new drugs are priced to provide a return commensurate with that high risk.  Waxman-Hatch was designed to create a generic drug industry that would sell copied versions of new medicines for roughly the cost required to manufacture those medicines.  It was anticipated that because generics would in effect be government-certified substitutes for the new medicines, which could be prescribed and dispensed to patients in lieu of the new medicines, generics would be able to take over the market for the new medicine, without the need to brand the copied versions, to otherwise promote them, or to educate physicians regarding their use.  Unburdened of these needs and the costs of new drug development, the entry of generic competitors to a particular drug would cause the price of that drug to drop.  In this regard, the legislation was right on the mark: in the United States, the entry of generic competition causes drug prices to plummet.

Nevertheless, Hatch-Waxman appreciated that the originators of new drugs would need to be able to recoup their investments and produce profits, or else those investments wouldn’t be made in the first place and the new drugs would never see the light of day.  The legislation chose to protect the innovators’ interests in a patent-centric manner: 

●             On the one hand, under Waxman-Hatch innovators were required to list relevant patents with the FDA, and the entry of generic drugs into the market was to await the expiration of those FDA-listed patents that would be infringed if the generic version were to be marketed.  Generic drug manufacturers, on the other hand, were provided with a vehicle to seek approval for their copies of the innovator drug prior to patent expiration, and were provided a mechanism to challenge the validity, and to defend against a prospective charge of infringement, of any of the originator’s FDA-listed patents, in order to determine the actual timing for generic drug entry. 

●                Furthermore, to encourage prompt challenges of questionable patents, generic companies were given an incentive to challenge the validity or the infringement of the FDA-listed patents: successful challengers were given the right to be the exclusive generic drug entrant into the market for a 180-day period.  This generic exclusivity period was justified on the basis that, absent the successful challenge, there would have been no generic drug entry until a later patent expiration date.

●                Additionally, recognizing that the time taken to prove the safety and efficacy of a new drug might eat into the patent lifetime, Hatch-Waxman provided a means for innovators to obtain up to five years of extension for a patent covering a new drug whose entry into the market had been delayed by the FDA approval process. 

This patent-centric regime does a poor job of ensuring that important new drugs reach the public.  The principal problem with Hatch-Waxman in creating this patent-centric regime was that, even when originally enacted, the legislation didn’t take into account the fact that patent life doesn’t correspond to the realities of pre-market drug development, let alone post-market drug development.  There is a time lag between patent filing and FDA approval; since the enactment of Hatch-Waxman, that time delay has only gotten worse. 

Thus under the no-publication-until-grant, 17-years from patent grant system in place at the time Hatch-Waxman was enacted, the scheme envisioned by the legislation wasn’t perfect, although it wasn’t necessarily unreasonable either.  Innovators with still-pending patent applications on new active ingredients that were likely to mature into drugs could delay the grant of the patents until around the time of FDA approval by making appropriate use of continuation applications.  And innovators with granted patents could still obtain an extension of patent term to compensate for time lost from the effective patent life due to regulatory review.  Nevertheless, it was possible for innovators to lose effective patent life due to the lag between patent grant and FDA approval of the new drug.

Subsequent to Hatch-Waxman, as part of its obligations under GATT-TRIPS, the United States moved to a 20-years-from-earliest filing regime.  This change in the law, without a commensurate change in the Hatch-Waxman provisions, meant that the effective lifetime of patents on new active ingredients was significantly foreshortened.  Under the post-TRIPs regime, patent applications still need to be filed early in the development process, but if FDA approval takes more than five years – which is routinely the case – the innovator isn’t compensated for the lost effective patent lifetime. 

Moreover, as part of the Medicare amendments of 2003, the 180-exclusivity for first generic filers was spread around to all generic drug companies that were the first to file abbreviated new drug applications (ANDA) on the same day, rather than the one company that was first to file in absolute terms, even if that was by a matter of minutes.  This has resulted in more generic challenges to listed patents.

As a result of this situation, companies that develop new drugs are reluctant to do so for any particular drug candidate if the drug approval process will be too long, because their period of market exclusivity – the period in which they will realize a return on their investment and generate profits for shareholders and, more importantly, for re-investment in the development of newer drugs – will simply be too short to justify the investment.  That’s the case even for drug candidates for which patent protection is available.  If there is no patent protection, forget about it: there will be no new drug, because no one will invest the hundreds of millions of dollars necessary to bring the drug to market.  (Although in the USA an innovator receives 5 years of FDA data package exclusivity protection independent of the existence of any patent protection, that five-year period is insufficient to warrant the necessary development in new drugs.)

Perversely, it is precisely the potential drugs that require the most testing, such as drugs for cancer or chronic diseases, that are the victims of this situation.  A case in point from Israel: there’s a research group here that in the early 1990’s synthesized and identified some potential anti-Alzheimer’s drugs, and file a patent application at that time.  Sometime after June 1995, the group filed a new application on some new compounds synthesized as part of their ongoing research.   Unfortunately for the group – and, possibly, for people with Alzheimer’s and their families – the group’s patent attorney made the mistake of filing the new application in the USA as a continuation-in-part of the first application, even though the new compounds could have been filed in a stand-alone application.  As a result, the new compounds lost several years of patent protection, and no one wanted to make the investment necessary to develop a commercially available drug from the group’s research.  The compounds are still sitting on the shelf today.  Maybe one of those compounds will make a good medicine for Alzheimer’s, but unde the current Hatch-Waxman scheme, we’ll never know, since at present, good patent protection is a necessary component of new drug development.

Mr. Armitage’s proposed solution for this problem is to de-couple protection for innovators from patent portfolios, by granting innovators 14 years of data exclusivity for their newly-approved drugs.  (The 14-year figure is taken from the article by Henry Grabowski published in 2008 in Nature Reviews Drug Discovery, Vol. 7, pp. 479-488.) 

This would elegantly address several issues: 

●             First, it would establish for all parties when generic competition may enter the market, rather than leaving that determination in limbo as courts deal with multiple Hatch-Waxman challenges to an innovator’s FDA-listed patents.  This in turn would enable innovators to properly assess the economics of proceeding with drug development.  It would also liberate resources within both innovator and generic companies that currently are directed to patent litigation.

●             Second, it would enable innovators to conduct after-launch testing and monitoring of the drug, including the development of new indications for the drug.  Such after-launch monitoring has become a matter of increasing concern in recent years, as the public has come to understand that the FDA does little in the way of after-launch monitoring. 

●             Third, it would not preclude others from conducting their own clinical trials and bringing their own copies of the approved drugs to market before the end of the 14-year period.   

●             Fourth, and most importantly, it would facilitate the development of drugs for cancer and chronic diseases, as the innovator would not have to concern itself with a ticking patent clock while it conducts the clinical trials necessary for drug approval.  In other words, it would enable development of the best medicines, not just the medicines with the best patents.

Mr. Armitage’s proposal makes awfully good sense.  Which is why I don’t hold out hope of it being adopted by legislators any time soon…although occasionally politicians do get things right…

Angiomax (Bivalirudin) – Another Day, Another Interim Extension and Another Patent

As discussed in earlier posts, back in early 2001 The Medicines Company (TMC) missed by one day the deadline to request a patent term extension (PTE) for US 5,196,404, which covers bivalrudin, the active ingredient in its flagship Angiomax^® drug product.  In March of this year, just days before the ‘404 patent was to expire, TMC convinced a federal judge in the Northern District of Virginia to order the USPTO to grant an interim PTE.  Per that order, the USPTO granted an interim extension until May 23, 2010. 

 

It’s now May 25, and inquiring minds are doubtlessly wondering, is the ‘404 patent in force or not?  Well, according to the Transaction History on PAIR, on Friday, May 21, 2010, the USPTO granted another interim PTE, although as of this writing that document does not appear in the Image File Wrapper; presumably it will be posted in the coming days.  Interestingly, neither the IFW nor the TH list a request for a second interim extension as having been filed, so it’s unclear from PAIR if such a request was filed by TMC or if the PTO itself docketed to issue an interim extension sua sponte in the absence of resolution of the district court proceedings in NDVa.  However, as reported by Kurt Karst at the FDA law blog, the second interim extension was granted by court order, upon an emergency motion filed by TMC.

 

Interestingly, apparently the PTO, in opposing an TMC’s emergency motion, said that it lacked the statutory authority to issue a second interim extension, and that the judge could not order the PTO to exceed its authority and in so doing violate an act of Congress, although it said it would comply with such an order if one issued.  It would have been fascinating to see what would have happened had the USPTO not obeyed the order and not issued the interim extension, thereby letting the patent expired.  The statute and rules provide for reinstatement of a patent that lapsed due to failure to pay a maintenance fee (see 35 U.S.C. §41(c) and 37 C.F.R. 1.378), with rights accruing to third parties who rely on the lapse during the intervening period.  And the statute provides for the PTO to issue interim extensions if the patent-protected product is still undergoing FDA review at the time the patent reaches the end of its natural life, at the request of the patentee (see 35 U.S.C. §156(d)(5)(B) and (C)).  But there’s nothing in the statute about reinstating a patent the term of which has expired.  Clearly, the drafters of §156 didn’t contemplate it taking over nine years from grant of FDA approval to determine whether or not a patentee was entitled to a patent term extension.  (I wonder why not?)

 

So had the USPTO had not issued a new interim PTE last Friday, and yesterday a competitor imported bivalirudin to the USA, would TMC have had any recourse?  Clearly the USPTO would disagree with the power of an Article III judge to order reinstatement of a patent in such a situation.  But even if the USPTO reinstated the patent under such circumstances, would the competitor now have acquired the right to sell the product imported while the patent was dead?

 

 

In a most definitely real and not hypothetical vein, TMC also recently acquired another patent to protect bivalirudin.  US 7,713,928, titled “Ready-to-use bivalirudin compositions”, issued on May 11, 2010 from USSN 12/563,821, filed in September 2009 as a continuation of 12/545,036, filed a month earlier.  (Curiously, PAIR does not link the issued patent to the earlier application.)  Like US 7,582,727 and US 7,598,343, both of which were filed in July 2008 and issued in the second half of 2009, the ‘928 patent was filed with both a non-publication request and a request for accelerated examination.  (Another case, USSN 12/180,550, also filed in July 2008, remains pending and unpublished, and from an IDS filed in during prosecution of the ‘928 patent, it appears there are two other related, still-pending applications, USSN 12/652,872 and 12/683,045, that have not yet come up for publication.)  However, the non-publication request was rescinded in January 2010, apparently to facilitate the filing of corresponding cases abroad. 

 

The independent claims of the ‘928 patent read as follows:

 

1.     A ready-to-use composition comprising (i) bivalirudin (SEQ ID NO: 1), or salts thereof; (ii) one or more pharmaceutically acceptable stabilizing agents, selected from the group consisting of buffering agents having a pK_a of about 2.5 to about 6.5, pH-adjusting agents, polymers, preservatives, antioxidants, sugars or polyols, and combinations thereof; and (iii) a pH of about 4 to less than 5, wherein total impurities are less than about 15% area-under-the-curve ("AUC") as determined by high performance liquid chromatography ("HPLC") at a wavelength of 215 nm after storage at 25ºC for 1 month.

 

19.    A ready-to-use composition comprising bivalirudin in an amount of about 5 mg/mL; (ii) a buffering agent having a pKa of about 2.5 to about 6.5, wherein the buffering agent is acetate; (iii) [9-10]-cycloimido bivalirudin; (iv) [11-12]-cycloimido bivalirudin; and (v) a pH of about 4.25, wherein after storage at 25ºC for one month, total impurities are less than about 15% area-under-the-curve ("AUC") as determined by high performance liquid chromatography ("HPLC") at a wavelength of 215.

 

20.    A ready-to-use composition comprising (i) bivalirudin in an amount of about 5 mg/mL; (ii) a buffering agent having a pKa of about 2.5 to about 6.5, wherein the buffering agent is acetate; (iii) sodium chloride; (iv) [9-10]-cycloimido bivalirudin; (v) [11-12]-cycloimido bivalirudin; and (vi) a pH of about 4.2, wherein after storage at 25ºC for one month, total impurities are less than about 15% area-under-the-curve ("AUC") as determined by high performance liquid chromatography ("HPLC") at a wavelength of 215 nm.

 

These claims will not present an impediment to companies wishing to copy Angiomax^®: that product is sold in lyophilized form and is reconstituted within 24 hours of use, whereas the specification of the ‘928 patent defines “ready-to-use composition” as excluding compositions which have been reconstituted within 24 hours of use.  This is in keeping with the goal, stated in the patent, of providing a bivalirudin composition that does not require reconstitution and which is stable for a long period of time in liquid form. 

 

Claims 19 and 20 are interesting in that they recite the presence of two impurities, viz. [9-10]-cycloimido bivalirudin and [11-12]-cycloimido bivalirudin.  The specification surmises that these impurities are intermediate structures involved in the formation of other, previously-identified impurities; the ‘727 and ‘343 patents are actually directed to compositions having low levels of these previously-identified impurities.  As there doesn’t appear to be any utility for the compositions containing the recited cycloimido bivalirudins, one wonders what would happen if the defense of claims 19 or 20 against the prior art came down to the presence of these two impurities.  An echo of the SKB-Apotex fight over crystalline paroxetine hydrochloride?

Angiomax: Last-Minute Reprieve for The Medicines Company (Or, How Sidley Austin Earned Its Keep)

In an earlier post, I discussed The Medicines Company’s last-ditch effort to save the exclusivity for its Angiomax product via its US 5,196,404, which was due to expire on March 23, 2010.  Last week, the Federal District Court for the Eastern District of Virginia ordered the USPTO to reconsider its decision denying TMC’s application for a patent term extension in light of issues raised by TMC, and to ensure that the patent would not lapse prior to disposition of the suit pending before the court.  In response, the USPTO issued an interim extension of the patent until May 23, but then issued a decision in which it again denied TMC’s application.  The decision did not rescind the interim extension order, and thus it still stands, unless the EDVa says otherwise before May 23. 

 

TMC’s Problem

To recap the situation, TMC’s application for a patent term extension (PTE) was filed a day late and denied on that basis.  So TMC requested reconsideration, but that too was denied in April 2007.  Rather than appeal that decision to the courts, TMC turned to lobbying, to try to secure an amendment that would have retroactively allowed for the late PTE filing.  But that effort also went nowhere.

 

Having exhausted its remedies, and having waited too long to appeal the PTO’s reconsideration decision, TMC embarked upon a new strategy: it would try to get the PTO into court through the back door, because it perceived something that could be regarded as a procedural flaw in the PTO’s reconsideration decision of April 2007.  Up until that decision, the PTO had regarded the 60-window for filing a PTE application as beginning the day after the FDA approved the relevant drug product.  The April 2007 reconsideration decision announced, for the first time, that proper statutory interpretation leads to the conclusion that the 60-window begins on the date the FDA approves the relevant drug product, not a day later.  So in December 2009, TMC requested leave to file a second petition for reconsideration, on the grounds that it hadn’t had an opportunity to properly address the new way of calculating the PTE filing deadline, since that new calculation scheme was only announced in the April 2007 decision itself.  

 

The PTO took the bait, allowed the filing of the second reconsideration request, and, as expected, denied it on January 8, 2010.  Whereupon, on January 27, less than two months before the ‘404 patent was to expire and close to three years after the second reconsideration request was denied, TMC sued the USPTO, the FDA, the Department of Health and Human Services, and their various heads in federal court in the Eastern District of Virginia, requesting that the court order the USPTO to regard the PTE request as having been timely filed and to grant the PTE.  (Undoubtedly, had the PTO denied leave to submit the second reconsideration request, TMC still would have found grounds to sue – denial of due process, perhaps? – and still would have reopened the whole can of worms.)

 

TMC Goes to Court

TMC’s argument before the court hinged on the meanings of 35 U.S.C. §156(d)(1) and §156(g)(1)(B)(ii), which respectively state in pertinent part

:

 

§156(d)(1).  To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use. * * * [emphasis added – DJF]

 

§156(g)(1)(B)(ii). For purposes of this section, the term "regulatory review period" has the following meanings:(1) (B) The regulatory review period for a new drug, antibiotic drug, or human biological product is the sum of - (i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 became effective for the approved product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507, and (ii) the period beginning on the date the application was initially submitted for the approved product under section 351, subsection (b) of section 505, or section 507 and ending on the date such application was approved under such section. [emphasis added – DJF]

 

TMC argued, first, that the FDA itself takes an inconsistent approach with regard to what constitutes a “date” under §156: for papers filed by applicants, the FDA adopted a “business hours” interpretation of the word “date”, such that papers filed with the FDA after business hours were considered to be filed on the next business day; but for papers sent by the FDA, it was the actual calendar date on which the document was sent, even the communication was sent after normal business hours.   This inconsistency within the same statutory section is ipso facto arbitrary and capricious, said TMC, and thus in violation of the Administrative Procedures Act. 

 

Furthermore, argued TMC,

(a)    the PTO adopted the FDA’s interpretation of “date” in §156(d)(1), when the PTO could instead have adopted its own interpretation of this term, namely an “after hours” definition of this term, and

 

(b)    although the PTO argued that an “after hours” definition of “date” in §156(d)(1) was precluded by the wording of the statute itself, the PTO was wrong, and an “after hours” interpretation of “date” in §156(d)(1) was not foreclosed by the statute. 

 

Since the notice from the FDA was faxed after hours on Friday, December 15, 2000, an “after hours” view of “date” in §156(d)(1) would mean that the 60-day window only opened on Monday, December 18, 2000, and thus TMC’s PTE application was timely filed.

 

The Court's Memorandum Order

On March 16, 2010 – seven days before the ‘404 patent was to have expired – the District Court issued a memorandum opinion and order.  The court ruled that in denying TMC’s second petition for reconsideration, the PTO had failed to address various many of the arguments set forth by TMC, and that the PTO itself, in earlier litigation regarding §156, had said that these statutory provisions should be “liberally construed” so as to enable the remedial nature of §156 to be given full effect. 

 

The court noted that the PTO had implicitly rejected the possibility of giving a “business hours” interpretation to “date” in §156(d)(1), without giving reasons for its position; and that this interpretation was at odds with the FDA’s own position on the use of this term in §156(g) with respect to papers filed by PTE applicants in their dealings with the FDA, but in it denial of TMC’s second reconsideration request, the PTO had not even tried to reconcile this difference. 

 

The court also noted that §156(d)(1) refers to the date on which the product “received permission”, whereas §156(g)(1)(B)(ii) refers to the date on which the application was “approved”, and therefore the “date” referred to in these sections is not necessarily the same. 

 

Thus the court issued a memorandum opinion and order vacating the PTO’s decision regarding the reconsideration petition and remanding to the PTO for reconsideration of the date of approval under §156, and ordering the PTO to “take such actions as necessary to ensure the ‘404 patent does not expire pending resolution of these proceedings”. 

 

Interim Extension

On March 18, 2010, TMC filed a request for an interim extension in accordance with 35 U.S.C. §156(e)(2).  TMC asked for the maximum 1-year interim extension, on the grounds that even if the PTO were to find immediately find that TMC had timely filed its PTE application, it would be well after March 23, 2010 when the matter would finally be resolved – it would take time for the FDA to check the amount of extension due, for that finding to be published, and for the period of public comment to pass before the PTE could be granted.  Conversely, wrote TMC, if the PTO again denied the PTE application as having been untimely filed, TMC would still entitled to seek reconsideration and subsequent court review.   

 

That same day (and in accordance with the court order), the PTO granted an interim extension  – but only until May 23, 2010. 

 

Even if TMC ultimately loses its bid for a PTE, it’s already won: every additional day of exclusivity for Angiomax is worth over ten million dollars, and its clear that the PTO will continue to grant interim extensions as long as proceedings are pending before the court.   The fact that the current interim extension was granted for only two months is a means of ensuring that TMC doesn’t drag out the proceedings longer than allowed by law, but will not result in faster disposition of the case - it will just mean that TMC will file its request for reconsideration on the last possible date.  Assuming, that is, that its lawyers at Sidley Austin (who were not the ones who handled the original PTE application) properly docket the deadline.  Which of course they will – lightning doesn’t strike in the same place twice, right?

 

The PTO's Rejection of TMC's Petition on Remand

On March 19, a day after issuing the interim extension, the PTO again determined that TMC’s PTE application wasn’t timely filed.  This time, though, the PTO addressed the points that the EDVa court said it had failed to address in its earlier decision denying the second request for reconsideration.  Among other things, the PTO said that it had originally determined the (un)timeliness of TMC’s PTE application on its own, without recourse to the FDA’s views on the matter; that a calendar day was the best way to interpret “date” in §156(d)(1) in view of the text, structure and purpose of the statute (among other things noting that a calendar day definition provide the most certainty in interpreting the statute); and that such interpretation of “date” in §156(d)(1) was consistent with both CAFC precedent and the USPTO’s historic practice (noting inter alia that the USPTO consistently uses a calendar day definition of “date” with regard to events outside the USPTO, such as events triggering an on-sale bar, and that the USPTO in its own dealings allows filings until midnight on the date in question).  Along the way, the USPTO noted that whereas the patent statute provides the Director with discretion to grant extensions in certain situations, or to allow applicants or patentees to rectify missed filing dates, no such provisions are made for the filing of PTE applications.  “By creating such a non-extendable period, Congress provided a date-certain period by which all players would know their future rights.”

 

Most entertaining were the PTO’s observation brought to support its conclusion that TMC’s predicament was of its own making.   Thus the PTO quoted from testimony given before Congress by TMC’s chairman, who averred that “Unfortunately, the 60-day requirement was evidently mistaken for a two-month requirement…”  It also cited numerous occasions on which TMC itself stated that approval for Angiomax was granted on December 15, 2000, such as in shareholder’s reports.  And no less importantly, noted the PTO, while the USPTO issued its denial of TMC’s reconsideration request in April 2007, TMC did not timely sue the USPTO or the FDA, but instead 

 

“spent the past three years lobbying Congress for a legislative fix to its problem…Thus, it was [TMC]’s choice to place itself on the courthouse steps on the eve of its patent expiration.  Just as [TMC] waited until the very last minute to file its PTE application, and them some, it likewise waited to the very last minute to seek redress of the USPTO’s adverse patent term extension decision.  [TMC]’s dire situation is therefore exclusively of its own making.” 

 

In my previous post on this topic, I likened TMC’s situation to the person who kills his parents, then pleads for mercy before the court because he’s an orphan.  Apparently the USPTO sees it that way as well. 

 

Whither the Third Parties, And Other Conundrums

Aside from the EDVa sanctioning TMC’s gaming of the system, there are other troubling aspects to this story. 

 

For starters, at least one company, Teva, has a pending ANDA for bivalirudin.  While the PTO recognized in its most recent decision that third parties (such as Teva) have a stake in the PTE determination, it is unclear that such third parties have any redress in the present situation.  I am not sufficiently versed in the administrative procedures act to know if Teva, for example, can intervene in TMC’s petitions, but considerations of justice would seem to mitigate in favor of such intervention.  Teva filed a paragraph III certification regarding the ‘404 patent, which means that but for the just-granted extension of the patent, the FDA could approve Teva’s ANDA for bivalirudin later this week.  So if FDA approval is the only thing holding Teva back from selling (and no preliminary injunction has issued against Teva on the basis of TMC’s late-granted US 7,582,727 and US 7,598,343 in the pending litigation on those patents, against which Teva amended its ANDA by filing paragraph IV notifications), then TMC will unfairly benefit from the present interim extension, Teva will lose an opportunity to make money, and consumers will pay more for bivalirudin than they otherwise should.  In the narrow administrative law view of the case taken by the EDVa, which focuses only on TMC and the USPTO’s actions, those concerns seem to have been lost.

 

Another interesting question is, why didn’t the USPTO include the explanations it provided in last week’s decision in its decision of January 8, 2010?  Inclusion of those explanations would have expedited the matter before the EDVa. 

 

Also, here the USPTO took just two days to issue a 15 page decision with annexes; so why does the USPTO putter around with re-examinations (which are supposed to be handled with “special dispatch”, i.e. quickly), especially in those cases where litigation is pending at the same time?  If the USPTO can produce this kind of work this quickly in this case, it can act more quickly in reexaminations.  Unless, of course, its new explanations aren’t new but were already in hand weeks ago…in which case, it again must be asked, why didn’t the USPTO include them in its decision of January 8?

 

This much is certain: the Waxman-Hatch amendment wasn’t meant to create the kind of uncertainty engendered in this case, or to enable players who clearly missed their deadlines to abuse the system.  And the lawyers at Sidley Austin who handled this action for TMC earned their keep – the extra income to TMC from the still-exclusive sales on March 24 will more than cover those lawyers’ fees.

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.

Angiomax (Bivalirudin): The Medicines Company sues Teva et al.; Teva as plaintiff against Lupin

Last month I discussed the issuance of The Medicines Company’s US 7,582,727, which caught my attention because (a) uncommonly for a pharmaceutical patent, it had been filed not only with request a for accelerated examination, but also with a non-publication request, and (b) it issued less than seven months before TMC’s earlier US 5,196,404, the patent that covers its product bivalirudin (sold in the USA under the name Angiomax^®), was due to expire on March 23, 2010.  Within days of the issuance of the patent, Teva and one of its daughter companies had filed a paragraph IV certification. 

 

Now, in the words of the late, great Paul Harvey, we get the rest of the story: Sherri Oslick at PatentDocs reports today that (not unexpectedly) last week TMC filed suit against Teva, Barr (a Teva subsidiary), and Pliva (which is owned by Barr).  Hello 30-month stay to Teva/Barr/Pliva’s ANDA for Angiomax.  Ok, not quite: Teva et al.’s ANDAs were filed before the ‘727 patent was listed in the Orange Book, so no 30-month stay is available.  But TMC will no doubt seek a preliminary injunction, which can still be quite valuable, even if it doesn’t extend for a full 30 months.

 

Given the relative ease with which infringement of the claims of the ‘727 patent can be avoided, and Teva’s position as the first paragraph IV challenger of this patent, it will be interesting to see if this case settles with some sort of reverse payment scheme. 

 

No less interesting is the filing last week by Teva of its own suit as a patentee against another ANDA filer, Lupin Pharmaceuitcals of India.  Lupin filed a paragraph IV certification for US Reissue Patent No. 39,861, which claims a method for the co-administration of estrogen and progestin for female contraception.  Teva is no stranger to litigation, but Teva is usually positioned as a defendant in patent infringement actions, or as a plaintiff in actions for declaratory judgment of non-infringement and/or patent invalidity.  While the suit against Lupin is not the first time Teva has sued someone for infringement of one of its patents – Teva sued Amgen last spring for infringement of its US 7,449,603 – infringement suits in which Teva is the plaintiff remain the exception.