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District Court Declines to Stay Integrelin Case, Putting Teva At Risk of Forfeiting 180-Day Exclusivity

By Aaron Barkoff

Millenium Pharms. and Schering Corp. v. Teva, No. 09–105 (D. Del. 2010)

Under the 'failure to market' forfeiture provision, the first ANDA filer forfeits its exclusivity is it fails to market its ANDA product within 75 days of a Federal Circuit decision of patent invalidity or noninfringement.  See 21 U.S.C. 355(j)(5)(D)(i)(I)(bb)(AA).  This presents a dilemma to ANDA applicants who wish to file a Paragraph III certification on a patent that will not expire until far in the future—specifically, more than 75 days after a Federal Circuit decision would be reached.

In this case, Teva filed an ANDA for generic versions of Integrelin (eptifibatide), an antiplatelet drug that is used to reduce the risk of acute cardiac ischemic events.  Teva's ANDA included Paragraph III certifications to U.S. Patent Nos. 5,686,570 and 5,756,451, which expire in 2014; and Paragraph IV certifications to U.S. Patent Nos. 5,807,825, 5,747,447 and 5,968,902, which expire in 2015.

Teva duly provided notice of its Paragarph IV certifications to Millenium and Schering, who last year responded by filing suit for infringing the ‘825, ‘447 and ‘902 patents under 35 U.S.C. 271(e)(2).  Last month, believing that the case will take roughly 2.5 years to litigate, and not wishing to forfeit its 180–day exclusivity, Teva filed a motion to stay the action until May 11, 2012 (2.5 years before the patents-in-suit will expire).  In its motion, Teva relied on last year's decision by the Northern District of Illinois in Abbott v. Matrix, which granted a motion to stay in similar circumstances.

Unfortunately for Teva, the District of Delaware saw things differently.  Last week, the court denied Teva's motion.  According to the court:

Given that Plaintiffs have demonstrated more than 'a fair possibility' that they will be harmed by the entry of a stay, Defendants must show that they have a 'clear case of hardship or inequity' in order to justify the granting of a stay.  Admittedly, Defendants have shown that they will be harmed if a stay is not entered, as they will likely forfeit their 180-day exclusivity period.  Defendants, however, have only themselves to blame for this result.  Defendants were aware of the statutory preconditions necessary for them to obtain the 180–day exclusivity period, and were aware of the potential that this could be forfeited given the timing of the filing of their ANDAs.  Although Defendants did not file this suit, they were well aware that their ANDA triggered the start of a 45-day period for Plaintiffs to defend the validity of their patents, and, in this sense, did control the timing of the present litigation.  Rather than wait until they could fully take advantage of their position as first filer, however, Defendants sought to prematurely reserve their place at the front of the line, and now seek an order from this Court that allows them to preserve that position.  This is not the type of hardship or balance of inequities that can appropriately convince this Court to issue a stay in the present proceedings.  Although Defendants may suffer a hardship, it is one of their own creation and, therefore, we do not think that it can outweigh the harm caused to Plaintiffs by granting this stay.

 ADDITIONAL READING:

• Millenium brief in opposition to Teva motion
• Teva reply brief
• Shearlings Got Plowed

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on April 19, 2010 (boomark / email).