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GPhA Files Amicus Brief in Appeal of "Baseless Paragraph IV Certification" Case; Warns of Chilling Effect on Future Patent Challenges

By Aaron Barkoff

Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir.)

In February 2006, the U.S. District Court for the Southern District of New York determined that Takeda's patent on pioglitazone, the active ingredient in ACTOS, is neither invalid for obviousness nor unenforceable due to inequitable conduct.  In the court's 124-page opinion, the court remarked, "The length of this Opinion is occasioned by the need to address the many iterations of the defendants' arguments, as they searched for a viable theory to attack the '777 patent."

Later in 2006, the court awarded $16.8 million in attorney fees to Takeda ($5.4 million from Alphapharm; $11.4 million from Mylan), finding this to be an exceptional case under 35 U.S.C. § 285.  In a 51-page opinion, the court explained that "Alphapharm and Mylan each filed baseless Paragraph IV certifications attacking the validity of the '777 Patent," in violation of the "duty of due care" ANDA filers are held to under the Hatch-Waxman Act.  Moreover, according to the court, they "each engaged in other litigation misconduct," including (by Alphapharm), "constantly shifting its theory of obviousness," in bad faith; attempting at trial to insert "entirely frivolous" arguments of inequitable conduct; and ignoring a court order and offering an untimely advice of counsel defense; and (by Mylan), acting "without a reasonable basis and in bad faith in pursuit of its inequitable conduct claim."

Alphapharm and Mylan appealed both decisions to the Federal Circuit.  In June of last year, the Federal Circuit affirmed the decision on the merits of the patent case, which will keep any generic versions of ACTOS off the market until at least 2011, when the '777 patent expires.  The appeal of the attorney fees decision has now proceeded to the briefing stage.  And, signaling that it has a "critical interest" in the case, GPhA has weighed in with its own amicus brief.

GPhA's brief asserts that the district court "placed too much weight on Mylan's and Alphapharm's decision to take the case to trial on grounds other than the particular theories of invalidity that they had stated in their respective pre-suit notice letters."  According to GPhA, "such an evolution of a defendant's litigating position is unexceptional.  Reversal is vital because this aspect of the district court's ruling will undermine the efficacy of the Hatch-Waxman scheme by deterring future ANDA filings by many companies, keeping generic drugs off the market and increasing the cost of drugs to the consumers who depend on them."  GPhA's brief addresses only this aspect of the district court decision.

Alphapharm's and Mylan's opening briefs are available below.  Takeda's opposition brief is due May 23rd; reply briefs will be due in June; and oral argument is expected to be scheduled for late fall.

More:

• Alphapharm's opening brief
• Mylan's opening brief
• 2006 article about baseless paragraph IV certifications, authored by lead counsel for Takeda

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on May 12, 2008 (boomark / email).