I have reproduced the article below (and it opened up on my computer without any prompting for a password so I think it should be an open-access article)..
My guesses as to the odds:
I agree with ifwal's >90% assessment that the S.Ct. will grant cert in both Classen and MNTA and both cases will be decided together. The fact that Fed. Cir. rendered inconsistent opinions in the 2 cases -- and the Fed. Cir. is the national appeals court for patent-related cases -- should suffice for S.Ct. review of both cases. The S.Ct.'s invitation to the Solictor General to present its views on Classen in June (before the MNTA panel decision in August) indicates that the some judges were interested in the issue. Until the MNTA decision, I knew little about the Solicitor General process, but it seems fairly rare that the SG is asked to chime in on cert petitions. After reviewing several "invitation" briefs on the SG website, the SG will likely provide a fairly comprehensive brief and express its opinion on how the cases should be decided. Of course, the SG opinion is not binding on the S.Ct., but it should have influence.
As to how the S.Ct. will decide, I would assign a 60/40 probabilty that the court will affirm Classen and reverse MNTA. The legislative history as recounted by Chief Judge Rader strongly favors MNTA's position. But the statute can be literally read, as Judge Moore did in MNTA without resort to legislative history, to favor Amphastar. Scalia has long advocated disregarding legislative history if the statutory language is clear. I belive this is called the "textualist" view of statutory interpretation. Presumably Scalia could pull along a few colleagues if he considers the Hatch-Waxman language to be clear.
Here's a link to the SG website for anyone interested:
Momenta To Take Generic Lovenox Fight To Supreme Court By Ben James Law360, New York (November 20, 2012, 5:05 PM ET) -- Momenta Pharmaceuticals Inc. plans to seek U.S. Supreme Court review of a Federal Circuit decision that overturned an injunction against Amphastar Pharmaceuticals Inc. and said a lower court had interpreted the Hatch-Waxman Act's safe harbor provision too narrowly, Momenta said Tuesday.
Momenta announced that the Federal Circuit had denied its bid for an en banc rehearing to reconsider a 2-1 Federal Circuit panel decision from Aug. 3, which nixed an injunction blocking Amphastar and its distribution partner Watson Pharmaceuticals Inc. from selling a generic version of the blood thinner Lovenox.
"We will continue to pursue our appellate options and we plan to file a petition for certiorari, asking the Supreme Court to review this case," Momenta President and CEO Craig Wheeler said. "We strongly believe that the [Federal Circuit] panel decision in this case finds no support in the statutory text of the safe harbor provision of the patent law, or in Supreme Court precedent, and a final decision upholding this case could have wide-ranging, negative effects on drug development."
When the Federal Circuit lifted the sales ban, it said that the lower court had too narrowly applied the Hatch-Waxman Act's safe harbor provision — which allows drug companies to engage in potentially infringing behavior if necessary for regulatory approval — when it found that Amphastar's testing process for its generic likely relied on methods covered by a Momenta patent.
According to the panel majority, the safe harbor provision can apply to activities carried out after a drug wins government approval. Under this safe harbor, sale or manufacture of a drug that would otherwise be infringing is deemed not infringing if done under the requirements of federal drug laws.
Momenta claimed Amphastar had infringed its patent on a method of producing enoxaparin, Lovenox's active ingredient. Amphastar said that the quality-control testing methods Momenta said were infringing were required by the U.S. Food and Drug Administration and thus fell under the safe harbor, even though the testing occurred after the company won FDA approval for its version of enoxaparin.
The majority holding inspired a lengthy and heated dissent by Chief Federal Circuit Judge Randall Rader, who argued that the safe harbor is intended only to cover experiments carried out before a drug receives approval. He maintained that the majority's opinion directly contradicts the Federal Circuit's August 2011 decision in Classen Immunotherapies Inc. v. Biogen Idec et al., which he said made clear that post-approval activities don't fall under the safe harbor.
The Classen decision has been appealed to the U.S. Supreme Court, which has asked for the U.S. solicitor general to weigh in.
The debate over the safe harbor could have big implications for the pharmaceutical industry. Judge Rader's dissent argues that by placing a wide array of activities under the safe harbor, the majority's decision "will render worthless manufacturing test method patents" and represents "a sad day for property owners."
The safe harbor of the 1984 law, also known as Section 271(e)(1), states that "it shall not be an act of infringement to make, use, offer to sell or sell … a patented invention … solely for uses reasonably related to the development and submission of information under a federal law which regulates the manufacture, use or sale of drugs or veterinary biological products."
Since the statute doesn't specifically mention the FDA approval process, the difference of opinion on the Federal Circuit hinges on whether the language and legislative history of the statute suggest it's limited to pre-approval activity.
The district court proceedings had been stayed pending the outcome of the en banc appeal, according to Cambridge, Ma.-based Momenta.
An attorney for Amphastar and Watson declined to comment. A spokesman for Watson could not be immediately reached for comment Tuesday.
The patent-in-suit is U.S. Patent Number 7,575,886.
Judges Randall R. Rader, Timothy B. Dyk and Kimberly A. Moore sat on the panel for the Federal Circuit.
Momenta is represented by Robert S. Frank Jr. and Eric J. Marandett of Choate Hall & Stewart LLP and Thomas P. Steindler of McDermott Will & Emery LLP.
Amphastar and Watson are represented by Patricia A. Millett, Anthony T. Pierce, Mark Mansour, L. Rachel Lerman, Emily C. Johnson and James E. Tysse of Akin Gump Strauss Hauer & Feld LLP.
The case is Momenta Pharmaceuticals Inc. et al. v. Amphastar Pharmaceuticals Inc. et al., case numbers 12-1062, 12-1103 and 12-1104, in the U.S. Court of Appeals for the Federal Circuit.
--Additional reporting by Ryan Davis and Scott Flaherty. Editing by Andrew Park.
AI
