Hatch-Waxman “Safe Harbor” Could Face Two-Front Battle In Supreme Court

Momenta plans to seek high court review of the scope of the “Bolar Amendment” in an enoxaparin patent dispute; activity in a second “safe harbor” case at the Supreme Court is expected to resume now that the appeals court proceedings in Momenta v. Amphastar have concluded.

The battle over the breadth of the Hatch-Waxman Act’s “safe harbor” provision will be waged on two fronts at the U.S. Supreme Court now that an appeals court has declined to reconsider its ruling in a dispute involving Lovenox generics.

On Nov. 20, the Federal Circuit U.S. Court of Appeals denied a petition from Momenta Pharmaceuticals Inc. and marketing partner Sandoz International GMBH asking the full court to reconsider an appellate panel’s 2-1 decision that Amphastar Pharmaceuticals Inc.’s enoxaparin quality control batch testing was protected under the safe harbor and did not infringe Momenta’s method patent.

Both sets of parties in the dispute – Momenta/Sandoz, and Amphastar along with its commercialization partner Allergan PLC – currently market generic versions of Sanofi’s blood thinner drug, and the Federal Circuit’s decision not to rehear the case has no impact on the commercial market’s status quo.

However, this unusual patent dispute among generic manufacturers will now move to the Supreme Court, where another case related to the safe harbor’s scope is waiting.

“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 in a statement. “We strongly believe that the [appeals court] 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.”

Following In The Footsteps Of Classen

In its Aug. 3 decision, the panel majority ruled that Amphastar’s testing was aimed at generating information necessary to satisfy FDA regulatory requirements, thus bringing the activity within the confines of the so-called “Bolar Amendment.” Under this provision, use of a patented invention “solely for uses reasonably related” to the development and submission of information under a federal law that regulates the manufacture or sale of drugs is protected from infringement claims.

The majority also held that Amphastar’s retention of batch testing records satisfied the safe harbor’s “submission” requirement even though such information may never be filed with the agency as part of an application (Also see "Manufacturing Patents In Peril After Court Extends Hatch-Waxman “Safe Harbor”" - Pink Sheet, 6 Aug, 2012.).

In a harsh dissent, Chief Judge Randall Rader said the ruling conflicts with the Federal Circuit’s own August 2011 holding in Classen Immunotherapies v. Biogen Inc., which is currently on appeal to the Supreme Court. In Classen, a divided panel ruled that the safe harbor did not protect GlaxoSmithKline PLC and Biogen Idec from claims that their post-approval activities violated Classen’s patents related to immunization schedules (Also see "Bilski's Broad Sweep: Federal Circuit Says Vaccination Schedule Analysis Is Patentable" - Pink Sheet, 31 Aug, 2011.).

Rader also suggested the Momenta v. Amphastar case should be reheard en banc by the appeals court, thereby setting the stage for a full court review.

In a petition for rehearing en banc, Momenta and Sandoz said the panel opinion conflicts with the Classen decision and threatens the viability of manufacturing and test method patents as well as drug compound patents. Amphastar and Watson opposed the rehearing request, saying that the panel decision squares with both Classen and Supreme Court case law interpreting the safe harbor and there is no evidence that the decision will negatively impact the pharmaceutical industry (Also see "Hatch-Waxman “Safe Harbor” Ruling Threatens Compound Patents, Momenta Says" - Pink Sheet, 22 Oct, 2012.).

Momenta’s announcement that it will file a petition for certiorari means that the Supreme Court will now have an opportunity to clarify the safe harbor’s scope, if it so chooses, in two different cases.

In June, the Supreme Court requested the U.S. Solicitor General submit a brief expressing the government’s views on the issues in the Classen case (Also see "Hatch-Waxman Safe Harbor Could Get Supreme Court Review" - Pink Sheet, 25 Jun, 2012.). However, that brief has not yet been submitted, and it was understood that the Solicitor General was awaiting the outcome of the rehearing petition in Momenta v. Amphastar before making its submission in Classen.

With the Federal Circuit proceedings in the enoxaparin dispute now complete, the Classen case is expected to move forward at the high court. However, the Solicitor General could decide to consider the Classen and enoxaparin cases together when submitting the government’s views on the safe harbor issue, a source told “The Pink Sheet” DAILY.