Momenta versus Amphastar and the safe harbour provision

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Momenta versus Amphastar and the safe harbour provision

Generics/General | Posted 26/10/2012 0 Post your comment

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).

The case concerns copies of Momenta’s blood thinning drug Lovenox (enoxaparin). The copy of the low molecular weight heparin produced by Amphastar, in the absence of a biosimilars pathway, was approved by FDA using the generic pathway via an abbreviated new drug application.

Momenta owns two patents for Lovenox and gets a share of the profit earned from a copy of Lovenox sold by Novartis’s Sandoz unit.

One of Momenta’s patents covers a method for analysing the drug for the presence of a particular compound. Such quality control testing was required by FDA when manufacturing batches of the drug in order to confirm the presence of the compound. Momenta therefore brought a claim for patent infringement against Amphastar, and the District Court granted a preliminary injunction preventing Amphastar from selling its product.

On appeal, however, the Federal Circuit found that the District Court incorrectly concluded that Momenta was likely to succeed on the merits of its patent infringement claim because the District Court had interpreted the safe harbour provision too narrowly. The safe harbour provision in the Hatch-Waxman Act permits patent-infringing activities to be carried out if they are ‘solely for uses reasonably related to the development and submission of information’ to FDA.

Momenta had argued that the safe harbour only applies to testing that is conducted in order to obtain regulatory approval of a product and not continued quality control testing (also required by FDA). The Federal Circuit, however, dismissed this argument finding that the testing in this case was reasonably related to the development and submission of information to FDA because the testing records had to be retained for at least one year after the expiration date of the batch and had to be available for FDA inspection at any time. The court distinguished this case from prior cases by emphasizing the fact that these test results were not ‘routine submissions’ to FDA, but were required to maintain FDA approval of the drug.

The ruling means that Watson Pharmaceuticals partner Amphastar can continue selling its version of enoxaparin until a trial is held. The decision has far-reaching implications, as it limits the right of patent owners to claim patent-infringement for processes that are necessary to maintain regulatory approval of generic medicines by FDA. It also expands the scope of a federal law that precludes infringement suits for actions taken in order to obtain FDA approval.

‘The opinion outlined in the ruling is a setback for Momenta in this particular litigation and has potentially wide ranging implications for all patent holders,’ commented Mr Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. He added that the company is reviewing the court’s opinion and considering its options for moving forward in this ongoing case.

*A safe harbour (law) is a provision of a statute or a regulation that reduces or eliminates a party's liability under the law, on the condition that the party performed its actions in good faith or in compliance with defined standards. Legislators may include safe-harbour provisions to protect legitimate or excusable violations, or to incentivize the adoption of desirable practices.

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Source: Momenta