As we have reported, three cases being argued at the Federal Circuit in November attracted amicus briefs. One of these cases is Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC. In it, Teva challenges a district court’s injunction requiring it to delist five patents from the Food and Drug Administration’s Orange Book. This is our argument preview.
In its opening brief, Teva argued “[t]he district court’s decision misapplies settled law making clear what it means to ‘claim’ a product: if the patent reads on the drug product, it ‘claims the drug’ as the statute uses that phrase.” In its view, “[t]he district court’s statutory interpretation likewise disregards the applicable statutory definition of the term ‘drug,’ which includes not just any ‘article’ that treats an illness or affects the body’s functioning, but also any ‘component’ of such an ‘article.’” Teva argued for reversal of the injunction and to allow litigation “to proceed as an ordinary Hatch-Waxman case.”
In its response brief, Amneal argued that “the Listing Statute is properly construed to permit listing a ‘drug product’ patent in the Orange Book only if it has at least one claim requiring the active ingredient of the [New Drug Application] to be present in the claimed invention.” It contended the “Asserted Patents do not qualify under the Listing Statute for inclusion in the Orange Book” because “none qualify for listing as a ‘drug product’ patent that ‘claims the drug for which [Teva] submitted the application.’”
In its reply brief, Teva maintained its central three arguments. First, regarding statutory interpretation, Teva suggested “it is well-established that a patent ‘claims’ a product if it ‘reads on’ that product.” Second, continuing to challenge the district court’s statutory interpretation, it argued “a patent that claims a ‘component’ of the drug product claims the ‘drug’ and must therefore be listed.” Third, regarding the application of the law to the facts, Teva contended the “Asserted Patents are drug product patents.”
The case attracted seven amicus briefs.
Two support reversal:
- Sanofi-Aventis argued any “effects on competition” by listing the patents in question “are a function of patent exclusivity, a core principle of incentivizing innovation.”
- AstraZeneca Pharmaceuticals argued the Federal Circuit “should confirm that the term ‘claims’ as used in the patent-listing statute has its ordinary patent-law meaning of ‘reads on.'”
Five support affirmance:
- The Federal Trade Commission voiced antitrust concerns in this case, arguing that, “[a]though Teva listed the patents at issue here as ‘drug product’ patents, they do not meet either of the statutory criteria.”
- 52 Professors Of Law, Economics, and Medicine argued that “this is a classic case of ‘evergreening'” because “Teva seeks to extend its exclusivity beyond the expiration of its core patents by improperly listing patents in the Orange Book.”
- 14 Professors of Law and Medicine maintained “Teva has adopted . . . strategies” that have been “employed to delay generic competition.”
- Sandoz Inc. argued that the precedent set in this case “could have far-reaching consequences for pharmaceuticals” in the United States and also emphasized the importance of maintaining the affordability of inhalers.
- Deva Holding A.S. argued “it is up to Congress, not the Courts, to fix any larger policy issue” because “each side of the pharmaceutical industry – the brand and generic sides – have public policy arguments about the Hatch Waxman Act interpretation.”
Oral argument is scheduled to be heard on Friday, November 8. We will keep track of this case and report on any developments.