Generic drug makers are pushing the limits of the Hatch-Waxman Act in a recent petition for U.S Supreme Court review. It will be interesting to see the response—from another generic firm

The petition also shows, interestingly, that generic firms face an issue new to them—the duty to disclose patents to a standards-setting body—but not to other technologies. 

At issue is interpreting the “safe harbor” under Hatch-Waxman, the 1984 law aimed at helping generic drugs enter the market by letting their manufacturers perform activities that would otherwise infringe patents in order to meet Food and Drug Administration requirements. 

The petition was filed by Amphastar, International Medication Systems and Actavis, three generic firms who are appealing a ruling that favors a fourth generic firm, Momenta. 

There’s no patent on anticoagulant Lovenox (enoxaparin sodium injection) at issue here, even though Hatch-Waxman’s intent was allowing challenges to brand-name manufacturers with drug patents. 

Instead, Momenta has a patent on the test used to analyze whether an enoxaparin sample is bioequivalent to the FDA-approved drug.

The test is required for FDA approval on an ongoing basis after market entry—but Hatch-Waxman didn’t contemplate ongoing testing. The term “bioequivalent” wasn’t even in Congress’s lexicon as they considered small-molecule pharmaceuticals in the early 1980s. 

The petition does mention that Momenta sat on a committee of the United States Pharmacopeia (USP) Convention and did not disclose that it had a patent on the standard USP test that was eventually approved. But it does not present the issue as a question for the high court to consider. 

In the 2000s, Rambus Inc. created a stir by arguably doing what Momenta did. It was a member of the Joint Electron Device Engineering Council on computer memory technologies without disclosing its patent protection on the JEDEC standard adopted. 

But the three generic drug petitioners haven’t pushed a duty-of-disclosure case in court. 

Maybe the biopharmaceutical community doesn’t consider the USP compendium as a collection of “standards” in the sense of Rambus. Or maybe the petitioners didn’t think such an argument would win. 

That’s understandable, considering that the Federal Circuit gave Rambus a pass on the fraud charge in 2003. The appeals court found that Rambus left the council before the Dynamic Random Access Memory (DRAM) standard in question was set. 

With bioequivalence becoming a bigger factor in drug approvals, it shouldn’t be long before the standards question is tested in court.