Academic journal article Boston University Law Review

Five Solutions to the Rems Patent Problem

Academic journal article Boston University Law Review

Five Solutions to the Rems Patent Problem

Article excerpt


Two principles collide in the pharmaceutical industry. On the one hand, the U.S. Food and Drug Administration ("FDA") approves potentially dangerous drugs under Risk Evaluation and Mitigation Strategies ("REMS") programs when a drug's benefits outweigh its risks.1 But on the other hand, brand firms can prevent generic competition by patenting these programs.

REMS patents, which claim compliance with FDA-imposed REMS programs, pose two problems-one procedural, the other substantive. First, current practice is to list REMS patents in the orange Book even though such listings may be invalid. This behavior has significant consequences as the listing allows the brand to obtain an automatic 30-month stay of generic approval. Second, because a REMS program appears on a product's label2 and generics must copy that label,3 REMS patents threaten generics with claims of induced infringement. As a result, the generic will typically infringe the REMS patent.

We offer five solutions to this problem. First, we target brands' listings of REMS patents in the Orange Book. Statutory provisions and FDA regulations make clear that REMS patents do not fall within the categories of patents that can be listed because they do not claim a drug or method of using a drug.4 We recommend that generic firms, after being sued for patent infringement, file counterclaims to delist REMS patents. We also propose that the FDA issue guidance making clear that REMS patents cannot be listed in the Orange Book.

Second, we suggest more rigorous scrutiny of REMS patents in the courts and at the U.S. Patent and Trademark Office ("PTO"). We explore options that the America Invents Act5 ("ALA") made available, such as inter partes review ("IPR") and covered business method ("CBM") review, and we examine challenges that raise significant concerns based on patentable subject matter and obviousness. Such challenges are particularly likely to be successful because most REMS patents in force today were prosecuted before the landmark Supreme Court decision in Alice Corp. v. CLS Bank International,6 which limited patentable subject matter.7

Third, we apply the four-factor test the Supreme Court articulated in eBay Inc. v. MercExchange, L.L.C.,8 for assessing whether courts should award injunctions in cases of infringement.9 We conclude that the outcome on the irreparable-harm factor is mixed but the other three factors counsel against an injunction because the adequacy of damages, balance of hardships, and public interest all favor monetary damages.

Fourth, based on the role REMS patents play in the regulatory system, the limited need for the patents, and the significant potential that such patents will block generic entry, we recommend that Congress mitigate REMS patents through amendments to the Food and Drug Administration Amendments Act of 2007 ("FDAAA").10 And fifth, we recommend, similar to the treatment of tax-strategy patents in the AIA, that Congress deem REMS patents to fall within the "prior art."

Each of these five solutions offers unique benefits. The first addresses the inappropriate 30-month bottleneck that arises from listing patents in the Orange Book. The second promises to root out invalid patents. The third incorporates policies at the heart of the regulatory regime by recommending damages rather than injunctions. And the fourth and fifth apply more global approaches that incorporate the lack of need for REMS patents and severe anticompetitive threats they pose. In short, the five solutions offer the hope of reconciling generic competition and REMS patents.

I. Regulatory Background

As much as any setting, the pharmaceutical industry is characterized by a complex regulatory regime. This Part introduces two of the leading components: the Hatch-Waxman Act11 and the FDAAA.

A.The Hatch-Waxman Act

The Hatch-Waxman Act created a comprehensive scheme governing pharmaceutical competition and innovation. …

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