Amicus Brief Filed in Oil States vs. Greene Energy Group Supreme Court Case: The Critical Role of Patent Challenges in Increasing Competition and Reducing Drug Prices

30 Oct 2017
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In 2011, Congress passed the Leahy-Smith America Invents Act (“AIA”) to curb the spread of unmerited patents, stop abusive litigation, and ensure a fair playing field for patent applicants. Leahy-Smith America Invents Act, Pub. L. No. 112- 20, 125 Stat. 284, 35 U.S.C. § 1 et seq. (2011). In the face of industry overreliance on patenting, the AIA took a major step towards restoring the integrity and strength of the U.S. patent system. Specifically, the legislation created an administrative framework known as inter partes review (“IPR”) to ensure that patent monopolies are restricted to their legitimate scope. Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144 (2016).

As a “specialized agency proceeding,” IPR enables the United States Patent and Trademark Office (“PTO”), through the Patent Trial and Appeals Board (“PTAB”), to reevaluate its initial patentability decision and cancel unpatentable claims. Id. at 2143- 44; see 35 U.S.C. § 316(c). Third-parties may request this procedure, and each case is heard by a panel of three judges who are experts in the patent field. This administrative framework promotes public participation and transparency in the U.S. patent system, and the PTAB has established itself as an effective and efficient arbitrator.

This brief articulates the policy rationales in favor of administrative review. In particular, IPR is crucial for the elimination of unmerited patents, which enable certain corporations to unfairly overmonopolize the pharmaceutical market. To increase profits, pharmaceutical companies routinely seek secondary patents that extend their drug’s 3 exclusivity period. A substantial portion of these patents are based on well-known scientific principles that have been in the public domain for decades. As such, many secondary patents are unmerited and do not satisfy the pertinent legal requirements. Instead, these patents seek to stifle competition from other drug manufacturers without providing further scientific advancements to the pharmaceutical field and the public. Extended exclusivity periods create prolonged monopolies which, in turn, contribute to rising drug costs.

The PTAB, however, represents one of the patent system’s most fundamental checks and balances. As an administrative body, the PTAB promotes the timely and efficient resolution of patent challenges without the delays and costs associated with litigation. The expedient review afforded by the PTAB through IPR is crucial to reduce the high cost of pharmaceutical drugs. IPR, therefore, is an important and necessary tool in the fight to lower drug prices because it allows the timely removal of unmerited patents, which promotes competition.

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