Senator Hatch Files Amendment To Shield Drug Patents From Challenge

An amendment to Senate Bill S.974 filed by Orrin Hatch (D, VT) seeks to protect brand-name pharmaceutical companies from post-grant patent challenges. The amendment, if passed, would require applicants for generic and biosimilar drugs to certify that “neither the applicant nor any party in privity with the applicant has filed, or will file, a petition to institute inter partes review or post-grant review” of a patent covering the brand name version of the drug. In addition, the amendment proposes to end “manipulative” use of IPRs by making it illegal for a petitioner, or an affiliate of a petitioner, to “engage[] in a short sale of any publicly traded security of the owner of the patent that is the subject of the petition” during the 90 day period before and after the filing of the petition.

Hatch has been critical of IPRs, but only in the way they effect the brand name drugmakers that have paid him over $500,000 over the past 5 years. His comments referred to the use of IPRs against drug companies as an “unintended consequence[]” and remarked that the procedure is a “blunt[] instrument.” Of course, large drug companies have always played by different rules, and Hatch’s amendment is just the latest in a string of advantages to which ordinary inventors simply lack access.

Hatch is correct, of course, that IPRs are a blunt tool that operate without nuance. The process places patent owners behind the proverbial eight-ball, interpreting patent claims in ways that make them harder to defend. Further, until very recently, patent owner amendments were not being properly considered. While Iancu’s influence may ultimately make IPRs are more neutral process, S.974 makes us wonder. If IPRs are “bad” for pharmaceutical inventions, aren’t they bad for all inventions?

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