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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Following several years of debate, the Senate Judiciary Committee voted 15?4 last week to approve a comprise patent reform bill, the "Patent Reform Act of 2009" (S. 515).
Following several years of debate, the Senate Judiciary Committee voted 15–4 last week to approve a compromise patent-reform bill, the “Patent Reform Act of 2009” (S. 515). The bill, which now moves to a full Senate vote, was supported by the biotechnology and generic-drug industries.
Senate Judiciary Committee Chairman Patrick Leahy (D-VT) and Sen. Orrin Hatch (R-UT) introduced the bipartisan bill in early March. The Senate Judiciary Committee first introduced patent reform in 2005 and since then has held eight hearings and several executive meetings to consider the legislation, according to a press release issued by Sen. Leahy. The House of Representatives passed patent-reform legislation (H.R. 1908) in the last Congress, and the Senate Judiciary Committee reported companion legislation in the Senate (S. 1145). The Senate Judiciary Committee held hearings on the most recent bill on Mar. 10, 2009.
The compromise bill represents a bipartisan effort and includes several amendments that were adopted to resolve some of the more divisive issues in the patent-reform debate, including damages, venue, and post-grant review. These amendments included measures adopted Apr. 2, Mar. 31, and Mar. 26.
The compromise bill gained the support of both the innovator and generic-drug industries. “While no compromise is ever perfect, we believe the committee’s product breaks the logjam on the major issues that have held up patent reform for the past several Congresses and will clear the path for a bill to be completed without undue delay,” said Jim Greenwood, president and CEO of the Biotechnology Industry Association, in a press release.
The Generic Pharmaceutical Association (GPhA) also supported the compromise bill and, in particular, applauded the preservation of the inequitable conduct penalty in the proposed legislation. Under the doctrine of inequitable conduct, a court can render a patent unenforceable if the patent applicant made material misrepresentation or withheld information during the patent application process with intent to deceive the US Patent and Trademark Office, according to GPhA.
“We are pleased that legislation as passed by the committee does not contain provisions that could have had the unintended consequences of erecting any barriers to the introduction of generic medicines that help consumers save money, particularly in these difficult times,” said Kathleen Jaeger, GPhA’s president and CEO, in a press release.