As Congress considers patent legislation known as H.R. 9, the Innovation Act, and S. 1137, the PATENT Act, health care leaders – from patient groups to Members of Congress to trade associations – continue reminding lawmakers about the critical importance of ensuring a fair and reliable patent system.
In their recent op-ed published in The Hill, John Castellani, president and chief executive officer, PhRMA, and James Greenwood, president and chief executive officer, Biotechnology Industry Organization (BIO), outline a clear path forward for reform: recognize the unique role of patents in the biopharmaceutical industry by exempting certain biopharmaceutical patents from the inter partes review (IPR) process at the U.S. Patent and Trademark Office (PTO). As Castellani and Greenwood write, “patents are the lifeblood of any new medicine. And our industry’s reliance on them is unique; while your cellphone might be protected by hundreds of patents, the new medicine you or your loved ones take is usually only protected by just a handful.”
While the new legislation’s intent is to address abuses in patent litigation by so-called “patent trolls,” the IPR process at the PTO currently enables abuse of the process to the detriment of the future development of innovative medicines. Biopharmaceutical patents are already subject to a separate review system that, over the past 30 years, has worked to encourage continued innovation while ensuring the timely introduction of generics and biosimilars. Exempting biopharmaceutical patents from the IPR is critical to preserving this balance, and addressing abusive practices that jeopardize new medicines.
Castellani and Greenwood also recently sent a joint letter to Senate Judiciary Committee Chairman Charles Grassley and Ranking Member Patrick Leahy, and House Judiciary Committee Chairman Robert Goodlatte and Ranking Member John Conyers, highlighting the uncertainty that IPR challenges cause to patents on FDA-approved medicines. This uncertainty – if not corrected – will have a chilling effect on the development of new biopharmaceuticals.
And, the concern is not just being voiced by industry.
America’s patients depend on stopping the abuse of biopharmaceutical patents and that’s why the Epilepsy Foundation and more than 90 national and state-based advocacy organizations sent a letter to the House and Senate Judiciary Committees on May 21 urging Congress to enact legislative reforms that maintain an effective patent system.
And just yesterday, a letter signed by 79 Members of Congress was sent to House leadership outlining how critical it is for patent litigation reform legislation to represent the views of the full spectrum of industries reliant on a well-functioning U.S. patent system.
Fortunately, it’s not too late.
Congress still has a chance to protect the substantial R&D investments needed to develop the next generation of new treatments and cures for patients.
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