BIO recently told the U.S. Patent and Trademark Office (USPTO) that proposed changes to the pharmaceutical patent process are flawed—and would harm innovation.
ICYMI: To “execute on the President’s drug pricing agenda,” USPTO sought comments on new proposals that would change the way patents would be examined, reviewed, and enforced. Hans Sauer, BIO’s Deputy General Counsel for IP, said during a USPTO listening session in January.
BIO submitted two sets of comments last week—arguing that proposed changes would be harmful, are based on flawed and unproven narratives, and are contradicted by empirical data.
“The existing tools and systems that ensure a robust and technology-neutral patent system are working well,” said BIO. “Moreover, patented bio/pharmaceutical innovations ultimately have pro-competitive benefits because these inventions, upon patent expiry, form the basis for the generic and biosimilar pipeline.”
Data backs it up: “There is no evidence that the drug and biopharmaceutical industries are obtaining patents that are different in scope, quality, duration, or number compared to any other industry. Empirical evidence shows that drugs and biologics developed by biopharmaceutical innovators are not covered by a disproportionate number of patents and they are not being used to extend patent terms,” says BIO.
The proposed USPTO-FDA collaboration “lacks focus and seems misdirected given the separate and distinct missions and roles of the PTO and FDA. Neither agency is tasked with the responsibility or authority for setting drug pricing, reimbursement, insurance coverage or the like.”
Why it matters: “[B]iologics and pharmaceutical patent protection plays an essential role in fostering life sciences innovation. That incentive to innovate and to foster further development of life-saving drugs and new uses for existing drugs should be carefully protected.”
Read BIO’s comments on patent rights.
Read BIO’s comments on proposed USPTO-FDA collaboration.
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