BIO has submitted briefs in three recent cases which could significantly impair drug and biotechnology efforts, urging reconsideration and review from both the Supreme Court and the U.S. Court of Appeals for the Federal Circuit.
BIO, in conjunction with PhRMA, submitted an amicus brief to the Supreme Court in Braintree v. Novel, arguing that the majority’s decision creates an unpredictable climate for patent claims. Vacating the prior claim construction precedent which had repeatedly interpreted “a” to mean “one or more” patients, the court instead deemed the term “a patient” to mean “a patient population.” This has narrowed the reading to exclusively more than one item, disrupting the consistency of claim terms and potentially harming the interests of BIO members.
In a brief to the Court of Appeals for the Federal Circuit in the case of Gilead v. Natco, BIO and PhRMA urged the court to review the case en banc. The court’s decision expanded the OPD doctrine in ways that conflict with Congressional intent and established precedent, risking immediate effects which could chill investment and development in biotechnology. The expansions of the ODP doctrine to limit the expected patent-derived marketplace exclusivity for some new drugs will reduce incentives for companies to invest and bring new drugs to market, endangering lives and suppressing innovation.
In Bristol-Myers Squibb v. Teva Pharmaceuticals, BIO argues that the panel’s decision to reject the patent for the BMS drug Baraclude® threatens to reduce incentive for researchers and investors in life saving compounds. Prior cases held that differences between a claimed compound and a prior art may be relevant evidence of non-obviousness, even if those differences are discovered after the patent application is filed.
The panel instead ruled that the evidence of the prior art compound’s toxicity, compared to the non-toxic inventive compound was not a relevant difference, and the non-toxicity of the inventive compound was not a relevant “unexpected result” because the prior art’s toxicity was not known at the time of invention. Researchers and investors will be unwilling to fund compounds with uncertain patent applicability, and may delay patent filing in case new, unexpected differences between the invention and prior art come to light during clinical testing. BIO strongly asserts that the patent system should promote research which seeks the best treatment, and this decision jeopardizes the future development of those treatments.