BIO weighed in on three Supreme Court cases in the last few months whose outcome could change the IP landscape for biotechnology companies.
BIO’s amicus brief in Nautilus v. Biosig Instruments argues that the petitioner misrepresents the Federal Circuit’s definiteness test and seeks to litigate an issue not properly before this court. Petitioner’s approach radically departs from established law and practice. Finally the petitioner’s approach would destabilize the patent system as it would inject substantial new uncertainty into the patent system and stifle innovation, conflates the distinct roles of the PTO and district courts in the patent system, and misplaces concerns about the “zone of uncertainty.”
In Baxter v. Fresenius, BIO argues that the Supreme Court’s guidance has proven critical to clarifying biotechnology patent rights. The Federal Circuit’s high finality standard is erroneous, inconsistent with its own precedent on finality, clashes with other circuits’ finality standards, and frustrates congressional intent for USPTO proceedings. A workable standard is needed to ensure that accused patent infringers, after litigating a case fair and square in district court, do not later seek administrative patent review in the PTO in order to cancel the unfavorable outcome of their court case.
In Limelight v. Akamai, BIO argues that the ‘single entity rule’ should not be the standard for proving indirect infringement of process or method claims. The statute does not support application of this rule and the narrow construction of direct infringement warrants rejection of this rule. The Federal Circuit’s rule under Section 271 (b) for inducement also does not affect the notice function of patents, and creative claim drafting would not solve the problems created by the ‘single entity rule’. BIO also argued that biotech companies rely heavily on proprietary processes to protect their sizeable investments in research and development and to the benefit of the public interest. Finally the federal circuit’s rule protects customers and end-users from infringement claims while still allowing the patentee to protect its patented invention.