Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With respect to granted cases, there is no new activity to report since our last update. With respect to petitions, a brief in opposition and a reply brief were submitted in two patent cases raising questions related to patent law’s written description requirement. The government also waived its right to respond to a petition filed in a tax case. Here are the details.
There is no new activity to report.
Brief in Opposition
Kite Pharma filed a brief in opposition to the petition in Juno Therapeutics, Inc. v. Kite Pharma, Inc., a patent case raising a question about the written description requirement. In this case, Juno asks the Court to consider the appropriate test for the requirement:
- “Is the adequacy of the ‘written description of the invention’ to be measured by the statutory standard of ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same,’ or is it to be evaluated under the Federal Circuit’s test, which demands that the ‘written description of the invention’ demonstrate the inventor’s ‘possession’ of ‘the full scope of the claimed invention,’ including all ‘known and unknown’ variations of each component?”
Effectively, Juno seeks to eliminate the current test for the written description requirement in favor of the current test for the enablement requirement.
Now, in response, Kite argues that, “[w]hen Congress established that the patent specification must describe both ‘the invention . . . and . . . the manner and process of making and using it,’ Congress plainly established two distinct requirements.” Kite contends, moreover, that “Congress has had ample opportunity to remove the written-description clause if it wanted the specification to describe the invention only in a way that enables its making and use,” but that it “has never done so.” Kite maintains that “the independent written-description requirement is ‘firmly embedded in the operation of the patent system’ and ‘only the most extraordinary justification could warrant’ ‘upsetting statutory interpretations as settled as this.’” Kite notes that “Juno’s petition challenges over 50 years of precedent about 35 U.S.C. § 112(a)’s [written description] requirement.” Moreover, it contends that “[t]his case is a poor vehicle for this Court to reverse course and revisit the written-description requirement.”
Waiver of Right to Respond
The government waived its right to respond in Ampersand Chowchilla BioMass, LLC v. United States, a tax case raising a question about federal tax benefits.
In Biogen International GmbH v. Mylan Pharmaceuticals Inc., another patent case raising another question about the written description requirement, the petition asks the Court to consider whether the written description requirement is met “when the specification describes the invention” or instead when “the specification also disclose data that demonstrates the claimed invention is ‘effective’ and emphasize the claimed invention by singling it out and describing it more than once.” In response, Mylan argued “Biogen tries to recast the court of appeals’ opinion as creating a ‘new, more stringent written description requirement.’” Mylan argues, however, that the Federal Circuit “merely found that the district court did not clearly err in rejecting” one of Biogen’s theories, emphasizing that Federal Circuit “did not create new law.”
Most recently, Biogen filed its reply in support of its petition. Biogen contends that it is “not seeking review of a case-specific factual determination,” but rather “the legal framework applied by the Federal Circuit—in particular, its decision to graft additional requirements onto Section 112’s plain text by demanding proof of an invention’s efficacy.” Biogen explains that the Federal Circuit’s ruling “heighten[s] the legal burden all patent applicants—not just Biogen— must meet.” Moreover, Biogen maintains that “the role of the courts is to effectuate Congress’s intent as reflected in the statutory language, not to impose judicially-crafted considerations with no basis in the text.” Accordingly, Biogen urges the Court to “grant certiorari to clarify the written description standard and conform it to the text of Section 112.”