In two recent decisions in Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit has made clear that broad functional patent claims must be fully enabled and underscored the high bar for enablement of broad biological compound claims including functional
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In Arthrex, Supreme Court held that the Acting Director cannot be prevented from review of Administrative Patent Judge decisions
On June 21, 2021, the Supreme Court held that “35 U.S.C. § 6(c) is unenforceable as applied to the Director insofar as it prevents the Director from reviewing the decisions of the [Patent Trial and Appeal Board] PTAB on his
What Qualifies as a Good “Good Cause” When Responding to a Patent Owner’s Preliminary Response?
In an inter partes review proceeding, the petitioner first files a petition to challenge the validity of a patent. In response to the petition, the patent owner can file a POPR. Typically, the PTAB then decides whether to institute an
One More Tool to Avoid Fintiv IPR Denial: File A Stipulation in District Court Relinquishing Potentially Duplicative Arguments
We have previously written about the Patent Trial and Appeal Board’s (“PTAB”) precedential decision in Apple Inc. v. Fintiv, Inc., which set forth six factors the PTAB will consider when assessing whether to discretionarily deny an IPR petition in light
Orange Book Transparency Act of 2020 Signed Into Law
On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must
Impact of the PTAB’s Motion to Amend Pilot Program
As part of the post-grant proceedings created in 2012 by the America Invents Act, a Patent Owner can choose to file a motion to amend its patent when that patent is challenged. See 35 U.S.C. § 316(d) (“Amendment of the
PTAB designates three precedential cases on Section 315’s time-bar and estoppel provisions
On December 4, 2020, the Board designated three cases from October as precedential. Together, the rulings help understand the Board’s approach to both serial challenges to issued patents and application of 35 U.S.C. § 315’s limitations on proceedings. Two
PTAB Publishes Final Rule on Institution and Presumption in AIA Trials
Today, the PTO’s Patent Trial and Appeal Board (PTAB) issued a final rule related to trial proceedings under the America Invents Act. The final rule goes into effect 30 days after publication in the Federal Register (scheduled for December 9,
PTAB Adds Online Public-Submission Forms
To guide and inform the public about the Patent Trial and Appeal Board’s practice surrounding post-grant proceedings, the Board periodically designates certain of its decisions as precedential or informative. As noted by the PTAB:
A precedential decision establishes binding authority concerning
PTAB Seeks Comments On Its Approach To Institution Decisions
Since the start of post-grant proceedings, the Patent Office has published a Patent Trial Practice Guide to provide a framework for conducting those proceedings, including setting out the structure and times for taking action in each of the new proceedings