Attorney:
Richard D. Kelly
July 11, 2023
The Federal Circuit on June 30 granted a petition for re-hearing en banc of its per curiam decision in LKQ Corp. v. GM Global Tch. Operations, LLC. finding the PTAB had correctly decided that GM’s design patent D797,625 was not unpatentable, i.e., valid. The issue raised was whether the Federal Circuit’s rulings in Durling v. Spectrum Furniture Co., Inc., 101 F.3d 100 (Fed. Cir. 1996); In re Rosen, 673 F.2d 388 in (C.C.P.A. 1982) followed by the PTAB in its decision created a “rigid” rule for obviousness in design patent in violation of Supreme Court’s 2007 KSR decision overturning the Federal Circuit’s rigid rule for obviousness of utility patents, the “teaching, suggestion motivation“ (TSM) test for obviousness. <... Read more
Attorney:
Richard D. Kelly
July 5, 2023
Amgen provides a window on the Supreme Court approach to patent issues - look to history and established policy as our patent law is not code based but rather common law based. The Court noted that the “enablement requirement” is found essentially unchanged in every version of the patent law since 1790. While Amgen concerned the enablement provision, the same approach applies to patent eligibility, the “judicial exceptions,” which have existed in our case law since the early 19th century. In deciding Amgen the Supreme Court did not consider previous Federal Circuit decisions but looked to history of the enablement provision which involved Court decisions from the 19th and early 20th century. While Amgen was the Court’s first antibody case, it found analogous cases which provided guidance as to how the enablement requirement had been interpreted. Since U.S. patent law is based on common law, this is the appropriate approach to provide the needed predictability. Without understanding the policy behind the exceptions, one will continue to wander aimlessly from one case to the next.<... Read more
Attorney:
Richard D. Kelly
May 30, 2023
On May 16, the Supreme Court distributed the CareDX cert petition for consideration at the June 1 conference since the Respondents waived filing a reply. The CareDX family of three patents, licensed from Stanford University, U.S.Ps. 8,703,652, 9,845,497 and 10,329,607, are directed to the noninvasive diagnosis of the state of a transplanted organ. The test provides the doctor with information on whether everything is okay, or that the organ is showing signs of being rejected. Both the district court and the Federal Circuit held the patent to be patent ineligible based primarily on admissions appearing in the specification of all three patents which are identical. Given the low success rate (recently zero) of requests for certiorari in the diagnostic/biomarker area, this raises the question as to the possibility the petition will be granted. The CareDx petition’s chances seem better than recent certiorari petitions. <... Read more
Attorney:
Richard D. Kelly
May 18, 2023
In a unanimous opinion the Court decided that the Federal Circuit’s decision was correct.<... Read more
Attorney:
Richard D. Kelly
May 15, 2023
Today the Supreme Court denied cert in GSK v. Teva in which the Solicitor General filed a brief in support of granting cert. The Solicitor argued that the decision in GSK’s favor threatened the availability of lower cost generic drugs. <... Read more
Attorney:
Richard D. Kelly
May 12, 2023
On April 28 the Supreme Court heard oral arguments on Amgen’s petition of the Federal Circuit’s decision affirming the district court’s decision on JMOL that Amgen’s antibody claims lacked an enabling disclosure. Much of the argument revolved around what was the quantum of experimentation that was too much for a claim to be enabled. At the end of Sanofi’s argument its counsel cited the Morse case where the Supreme Court invalidated Morse claim 8 which defined the transmission of symbols in solely functional terms:<... Read more
Attorney:
Marina I. Miller, Ph.D.
February 22, 2023
CareDx is the exclusive licensee of U.S. Patents 8,703,652, 9,845,497, and 10,329,607 entitled “Non-Invasive Diagnosis of Graft Rejection in Organ Transplant Patients” owned by Stanford. The patents describe diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (“cfDNA”). When an organ transplant is rejected, the recipient’s body, through its natural immune response, destroys the donor cells, thus releasing cfDNA from the donated organ’s dying cells into the blood. The increased levels of donor cfDNA, which occur naturally as the organ’s condition deteriorates, can be detected and used to diagnose the likelihood of an organ transplant rejection. Claim 1 of the ’652 patent reads (simplified):<... Read more
Attorney:
Grace Kim
December 13, 2022
Update by Grace Kim and Sara Pistilli, PharmD.
On December 6, 2022, the Patent Trial and Appeal Board (PTAB) overturned a rejection of a claim to a plant extract based on patent ineligible subject matter (Appeal 2022-001062). Claim 1 of the application US 15/521,212 (the 212 Application) is directed towards:<... Read more
Attorney:
Richard D. Kelly
October 5, 2022
The Supreme has relisted the petition for certiorari in Juno Therapeutics, Inc. v. Kite Pharma, Inc., 21-1566 where Juno petitioned for review of the Federal Circuit’s decision reported at 10 F.4th 1330 (2021) reversing the decision of the lower court finding U.S.P. 7,446,190 to not be invalid for lack of written description or enablement and awarding damages of over $1.2 billion. While the relisting of a certiorari petition does not guarantee cert will be granted, statically since 2016 between about 30 and 40% of relisted petitions have been granted. The SCOTUS blog has detailed analysis here. Considering that the overall grant rate for petitions is only about 4% this indicates that the Juno petition has a much greater than normal possibility of being granted.<... Read more
Attorney:
Richard D. Kelly
October 3, 2022
Just two days after the Federal Circuit denied a stay of its mandate in Novartis v. HEC Pharm Co., Ltd., the Supreme Court granted a stay of the mandate pending a further order of the Court and requiring HEC to file a response to the Novartis stay request.<... Read more