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:
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:
Marina I. Miller, Ph.D.
October 5, 2022
Integrated Technology Solutions, LLC (“ITS”) alleged that products manufactured and distributed by iRacing.com Motorsport Simulations, LLC ("iRacing") infringed on U.S. Patent 10,046,241. iRacing moved to dismiss, arguing that the ‘241 patent was invalid under 35 U.S.C Section 101, as construed by Alice Corp. Pty. Ltd. v. CLS Bank Int'l., 573 U.S. 208 (2014), and its progeny, because the asserted claims were directed to an abstract idea and were patent-ineligible. The U.S. District Court, D. Massachusetts (“the Court”) found that the claims at issue were directed at patent-ineligible concepts, and that the elements of each claim did not transform the claim into patent-eligible application, and granted the motion to dismiss. <... Read more
Attorney:
Richard D. Kelly
July 25, 2022
On July 18 the Federal Circuit in Cardex, Inc. v. Eurofins Viracor, Inc., affirmed the district court decision finding that diagnostic method claims directed to detecting organ transplant rejections in U.S.P.s 8,703,652 (‘652), 9,845,497 (‘497), and 10,329,607 (‘607) were not patent eligible. The following claim from ‘652 is representative of the claims on appeal, emphasis in the decision:<... Read more
Attorney:
Richard D. Kelly
July 5, 2022
On the last day of June to the dismay of many, the Supreme Court denied cert in yet another Federal Circuit patent eligibility decision, American Axle. Many had been hopeful of a grant because the Court had requested the Solicitor General’s view on the petition. In May the SG provided comments favoring granting cert. A dispassionate viewer would probably not have been surprised by the denial since it’s not apparent how any new decision by the Supreme Court could result in consistency from the Federal Circuit. As Judge Albright noted in deciding Health Discovery Corp. v. Intel Corporation, 6:20-cv-666ADA (WD TX December 27, 2021), he found it difficult to extract a unified theory of Alice’s two steps from the Federal Circuit’s § jurisprudence. The function of a circuit court is to take a Supreme Court decision and derive theory of how one is to apply it. While different circuit court’s may arrive at different conclusions as to how a decision is to be applied, it is rare for a circuit court to be unable to be consistent in its application of the law as announced by the Supreme Court. Yet this is the position of the Federal Circuit. A situation hardly conducive to “furthering the progress of the useful arts.”<... Read more
Attorney:
Richard D. Kelly
June 22, 2022
On June 21, 2022, the Federal Circuit acting on a request for panel rehearing in the decision by the Federal Circuit in Novartis v. Accord Health Care, Inc., 21 F.4th 1362 (Fed. Cir. 2022), affirming the district court’s decision of infringement and validity of the Novartis patent on Gilenya, U.S.P. 9,187,405, granted the request and proceeded to reverse the original decision and hold the asserted claim invalid for failing to comply with the written description of 35 U.S.C. § 112(a).<... Read more
Attorney:
Grace Kim
October 15, 2021
Patents are undoubtedly essential to many industries, and in recent years, the decisions regarding patent eligibility, written description, and enablement have certainly shaken up the life sciences industry in particular. There is an increasing burden on patent applicants and patentees to provide complex, lengthy, thoroughly written disclosures to satisfy the rising standards for written description and enablement, as well as the added pressure to draft multiple claims of varying scope.<... Read more
Attorney:
Richard D. Kelly
April 22, 2021
The USPTO 101 Guidance document has been under a cloud when Judge Brinkema refused to follow the guidance in Cleveland Clinic Found. V. True Health Diagnostics LLC., affirmed at 760 F. App'x. 1013, 1020 (Fed. Cir. 2019). Cleveland Clinic relied on Guidance example 29, claim 1 to assert that its claims were patent eligible since they were drafted in the same manner. The Federal Circuit in rejecting the argument found the 101 Guidance example 29, claim 1 to be "strikingly" similar to claim 1, see760 F. App'x. at 1020, which the Federal Circuit held was patent ineligible. The guidance teaches that example 29, claim 1 is patent eligible. The USPTO has not responded to the Court's criticism and example 29 continues to appear in the Guidance unchanged.... Read more
Attorney:
Marina I. Miller, Ph.D.
April 6, 2021
The Board of Trustees of the Leland Stanford Junior University (“Stanford”) appeals the final rejection of patent claims in its patent Application No. 13/486,982. The patent examiner rejected the claims as involving patent ineligible subject matter. The PTAB affirmed the examiner’s rejection. On appeal, the Federal Circuit affirmed the decision of the PTAB that the rejected claims were drawn to abstract mathematical calculations and statistical modeling, and similar subject matter that is not patent eligible.<... Read more
Attorney:
Marina I. Miller, Ph.D.
July 20, 2020
Electronic Communication Technologies, LLC (“ECT”) sued ShoppersChoice.com, LLC (“ShoppersChoice”), alleging that ShoppersChoice infringed claim 11 of U.S. Patent 9,373,261 (“the ’261 patent”). The district court granted ShoppersChoice’s motion for judgment on the pleadings that claim 11 was invalid under 35 U.S.C. § 101. ECT appealed. The Federal Circuit (“the Court”) affirmed the judgment of the district court.<... Read more