April 4, 2023
Minerva Surgical, Inc. sued Hologic, Inc. and Cytyc Surgical Products, LLC in the District of Delaware for infringement of U.S. Patent No. 9,186,208. After discovery, the district court granted summary judgment that the asserted claims were anticipated under the public use bar of pre-AIA 35 U.S.C. § 102(b). Minerva appealed. The Court of Appeals for the Federal Circuit (the Court) affirmed.<... Read more
April 3, 2023
In Bausch Health Ireland v. Mylan Pharms. N.D. WV., 1:22CV20 Bausch moved for judgment of infringement on the pleadings under Rule 12(c) to prevent Mylan’s launch of its generic equivalent to Bausch’s drug Trulance® for treating chronic idiopathic constipation and irritable bowel syndrome with constipation. Bausch’s motion was predicated on the failure of Mylan to assert in its Paragraph IV notice (PIV) non-infringement of two claims of the asserted patents. Bausch also moved to strike Mylan’s affirmative defenses under Rule 12(f). In its answer Mylan denied infringement of all asserted claims.<... Read more
March 6, 2023
The Federal Circuit on February 24th affirmed the Delaware District order in Jazz Pharm., Inc. v. Avadel CNS Pharm., LLC., 2023-1186, that Jazz delist from the Orange Book its Patent 8,731,963 directed to a REMS to control access to its drug Xyrem, also known as gamma hydroxyl butyrate (GHB) which was misused to facilitate rape, the “date rape” drug.” The decision considered whether to list a drug in the Orange Book was proper. Patents may be listed in the Orange Book if it either claims the drug or methods of using the drug. 21 U.S.C. § 355(b)(FDCA) and 21 C.F.R. § 314.53(b)(1). Jazz contended that patent law did not provide the correct framework determining whether a patent should be listed in the Orange Book. Both the statute and rule look to the patent claims to determine if a patent claims either the drug or a method of using the drug. Here the issue was whether the ‘963 claims were directed to a method of using Xyrem.<... Read more
March 3, 2023
On March 2, 2023, the USPTO announced that beginning on May 1, 2023, all patent term extension requests (PTEs) are to be filed via the USPTO patent electronic filing system (Patent Center or EFS-Web). During the pandemic, the USPTO had allowed for the electronic filing of PTEs. Electronic filing will now be mandatory. A link to the USPTO’s final rule is here.<... Read more
March 3, 2023
co-authored by Sara Pistilli, PharmD. and Richard D. Kelly<... Read more
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
February 7, 2023
In the matter of Ex parte Taleb, et al., the Patent Trial and Appeal Board (PTAB) determined on January 31, 2023, that an examiner (James Anderson, supported by Supervisory Patent Examiners, Jeffrey Lundgren and Kortney Klinkel) failed to establish the obviousness of claims by failing to establish a reasonable expectation of success in achieving a claimed result of a method claim. The claim in question recited<... Read more
January 23, 2023
Update by Kasumi Kanetaka & Grace Kim
Last month, the Federal Circuit issued a non-precedential decision affirming the PTAB’s holdings in two final written decisions. P Tech, LLC (herein “P Tech”) appealed the PTAB decisions holding that claims 1 and 4 of U.S. Patent 9,192,395 (herein “’395 patent”) and claims 1-20 of U.S. Patent 9,149,281 (herein “’281 patent”) are unpatentable because they would have been obvious over the cited prior art, U.S. Patent 6,331,181 (herein “Tierney”) in view of U.S. Patent 5,518,163 (herein “Hooven”).P Tech, LLC, v. Intuitive Surgical, Inc., No. 22-1102, No. 22-1115 (December 15, 2022)<... Read more
December 14, 2022
Update by Grace Kim
Colgate-Palmolive Co. appealed the Examiner’s rejection of U.S. Application No. 15/539,725 (filed June 26, 2017) as indefinite under 35 U.S.C. §112(b) and obvious under §103 in light of U.S. Application No. 2007/0025928 A1 (published February 1, 2007), “Glandorf.” The PTAB reversed the Examiner’s rejections under §112(b) and several of the Examiner’s rejections based on the Glandorf reference but affirmed an obviousness-type double patenting rejection over U.S. Patent No. 10,350,151 B2 (issued July 16, 2019) to Qiao in view of Glandorf. The Board quickly dispatched the Examiner’s indefiniteness rejection based on the claims’ express limitation that the complex must have a 20:1 phosphorous to zinc mole ratio before focusing on the obviousness rejections.<... Read more
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