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
May 11, 2023
On May 2, 2023, the Patent Trial and Appeal Board (PTAB) reversed the Examiner’s rejection of a claim directed to a method of creating an immobilized DNA library while preserving contiguity information of a target nucleic acid as being both anticipated and obvious (Appeal 2023-000053). Claim 1 of the application US 15/519,482 (the ‘482 Application) is directed towards:<... Read more
April 20, 2023
The USPTO today announced Advance Notice of Proposed Rulemaking for PTAB reforms regarding IPRs/PGRs. The proposal related to five areas:<... Read more
April 10, 2023
On March 15, 2023, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) issued an opinion in the appeal of US Appl. Ser. No. 15/395,642, Ex parte Chris Fish (Appeal 2022-001172, Technology Center 1700, Appellate Patent Judges Adrienne Lepiane HANLON, Catherine Q. TIMM, and Jeffrey B. ROBERTSON) reversing Examiner Nathan H. EMPIE’s finding of obviousness based on an alleged motivation to modify beyond the range taught by the prior art.<... Read more
April 7, 2023
The Regents of the University of Minnesota (“Minnesota”) appealed from a final decision of the U.S. PTO Patent Trial and Appeal Board (“the Board”) holding that the claims of U.S. Patent 8,815,830 were unpatentable as anticipated. The Court of Appeals for the Federal Circuit (“the Court”) affirmed.<... Read more
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