USPTO Issues Advance Notice of Proposed Rulemaking for America Invents Act (AIA) Proceedings Before the Patent Trial and Appeal Board

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

PTAB Finds Teaching Away in Non-Overlapping Range

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

A Broad Outline of a Genus's Perimeter Is Insufficient For Written Description of the Members of the Genus

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

Anticipation Under the Public Use Bar

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

PIV Notice Need Not Address All Claims to Preserve Rights

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

Risk Evaluation and Mitigation Strategy Patent Not listable in Orange Book

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

USPTO Announces all Patent Term Extension Requests to be Filed Electronically

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

Federal Circuit Reiterates: Isolated Natural Products Alone Are Not Patent Eligible Without A Markedly Different Characteristic

March 3, 2023

co-authored by Sara Pistilli, PharmD. and Richard D. Kelly<... Read more

Claims Directed to Detecting Natural Phenomena Using Conventional Techniques Are Patent Ineligible

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

Reasonable Expectation of Success in Treating Different Conditions Not Implied by Structural Similarity

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