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

CAFC Affirms Obviousness Rejections Regarding Lack of Motivation to Combine

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

PTAB Reverses Obviousness Rejection Based on Overlapping Ranges and Affirms Double-Patenting Rejection with Terminal Disclaimer

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

PTAB Reverses §101 and §103 Rejections for Plant Extract

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

USPTO Announces Cancer Moonshot Expedited Examination Pilot Program

December 9, 2022

The USPTO has published a Federal Register Notice announcing a new program: the Cancer Moonshot Expedited Examination Pilot Program. Beginning on February 1, 2023, the new program expedites examination for a broad scope of technologies to prevent cancer and cancer mortality. Patent applications pertaining to the qualifying technologies will be accorded special status and reviewed earlier. The program is scheduled to run until either January 31, 2025, or the date by which the USPTO accepts a total of 1,000 grantable petitions, whichever is earlier.... Read more