Current written description jurisprudence can make it difficult to obtain broad antibody patents, leading practitioners to explore alternative claiming strategies in an effort to bypass the limited scope afforded under the...more
The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more
Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of unexamined patent applications....more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
1/21/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Competitive ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements
I have been waiting for developments on the Patent Eligibility Restoration Act (PERA) since I testified before the Subcommittee on Intellectual Property of the Senate Judiciary Committee in January 2024, and in the meantime...more
The USPTO has taken another step towards implementing fee adjustments in January 2025, by publishing a Notice of Proposed Rulemaking (RPRM) on April 3, 2024.. The NPRM stands by most of the significant fee adjustments it...more
The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more
The Supreme Court recently declined to review Personalized Media Communications, LLC v. Apple Inc., where a divided panel of the Federal Circuit upheld the district court’s finding that a PMC patent is unenforceable due to...more
It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it...more
Without naming names or technology, I wanted to share an interesting rationale for obviousness I came across recently. The rejection was an “obvious to try” type rejection, based on the assertion that it would have been...more
The USPTO has announced changes to the “technical and scientific qualifications that may typically make applicants eligible” to take the patent bar exam. The changes are being implemented after consideration of public...more
In Minerva Surgical, Inc. V. Hologic, Inc., the Supreme Court limited the equitable doctrine of assignor estoppel that prevents an assignor from subsequently challenging the validity of the patent he or she assigned. The...more
In Chudik V. Hirshfeld, the Federal Circuit upheld the USPTO’s determination that a Patent Term Adjustment (PTA) award for “C” delay is not available when an examiner reopens prosecution after an Appeal Brief is filed,...more
One year into the COVID-19 pandemic, and its affects still are impacting patent prosecution, especially as it relates to the difficulty of obtaining paper copies of official documents. While the USPTO rarely requires...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc. the Federal Circuit decided that, for the purpose of establishing venue in ANDA litigation, the place “where an act of infringement has occurred”...more
In a decision that is not very surprising but nonetheless worth taking note of, the Federal Circuit found that a reasonable jury could have found claims reciting methods using a recombinant polypeptide to be anticipated by...more
In Biogen International GmbH v. Banner Life Sciences LLC, the Federal Circuit construed language of the Hatch-Waxman patent term extension statute in a manner Biogen argued was inconsistent with the “active moiety” focus of...more
In Illumina, Inc. v. Ariosa Diagnostics, Inc., a divided panel of the Federal Circuit found claims directed to methods of preparing DNA samples for analysis satisfy the patent eligibility requirement of 35 USC § 101. Although...more
The Federal Circuit decision in HZNP Medicines LLC v. Horizon Pharma USA, Inc. is a good reminder that even standard “patent lingo” can cause trouble down the line. Now that the court has denied rehearing en banc (with Judges...more
The January 29, 2020, Federal Circuit decision in Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc., is a non-precedential decision that was issued on the briefs (without oral argument), but is worth reviewing for...more
Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...more
1/10/2020
/ Alice Corporation ,
Amicus Briefs ,
Bilski ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Personalized Medicine ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Solicitor General ,
Split of Authority
In Liqwd, Inc. v. L’Oreal USA, Inc., the Federal Circuit vacated a decision of the USPTO Patent Trial and Appeal Board (PTAB) that failed to take into account evidence of copying in its obviousness analysis. The Federal...more
In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more
10/17/2019
/ Apotex ,
Clinical Trials ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Reasonable Expectations Test ,
Reversal
In Mayo Foundation for Medical Education and Research v. Iancu, the Federal Circuit agreed with the USPTO’s Patent Term Adjustment (PTA) calculation that excluded prosecution that occurred after an interference was decided...more
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment...more