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Another Step Forward for the Patent Eligibility Restoration Act

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

USPTO Stands Behind Significant New Fees for 2025

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

Federal Circuit Applies Safe Harbor to Imported Medical Device Samples

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

Prosecution Laches—Another Arrow In The Quiver For Challenging Patents

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

Federal Circuit Weighs In On Patent Eligibility Of Isolated Vitamin

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

Is Motivation To Obtain A Patent Motivation For Obviousness?

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

UPSTO Revises Patent Bar Qualifications

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

Supreme Court Limits Patent Assignor Estoppel

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

Early RCE Creates Gaps In Patent Term Adjustment Award

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

USPTO Offers Relief for COVID-Related Delays in Submitting Priority Documents

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

Federal Circuit Limits Venue In ANDA Litigation

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

Federal Circuit Finds Recombinant Polypeptide Anticipated By Native Polypeptide

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

Federal Circuit Focuses On Active Ingredient, Not Active Moiety, For Scope Of Patent Term Extension

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

Federal Circuit Finds Eligibility In Non-Diagnostic Method

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

Consisting Essentially Of Trouble

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

Necessity Is The Mother Of Single Reference Anticipation By Inherency

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

Unpacking The Solicitor General’s Brief In Vanda

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

Evidence of Copying Must Be Considered In Obviousness Analysis

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

Federal Circuit Reverses PTAB On Reasonable Expectation Of Success For TARCEVA Patent

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

RCE PTA Carve-Out Resumes After Interference

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

Federal Circuit Finds Method Withholding Treatment Ineligible For Patenting

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

Federal Circuit Contrives Substantially Similar Written Description Test

In contrast to its decision in Nuvo Pharmaceuticals, Inc. v. Dr. Reddy’s Laboratories Inc., which seemed to impose a higher standard for satisfying the written description requirement, the Federal Circuit decision in...more

Doctrine Of Equivalents Not Barred By Claim Amendments

Recent Federal Circuit decisions demonstrate that the doctrine of equivalents is alive and well, and not always barred by claim amendments. In both Ajinomoto Co. v. ITC and Eli Lilly and Co. v. Hospira, Inc., the Federal...more

Federal Circuit Agrees Genotyping Method Is Not Eligible For Patenting

In Genetic Veterinary Sciences, Inc. v. Laboklin GMBH & Co., the Federal Circuit upheld the district court decision that held claims directed to methods for genotyping a Labrador Retriever invalid under 35 USC § 101 at the...more

Federal Circuit Agrees “Pharmaceutical Composition” May Be Toxic

The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads, and highlights that it’s rarely possible to...more

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