The Bayh-Dole Act, 35 U.S.C. §§ 200-212[1], creates a program that, ostensibly, encourages the practical use of inventions that are supported by federally funded research. As stated in Bayh-Dole, Congress seeks “to use the patent system to promote the utilization of inventions arising from federally supported research or development.”[2] The Bayh-Dole Act
Harness Dickey Blog
Harness Dickey’s team of trademark and patent attorneys serve clients in all areas of intellectual property law, including patents, trademarks, IP litigation, PTAB Proceedings, trade secrets, due diligence investigations, and global IP management.
In response to Detroit’s growing automotive industry, J. King Harness established Harness Dickey in 1921. Serving as the head of the patent department for the Ford Motor Company, Harness understood the value of expertise in intellectual property and set out to open a firm that would focus exclusively on intellectual property law.
Today, we are one of the top IP law firms in the U.S. measured by both the number of attorneys and by objective rankings of results. Our trademark and patent attorneys represent world leaders in business and technology, and our collective experience spans practically every practice area and niche specialty within intellectual property law.
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Website and Press Releases Created Plausible Claim of Inducement of Infringement by a Skinny Labelled Generic Product
In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA, Inc., [2023-1169] (June 25, 2024), the Federal Circuit reversed the dismissal of Amarin’s complaint for failure to state a claim for induced infringement.
Less than a month after Hikma launched its generic icosapent ethyl product, Amarin sued under 35 U.S.C. § 271(b), alleging that Hikma had…
Plaintiff Failed to Show It was Entitled to a Preliminary Injunction to Protect its Trade Secrets
In Insulet Corp. v. Eoflow, Co, Ltd., [2024-1137] (June 17, 2024), the Federal Circuit reversed a preliminary injunction against manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.
Insulet and EOFlow are medical device manufacturers that make insulin…
Supreme Court Affirms 100+ Year Period for Copyright Damages
In Warner Chappel Music, Inc., v. Sherman Nealy, [22–1078] (May 9, 2024), the Supreme Court finally clarified copyright’s 3-year statute of limitations (17 U. S. C. §507(b)), holding that a copyright plaintiff who timely brings a copyright infringement claim, can recover damages for the entire period of infringement, and not limited to the three year period…
What Foreign [And U.S.] Patent Practitioners Need To Know About Means-Plus-Function Claim Interpretation In the U.S. – Understanding 35 U.S.C. § 112(f)

Introduction
We’ve all seen it. Patent attorneys love making up words. For example, instead of claiming a pipe, a hose, or a tube, we draft patent claims reciting “a fluid delivery system” or “a fluid conduit.”
Why do we do it? Because it is our job to secure the broadest patent protection available for our…
Routine Optimization Does Not Necessarily Require a Disclosure of Ranges Under the Results-effective Variable Doctrine – Pfizer v. Sanofi, No. 19-1871 (Fed Cir 2024)
The results-effective variable doctrine is a caselaw principle where prior art disclosing the “general conditions of a claim” invokes a presumption of obviousness if the particular workable ranges are identifiable through routine experimentation. The presumption can be rebutted with evidence that the given parameter was not recognized as being result-effective. Sanofi Pasteur, Inc. and SK…
USPTO Releases Inventorship Guidance for AI-assisted Inventions
The USPTO released inventorship guidance on February 12, 2024, for inventions assisted by artificial intelligence (AI). The Federal Circuit previously held that an AI system cannot be listed as an inventor in Thaler v. Vidal, 43 F.4th 1207 (Fed. Cir. 2022), and this release provides guidance regarding the open question of human inventorship for inventions…
USPTO Guidelines on Enablement Requirement published 10 January 2024
In view of the recent Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023)(hereinafter Amgen), the USPTO has published guidelines for determining enablement requirement (35 U.S.C. § 112(a)) compliance among all utility patent applications regardless of technology. You can access the published guidelines here.
The guidelines…
Have a Seat Over There — Petitioner Has No Standing to Appeal PTAB Decision
In Allgenesis Biotherapeutics Inc., v. Cloudbreak Therapeutics, LLC, [2022-1706] (November 7, 2023), the Federal Circuit dismissed the appeal of the PTAB’s final written decision that claims 4 and 5 of U.S. Patent No. 10,149,820 had not been shown to be unpatentable, because Allgenesis has failed to establish an injury in fact sufficient to confer standing to…
Extrinsic Evidence Needed to Construe Numerical Limitation in the Claims
Actelion Pharmaceuticals Ltd, v. Mylan Pharmaceuticals Inc., [2022-1889] (November 6, 2023), the Federal Circuit vacated the district court’s claim construction order with respect to the term “a pH of 13 or higher” in U.S. Patent Nos. 8,318,802 and 8,598,227 and the judgment of infringement, and remand for the district court to consider the extrinsic evidence…