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WIPO Member States Adopt New Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge

On May 24, 2024, member states of the World Intellectual Property Organization (WIPO) adopted a new treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge that was over 20 years in the making....more

The Federal Trade Commission Put Brand Drug Manufacturers on Notice About Improperly Listing Patents in the Orange Book and Then...

The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more

Teva v. GSK: The “Skinny” Label Case Pending Before the Supreme Court

On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more

Natural Alternatives International, Inc. v. Creative Compounds, LLC.: Dietary Supplement Containing A Natural Product Incorporated...

In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of...more

Proposed Legislation: The Hatch-Waxman Integrity Act

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

District Court Finds Mallinckrodt Patents Claim Unpatentable Natural Phenomena

The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the...more

Janssen and Celltrion: Remicade Biosimilar Patent Dance

Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster arthritis biologic medicine Remicade (infliximab) and Celltrion’s biosimilar, as required by the Biologics Price Competition...more

Matching Claim Language with Label Language Ensnares Infringers

On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of...more

Not Just a Formality? USPTO Sequence Rules May Impact Existing Biotech Portfolios

Patent applications containing nucleic acid or protein sequences are required to include an electronic sequence listing using a required format and standard symbols. The United States Patent and Trademark Office (USPTO), in...more

Getting the Most from Biotech Patents in Europe Without Breaking the Bank: Selecting the Right Countries for Validation

Once a European patent application has been granted, all patentees must then choose to validate the granted application in one or more European countries. Such a decision may have long-term business and legal consequences. ...more

Federal Circuit Relies on Robust Disclosure to Save Priority Date

On September 20, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the summary judgement that Abbott’s U.S. Patent No. 5,344,915 (“the ’915 Patent”) was sufficiently supported by the written...more

Navigating the Patent Minefield

In This Presentation: • Patent infringement suits – Costly – Risk of preliminary injunction – Time consuming – Risk of customers being sued – Damages • Lost profit or reasonable royalty • Treble...more

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