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End of the Road for Jepson Format Claims in the Life Sciences?

In In re: Xencor, Inc., the US Court of Appeals for the Federal Circuit confirmed that the limiting preamble of a Jepson claim must be supported by the specification with “sufficient written description.” In its decision, the...more

UPOV Releases Explanatory Notes Further Defining Protection for Essentially Derived Varieties

On October 27, 2023, the International Union for the Protection of New Varieties of Plants (UPOV) released its third set of explanatory notes on essentially derived variety (EDV) protection. In this alert, we provide a brief...more

Two Recent Federal Circuit Opinions Illustrate Risk of Product Demonstrations for Patent Validity

Section 102 of the Patent Act holds that an invention may not be patented if it was in public use before the effective filing date of the patented invention. The public use bar to patenting is triggered if the invention is...more

Supreme Court Affirmance in Amgen v. Sanofi Leaves Legal Standard for Patent Enablement Undisturbed

The legal standard for enablement – the statutory requirement under 35 USC § 112 that a patent must enable those skilled in the art to “make and use” the claimed invention – remains unchanged after the US Supreme Court...more

Illegality Doctrine Rejected in Legal Cannabis Patent Case, Confirming Patent Enforceability

As the industry for cannabis that is legal under state and/or federal law continues to expand, a flurry of court cases in recent years have addressed whether these businesses can utilize the federal courts to vindicate their...more

Alert - GSK v. Teva: Federal Circuit Opinion After Rehearing Confirms Induced Infringement Liability Despite Skinny Label

In October 2020, as reported in a previous Cooley alert, the US Court of Appeals for the Federal Circuit reinstated a jury’s verdict that Teva infringed GSK’s patented method of using its Coreg drug product, even though...more

Alert: Orange Book Transparency Act Creates Some New Obligations

The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more

Alert: New Law Establishes Purple Book Patent Disclosure Requirement

Signed into law on December 27, 2020, the Biological Product Patent Transparency Act (42 U.S.C. § 262(k)(9)) requires biological reference product sponsors to provide to the US Food and Drug Administration within 30 days of...more

Alert: GSK v. Teva – Induced Infringement Liability Despite Skinny Label

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit reinstated a jury's verdict that Teva infringed GSK's patented method of using its Coreg® drug product, even though Teva's product was initially...more

Alert: EPO: Plants and Plant Materials Not Patentable if Exclusively Obtained by Essentially Biological Process

A recent opinion issued by the Enlarged Board of Appeal (EBoA) of the European Patent Office (EPO) has established that plants and plant materials are not patentable if they are exclusively obtained by means of an essentially...more

Alert: Syngenta Confirms Section 271(g) Infringement Does Not Require Single Entity Perform All Steps of Patented Method

Opinion also contains important holdings for labeling and copyright infringement in the context of the Federal Insecticide, Fungicide, and Rodenticide Act In Syngenta Crop Protection LLC v. Willowood LLC, et al., the US...more

Alert: USDA Announces Acceptance of PVP Applications for Hemp

Recent developments following the enactment of the 2018 Farm Bill have now made it easier for hemp growers to protect their genetics. The 2018 Farm Bill removed hemp as a Schedule I substance. (See January 2019 Cooley Alert.)...more

Alert: Helsinn Confirms Longstanding Law Concerning “On-Sale” Bar

US patent law has long held that inventions put on sale or placed in public use may not be patented if those sales or uses occurred more than one year before filing for patent protection. These rules apply to all forms of...more

Alert: 2018 Farm Bill Enacted With Important Provisions for Plant IP and Cannabis-Related Business

The $867 billion farm bill ("Agriculture Improvement Act" – House Res. 2) was signed into law by the president on December 20. The new farm bill law contains several important provisions relating to intellectual property...more

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