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Plaintiffs Cannot Defeat Federal Removal Jurisdiction by Artful Pleading

The allegations of a plaintiff’s complaint do not control when evaluating removal under the federal officer removal statute, 28 U.S.C. § 1442(a)(1), and instead the court must credit the defendant’s theory of the case when...more

Copyright Office Calls for Law on AI-generated Digital Replicas

The U.S. Copyright Office is tackling the issue of digital replicas -- videos, pictures or audio recordings digitally created or manipulated to falsely depict an individual – and is calling on Congress to pass a federal law...more

AFFF MDL Bellwether Process Extended to Claims for Thyroid and Liver Cancer Caused by PFAS

The court in the aqueous film-forming foams (“AFFF”) multidistrict litigation recently established a bellwether process to address personal injury claims alleging that polyfluoroalkyl substances (PFAS) in AFFF caused thyroid...more

Claims Specifying a “Therapeutically Effective” Dose Have No Additional Efficacy or Safety Limitations

In United Therapeutics Corporation v. Liquidia Technologies, Inc., the U.S. Court of Appeals for the Federal Circuit held that a claim to a method of treatment for pulmonary hypertension was not invalid for lack of enablement...more

Amgen Inc. v. Sanofi: U.S. Supreme Court Addresses Enablement for Biotechnology Inventions

I’m a bit behind and therefore am not part of the slew of commentary that flowed from the Supreme Court’s decision in Amgen Inc. v. Sanofi, 143 S. Ct. 1243, 1248 (2023), addressing Amgen’s claims to “antibodies that (1) bind...more

Unitary Patent System Launching in Europe – Patent Holders May Need to Take Action

Businesses throughout the world holding or planning patents in Europe should familiarize themselves with the new Unitary Patent and Unified Patent Court and – depending on patent protection strategy -- may want to take action...more

U.S. Supreme Court to Decide on Enablement Standard for Biotech Antibody Patents in Amgen v. Sanofi

In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more

Federal Circuit Imposes Heightened Standard for Written Description Support of Negative Claim Limitations

In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held patent claims invalid for lack of written description where a negative limitation was...more

Intellectual Property Law: Year in Review 2021

Specification and Prosecution History Narrow the Plain Meaning of “0.001%.” The claim at issue included a concentration of 0.001% of PVP. The term’s plain meaning is 0.001% within one significant figure (i.e., 0.0005% to...more

Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges

Examples in Specification Did Not Provide Written Description Support for Bounded or Closed Ranges - The Federal Circuit Court of Appeals affirmed the Patent Trial and Appeal Board's determination that a patent...more

Patent Trial and Appeal Board Determination of "Reasonable Expectation of Success" Must Be Supported by Substantial Evidence

The Federal Circuit Court of Appeals reversed a decision of the U.S. Patent Trial and Appeal Board (“Board”), finding a patent on a method of disinfection obvious. The reversal was based in part on a finding that the Board’s...more

Federal Circuit Court of Appeals Reverses $1.2 Billion Verdict in Juno v. Kite Pharma, Invalidating Genus Claims to a Three-Part...

Functional claims took another hit at the Federal Circuit Court of Appeals. The patent at issue broadly claimed a three-part chimeric antigen receptor including all scFvs that bind to any target. The Court found written...more

Federal Appeals Court Hears Arguments on CAR T-Cell Therapy Patent Dispute [Audio]

T-Cell Therapies offer enormous promise in the development of novel approaches to treating cancer. A federal appeals court recently heard arguments in a patent dispute between two companies that have emerged as leaders in...more

Federal Circuit Denial of En Banc Rehearing in Amgen v. Sanofi Prompts New Considerations in Genus Claims

Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Claiming a New Manufacturing Method Cannot Impart Novelty to Composition or Method of Treatment Claims

In Biogen MA, Inc. v. EMD Serono, Inc., the Court of Appeals for the Federal Circuit has reconfirmed, and to an extent clarified, that an existing product and known method of treatment using that product are not patentable...more

Federal Circuit Construes the Terms “Antibody” and “Antibody Fragment”

The Federal Circuit issued a decision in Baxalta Inc. v. Genentech, Inc., ___ F.3d __, 2020 WL 5048435 (Fed. Cir. Aug. 27, 2020) construing the terms “antibody” and “antibody fragment.” According to the decision: Antibody:...more

IBSA v. Teva: Indefinite Scope of Key Term in Patent Description Rendered a Thyroid Medication Patent Invalid Under Section 112

In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more

Federal Circuit Issues Two Decisions Clarifying Patent-Eligible Subject Matter

One of the murkier areas of patent law is subject matter eligibility—when are patent claims directed to laws of nature, natural phenomenon or abstract ideas and when are they directed to patentable applications of those laws,...more

Specification References to Publicly Available Databases or Deposits Can Satisfy the Written Description Requirement for a...

In Immunex Corp. v. Sandoz, Inc. No. 20-1037 (July 1, 2020), the Federal Circuit Court of Appeals addressed whether references to publicly available databases or deposits could provide adequate written description support for...more

Verdict in T-Cell Immunotherapy IP Case Tests 'Reasonable Royalty' Concept for Large Damage Awards [Audio]

One of the most interesting and promising areas of medical research today involves the use of T-Cell therapies, which offer hope and promise as a new approach to cancer treatment. It has also made for a robust climate for...more

Prevent Your Licensee From Instituting Inter Partes Review with a Forum Selection Clause

Courts have a general policy prohibiting licensees from challenging patent validity (even though the licensee may have voluntarily agreed to forego challenges as a part of the negotiation). In Lear, Inc. v. Atkins, the...more

USPTO Extends Certain Patent-Related Deadlines due to COVID-19 Crisis

The United States Patent and Trademark Office (“USPTO”) has further extended the time to file certain patent-related documents or pay fees due to the COVID-19 outbreak. This extension supersedes prior USPTO waivers of...more

Federal Circuit Ruling in Patent Case Expands 'Obviousness' Doctrine

The Federal Circuit held that a prima facie case of obviousness can be established by prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range in Valeant...more

Patent Infringement: Successful Litigation Stays the "Course" [Audio]

What happens when your competitors infringe your patent for golf equipment – then declare bankruptcy to avoid paying up? In this episode, Harris Beach intellectual property (IP) attorneys share the story behind the $12...more

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