News & Analysis as of

Inventions Biotechnology

Maynard Nexsen

Patenting Microbial Products: Pitfalls, Value, and Special Concerns

Maynard Nexsen on

The use of microorganisms in human industry is ancient, but has increased markedly in recent years. The modern recognition of the role of microbial communities in the human body has intensified innovation in fields like...more

Rothwell, Figg, Ernst & Manbeck, P.C.

3 Tips for Avoiding Having to File a Budapest Treaty Declaration When Prosecuting Patent Applications on Biological Materials

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure is an international agreement to establish a uniform system for depositing microorganisms and other...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Inventorship Considerations in AI-assisted Drug Development

The utilization of artificial intelligence (“AI”) is becoming ubiquitous across a wide range of industry sectors. The biotech industry is no exception. AI-driven platforms have become increasingly useful to biotech...more

Orrick, Herrington & Sutcliffe LLP

Developing and Patenting AI Inventions: 5 Things for Biotech Companies to Consider

As AI tools become more prevalent in the life sciences, biotechnology companies need to evaluate AI’s impact on their ability to protect the results of their research. Recent U.S. Patent and Trademark Office (PTO) guidance...more

Knobbe Martens

Introduced Patent Eligibility Restoration Act of 2023 (PERA) Seeks to Revitalize Patent Eligibility Standards

Knobbe Martens on

On June 6, 2023, the Senate Judiciary Committee's Subcommittee on Intellectual Property introduced a Bill entitled “Patent Eligibility Restoration Act of 2023” (PERA) aiming to amend the law relating to patent subject matter...more

Knobbe Martens

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

Knobbe Martens on

On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

Jones Day

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

Jones Day on

The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

Goodwin

Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Implications for...

Goodwin on

On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more

Foley & Lardner LLP

Safeguarding AI Innovation in Stem Cell Therapy

Foley & Lardner LLP on

The use of artificial intelligence (AI) to advance stem cell therapy has produced exciting results, with a key role in driving recent growth and innovation. Separated into three parts, this article provides an overview the...more

Kilpatrick

Enabling Biotech Genus Claims Defined Only by Function — A Nearly Impossible Goal — Baxalta Incorporated v. Genentech Inc. (Fed....

Kilpatrick on

In the aftermath of Amgen v. Sanofi, courts continue to invalidate genus claims for lacking enablement. Baxalta Incorporated v. Genentech Inc.2 shows that it is nearly impossible to meet the enablement requirement for claims...more

Morrison & Foerster LLP - Government...

Biden Executive Order Has Potential To Discourage U.S. Company Participation In Federal Research

A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic...more

Harris Beach Murtha PLLC

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

Dorsey & Whitney LLP

Supreme Court Upholds Patent Law Precedent

Dorsey & Whitney LLP on

The case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...more

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more

Schwabe, Williamson & Wyatt PC

SUPREME COURT RULING: Amgen Inc. et al. v. Sanofi et al, May 18, 2023

Amgen Inc. et al. v. Sanofi et al, No. 21-757 (S. Ct. May 18, 2023) The Supreme Court issued a long-awaited decision today concerning the enablement requirement found in Section 112 of the Patent Act. Specifically, the...more

Bradley Arant Boult Cummings LLP

Supreme Court Delivers the Final Blow to Amgen

The questions from the high court during oral argument at the end of March 2023 were fairly telling of the 9-0 ruling that came down yesterday in Amgen, Inc. v. Sanofi (No. 21-757). In fact, it did not come as much of a...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Supreme Court Affirms Federal Circuit’s Decision in Amgen v. Sanofi

This morning, the US Supreme Court issued its opinion in Amgen v. Sanofi, a closely watched case concerning patent law’s enablement requirement. Under that requirement, codified at 35 U.S.C. § 112(a), a patent specification...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

4 Potential Paths For High Court In Amgen Patent Case

On March 27, the U.S. Supreme Court heard oral argument in Amgen v. Sanofi, a closely watched case concerning the appropriate legal standard for patent law's enablement requirement. That requirement is found in Title 35...more

Axinn, Veltrop & Harkrider LLP

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Amgen Inc. v. Sanofi Live Coverage

On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more

Foley & Lardner LLP

Building Biotech with Brains: Strategies for Maximizing Value of AI-Driven Biotechnology Inventions

Foley & Lardner LLP on

The rapid rise of artificial intelligence (AI) and machine learning (ML) in biotechnology products and services is becoming a driver of the personalized medicine and health care sectors. While this integration can require...more

Procopio, Cory, Hargreaves & Savitch LLP

Pharma-Related Patent Enablement Reaches the Highest Court

The U.S. Supreme Court has agreed to hear a case that is extremely significant for companies that operate in the biotechnology, pharmaceutical, and chemical sectors. At issue in Amgen v. Sanofi is a determination of the...more

Sheppard Mullin Richter & Hampton LLP

Takeaways From the U.S. Patent and Trademark Office’s Artificial Intelligence and Emerging Technologies Partnership Series – Part...

On September 22, 2022, the U.S. Patent and Trademark Office (USPTO) conducted a live meeting for its Artificial Intelligence (AI) and Emerging Technologies (ET) Partnership Series. During this meeting, panelists from industry...more

MoFo Life Sciences

Traversing Higher Hurdles For Functional Limitations Under Section 112

MoFo Life Sciences on

Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening...more

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