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United States Patent and Trademark Office › Patent-Eligible Subject Matter › Pharmaceutical Industry

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

American Conference Institute (ACI) on

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

American Conference Institute (ACI) on

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Fox Rothschild LLP

Problems – And Solutions – For Securing Patent Protection Over Diagnostic Technologies

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Drafting claims for methods of diagnosing and treating patients can be challenging since they involve the measurement of patent-ineligible subject matter and because these methods are often performed by multiple parties. ...more

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

Patent Prosecution Tool Kit: Summary of Subject Matter Eligibility: Biotech/Pharma Inventions

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

It has nearly been ten years since the Supreme Court’s landmark Mayo v. Prometheus (132 S.Ct. 1289 (2012)) decision, in which the Court established a two-prong test for determining patentable subject matter under 35 U.S.C. §...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

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Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

Jones Day on

The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more

Foley & Lardner LLP

USPTO October 2019 Patent Eligibility Guidance Update Includes New Guidance And Examples For Life Sciences

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The USPTO has released additional patent eligibility guidance to supplement the guidance released in January. While much of the October 2019 Patent Eligibility Guidance Update relates to claims falling under the “abstract...more

Foley & Lardner LLP

Federal Circuit Finds Endo Method Of Treatment Claims Satisfy 35 USC 101

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In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more

Foley & Lardner LLP

Federal Circuit, USPTO Clarify Subject Matter Eligibility for Methods of Treatment

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On June 7, 2018, the USPTO issued new guidance in the form of a memorandum regarding the patentability of methods of treatment. This memorandum, issued in response to the Federal Circuit’s holding in Vanda Pharmaceuticals...more

Foley & Lardner LLP

USPTO Vanda Memo Emphasizes Patent Eligibility Of Method Of Treatment Claims

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On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals....more

Fenwick & West Life Sciences Group

USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the...

Fenwick & West Life Sciences Group on

At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Releases Memorandum on Subject Matter Eligibility

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On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more

Bradley Arant Boult Cummings LLP

The Government Whittles Away at Life Sciences Patents

Bradley Arant Boult Cummings LLP on

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

Foley & Lardner LLP

USPTO Releases Patent Eligibility Update

Foley & Lardner LLP on

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

McDonnell Boehnen Hulbert & Berghoff LLP

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

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Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

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On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Foley & Lardner LLP

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

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On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

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On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- ACLU

McDonnell Boehnen Hulbert & Berghoff LLP on

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Foley & Lardner LLP

Putting Structure and Function Into Context for USPTO Patent Subject Matter Eligibility Guidance

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The USPTO’s ”Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, and Natural Products” has been criticized for requiring a product to be markedly different in...more

Foley & Lardner LLP

The New USPTO Patent Eligibility Rejections Under Section 101

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Well, it’s happening. Office Actions with new patent eligibility rejections based on the USPTO’s March 4, 2014 Guidance are being mailed out to patent practitioners across the nation. While some new rejections under §101 were...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance

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The U.S. Patent and Trademark Office spent the entire afternoon session of today's biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting focusing on the guidance memorandum for determining the subject...more

McDonnell Boehnen Hulbert & Berghoff LLP

Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)

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The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more

Womble Bond Dickinson

Comments on 3/4/2014 USPTO “Guidance for Determining Subject Matter Eligibility…”

Womble Bond Dickinson on

On March 4, 2014, the United States Patent and Trademark Office issued a memorandum and quick reference sheet on the “2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of...more

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