News & Analysis as of

Biotechnology Prior Art

Knobbe Martens

USPTO Issues Training Materials to Examiners for Searching FDA and NIH Resources

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On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more

Harris Beach PLLC

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2022)

Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Knobbe Martens

Ranges for Interdependent and Interactive Components Can Be Tricky to Derive

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION - Before Lourie, O’Malley and Stoll.  Appeal from the Patent Trial and Appeal Board. Summary: A presumption of obviousness based on overlapping ranges requires showing...more

Proskauer - Life Sciences

When (Patent) Success Isn’t Obvious

In Univ. of Strathclyde v. Clear-Vu Lighting LLC, the Federal Circuit grappled with the issue of whether claims directed to methods and systems for inactivating bacteria using blue light were obvious in view of a prior art...more

Mintz - Intellectual Property Viewpoints

Examining Art Units to Avoid Subject Matter Eligibility Challenges for Bioinformatics and AI-related Patents

Overview of Subject Matter Eligibility Challenges Computer-based - inventions – especially in the machine learning (ML), bioinformatics, and artificial intelligence (AI) fields – are susceptible to subject matter...more

MoFo Life Sciences

Traversing Higher Hurdles For Functional Limitations Under Section 112

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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

Proskauer - Life Sciences

Prior Art Showing An Invention To Be “At Least Possible” Found Sufficient To Invalidate Surgical Device Patent

On August 23rd, the Federal Circuit upheld in part and reversed in part a decision from the Patent Trial and Appeal Board’s (PTAB or Board) concerning Ethicon’s patent on a robotic surgical tool, holding that the Board’s...more

Fenwick & West LLP

Patent Eligibility Reform in Congress: Updates on the Tillis-Coons Proposal

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In April, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) proposed a draft framework for legislation reformulating the standards for determining patent eligibility under § 101 of the Patent Act. The framework largely...more

Troutman Pepper

Why Biotech and Pharma Patents Survive IPR

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When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

Faegre Drinker Biddle & Reath LLP

3 Areas of Renewed Interest for Biotechnology, Chemical and Pharmaceutical Patents

The United States Patent & Trademark Office (USPTO) has renewed its interest in obviousness, functional claiming and requests for information, especially for biotechnology, chemical and pharmaceutical patents. The USPTO...more

Foley & Lardner LLP

Federal Circuit Upholds Zomig Patents Finding Intranasal Delivery Not Obviousness

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In Impax Laboratories Inc. v. Lannett Holdings Inc., the Federal Circuit upheld the district court decision finding that defendants had failed to establish obviousness of AstraZeneca’s Zomig patents (directed to intranasal...more

Jones Day

Prior Art Chemical Structures Must Be More Than A “Code Name”

Jones Day on

The PTAB recently rejected a request for rehearing by Bayer CropScience LP (“Bayer”). Bayer Cropscience LP, v. Syngenta Limited, IPR2017-01332, Paper 15 (P.T.A.B. Apr. 2, 2018). The PTAB stated that when the prior art does...more

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

Why Design Patents Are Surviving Post-Grant Challenges

As of January 2017, the institution rate for Patent Trial and Appeal Board trials involving design patents was 37 percent. That is significantly lower than every other technology area and makes design patents the only...more

Law Matters

Publish or Perish? The Balance Between Public Disclosure and IP Protection in Scientific Research

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Public disclosures can destroy intellectual property rights related to the work. Scientists and their attorneys need to strike a delicate balance between competing interests. ...more

Knobbe Martens

Inherent Anticipation for Biotechnology Inventions

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Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

McDermott Will & Emery

PTAB Denies Priority Claim, Has No Affinity for “Antibody Rule”

Addressing enablement and written description issues in the context of a priority challenge, the Patent Trial and Appeal Board (PTAB or Board) found that the challenged claims were not entitled to the benefit of the parent...more

Foley & Lardner LLP

Kyle Bass Loses Round 1 of IPR Attack Against Pharma/Biotech Patents

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On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter Partes Reviews (IPRs) of Acorda’s patents (U.S. Patent Nos: 8,007,826,...more

Knobbe Martens

The PTAB May Be Taking a More Balanced Approach in Biotech and Pharmaceutical IPRs

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Patent challengers were first able to file inter partes review (IPR) petitions on September 16, 2012. Since then IPRs have become an increasingly popular way of challenging the validity of patents. In the first three months...more

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