News & Analysis as of

Section 112 Patents Written Descriptions

Venable LLP

[Ongoing Program] Life Sciences Series - Current Trends in ANDA Litigation - October 31st, 1:00 pm - 2:00 pm ET

Venable LLP on

We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more

Bradley Arant Boult Cummings LLP

Searching for Claim Support in a Patent Specification? You Better Blaze a Trail

Last month the Federal Circuit affirmed a PTAB inter partes review (IPR) decision finding that the University of Minnesota’s patent claim directed to the anti-cancer drug sofosbuvir was not adequately supported by the written...more

Bradley Arant Boult Cummings LLP

Is SCOTUS Looking to Change the Enablement Requirement for Patents?

The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2022 Decisions

As part of the recovery from the global COVID-19 pandemic, the U.S. Court of Appeals for the Federal Circuit took steps to return to normal operations. It began requiring live oral arguments in August 2022 and, by November,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies Petition for Rehearing en Banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.

On March 16th, the Federal Circuit denied Biogen's petition for panel rehearing and rehearing en banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.  Judges Cunningham and Stoll did not participate in the decision, which...more

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

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...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

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

Is Silence Disclosure?

On January 3, 2021, The Federal Circuit held in a 2-1 decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022) that the claims of Novartis’ U.S. Pat. No. 9,187,405 (“the ’405 patent”) met the...more

Haug Partners LLP

No Clear Error to Find Lack of Written Description for a Method of Treatment Patent Despite Separate Disclosures of the Drug,...

Haug Partners LLP on

Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more

Proskauer - Minding Your Business

CAFC Tightens Enablement Standard for Functional Claiming of Antibodies

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35...more

Fenwick & West LLP

Written Description of Therapeutic Efficacy

Fenwick & West LLP on

Inventors are generally counseled to file a patent application as soon as they have a patentable invention to avoid potential forfeiture of important rights in today’s first inventor-to-file system. However,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Actavis Laboratories v. Nalproprion Pharmaceuticals

In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more

Knobbe Martens

Federal Circuit Review - October 2019

Knobbe Martens on

The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Bradley Arant Boult Cummings LLP

Yet Another Pharmaceutical Patent Falls Under the Scrutiny of 35 U.S.C. § 112

Last week, the Federal Circuit confirmed that Idenix Pharmaceuticals will not be the proud recipient of what was previously regarded as the largest damages award ever recorded in a U.S. patent case. In fact, the majority’s...more

Knobbe Martens

Large Quantity of Routine Experimentation Can Be “Undue Experimentation”

Knobbe Martens on

IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more

Mintz - Intellectual Property Viewpoints

Understanding the USPTO’s Interpretation of 35 U.S.C. § 112 for Computer-Implemented Functional Claim Limitations

Patent practitioners, inventors, in-house counsel, and patent examiners alike have been clamoring for more guidance on computer-implemented functional claim limitations invoking § 112(f) since the Federal Circuit’s en banc...more

Bradley Arant Boult Cummings LLP

A Federal Circuit Prescription to Take Away the Pain for Generics - Intellectual Property News

The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more

Sunstein LLP

January 2019 IP Update - New Guidelines Proposed for Functional Claiming in Computer-Related Inventions

Sunstein LLP on

In a second notice of proposed rulemaking (besides the one for patent eligibility) announced January 4, 2019 and published in the Federal Register on January 7, 2019, the Patent and Trademark Office has proposed guidelines...more

Sheppard Mullin Richter & Hampton LLP

Challenges in Filing Successful IPR Petitions for Video Game Patents

Video game patents being asserted in litigation are frequently challenged by defendants at the Patent Trial and Appeals Board by filing a petition requesting inter partes review (IPR), post-grant review (PGR), or (less...more

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

PTAB Strategies and Insights - September 2018: Best Strategies for ITC Respondents When Considering a PTAB Action

When faced with allegations of patent infringement at the International Trade Commission (ITC), a respondent must quickly evaluate whether or not to request an AIA review (hereinafter, inter partes review for convenience) at...more

Burr & Forman

Risks of Cover Page Provisional Applications

Burr & Forman on

Since June 8, 1995, the United States Patent and Trademark Office (USPTO) has offered inventors the option of filing a provisional patent application. These applications are typically used as a faster and lower-cost first...more

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