News & Analysis as of

Patent Examinations Pharmaceutical Patents Patent Applications

Manatt, Phelps & Phillips, LLP

U.S. Patent Office Enablement Guidelines in View of Supreme Court Amgen v. Sanofi Decision

The U.S. Patent Office has published updated examination guidelines regarding the enablement requirement in view of the Supreme Court’s May 2023 decision in Amgen v. Sanofi. The guidelines generally reiterate that (1)...more

Goodwin

USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

Goodwin on

In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more

Linda Liu & Partners

CNIPA’s Requirements on Supplementary Experimental Data and Inventiveness Evaluation of CN Patent Application in Biology and...

Linda Liu & Partners on

On December 14, 2020, the China National Intellectual Property Administration released “Announcement about Amendments to the Guidelines for Patent Examination (Announcement No. 391)” on its website, showing that the amended...more

Linda Liu & Partners

[Webinar] Best Practice to Procure a Pharmaceutical Patent in China - September 28th, 10:00 am - 11:00 am CEST

Linda Liu & Partners on

China's stance on pharmaceutical patents catches the eye of the entire globe due to its market position. Effective on January 15, 2021, the newly revised China’s Patent Examination Guideline provides new examination rules of...more

Linda Liu & Partners

China: Criteria for Examining Inventive Step of Crystalline Form Inventions and Suggestions for Patenting Crystalline Forms

Linda Liu & Partners on

Polymorphism of a pharmaceutical compound refers to its state of existing in different solid forms that is caused by the fact that the molecules of the compound, though being of the same chemical structure, are arranged in...more

Goodwin

The USPTO’s Increasing Focus on FDA Submissions and the Duty of Disclosure

Goodwin on

​​​​​​​The United States Patent and Trademark Office (USPTO) imposes a Duty of Disclosure, Candor and Good Faith (Duty of Disclosure) on all individuals associated with the filing and prosecution of a patent application...more

Knobbe Martens

Federal Circuit Newsletter - January 2022 (Chinese)

Knobbe Martens on

避而不谈可能支持否定性权利要求限定 - 在 Novartis Pharmaceuticals 诉 Accord Healthcare Inc. 一案(上诉案件编号:21- 1070)中,联邦巡回上诉法院认为,一项对药物“速效剂量”避而不谈的专利申请,为要求不存在此类剂量的否定 性权利要求限制提供了书面说明支持。 ...more

Knobbe Martens

Federal Circuit Newsletter - January 2022 (Japanese)

Knobbe Martens on

記述がないことがクレームの否定的限定のサポートと解釈できる場合がある Federal Circuit は、Novartis Pharmaceuticals v. Accord Healthcare Inc. (Appeal No. 21-1070) に おいて、薬剤の「初回負荷用量」についての記述がない特許出願は、そのような用量がないことを要 求するクレームの否定的限定に記述によるサポートを提供していることになると判示した。 ...more

Knobbe Martens

Federal Circuit Review - January 2022

Knobbe Martens on

January 2022 Federal Circuit Newsletter (Japanese) January 2022 Federal Circuit Newsletter (Chinese)  Silence May Support Negative Claim Limitation In Novartis Pharmaceuticals v. Accord Healthcare Inc. Appeal No. 21-1070, the...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

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

Brazilian Supreme Court Ends Patent Term Extension and Retroactively Cuts Pharmaceutical and Medical Device Patent Terms

On May 6, 2021, the Brazilian Supreme Court determined that the minimum ten-year patent term set forth in Article 40 of the Brazilian Intellectual Property Statute (Law No. 9,279) was unconstitutional (ADI 5529), and, on May...more

Foley & Lardner LLP

Consisting Essentially Of Trouble

Foley & Lardner LLP on

The Federal Circuit decision in HZNP Medicines LLC v. Horizon Pharma USA, Inc. is a good reminder that even standard “patent lingo” can cause trouble down the line. Now that the court has denied rehearing en banc (with Judges...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

PATENT CASE THIS WEEK - In an appeal from a bench trial finding patents unenforceable, the Federal Circuit issued a rare decision on the doctrine of unclean hands. The doctrine of unclean hands in patent law arises from...more

Patterson Belknap Webb & Tyler LLP

USPTO Adopts Amgen v. Sanofi, Excises “Newly Characterized Antigen” Test from its Written Description Guidance for Antibody Claims

Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

15 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide