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Patent Examinations Pharmaceutical Patents

Goodwin

USPTO Emphasizes Searches of FDA Databases for Pharmaceutical Patent Applications

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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

Knobbe Martens

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

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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

Linda Liu & Partners

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

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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

Influence of Implementability of Prior Art in Determination of Novelty and Inventiveness

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In patent examination, the examiner will cite a prior art document in order to determine whether or not an invention or utility model is novel and inventive. The applicants challenge the implementability of the cited prior...more

Linda Liu & Partners

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

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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

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​​​​​​​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

McDonnell Boehnen Hulbert & Berghoff LLP

Senator Tillis' Patent Eligibility Reform Proposal: A Biopharma Perspective

Senator Thom Tillis (R-NC) introduced S. 4734, entitled "A Bill to amend Title 35, U.S. Code, to address matters relating to patent subject matter eligibility, and for other purposes" last night, as was discussed in an...more

McDonnell Boehnen Hulbert & Berghoff LLP

Faux-Populist Patent Fantasies from The New York Times

On a spring Saturday in a year when three major holidays -- Easter, Passover, and Ramadan -- coincided or overlapped, The New York Times Editorial Board decided it was time to announce that the "United States Patent and...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)

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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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2021: #7 to #9

After reflecting upon the events of the past twelve months, Patent Docs presents its 15th annual list of top patent stories. For 2021, we identified nine stories that were covered on Patent Docs last year that we believe had...more

Goodwin

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

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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

Perkins Coie

Three Changes to Pharmaceutical Patents in the PRC

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This update addresses three important changes to pharmaceutical patents in the People’s Republic of China (PRC) in view of the newly amended PRC Patent Law (the Law), which will take effect on June 1, 2021, and the recent...more

McDonnell Boehnen Hulbert & Berghoff LLP

Idorsia Pharmaceuticals, Ltd. v. Iancu (Fed. Cir. 2020)

This week, in Idorsia Pharmaceuticals, Ltd. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting summary judgment in favor of the U.S. Patent and Trademark...more

Foley & Lardner LLP

Consisting Essentially Of Trouble

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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

Latest Federal Court Cases - April 2019

Grunenthal GMBH v. Alkem Labs., Ltd., Appeal Nos. 2017-1153, -2048, -2049, -2050 (Fed. Cir. Mar. 28, 2019) - This week the Federal Circuit issued a rare decision concerning the utility doctrine in patent law. In general,...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

Sunstein LLP

July 2018 IP Update: New Guidance for Patenting Method-of-Treatment Inventions

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The U.S. Patent and Trademark Office (USPTO) issued a memorandum on June 7 (the “Memorandum”), providing much-needed guidance to patent examiners as to whether method of treatment claims are to be considered patent-eligible...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

Mintz - Intellectual Property Viewpoints

With its Vanda Pharma and Berkheimer memos, USPTO provides increased clarity around personalized medicine patent eligibility

In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018) the US Patent and Trademark Office (USPTO) has issued two memos...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

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