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Effective July 8, 2025, the U.S. Patent and Trademark Office (USPTO) expanded the availability of prioritized examination, increasing the limit on the number of requests from 15,000 to 20,000 in a fiscal year. The 20,000...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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