On May 10, 2024, the United States Patent and Trademark Office (USPTO) issued a notice of proposed rulemaking that, if enacted, would tie the enforceability of every claim of a patent subject to a terminal disclaimer to the...more
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more
5/23/2024
/ Administrative Review ,
Appeals ,
Double Patent ,
Final Written Decisions ,
Indefiniteness ,
Jepson Claims ,
Life Sciences ,
Means-Plus-Function ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On April 1, 2024 the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and...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 February 12, 2024, the US Patent Office and Trademark Office (USPTO) released the Inventorship Guidance for AI-assisted Inventions (the Guidance). ...more
Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office’s statistics portal, as of January 30, 2024 there have been 18,721 registered...more
On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major...more
On January 23, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) issued its decision granting the USPTO’s request to remand Xencor’s appeal of the rejection of U.S. Patent App. No 16/803,690 (“’690...more
On December 26, 2023, the United States Court of Appeals for the Federal Circuit issued its decision in K-Fee System GMBH v. Nespresso USA, Inc. While nominally a case related to coffee makers, its teachings are highly...more
On January 5, 2024, in litigation between REGENXBIO and Sarepta Therapeutics, Judge Richard Andrews of the U.S. District Court for the District of Delaware District Court granted summary judgment for Sarepta and ruled that...more
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in...more
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The Bayh-Dole march-in...more
12/13/2023
/ Bayh-Dole Act ,
Biotechnology ,
Inventions ,
Life Sciences ,
March-in-Rights ,
NIST ,
Patent Applications ,
Patent Ownership ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Comment
On October 10, 2023, the Enlarged Board of Appeal of the European Patent Office (EPO) issued a consolidated decision in cases G1/22 and G2/22 clarifying a common issue regarding the validity of a priority claim made at the...more
The USPTO has proposed several fee changes for implementation in 2025. If implemented, these changes will increase filing fees for Inter Partes Reviews (IPRs) and Post Grant Reviews (PGRs) by 25% “to improve cost recovery.”...more
The United States Patent & Trademark Office (USPTO or PTO) recently announced proposed changes to certain fees it charges with respect to patent applications, design patents, and America Invents Act (AIA) trials. These...more
5/17/2023
/ America Invents Act ,
Comment Period ,
Fees ,
Filing Fees ,
Patent Applications ,
Patents ,
Proposed Amendments ,
Public Hearing ,
Trademark Registration ,
Trademarks ,
USPTO
On February 1, 2023, the United States Patent & Trademark Office (USPTO) will begin accepting petitions to accelerate examination under the Cancer Moonshot Expedited Examination Pilot Program (the “Moonshot Program”). The...more
The Unified Patent Court (“UPC”) is set to begin on June 1, 2023. Under the UPC framework, a single court proceeding could result in simultaneous revocation of European Patents across multiple European Union (“EU”) countries,...more
On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more
9/26/2022
/ Biden Administration ,
Biotechnology ,
Data Management ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Innovation ,
National Science Foundation ,
Pharmaceutical Industry ,
Technology Sector ,
U.S. Commerce Department
On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the...more
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
On August 2, 2022, Senator Thom Tillis (R-NC) released a proposed bill to further codify what is and is not proper subject matter for a patent claim at the United States Patent and Trademark Office (USPTO). The Patent...more
On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former...more
7/13/2022
/ America Invents Act ,
Biden Administration ,
Competition ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Orange Book ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Purple Book ,
USPTO
Canadian Patent Examination -
Significant fee increases will be effective at the Canadian Intellectual Property Office (“CIPO”) on October 3, 2022 related to excess claims (claims over 20) and the number of examination...more
On May 5, 2022, the Office of Foreign Assets Control of the U.S. Department of the Treasury issued General License No. 31 (“GL31”), which authorizes transactions in connection with the filing and prosecution of patent...more
5/9/2022
/ Australia ,
Canada ,
Economic Sanctions ,
EU ,
General Licenses ,
Member State ,
Military Conflict ,
Office of Foreign Assets Control (OFAC) ,
Patent Infringement ,
Patent Prosecution ,
Patents ,
Russia ,
UK
Seven years after the Member States of the EU signed the Agreement on a Unified Patent Court (“UPCA”), the Unitary Patent (“UP”) and the Unified Patent Court (“UPC”) are likely to commence during the second half of 2022. This...more
4/20/2022
/ Corporate Counsel ,
Enforcement Actions ,
EU ,
European Patent Convention ,
European Patent Office ,
Intellectual Property Protection ,
Member State ,
Opt-Outs ,
Patent Applications ,
Patent Filings ,
Patent Infringement ,
Patent Litigation ,
Patent Prosecution ,
Patents ,
Unified Patent Court ,
Unitary Patent