President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or biologics to the marketplace for years, denying Americans access to lower cost drugs. The President called for…
On June 29, 2022, the United States Patent & Trademark Office (USPTO) announced that it was temporarily extending its Cancer Immunotherapy Pilot Program (”Patents 4 Patients” or “P4P”) to September 30, 2022, and also issued a request for public input on the P4P. Under the P4P, Applicants can file a…
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 reports it issues during prosecution. These changes may negatively impact the breadth of patent protection an applicant could…
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 promises to bring significant changes to patent protections across Europe, potentially…
Clinical drug candidates are often claimed in a patent as a pharmaceutical composition or formulation with a specified concentration range of the drug or an excipient; as being purified within certain temperature or pH ranges; or in a method of treating a disease by administering the drug at a certain…
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs and biological products in 2021 (not including the vaccines, cellular and gene therapy products, or other products approved in 2021 by the Center for Biologics Evaluation and Research). As in past years, small molecule drug approvals dominated…
Idenix’s Pharmaceuticals’ patent (U.S. Patent No. 7,608,597) was invalidated for having a genus that was “too broad.” The trial judge ruled that the patent did not enable a person of skill in the art to select a single compound from the “billions and billions” of compounds encompassed by the genus….
In an effort to lend further support to the expedited development of COVID-19-related vaccines and therapeutics (see Covid-19 Prioritized Examination Pilot Program), the United States Patent and Trademark Office (USPTO) has implemented a deferred-fee provisional patent application pilot program whereby applicants filing under 35 U.S.C. 111(b) can elect to defer…
When submitting a new drug application (“NDA”) with the FDA, an applicant (or branded company) is required to file a list of patents that cover the drug product. These patents will be listed in the FDA’s Orange Book upon approval of the drug for commercial sale. Patents that are eligible…
The Food and Drug Administration (FDA) maintains two searchable online databases for approved products: the Purple Book (approved licensed biological products) and the Orange Book (approved drug products). The Orange Book provides details about an approved drug product, including the patents covering the approved drug product and the expiration dates…
