The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical ingredient) or its methods of use can be listed. However, other kinds of patents may require a more careful evaluation, especially in light of a
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A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for biosimilars.
In September 2023, the Food and Drug Administration (FDA) proposed changes in the labeling requirements for biosimilars and interchangeable biosimilars in…
USPTO Report On COVID-19 Diagnostic Patent Filings
The U.S. Patent and Trademark Office (USPTO) released a report on innovations in COVID-19-related diagnostics as a case study of how innovation and intellectual property operate during times of crisis. The study utilized publicly available data from December 2019 through April 2023. Highlights that might be of interest to stakeholders in this space include trends…
Time Is Running Out For The EPO’s 10-Day Rule
Stakeholders accustomed to having “ten more days” to respond to a communication from the European Patent Office will have to update their calendaring systems for documents dated on or after November 1, 2023. This is because the European Patent Office (“EPO”) is abolishing its “10-day rule” such that all response periods will be measured from…
Prosecution Laches—Another Arrow In The Quiver For Challenging Patents
The Supreme Court recently declined to review Personalized Media Communications, LLC v. Apple Inc., where a divided panel of the Federal Circuit upheld the district court’s finding that a PMC patent is unenforceable due to prosecution laches. The district court had found “an inequitable scheme to extend … patent rights” involving 328 pre-GATT patent…
Federal Trade Commission Warns Against Improper Orange Book Listings
As announced in a September 14, 2023, press release, the FTC has issued a policy statement “warning pharmaceutical companies that make and sell brand-name drugs that they could face legal action if they improperly list patents in the FDA’s [Orange Book].” The policy statement builds on the premise that “[b]rand drug manufacturers may be…
Federal Circuit Puts Patent Term Adjustment On The Chopping Block
In In re Cellect, the Federal Circuit effectively held that Patent Term Adjustment (PTA) awarded under 35 USC § 154 is not protected from obviousness-type double patenting (OTDP) in view of a patent with the same 20-year term, such as may arise between a parent and child patent. In so doing, the court drew a…
Trends In Orange Book and Biologic PTAB Trials
The USPTO has released an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book or biologic patents, taking into account data through March 31, 2023. Highlights of the report that might be of interest to stakeholders in this space include trends in differences in numbers of petitions, institution…
USPTO Announces Director Review For Ex Parte Appeals
In a bulletin issued July 24, 2022, focused on Director Review of Patent Trial and Appeal Board (PTAB) decisions in AIA trials, the USPTO also announced the creation of “a new Appeals Review Panel (ARP), which may be convened by the Director sua sponte, to review PTAB ex parte, reexamination, or reissue appeal decisions,” and…
Would The Patent Eligibility Restoration Act Strike The Right Balance?
Senators Chris Coons and Thom Tillis recently introduced the bipartisan 2023 Patent Eligibility Restoration Act that would make significant changes to U.S. patent eligibility law. The “Findings” section of the Act states that “Efforts by judges of district courts and courts of appeals of the United States to apply the [judicially-created] exceptions [to patent eligibility]…