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 recent policy statement issued by the FTC signaling plans “to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade ..read more

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(FDA) proposed changes in the labeling requirements for biosimilars and interchangeable biosimilars in the draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products: Guidance for Industry.” When finalized, these nonbinding recommendations will replace the 2018 FDA industry gu ..read more

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 in the volume of COVID-19 diagnostic patents filed, the entities filing them, and countries with the most identified patent families in this field. For example, the report found that most of the patents identified were filed by small ..read more

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 the date printed on the document, effectively ending the 10-day grace period.   EPO Deadlines Measured from “Delivery” Date While most USPTO deadlines are measured from the date the Office Action was issued by the USPTO, many EPO deadlines are measure ..read more

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 harming generic competition through the improper listing of patents” in the Orange Book, and warns that the “FTC intends to use its full legal authority to protect patients and payors … from business practices that tend to negatively affect competitive conditio ..read more

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 line between other Federal Circuit decisions holding that Patent Term Extension (PTE) awarded under 35 USC § 156 is protected from OTDP. This decision may lead stakeholders to reconsider patent strategies that include routinely obtaining continuation patents, especially after a parent pate ..read more

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 rates, and outcomes as between Orange Book-listed patents and biologic patents. While the Hatch-Waxman ANDA litigation paradigm may favor district court litigation over PTAB trials for Orange Book-listed patents, it is interesting to consider possibl ..read more

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 published a memorandum and updated internal operating procedures pertaining to ex parte appeals. The ARP and memorandum will be of interest to practitioners and stakeholders with ex parte PTAB appeals. The New Appeals Review Panel (ARP) The bulletin does not say much abou ..read more

Effective July 17, 2023, the USPTO will "require" Information Disclosure Statement (IDS) Patent Term Adjustment (PTA) safe harbor statements to be made on a specific USPTO form and electronically filed under a specific document code. According to the Federal Register Notice, if these procedures are followed, the USPTO PTA calculation should recognize the safe harbor filing and not charge a PTA deduction for the concurrently filed IDS.  Although the rule "requires" use of the new form, the USPTO will permit patent owners who submit a safe harbor statement in a different format to request r ..read more

In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation, the court rejected the district court’s application of the “at once envisage” rubric when the issue presented is whether a claimed range is anticipated by prior art disclosing an overlapping range. In reaching its decision on obviousness, the Federal Circuit upheld the district court’s application of the “blocking patents” doctrine.   The Patent at Issue and Neupro ..read more