Posts in Government

On April 9, Knowledge Ecology International (KEI), the Union for Affordable Cancer Treatment (UACT) and Universities Allied for Essential Medicines (UAEM) sent a letter to Chiquita Brooks-LaSure, Administrator for the Centers for Medicare and Medicaid Services, requesting that CMS use alleged statutory authority to allow companies to make and sell generic versions of the blockbuster prostate cancer drug, Xtandi®. The letter comes two months after the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the drug under 35 USC §203.

The Medical Device Manufacturers Association (MDMA) and the Alliance of U.S. Startups and Inventors for Jobs (USIJ) sent a letter today to the leadership of the Senate Judiciary Committee and the Judiciary Committee’s Subcommittee on Intellectual Property to express their support for both the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) and the Patent Eligibility Restoration Act (PERA). Both PREVAIL and PERA were introduced on June 22, 2023. The PREVAIL Act aims to reform Patent Trial and Appeal Board (PTAB) practices while PERA would eliminate all judicially-created exceptions to U.S. patent eligibility law.

The U.S. Patent and Trademark Office (USPTO) today announced guidance for practitioners and the public regarding the use of artificial intelligence (AI) in the preparation of filings for submission to the Office. The guidance comes two months after the Office issued a guidance memorandum for the Trademark and Patent Trial and Appeal Boards (TTAB and PTAB) on the misuse of AI tools before the Boards that clarified the application of existing rules to AI submissions.

Independent Presidential candidate Robert F. Kennedy, Jr’s Vice-Presidential running mate, Nicole Shanahan, a mercurial patent analyst, intellectual property lawyer and incidentally rich entrepreneur, is in the position to influence declining patent reliability and increasing copyright abuse. But will she? This column is not intended to opine on Shanahan’s merits as an independent Vice-Presidential candidate, but to attempt to understand her motivation for running and its potential impact on IP rights, creators and assignees.

In a significant milestone for the preservation of biodiversity, Decree 11,865/2023, published in the Official Gazette on 12/28/2023, enacted the Nagoya Protocol in Brazil. The protocol, providing for access to genetic resources and the fair sharing of benefits arising from their use, is part of the renowned Convention on Biological Diversity (CBD). The Nagoya Protocol, in force since October 12, 2014, relates to the international commitment of 140 countries, including Brazil, to implement the objective of the CBD on the fair and equitable sharing of benefits from the use of genetic resources and the traditional knowledge associated with them (TK).

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal vacated and remanded a decision of the Patent Trial and Appeal Board (PTAB) on Friday that had denied institution of an inter partes review (IPR) requested by auto parts manufacturer, Mahle Behr Charleston, Inc. U.S. Patent No. RE47,494 E is owned by inventor Frank Amidio Catalano and covers “a device to prevent corrosion [in motor vehicle radiators] caused by electrolysis.” Mahle Behr requested IPR of the patent, arguing that a prior art reference called Godefroy anticipates and renders obvious certain claims.

“Many believe the root cause of the patent system’s dysfunction is that the U.S. Patent and Trademark Office [USPTO] is issuing too many invalid patents that unnecessarily drain consumer welfare, stunt productive research, and unreasonably extract rents from innovators.” That quote from Professors Michael Frakes and Melissa F. Wasserman echoes a common complaint in patent policy conversations. The USPTO is widely perceived as issuing too many bad patents.

The protection of privilege in communications between clients and lawyers is a very important one under U.S. law. The basic rule is that when a client seeks legal advice from a lawyer, the communication between the client and the lawyer is confidential and cannot be discovered during litigation. An important purpose of this rule is to encourage clients to communicate fully and freely with lawyers in the process of seeking legal help. The lawyers here include both external lawyers and in-house lawyers.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday affirmed a number of district court orders against inventor Urvashi Bhagat, whose patent application  was rejected by the U.S. Patent and Trademark Office (USPTO). Bhagat’s U.S. patent application No. 13/877,847 covers orally-delivered nutritional formulations containing omega-6 fatty acids and antioxidants. The application was filed in 2013 and the USPTO examiner rejected all claims as obvious, two claims as lacking written description, several other claims as indefinite and others for improper dependency. On appeal to the PTAB, the Board summarily affirmed the dependency and indefiniteness rejections, affirmed the obviousness rejection on the merits and reversed the written description rejection. Bhagat then appealed to the U.S. District Court for the Eastern District of Virginia, claiming the USPTO erroneously rejected her patent claims and asking for damages due to the Office’s bad faith and for taking her property.

In a nod to Mark Twain’s famous quote, the rumors of the death of IP Edge are greatly exaggerated. It appears the prolific NPE aggregator has either sold or transferred at least one portfolio (and potentially up to 40) to a new entity, Inferential Capital, LLC, which after hiring, has begun asserting again—more below.  On the stats, it was a slightly below average week at both the Patent Trial and Appeal Board (PTAB) and in the district courts. At the PTAB, there were 25 new patent filings, with one post-grant review and 24 inter partes reviews (IPR). 

The European Union Intellectual Property Office (EUIPO) announced today that it has for the first time referred questions of legal interpretation of the EU Trade Mark Regulation (EUTMR) to the enlarged Board of Appeal. The EUIPO’s Executive Director, João Negrão, asked the Office’s Grand Board of Appeal to weigh in on five questions concerning the practice of “conversion,” which allows an EU Trade Mark (EUTM) application or registration to be converted into one or more national applications when necessary. The process is meant to address situations in which an EUTM faces a ground of non-registrability in one or several Member States; through conversion, “the EUTM applicant can convert the EUTM into one or more trade mark applications in the Member States not affected by the problem,” explained the Executive Director’s Referral of Questions.

For the second year in a row, we pulled and analyzed data on the number of women who appeared in International Trade Commission (ITC) investigations. This year’s data confirms what we saw last year: that women are underrepresented at the ITC. While research shows women make up about 50% of the population, 50% of associates, and 39% of the profession generally, they only made up 27% of the ITC advocates in both 2022 and 2023. The difference in years of experience between male and female advocates is even starker, with men having on average nearly 7 more years of experience than women. This year’s statistics are examined in detail below and compared to what we found in our article published last year.

After VLSI Technology filed a complaint against Patent Quality Assurance (PQA) and its representative, Joseph Uradnik, in the Circuit Court of the City of Alexandria in late January this year, Uradnik recently filed a Notice of Removal with the U.S. District Court for the District of Alexandria, Alexandria Division, arguing the case should be tried there instead. VLSI’s complaint alleged abuse of the inter partes review (IPR) system and is seeking approximately $3.2 million in legal fees from Uradnik, according to the March Notice of Removal.

The U.S. Supreme Court’s flimsy eligibility jurisprudence offers the U.S. Court of Appeals for the Federal Circuit (CAFC) several “softball pitches” to avoid a patent bloodbath. To date, the Federal Circuit has struck out at preserving the patent system — at least twice without really even taking a swing! The first softball pitch appears in the High Court’s initial decision to exalt judge-made “exceptions” over the 200-year-old statutory rule, namely, Mayo v. Prometheus.

The Indian Ministry of Commerce and Industry, which administers the Department for Promotion of Industry & Internal Trade, published changes to its 2003 Patent Rules in its Official Gazette on March 15, 2024. These rules are known as the 2024 Patent (Amendment) Rules (hereinafter “Amendment”). This article analyzes key provisions of the Amendment in light of U.S. patent rules and practices.