Posts Tagged: "patent"

In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. According to the brief, when Moderna was seeking approval for its COVID-19 vaccines, the company “candidly represented to the FDA that prior studies for related vaccines…supported an expectation of safety and efficacy. But now, faced with invalidating vaccine prior art…Moderna wrongly casts the same vaccine prior art as irrelevant.” The brief referred to this as a “litigation-driven one-eighty.”

Speakers at IPWatchdog’s PTAB Masters 2024 program this week predicted there will be little movement on the U.S. Patent and Trademark Office’s (USPTO) Advance Notice of Proposed Rulemaking anytime soon, but some pinned their hopes for change at the Patent Trial and Appeal Board (PTAB) to the pending Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. Both panelists who typically represent petitioners and those who represent patent owners at the PTAB also agreed there are a number of ways the perception of the Board could be improved. These could include changes like allowing oral argument more often, allowing experts to testify in person, and a more meaningful rehearing procedure, for example.

Last week, biopharmaceutical company Liquidia Technologies filed a petition for writ of certiorari with the U.S. Supreme Court to appeal a Federal Circuit ruling that affirmed induced infringement findings against Liquidia following the patent at issue being invalidated at the Patent Trial and Appeal Board (PTAB). In the petition, Liquidia argues that two previous Supreme Court rulings lead to a result contrary to the Federal Circuit’s determination that the invalidation of patent claims at the PTAB do not have preclusive effect on infringement litigation pending an appeal of the PTAB’s decision.

It was little more than a month ago when the Biden Administration unleashed its draft guidelines for applying the march-in provisions of the Bayh-Dole Act. For more than 43 years, the law was implemented as written. Every Administration—including the Biden Administration—rejected repeated attempts to misuse the law so the government could license copiers when critics felt that a product based on a federally-funded invention was too expensive. This was mainly sought under the guise of lowering drug prices. Even though the Administration issued a stinging denial of the most recent attempt last March, in December it reversed course.

An examiner interview is the best tool available to progress patent prosecution. Examiner interviews provide an avenue to quickly clear up misunderstandings, explore options, and reach resolutions. By the time I left law firm life to work in-house, I was interviewing nearly every Office Action. Over the years, I refined a style that was very effective, so much so that a partner once asked me how I was getting such good results, but at the time, I could not articulate what exactly I was doing or why it worked. In retrospect, I was successful because I argued less and negotiated more.

Filings began picking up again this week after a slow start in the new year in both the Patent Trial and Appeal Board (PTAB) and district courts. The PTAB had a busy week with 31 new filings—one Post Grant Review (PGR) and the rest Inter Partes Reviews (IPRs). Nearly half of all new PTAB filings came from just two entities: Apple and Neurent Medical…. The PTAB was also busy issuing 27 institution decisions (21 instituted and 6 not instituted).

Today, a letter signed by a coalition of top academics opposing the Biden Administration’s efforts to exercise march-in rights under the Bayh-Dole Act of 1980 was sent to the White House. Signed by academics in fields including law, economic policy and sciences, the letter warns the Biden Administration that its efforts to drive down drug pricing by seizing patent rights will “undermine fundamental principles that have made the American IP system the golden standard for supporting domestic innovation.” A growing topic during recent Congressional debates, march-in rights under Bayh-Dole took on a new focus in early December when the National Institutes of Standards and Technology (NIST) and the U.S. Department of Commerce released a draft framework of factors that federal agencies should consider for the exercise of authority codified at 35 U.S.C. § 203 that would compel patent owners holding rights to federally-funded inventions to license those rights to “responsible applicants.”

The U.S. National Science Foundation (NSF) announced today that it is launching the National Artificial Intelligence Research Resource (NAIRR) pilot, as directed by President Biden’s Executive Order on AI in October 2023. The U.S. Patent and Trademark Office (USPTO) is one of 10 government agencies that are partnering with NSF on the pilot. Biden’s October Executive Order (EO) announced a series of new agency directives for managing risks related to the use of artificial intelligence (AI) technologies, prioritizing risks related to critical infrastructure, cybersecurity and consumer privacy. The EO in part directed NSF to launch a pilot for NAIRR within 90 days, which it said was “consistent with past recommendations” of a task force on the subject.

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal on Monday made public an order from December awarding VLSI Technology LLC $413,264.15 for “time spent addressing OpenSky’s abusive behavior” in a years-long and circuitous case between the two companies. Vidal first issued her precedential Director review ruling in October 2022, holding that inter partes review (IPR) petitioner OpenSky Industries, LLC abused the IPR process in its conduct with patent owner, VLSI Technology LLC, and sanctioning OpenSky by excluding it from the IPR proceedings by relegating it to be a “silent understudy” in the proceedings and “temporarily elevating Intel to the lead petitioner.”

The Senate Judiciary Committee’s Subcommittee on Intellectual Property today held a hearing featuring eight witnesses who testified about the need to restore certainty to U.S. patent eligibility law. Most, but not all, agreed such a need exists and urged quick passage of the Patent Eligibility Restoration Act of 2023 (PERA). Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced PERA in June of last year. The bill would eliminate all judicially-created exceptions to U.S. patent eligibility law.

When licensing standard essential patents (SEPs), the SEP licensor and the standard implementer (also known as the SEP licensee), go through two phases of negotiation. The first phase is the technical phase, followed by the second phase, the commercial discussion. In the technical phase, the SEP licensor must provide evidence that at least one patent of its portfolio is valid and standard essential. This is done by providing rigorously conducted claim charts that map claims against the standard’s sections, providing evidence that all claim elements read on the technical standard specification. Typically, only a few claim charts are needed in this first technical phase, since only one patent must be valid and essential to make the case that the standard implementing party is infringing. The second phase, the commercial discussion, is much more complex. Here, the SEP owner must provide evidence of the value of its SEP portfolio for a given standard supporting why the proposed royalty rate is FRAND (fair reasonable and non- discriminatory).

At the end of 2023, Law 14,785/2023 was published in Brazil’s official gazette, creating a new regulatory framework for chemical pesticides and environmental control products. The result of decades of discussions in the National Congress, the new law brings provisions that represent improvements to the system, such as the mandatory use of risk analysis in the process of granting registration of products and the requirement to harmonize with internationally established standards.

Today, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in CyWee Group Ltd. v. ZTE (USA), Inc. affirming the Patent Trial and Appeal Board’s (PTAB) invalidation of CyWee’s 3D pointing device patent claims. In affirming the final written decision, the appellate court found that ZTE’s lack of adversarial nature in inter partes review (IPR) proceedings allowed LG Electronics, a joined party that was otherwise time-barred, to properly oppose CyWee’s motion to amend patent claims.

The Bayh-Dole Coalition yesterday submitted comments to the National Institute of Standards and Technology (NIST) asking the agency to withdraw the recently published Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. The Coalition’s Executive Director, Joseph Allen, who authored the letter and formerly served as the Senate Judiciary Committee staffer to Senator Birch Bayh (D-IN), explained that “the framework would irreparably undermine one of the most successful laws in American history.” While Bayh-Dole contemplates march-in rights, the law strictly limits the situations in which such rights can be exercised and does not make any reference to pricing as a criterion for marching in. March-in requests have been rejected on a bipartisan basis multiple times since the bill became law and even then-Senator Joe Biden himself has opposed attempts to inject price controls into the law.

Jamie L. Simpson is the Chief Policy Officer and Counsel for the Council for Innovation Promotion (C4IP) and has previously served as Chief Counsel for the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, and in various roles at the U.S. Patent and Trademark Office (USPTO). In the latest episode of The SEP Couch, Tim Pohlmann spoke with Simpson about  how IP is dealt with in the United States and, in particular, the topic of standard essential patents (SEPs), and explained that the situation is certainly more complicated than is appreciated from the outside.