Pfizer Alleges Inconsistencies in Moderna’s Statements to FDA and PTAB

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.”

Where Trade Secrets and Data Privacy Strategies Overlap

Innovation continues across industries at a rapid pace. Many companies maintain highly valuable trade secrets and private data that provide them with a competitive market advantage. The rapidly evolving technological landscape, however, leads to new and more sophisticated threats to a company’s trade secrets and other private information. Whether organizations are equipped to confront this challenge is an open question.  

The Briefing: Navigating the Evolving Landscape of Influencer Marketing – A Guide to the Latest FTC Changes

As we step into a new year, the landscape of influencer marketing is witnessing notable changes that impact both brands and talent due to recent updates to the Federal Trade Commission’s (FTC) Guide on Endorsements and Testimonials in Advertising. Let’s delve into the key insights shared in this informative conversation.

Iancu, Michel and Other PTAB Masters Panelists Float Ways to Make the System Better

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.

The Federal Circuit Could Make the ITC a More Appealing Forum

In a pending case, the Federal Circuit is primed to provide much-needed clarity on the economic prong of the domestic industry requirement at the United States International Trade Commission (ITC). In ruling, the court will likely resolve a long-running dispute between individual commissioners regarding how to apply the so-called “mere importer” test when determining whether the domestic industry requirement is met. If the complainant, Lashify, prevails, it could make the ITC a more appealing forum for patent infringement suits involving entities that have under-utilized the ITC, including inventors, universities, and start-ups. The case at issue is Lashify, Inc. v. ITC, No. 23-1245.

Liquidia Urges SCOTUS to Restore Preclusive Effect to PTAB Final Written Decisions

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.

The March-In Drug Price Control Narrative Crumbles While Its Damage to American Innovation Grows

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.

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