Posts Tagged: "innovation"

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed in a precedential decision the Patent Trial and Appeal Board’s (PTAB’s) finding that Moderna Therapeutics proved certain claims of Arbutus Biopharma Corporation’s mRNA delivery patent invalid as anticipated. U.S. Patent No. 9,404,127 is titled “Non-liposomal Systems for Nucleic Acid Delivery” and is directed to “an invention that provides stable nucleic acid-lipid particles (‘SNALP’) that have a non-lamellar structure and ‘comprise a nucleic acid . . . methods of making the SNALP, and methods of delivering and/or administering the SNALP.’” SNALP has a three-dimensional structure that is either a lamellar morphology or non-lamellar (pictured).

This week in Washington IP news, Congress is still on a state work period, but events continue in the Washington area as the United States Patent and Trademark Office (USPTO) holds a STEM educational event for K-12 students and their families. Elsewhere, the Brookings Institution will hear from U.S. Treasury Undersecretary Jay Shambaugh about the state of the global economy.

Current artificial intelligence (AI) systems can generate an astonishing variety of content, including text-based works, audio, video, images, programming code, product designs, technical papers, etc. In many cases, the output from an AI system is virtually indistinguishable from that of a human. This trend is expected to continue at an ever-increasing rate in the coming years. Since content solely generated by an AI system is not available for protection under existing intellectual property laws, the following are practical guidelines for human creators who wish to protect content that was created with the assistance of an AI system.

On Wednesday, April 4, the Patent Trial and Appeal Board (PTAB) denied VLSI’s motion to terminate Intel’s involvement in an inter partes review (IPR) of VLSI’s U.S. Patent No. 7,725,759. In addition to Intel, OpenSky is also a petitioner in the IPR, which pertains to claims 1, 14, 17, 18, 21, 22, and 24 of the ‘759 patent. VLSI argued that a previous March 2021 district court ruling that found Intel had not proven invalidity of claims 14, 17, 18, and 24 of the patent precluded the tech firm from continuing to pursue this IPR. However, Intel successfully made the case that claim preclusion does not apply thanks to the America Invents Act (AIA). Additionally, it argued that the IPR and district court proceedings do not involve the same accused product and have different standards of proof.

On March 30, U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal issued a decision on sua sponte Director review that vacated a decision of the Patent Trial and Appeal Board (PTAB), which had previously denied institution of inter partes review (IPR) proceedings brought by semiconductor company Wolfspeed. In her latest in a series of sua sponte decisions, Director Vidal ruled that the PTAB erred in determining that prior art asserted by Wolfspeed was essentially the same as other prior art asserted against the same Purdue University patent claims in previous IPR proceedings that were also denied institution by the PTAB.

On March 31, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Philip Morris Products S.A. v. International Trade Commission affirming a Section 337 ruling by the U.S. International Trade Commission (ITC) that blocked the importation and sale of electronic vape tobacco products infringing patents owned by R.J. Reynolds Vapor Company. While much of the precedential decision deals with Philip Morris’ procedural and agency challenges to the ITC’s ruling, the Federal Circuit also rejected arguments that several patentability findings entered by the ITC were not supported by substantial evidence. The present appeal stems back to an ITC complaint filed by R.J. Reynolds in April 2020 seeking a Section 337 investigation into Philip Morris’ IQOS line of heat-not-burn tobacco vaping products. The two patents asserted by R.J. Reynolds are U.S. Patent No. 9901123, Tobacco-Containing Smoking Article, and U.S. Patent No. 9930915, Smoking Articles and Use Thereof for Yielding Inhalation Materials. After a yearlong investigation, the administrative law judge (ALJ) concluded that the accused IQOS products infringed claims of both patents, that R.J. Reynolds established the existence of a domestic industry with respect to both patents, and that the public interest did not weigh against entry of a limited exclusion order (LEO).

The U.S. Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S. Court of Appeals for the Federal Circuit (CAFC) got it wrong, and that the decision could upend the careful balance contemplated by the Hatch-Waxman Amendments between incentivizing new brand name drugs and allowing cheaper generics into the market.

A bipartisan group of congress members sent a letter to U.S. Patent and Trademark Office Director Kathi Vidal late last week urging her to implement some of the proposals outlined in her October 2022 Request for Comments on Robust and Reliable Patents in order to address problems around drug pricing. The letter was sent by Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Michael Burgess (R-TX), Ann McLane Kuster (D-NH), and Darrell Issa (R-CA). They specifically expressed concerns about the practice of “patent thicketing” and gave the example of two separate patents granted for a rheumatoid arthritis biological drug by the same company, where the difference in the claims was seemingly minor. The letter cites to a video titled “The Case for Patent Reform,” featuring Senior Vice President and Head of Legal & Intellectual Property Biosimilars at Fresenius Kabi, for this reference.

The International Trade Commission (ITC) conducted an all-day hearing today featuring a range of stakeholders with interests in the World Trade Organization’s (WTO) pending decision on extending what has come to be known as the TRIPS [Agreement on Trade-Related Aspects of Intellectual Property Rights] waiver from strictly COVID-19 vaccine technologies to COVID-19 related therapeutics and diagnostics. The initial agreement on waiver came in June of last year and left most of those at the table unhappy. The decision presently applies only to “ingredients and processes necessary for the manufacture of the COVID-19 vaccine” and contemplates extending that to therapeutics and diagnostics no later than six months after the date of the decision, which would have been December 17, 2022. However, that was delayed in December amid concerns there wasn’t enough information to make an informed decision on extension.

As an update to my previous posts from 2017, 2019, 2020, March 2021, August 2021, and 2022, it has now been almost nine years since the U.S. Supreme Court’s 2014 Alice Corp. v. CLS Bank decision. Yet the debate still rages over when a software (or computer-implemented) claim is patentable versus being simply an abstract idea “free to all men and reserved exclusively to none” (as eloquently phrased over 74 years ago by then-Supreme Court Justice Douglas in Funk Bros. Seed Co. v. Kalo Inoculant Co.). Further, it has been 12 years since famed venture capitalist Marc Andreessen wrote the influential and often-quoted op-ed piece in the Wall Street Journal titled “Why Software Is Eating the World.” Today, the digital transformation where software is “eating the world” is undeniable. Artificial Intelligence (AI), the Metaverse, Web3, cloud, gene editing, autonomous driving, quantum computing, and “green tech” dominate the technology news headlines and technology trend forecasts – all heavily reliant on software-related innovation – [Forbes] [Gartner] [World Economic Forum], but we are still without concrete guidelines for software-related patenting.

U.S. companies and inventors still filed more patent applications with the European Patent Office (EPO) than any other country, according to its Patent Index 2022, which was released today. The index showed that U.S. patent applications numbered 48,088, a 2.9% increase from 2021. However, China’s filings jumped by 15.1% over 2021, keeping it in fourth place out of the top five countries of origin for applications and narrowing the gap between it and Japan, the number three filer.

The U.S. Supreme Court heard three separate arguments today in Amgen v. Sanofi, a case that even Sanofi’s counsel agreed could effectively wipe out patents involving genus claims if the Court sides with Sanofi, or—as counsel for Sanofi and the Solicitor General’s Office suggested the Court could do—if it were to dismiss the case as improvidently granted.

This week in Washington IP news, the House Subcommittee on Economic Growth, Tax, and Capital Access examines how well creditors are able to identify small businesses that are eligible for additional capital. Elsewhere, the United States Patent and Trademark Office (USPTO) hosts the third event of the 2023 Women’s Entrepreneurship Symposium. Also, the Information Technology and Innovation Foundation (ITIF) discusses the future of manufacturing innovation in Germany and the United States.

On Monday, March 27, the Supreme Court will hear oral argument in Amgen v. Sanofi, a case with the parties and 27 Amici, including the United States, weighing in on whether and how the Court should address the enablement requirement of Section 112 in the context of genus claims, and in particular, genus claims to antibodies in the pharmaceutical sciences. Depending on how the court focuses its analysis, the opinion could be as narrow as how the jury instruction should read for pharmaceutical antibody claims written in the form of “a binding site plus a function.” But some of the briefs invite the court to loosen the constraints of Section 112 by eliminating the requirement of enablement of the “full scope” of the claimed embodiments in favor of a test focused on the “make and use the invention” language in the statute without the “full scope of the claimed embodiments” language the courts have used for years, with implications not just for pharma but for any art that uses functional or genus claiming.