Posts Tagged: "patents"

The United States Trade Representative (USTR) released its annual Special 301 Report on April 26, adding two countries to the “Watch List”: Bulgaria and Belarus. In total, there are now 29 countries on either the Priority Watch List or Watch List, up from 27 last year. Belarus was added because it passed a law that “legalized unlicensed use of certain copyrighted works if the right holder is from a foreign state ‘committing unfriendly actions.’” This includes the U.S. sanctions imposed on Belarus for its support of Russia’s invasion of Ukraine. “

With the planet now awash in unused vaccines, efforts are underway to extend the TRIPS waiver to our COVID diagnostics and therapeutics (terms that are poorly defined). By the way, China is considered a “developing country” that could use the waiver. The U.S. Trade Representative asked the U.S. International Trade Commission to investigate whether or not such an extension is justified. That effort includes seeking public comments, which are due by Friday, May 5, 2023. The Bayh-Dole Coalition, which I lead, just submitted to following letter to US ITC Secretary, Lisa Barton, laying out some of the many reasons why the extension would be a colossal blunder.

The U.S. Patent and Trademark Office (USPTO) held its East Coast Listening Session on AI Inventorship today, featuring both USPTO staff and patent stakeholder speakers contemplating possible approaches to patenting in a world in which generative artificial intelligence (AI) almost seems to have snuck up on everyone. While many speakers cautioned against moving too quickly to change the rules for AI-generated inventions, others warned that doing nothing could result in chaos for the USPTO and grave economic and innovation losses for the country.

One day before the U.S. Patent and Trademark Office (USPTO) is set to hold its first public listening session on AI inventorship, the U.S. Supreme Court today denied certiorari in the case of Thaler v. Vidal, which asked the Court to consider the question: “Does the Patent Act categorically restrict the statutory term ‘inventor’ to human beings alone?” Dr. Stephen Thaler lost his case at the U.S. Court of Appeals for the Federal Circuit (CAFC) last August, when the CAFC said the USPTO’s reading of the statute as clearly referring to inventors as natural person was “unambiguously” correct.

The European Union is reportedly considering sweeping new regulations for the licensing and litigation of standard essential patents (SEPs), which make fair-minded observers wonder whether any sane adults are in charge at the European Commission (EC). The EU’s proposed new regulatory regime is scheduled to be released on April 26 by the Directorate for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) of the European Commission (EC). And recently leaked drafts suggest that proposal will contain sweeping new regulations that will effectively put an end to the licensing and litigation of SEPs as it exists today.

The U.S. Patent and Trademark Office (USPTO) today published an Advanced Notice of Proposed Rulemaking (ANPRM) indicating it is considering changes to America Invents Act (AIA) proceedings before the Patent Trial and Appeal Board (PTAB). Perhaps most notably, one of the proposals it is asking for input on has to do with creating rules that would authorize discretionary denial of inter partes review (IPR) proceedings “to ensure that certain for-profit, non-competitive entities do not use the IPR and PGR processes in ways that do not advance the mission and vision of the USPTO to promote innovation or the intent behind the AIA to improve patent quality and limit unnecessary and counterproductive litigation costs.”

Yesterday, in a precedential decision, the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a district court ruling that upheld the validity of several claims in two Amgen patents and barred Sandoz and Zydus from producing generic versions of Amgen’s psoriasis drug Otezla until 2028. The CAFC ruling also upheld the district court’s ruling that three claims in Amgen’s U.S. Patent 10,092,541 were invalid. However, that did not stop Amgen from declaring victory in the case in a press release.

Although the mining and metallurgical sectors are still seen as environmentally unfriendly industries, innovation in these sectors has been increasing since the beginning of the century, including in the development of green technologies. Four years ago, the World Intellectual Property Organization (WIPO) released a study measuring innovation in the mining industry with patents, “Mining patent data: Measuring innovation in the mining industry with patents”, showing a sharp increase in the number of correlated patent applications since 2005, which is a clear sign of the growth in investments in R&D and innovation made by these industries.

U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal held a virtual conversation with the intellectual property (IP) press on Wednesday to coincide with a one-year anniversary Director’s blog post published today. “If last year was about listening…this is really the year where we’re trying to bring that to impact,” said Vidal. Vidal said the work she did in her first year in office was about providing clarity and sometimes learning from “unintended consequences,” but this year is going to be about implementation based on the feedback they’ve been provided via the various requests for comments, listening sessions and other initiatives the Office has undertaken. “We now have more knowledge to shape real policy,” Vidal said.

On Wednesday, April 5, the United States Solicitor General (SG) recommended that the U.S. Supreme Court grant certiorari in two patent eligibility cases in order to “clarify the proper reach and application of the abstract-idea exception to patent eligibility under Section 101.” The SG filed the same brief in each of the two cases, Interactive Wearables, LLC v. Polar Electric Oy and David A. Tropp v. Travel Sentry, Inc. et. al.

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.

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.

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.

Perhaps after their favorite theory was blown apart again, as it has been every time it’s been trotted out over the past 20 years, the critics of the Bayh-Dole Act learned a painful lesson. Their carefully constructed thesis that the law contains a hidden provision allowing the government to set prices on successfully commercialized products has been summarily rejected by every Democratic or Republican Administration which has considered it. They say the definition of insanity is doing the same thing repeatedly while expecting a different result. But that didn’t keep the proponents from refiling the same petition which was rejected three times in the Obama-Biden Administration. So once again, the National Institutes of Health (NIH) denied the request that it should “march-in” under the law against the prostate cancer drug, Xtandi, because critics felt it is not “reasonably priced.” Apparently, the petitioners thought that the fourth time would be the charm. Now they know better. And this time, NIH included a subtle, but fatal blow to attempts to go down this path again.