Posts Tagged: "innovation"

In what has to be the unkindest cut of all, those expected to benefit from the proposed misuse of march-in rights so the government can impose drug price controls say they don’t support it either. The proponents promoting this hot house theory have seen it denounced by those who created the Bayh-Dole Act as being unauthorized under their law and seen evidence they can’t refute that it would have little impact on drug prices but would devastate small business entrepreneurs in all fields of federally supported research and development. And now they’ve lost the generic drug industry.

The recent U.S. auto workers strike has had a wide reaching impact on the automotive industry, including spurring investors to review their current automotive investments. While significant events like the strike often cause this sort of reaction, more common practices from automakers should – but usually don’t – draw investor attention, including intellectual property management. Our recent three-part analysis on the financial impact of patent lapse strategies for major automotive manufacturers found, among other data points,that major auto brands overspend several million dollars annually by paying fees to renew non-strategic U.S. patents. Investors who understand the patent lapsing strategies of these automotive companies can more effectively evaluate their growth plans and innovation strategies. 

On February 20, 2024, a Brazilian congress member, Antônio Luiz Rodrigues Mano Júnior (known as Júnior Mano), introduced a bill to amend the national IP Statute (Law #9,279/96) and regulate the ownership of inventions generated by artificial intelligence systems. Bill #303/2024 proposes the addition of a paragraph to Article 6 of the IP Statute, which regulates ownership of inventions, with the following wording: “in the case of inventions autonomously generated by artificial intelligence system, the patent can be requested in the name of the artificial intelligence system that has created the invention, being the artificial intelligence system considered the inventor and owner of rights arising from the invention.”

When the Biden Administration unleashed its proposed march-in guidelines last December, it claimed they would be a powerful tool for lowering drug prices by allowing the government to “march in” to license copiers under the authorities of the Bayh-Dole Act. It did so despite previously joining every other Administration denying price control petitions as not authorized under the law. It should have known the proposal would have minimal impact on drug prices—but would have a devastating impact on American innovation. That’s because the guidelines apply to all federal R&D agencies—not just the National Institutes of Health — so they cover inventions across the spectrum, not just the life sciences.  Now the chickens are coming home to roost. Three Congressional letters illustrate the point.

On February 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) released the 2024 International IP Index, which provides an annual snapshot of the impact of legal developments in intellectual property (IP) on the innovation ecosystem in dozens of nations across the world. While this 12th version of the GIPC’s index noted some positive developments in national IP frameworks, stagnation among the recurring leaders of the IP Index is a major concern given growing efforts by governments to control prices in critical sectors of the economy, especially in pharmaceuticals.

A bipartisan group of 28 members of congress, including Senate IP Subcommittee Chair Chris Coons (D-DE), Ranking Member Thom Tillis (R-NC) and House IP Subcommittee Chair Darrell Issa (R-CA), sent a letter yesterday to President Biden urging the administration to reconsider its December proposal to allow agencies to consider pricing in deciding whether and when to “march in” on patent rights. Also yesterday, four bipartisan senators wrote to National Security Advisor Jake Sullivan in opposition to the negotiating text of the World Health Organization (WHO) Pandemic Agreement, warning that it “would undercut—if not destroy—the very aspects of our innovation ecosystem that just recently produced such positive results.”

As artificial intelligence (AI) systems become increasingly sophisticated and play a greater role in our society, questions surrounding patentability and inventorship have come to the forefront of intellectual property discourse. This is particularly so in the wake of Thaler v. Vidal, 43 F. 4th 1207, 1213 (Fed. Cir. 2022), cert denied, 143 S. Ct. 1783 (2023), in which the Federal Circuit held that “only a natural person can be an inventor, so AI cannot be.” The U.S. Patent and Trademark Office (USPTO) recently issued guidance aimed at addressing these concerns.

The U.S. Patent and Trademark Office (USPTO) today released guidance for determining inventorship of artificial intelligence (AI)-assisted inventions. As the Office has previously stated, the guidance clarifies that “while AI-assisted inventions are not categorically unpatentable, the inventorship analysis should focus on human contributions, as patents function to incentivize and reward human ingenuity.” The USPTO issued a call for comments on AI inventorship in February 2023. That Federal Register Notice (FRN) asked the public to respond to 11 questions, including “how does the use of an AI system [in the invention process]…differ from the use of other technical tools”; whether AI inventions may be patentable under current patent laws on joint inventorship by, for example, simply listing the natural person involved in inventions created by AI machines; and whether statutory or regulatory changes should be made to better address AI contributions to inventions.

The importance and profitability of diversity are already well-known by companies. Research conducted by McKinsey & Company shows that in 2019 companies in the top quartile for gender diversity on executive teams were 25% more likely to have above-average profitability than companies in the fourth quartile. However, when we look at diversity in the patent sphere, a report published by the World Intellectual Property Office (WIPO) showed that, in 2021, women accounted for only 16.5% of all inventors listed in Patent Cooperation Treaty (PCT) applications.

The U.S. Senate Committee on Health, Education Labor & Pensions held a hearing today on why the United States pays “by Far, the Highest Prices in the World for Prescription Drugs.” Patents came up throughout the hearing as one barrier to lowering prescription drug prices, while pharmaceutical industry representatives underscored the cost of bringing innovative and life-saving drugs to market and the superior access Americans have to such drugs compared with other countries.

One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, published by the National Institute of Standards & Technology (NIST) and the Department of Commerce last month, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.

Today, the U.S. Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market. Opponents of the program, including the U.S. Chamber of Commerce, which is suing the government over the plan, argue it cannot be characterized as a voluntary negotiation since the affected companies would be subject to onerous excise taxes for refusing to participate and because it would have devastating consequences for patients if companies were to actually pull the affected drugs. The amounts of today’s initial offers were not revealed.

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.”

With each new year comes an uptick in purchases of workout equipment, blenders, gym memberships and wearable devices of all shapes and sizes. Plans are made and uploaded to a wearable device—including smart rings, shoes and bands—and its accompanying app to track progress. These devices and apps share information with each other and across platforms, tracking a person’s diet, sleep or even sexual activity.

Both the Biden and Trump Administrations have made it abundantly clear that economic and technology security is now national security. In the latest National Security Strategy, the Biden Administration stated, “Technology is central to today’s geopolitical competition and to the future of our national security, economy, and democracy. U.S. and allied leadership in technology and innovation has long underpinned our economic prosperity and military strength. In the next decade, critical and emerging technologies are poised to retool economies, transform militaries, and reshape the world.”