Posts Tagged: "Government"

On April 16, the U.S. Department of Commerce announced that the Biden Administration had issued a notice of funding opportunity (NOFO) earmarking $54 million in funds available under the CHIPS and Science Act to fund advances in measurement technologies critical to semiconductor production. These funds, administered via grant through the Small Business Innovation Research (SBIR) program, are expected to improve U.S. leadership in computer chip manufacturing by mitigating production defects and increasing production yields.

The U.S. Patent and Trademark Office (USPTO) announced Monday that it has created an Office of Public Engagement (OPE) “to advance the agency’s mission of increasing participation in the innovation ecosystem by strengthening outreach and support to American communities.” The OPE will be on par with the Patents and Trademarks units and will consolidate a number of existing offices into one, including the four USPTO Regional Offices.

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.

Maintaining control over trade secrets is mostly about risk management, and one dimension of risk lies in having to tell hundreds or thousands of employees to keep quiet and then depend on each of them to do so. Human nature being what it is, risk increases quite a bit when the secret is about something really big and important. And it increases even more if the secret shows that your employer is lying to the public. Indeed, you might think that kind of information is the very hardest to keep under wraps. But there seems to be a growing number of people who think it’s quite easy.

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.”

On Friday, July 28, President Biden announced a new Executive Order titled “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs.” Rumors that the Administration was considering extending the deeply flawed Department of Energy (DOE) policy (see “More DOE Bureaucracy Equals Less Innovation” to all agencies had been swirling for months. Luckily, the new Executive Order doesn’t do that, but how it will be applied is subject to a convoluted interagency process, so it will be months before we see if it’s meeting its intended goal or not.

In a webinar hosted today by the Council for Innovation Promotion (C4IP), the organization’s founders, Andrei Iancu and David Kappos, both former Directors of the U.S. Patent and Trademark Office (USPTO), spoke with former U.S. Secretary of Commerce, Gary Locke, about the increased skepticism surrounding a plan to extend the waiver of intellectual property protections for COVID-19 vaccines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to COVID-19 diagnostics and therapeutics. According to Kappos, while World Trade Organization (WTO) member countries were supposed to decide on December 17 whether to extend the waiver, “given the rising opposition and other countries starting to raise their hands” with questions, “it’s seeming likely the WTO will defer its decision until the New Year.”

Despite high aspirations among political leaders, lawyers and others for a rules-based international order, a major new study from researchers at York University finds that the 250,000 existing treaties designed to foster international cooperation have mostly been ineffective. One big exception, however, is in the area of trade and finance, where negotiators wisely put meat on the bones of the commitments by including meaningful enforcement mechanisms. As a result, the researchers found, these international agreements were effective in increasing commerce and global prosperity.

As we celebrate World IP Day this week, the theme of which is “IP and SMEs [small and medium enterprises]”, we must remember that – from its founding – the United States’ economic success has depended on fostering an environment where innovators and entrepreneurs can dream big and achieve success. But that success is now at risk because our nation is lagging behind others in ensuring that everyone, everywhere, can access the most important tool of our time – the internet.

One would think it was ripped from today’s headlines: a deadly respiratory disease sweeps across the world—killing one person every 22 seconds. But this disease is not COVID-19. The threat is tuberculosis (or TB), which has flourished for centuries thanks to the ability of the bacteria that cause the disease (Mycobacterium tuberculosis) to quickly spread from person to person through the air that we breathe. Even though treatments exist, TB can easily become a chronic or fatal condition if left unchecked. According to the World Health Organization (WHO), in 2019, 10 million people became ill with TB, and 1.4 million people lost their lives to the disease—a serious, even silent pandemic that is deadlier than HIV.

On July 16, 2020, the U.S. Chamber of Commerce and national business associations of the UK, France, Germany, Korea, and Canada, published an Open Letter to Heads of States and Government leaders titled “Working Together to Discover and Deliver Innovative and Creative Solutions to the Pandemic’s Challenges”.  The letter highlighted the contributions made by businesses in response to COVID-19, noting that businesses have expended a considerable amount of time and resources to “accelerate the research, development and manufacture of protective equipment, advanced diagnostics, disinfection products, medical devices and potential treatments and vaccines.”

For over a decade, the National Intellectual Property Rights Coordination Center (IPR) has been at the forefront of the United States government’s response to combating global intellectual property (IP) theft and enforcement of its international trade laws. The IPR Center brings together over 25 global partners, including government and law enforcement agencies focused on IP enforcement. Steven Francis is the IPR Center Director and is also the Assistant Director for Global Trade Investigations at Homeland Security Investigations, with over 22 years of federal law enforcement experience. This month, I had the opportunity to interview Francis about the work of the IPR Center, particularly during Covid-19, and how the center is partnering with the stakeholder community through initiatives such as Operation Stolen Promise.