PROTECTING SMALL BUSINESS, PROMOTING ENTREPRENEURSHIP

USPTO Comments Filed: WIPO IGC Negotiations on Genetic Resources and Associated Traditional Knowledge

By at 17 January, 2024, 1:20 pm

The Honorable Kathi Vidal

Director

United States Patent and Trademark Office

P.O. Box 1450

Alexandria, VA, 22313-1450

 

Docket No. PTO-C-2023-0019: Request for Information Related to WIPO IGC Negotiations on Genetic Resources and Associated Traditional Knowledge, 88 Fed. Reg. 13003 (Oct. 24, 2023)

 

Dear Director Vidal,

The Small Business & Entrepreneurship Council (SBE Council) appreciates the opportunity to respond to the 10/24/2023 Request for Information from the World Intellectual Property Organization (WIPO) Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge, and Folklore. Specifically, I am writing to express grave concern regarding the IGC’s proposed mandatory patent disclosure requirements (PDRs) for the origin of genetic resources and traditional knowledge, which would irreparably harm the startup and small business ecosystems that drive innovation in the United States and the world at large.

As president and CEO of SBE Council, I represent a diverse range of small companies that drive revolutionary advances in sectors like medicine, agriculture, finance, manufacturing, technology, climate technology and more – generating the lion’s share of U.S. GDP, innovation and job creation.

Such innovative firms owe much of their success to clear and enforceable intellectual property (IP) rights. Patents, trademarks, and other forms of IP allow small firms to generate a return on their risk-taking into products, goods and services following upfront R&D costs, some of which are very significant investments. That being the case, the startup and small business communities applaud your Office for its resolute leadership in protecting IP rights, both in the United States and abroad. These IP protections and rights must stay secure in order for entrepreneurial opportunity and innovation to flourish.

On the current matter, if the USPTO fails to oppose the IGC’s newest PDR proposal, the long-term viability of America’s world-class IP system and IP leadership – along with the entrepreneurs who depend upon it – will no longer be guaranteed.

The plan would mandate patent applicants to publicly disclose the origins of “traditional knowledge” and “genetic resources” – such as plant varieties, genetic sequences, and microorganisms – used in their goods and products. In pushing for this measure, some WIPO members claim that PDRs would bolster global biodiversity and better enable developing countries to accurately price genetic resources. Indeed, those are laudable goals.

However, PDRs would do nothing to achieve them. In fact, by hindering the ability of businesses worldwide to pursue groundbreaking innovation through R&D, the IGC’s proposal would deprive people in every country of life-changing technologies.

To start, it is simply impossible for many inventors to determine the precise geographic or biological origin of a specific genetic resource. Tracing the full history of a unique microorganism or amino acid sequence generally falls within the domain of academic research – and even then, it’s often an exercise in futility. The notion that businesses (especially small businesses) will be able to reliably determine such information is problematic. In fact, highly unrealistic.

Even when GR sourcing is feasible, it’s incredibly time-consuming and expensive. Given that start-ups and small companies often have fewer resources, including staff (most have fewer than 20 employees), a mandatory PDR regime would inevitably force a large share to abandon their research altogether. The financial and administrative burden would be insurmountable.

Apart from more obvious logistical challenges, PDRs would also chill R&D activity and investment by inserting enormous uncertainty into our patent system. For generations, IP-intensive businesses have operated with the understanding that there are three relatively straightforward requirements for patentability: novelty, utility, and non-obviousness. By adding a far more confusing stipulation to this long-established criteria, PDRs would undermine the confidence many businesses have in their ability to secure and protect otherwise reliable patents.

As a result, routine decisions concerning investment and distribution would suddenly be placed in doubt. Firms could be forced to shift their entire business models overnight if the IP protections on certain products are no longer enforceable.

Small companies in the life sciences sector would be disproportionately impacted. Start-up biotechs often stake their future revenue streams on just one or two potential therapies. Imposing PDRs on nascent medicines would further slow the decades-long process that it takes for a drug to receive FDA approval. It would all but ensure that fewer small life sciences companies survive, given that nine in ten treatments that enter clinical trials already fail to receive FDA approval.

We know from real-world experience that PDRs hugely encumber the entire patenting process, because it’s already happened in India and Brazil – which have seen significant delays and application backlogs since PDRs were implemented. There’s no reason to believe the outcome in the United States would be any different. Like patent examiners in those countries, the USPTO would be forced to waste thousands of valuable hours verifying the accuracy of each submitted GR.

Entrepreneurs and small business owners inherently understand that onerous, anti-innovation government regulations like PDRs are inimical to their innovative pursuits, competitiveness and survival. Moreover, such policies ultimately inflict even more damage on consumers and the public. If IGC’s plan passes, both Americans and those in developing countries would lose out on countless life-saving medicines, efficient technologies – including climate technologies – and other goods and products across every sector.

The United States and its patent system have been responsible for most of the world’s transformative discoveries and inventions of the past century – many coming from startups and small businesses. To preserve the environment and spirit of innovation and entrepreneurship for future generations, I urge you to reject the IGC’s newest proposal.

Sincerely,

Karen Kerrigan, President & CEO

 

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