BIO opposes proposed USPTO rule on challenging patents

We have details on BIO’s comments on a U.S. Patent and Trademark Office proposal that would harm the patent system—plus, more groundbreaking companies featured at the NIH Innovation Zone at BIO 2024 and how to nominate a leader for the California Life Sciences Pantheon Awards. Don’t forget to take our reader survey! (623 words, 3 minutes, 6 seconds)

BIO opposes proposed USPTO rule on challenging patents

A U.S. Patent and Trademark Office (USPTO) proposal to make it easier to challenge patents “would cause extensive harm to the patent system,” says BIO in comments.

The proposal: USPTO’s Notice of Proposed Rulemaking (NPRM) regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting is intended to make it cheaper and easier to strike down whole families of patents to prevent them “from potentially deterring competition.” 

“BIO believes that the proposed rule "is unsupported by the factual record, lacks legal authority, lacks a policy justification, is inconsistent with statutory and case law, and would cause extensive harm to the patent system,” says BIO’s comments.

Why it matters: “The most R&D-intensive industry in the U.S.,” biotechnology needs strong patent protections so investors know they can recoup money spent on developing drugs and other biotech innovations. 

BIO’s specific objections include:

• The proposed rule is based on the assumption that many innovative products are protected by “too many” patents, but for drugs the average number of patents for products registered with the Food and Drug Administration is 3-5.
• USPTO has no legal right to make such overarching changes to patent protections.
• The proposed rule “would undermine the value of U.S. patents, and discourage innovators from seeking U.S. patents on improvement inventions and follow-on technologies."
• It would raise the cost of patent examinations. 

The bottom line: BIO believes the proposal rule "suffers from too many fundamental flaws to be salvageable by amending or modifying it,"  laid out,” says BIO. “Because the proposed rule "lacks any redeeming features, it should be withdrawn immediately.”

NIH Innovation Zone: Identifying microbe interactions and cancer targets

Innovations to allow for a more realistic study of microbe interactions and to more precisely target cancer were among many highlighted at the 2024 BIO International Convention, Bio.News reports.

Watch this space: Thirty exciting innovators supported by the National Institutes of Health (NIH) SEED program presented on the NIH Innovation Zone Stage at the 2024 BIO International Convention—including Concerto Biosciences and Immuto Scientific.

Concerto Biosciences enables the study of how microbes interact in a microbiome to let researchers “discover microbial solutions that capture the fullest capabilities of microbes,” the co-founders tell Bio.News.

Concerto’s kChip “physically constructs millions of miniature, defined microbial combinations and measures how each affects a biological target of interest.” It can enable “discovery of effective microbe-based therapeutics and consumer products.”

Immuto Scientific uses new technology to identify proteins on the surface of tumor cells so drugs can be directed toward “a new class of targets that are highly cancer-specific,” Bio.News reports.

Immuto’s PLIMB “enables empirical characterization of protein structures directly in living cells…to label the surface exposed amino acids of proteins, which are detected and quantified by mass spectrometry to reveal important structural insights.”

For over 20 years, California Life Sciences (CLS) has recognized leaders in biotech, pharma, and other life sciences sectors with the Pantheon Awards.

Who can be nominated? Outstanding performers and companies based in California, in academia, biopharma, convergent technologies, emerging innovation, leadership, health equity, and future leadership. This year’s new Impact Award recognizes a life sciences organization demonstrating “continuous commitment to making a positive, lasting impact in their local community.”

Who wins? Last year, BIO members BioMarin and Twist Bioscience won Pantheon Awards.

Click here to learn more and nominate a California biotech leader by August 15.

President Biden’s Thursday: Meeting President Volodymyr Zelenskyy of Ukraine during the NATO summit in Washington. Zelenskyy urged more NATO support for Ukraine yesterday, AP reports.

What’s Happening on Capitol Hill: The Senate Appropriations Committee will mark up three bills including one on Agriculture-FDA appropriations and 2025 allocations. In other news, the Wall Street Journal reports that the Federal Trade Commission (FTC) plans to sue the three largest PBMs “over their tactics for negotiating prices for drugs including insulin, after a two-year investigation into whether the companies steer patients away from less-expensive medicines.”