We are ready to help our clients navigate the potential legal and regulatory changes that could arise under a Biden Administration, as affected by the final outcome of the U.S. Senate races – including an increased focus on Intellectual Property.
Some considerations under a Biden Administration include:
- Likely replacing the current United States Patent and Trademark Office Director, Andrei Iancu, with someone who may be less pro-patent and more accommodating to patent challenges before the Patent Trial and Appeal Board, particularly as it relates to discretionary denials and patent eligibility.
- Policy at the non-partisan U.S. International Trade Commission is not likely to be affected by a change in administration. If the new Congress or Biden administration take an increased interest in the effect of imports on domestic industries, the USITC could be requested to conduct more 332 studies.
- Advising on the revisit of President Trump’s trade and IP relationship and dealings with other countries including China – and potential for a more consistent approach to worldwide exchange of intellectual property enforcement.
- U.S. policy on IP protection and regulation of Artificial Intelligence may change under a new administration; see the U.S. Office of Management and Budget Draft Guidance for Regulation of Artificial Intelligence Applications, Jan. 8, 2020 outlining principles which agencies should consider and implement when developing regulations of AI invention.
- U.S. policy (per USPTO/DOJ/NIST) on the treatment of Standard Essential patents, e.g., recent DOJ business review letters to the IEEE and Avanci, and the December 2019 joint policy statement issued concerning standard essential patents. The current trend in treating SEPs as any other patent for purposes of remedies may change under new leadership.
- Counseling in preparation for a potential impact on DOJ/FTC enforcement actions regarding patent-antitrust issues, e.g., standard essential patent issues and reverse payment settlements in ANDA litigation.
- U.S. treatment and restrictions on interactions with certain foreign companies and governments deemed to be harmful to U.S. interests – the Department of Commerce, Bureau of Industry and Security, “BI&S Entity List.”
- Interim Final Rule issued in June 2020 may be reversed or modified under a new administration.
- On Tuesday, November 10th, the Supreme Court heard arguments concerning the Trump Administration’s effort to strike down the Affordable Care Act in its entirety. If the administration is successful, the current biosimilar approval pathway as the Biologics Price Competition and Innovation Act would be eliminated as it was passed as a part of the ACA. While a replacement approval pathway would likely be passed under a Biden Administration with bipartisan support, it is quite possible that a Biden Administration would desire to modify certain features of the BPCIA, leading to significant implications for life science companies. For example, modification of the 12-year exclusivity period for newly approved biologics would disturb settled expectations concerning the economic value of current and future biologic medicines.
- Returning to and expanding on the National Cancer Moonshot Initiative to drive innovation and investment in life sciences given the significant social and economic impact of the COVID pandemic.
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Baker Botts is an international law firm of approximately 700 lawyers practicing throughout a network of 13 offices around the globe. Based on our experience and knowledge of our clients' industries, we are recognized as a leading firm in the technology, energy, and life sciences sectors. Since 1840, we have provided creative and effective legal solutions for our clients while demonstrating an unrelenting commitment to excellence. For more information, please visit bakerbotts.com.