We hear that the confirmation hearing for President Biden’s nominee for U.S. Patent & Trademark Office Director, Kathi Vidal, will happen tomorrow, December 1st at 10am ET. Thank goodness! We badly need a new Director after the last one, Andrei Iancu, repeatedly abused his power to benefit big pharmaceutical and technology companies—including many, like Eli Lilly and Facebook, that are clients of the law firm he worked at before and after taking office. Some of the most important challenges facing the next Director are:

(1) making the patent system more accessible and accountable to the public,

(2) supporting patent examiners and improving patent quality,

(3) tracking and improving diversity within the patent system,

(4) reversing arbitrary restrictions on administrative challenges to invalid patents, and

(5) enforcing applicants’ duties of candor and disclosure to prevent undue drug monopolies.

To find out if Ms. Vidal is up to those challenges, here are questions we would ask her and why:

1.     Making the Patent System More Accessible and Accountable to the Public

The Patent Public Advisory Committee (PPAC) is the only formal mechanism for public interaction with USPTO leadership, yet its members include no representatives of members of the public who do not own or assert patents, but are concretely affected by the patent system. These constituencies include medical patients, science researchers, consumers, farmers, early stage startups, and open source technology developers.[1] Instead, the PPAC’s members primarily include representatives of some of major pharmaceutical and technology companies, including Eli Lilly and Facebook.

·      Will you commit to treating all members of the American public as stakeholders in the patent system?

·      Will you commit to finding meaningful ways to bring more public voices and perspectives into the USPTO’s processes?

·      Will you commit to broadening PPAC membership to include representatives of constituencies who are concretely affected by the patent system, but do not own, acquire, or assert patents?

2.     Supporting Patent Examiners and Improving the Quality of Granted Patents

The Patent Office Professional Association has reminded the USPTO that “basic competent examination is a complex task under any circumstances, and that without the necessary time, training and support, it is extremely difficult to achieve,” and asked it “to step up its support of the examiners and the existing examination process.”[2] Empirical research shows that the time constraints cause examiners to issue low quality secondary pharmaceutical patents (which cover subsidiary features of patented pharmaceutical compounds), driving up drug prices and preventing generic competition.[3]

·      Will you commit to stepping up the USPTO’s support of examiners so that they have the time, training, and support competent examinations require? 

·      Will you commit to providing guidance to patent examiners to ensure they apply the Patent Act and Supreme Court precedents correctly and consistently?

·      Will you commit to making public all guidance and training materials provided to instruct patent examiners on the application of the Patent Act?

3.     Tracking and Improving Diversity within the Patent System 

The lack of diversity among people registered to practice before the U.S. Patent & Trademark Office (USPTO) as patent examiners, agents, and attorneys is staggering: 6.5% of USPTO registrants are racially diverse and 21.8% are women.[4] Scholars, including Colleen Chien, a law professor and advisor on IP issues to the White House under Presidents Biden and Obama, have called for the USPTO to systematically collect and distribute demographic data about those who apply for patents as well as those who are registered to practice before the USPTO as patent examiners, agents, and attorneys.[5]

·      Do you believe diversity among patent practitioners, applicants, and assignees needs to improve?

·      Will you commit to taking steps to implement systems for collecting and distributing data that supports the tracking of diversity within the patent system, including among people USPTO registrations, named inventors, patent applicants, and patent owners?

·      Can you describe any efforts you have undertaken to improve racial and/or gender diversity among patent attorneys in private practice?

4.     Reversing Arbitrary Restrictions on Administrative Challenges to Invalid Patents

In 2011, the America Invents Act created streamlined administrative proceedings to make it easier, cheaper, and faster for members of the public to challenge invalid patents without wasting huge amounts of time and money on trials in court. Former Director Iancu unilaterally enacted policies that restricted access to these proceedings in ways that contradicted the letter and spirit of that statute. In particular, former Director Iancu authorized administrative patent judges to refuse, arbitrarily, to review invalid patents so that trials in district courts or the International Trade Commission could proceed. That directly undermined Congress’s intent, benefited Director Iancu’s clients, and insulated numerous low quality patents on expensive pharmaceutical treatments from compelling legal challenges.  

·      Do you agree the USPTO Director does not have unfettered discretion to develop and impose policies that affect the application of the Patent Act?

·      Will you commit to engaging in publicly accessible, transparent processes—rather than relying on unreviewable adjudicatory decisions and directorial discretion— when developing policies that affect the application of the Patent Act?

·      Will you commit to reviewing, and as appropriate, retracting precedential or informative decisions—such as Apple v. Fintiv—that restrict access to inter partes review proceedings in ways that conflict with the America Invents Act?

5.     Enforcing Patent Applicants’ Duty of Candor to Prevent Undue Drug Monopolies

Evidence shows that pharmaceutical companies frequently make statements to other federal agencies, such as the Food and Drug Administration, that conflict directly with those made in their patent applications.[6] These statements undermine patent quality, market competition, and the integrity of the patent system, which depends on patent applicants to comply with their duties of disclosure and candor.

·      Will you commit to taking steps to enforce patent applicants’ obligations to disclose relevant statements made to other government agencies?  

·      Will you commit to working with other federal agencies to identify conflicting statements made by patent applicants?

·      Will you commit to considering, and as appropriate, imposing, penalties on patent owners who violate their obligations of disclosure or candor?

References

[1] USPTO, Patent Public Advisory Committee Members Biographical Information, https://www.uspto.gov/about-us/organizational-offices/public-advisory-committees/patent-public-advisory-committee/patent (last visited Nov. 29, 2021).

[2] Patent Office Professional Association, Quality Initiatives, http://www.popa.org/about/history/quality-initiatives/ (last visited Nov. 29, 2021).

[3] Frakes, Michael D. and Wasserman, Melissa F., Investing in Ex Ante Regulation: Evidence from Pharmaceutical Patent Examination, National Bureau of Economic Research Working Paper No. 27579 (July 2020), https://www.nber.org/papers/w27579.

[4] American Bar Association, Diversity in Patent Law: A Data Analysis of Diversity in the Patent Practice by Technology Background and Region (September/October 2020), https://www.americanbar.org/groups/intellectual_property_law/publications/landslide/2020-21/september-october/diversity-patent-law-data-analysis-diversity-patent-practice-technology-background-region/.

[5] Chien, Colleen V., Increasing Diversity in Innovation by Tracking Women, Minority, and Startups Innovators that Patent and Supporting Experimentation in Inclusive Innovation Santa Clara Univ. Legal Studies Research Paper No. 01-19 (June 30, 2019), https://ssrn.com/abstract=3413805 or http://dx.doi.org/10.2139/ssrn.3413805.

[6] Letter from Senators Leahy and Tillis to Acting USPTO Director Andrew Hirshfeld, Sept. 9, 2021, https://www.leahy.senate.gov/imo/media/doc/20210909%20Letter%20to%20PTO%20on%20FDA%20submissions.pdf.