Posts Tagged: "Senator Thom Tillis"

The Initiative for Medicines, Access & Knowledge (I-MAK) has responded to a letter it received from Senator Thom Tillis (R-NC) in January asking the organization to address claims that its data on the effects of pharmaceutical patents on drug pricing is faulty. In the letter, I-MAK defended its underlying patent data and, in reference to the question of why the data differs significantly from public sources like the Food and Drug Administration’s (FDA’s) Orange Book and court filings, explained that “relying on public sources and court filings is not an accurate methodology for identifying all patents on a drug.” I-MAK’s view is that the U.S. patent system creates patent monopolies that lead to the practice of “evergreening”, in which innovator pharmaceutical companies extend their rights beyond the original patent terms, preventing competition from generics, which in turn causes drug prices to remain high. As part of its mission, I-MAK has developed a database of patents covering key drugs. Its reports are often cited by academics, including in law journals, policymakers and in congressional hearings. As a result, I-MAK has become one of the most authoritative sources for information on patents in this space.

Earlier this month, Senator Thom Tillis (R-NC) sent a letter to the U.S. Patent and Trademark Office (USPTO) and to the U.S. Food and Drug Administration (FDA), expressing concern about policymaking on drug patents and drug prices being driven by a narrative rooted more in policy goals than in actual data. He sent another letter to a policy organization, Initiative for Medicines, Access, and Knowledge (I-MAK), which has held itself out as go-to source for data on the number of patents covering drugs. I-MAK has become very popular; its drug patent numbers are invoked as fact by congresspersons, academics, congressional witnesses, and policy activists. Senator Tillis is to be commended for expressing serious concerns about the unreliability of drug patent numbers repeatedly invoked in the policy debates over drug prices in Washington, D.C. His letter to the USPTO and FDA requests that the agencies engage in an “independent assessment and analysis of the sources and data that are being relied upon by those advocating for patent-based solutions to drug pricing.”

North Carolina Republican Senator Thom Tillis has raised the possibility of a combined patent, trademark and copyright office so as to improve the federal government’s approach to all aspects of intellectual property. On January 26, the Senator sent a letter to the Chairman and Counsel for the Administrative Conference of the United States (ACUS) to undertake a study into whether there should be a unified, independent Intellectual Property Office. The Administrative Conference is an independent agency that makes procedural recommendations to the federal government. Tillis’ request is premised upon his view that currently there is a fractured approach to intellectual property in our federal government, with multiple IP functions spread across different agencies, leading to conflicting policy agendas and unnecessary bureaucracy. Tillis is the Ranking Member of the Senate’s Judiciary Committee’s subcommittee on Intellectual Property.

On February 3, during an Executive Business Meeting of the Senate Judiciary Committee, Senator Thom Tillis (R-NC) proposed several amendments on the markup of S. 2710, the Open App Markets Act. The bill would apply existing U.S. antitrust law under the Federal Trade Commission (FTC) Act or the Clayton Act for enforcement actions against companies that engage in anticompetitive practices in app stores, such as requiring app developers to use a favored in-app payment system for accessing consumers through that app store.

Just over one week ago, Professor Adam Mossoff of the Antonin Scalia Law School at George Mason University published a Policy Memo with the Hudson Institute charging that some of the key data relied upon in the heated debate over the effects of pharmaceutical patents on drug pricing and access may be faulty. Now, Senator Thom Tillis (R-NC) has written letters to the key organization providing that data, the Initiative for Medicines, Access & Knowledge (I-MAK), as well as the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), expressing concern about the findings of Mossoff’s memo and requesting more information from I-MAK about its methodology.

The first day of IPWatchdog’s PTAB Masters™ 2022 program featured a welcome from Senator Thom Tillis (R-NC), Ranking Member of the Senate Judiciary Committee’s Subcommittee on Intellectual Property, who told attendees that Congress should consider codifying some of the reforms made by former U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu in order to better avoid “gamesmanship” at the Patent Trial and Appeal Board. Tillis specifically called out entities like OpenSky Industries, who last December petitioned the PTAB to institute an IPR proceeding challenging claims from one of two patents involved in VLSI Technologies’ $2.175 billion jury verdict for patent infringement against Intel, which was handed down in March 2021 in the Western District of Texas.

Senator Thom Tillis has come out on the record in support of Kathi Vidal to be the next Director of the U.S. Patent and Trademark Office (USPTO), on the eve of a Senate Judiciary Committee vote on her confirmation. Despite recent scrutiny of her ties to big tech and Silicon Valley, Tillis in a statement today said that he was satisfied with Vidal’s responses to his “tough questions” during the confirmation hearing process and feels he has received her commitment that she will continue the reforms implemented by former USPTO Director Andrei Iancu.

On November 30, Senator Thom Tillis (R-NC) wrote a letter  addressed to President Joe Biden asking Biden to withdraw the nomination of Gigi Sohn, a co-founder of the open Internet advocacy group Public Knowledge, to serve as a commissioner with the Federal Communications Commission (FCC). Tillis is one of a growing number of Republican lawmakers who are speaking out strongly against Biden’s nomination of Sohn, who previously served as a senior staffer to former FCC Chairman Tom Wheeler during the Obama Administration. Tillis’ letter to President Biden certainly pulls no punches in assessing the likely impact of Sohn’s nomination on copyright owners especially. “[Sohn] is a radical open-content activist with no respect for intellectual property rights,” Tillis wrote. “As an activist, Ms. Sohn has consistently worked against commonsense measures that would crack down on illegal piracy. She has even testified before Congress that ‘piracy has absolutely no effect on [music] prices whatsoever.’”

Today, the full Senate Judiciary Committee held a hearing to question two key IP nominees: Judge Leonard Stark of the of the United States District Court for the District of Delaware, who was nominated to replace Judge Kathleen O’Malley on the U.S. Court of Appeals for the Federal Circuit (CAFC); and Katherine Vidal, the nominee for Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO). IPWatchdog has previously reported on the qualifications of both candidates and what their appointments might mean for IP law and practice going forward. While neither nominee made any particularly earth shattering statements, as is often the case in such hearings, Senator Thom Tillis (R-NC), a vocal IP advocate, said he was heartened by Vidal’s acknowledgement that it has become “very difficult to understand the contours of [patent eligibility] law.” Vidal also stated that the current USPTO guidelines on eligibility, which were revised by former USPTO Director Andrei Iancu to provide more clarity, are consistent with the law right now.

Dear Ambassador Tai: I write you again today for the fourth time about the Biden Administration’s waiver of international obligations under the Trade-Related Aspects of Intellectual Property Rights, or TRIPS agreement. Last week, several open-content organizations wrote to President Biden and argued that your proposed TRIPS Waiver should cover not just patents, but also copyright and other intellectual property rights. These organizations ask that you include copyright simply because it may apply to software, medicine labels, manuals, or “tools” associated with vaccines. The letter fails to address the importance of these protections to the economy, trade, and employment, the limitations placed on protections to ensure a balanced system, and how copyright protection facilitates the very innovation, creativity, and knowledge sharing that will make it possible for us to end this once in a lifetime pandemic. The inclusion of copyright is both unsubstantiated and unwarranted, and would impose devastating consequences on American creators, businesses and workers, while doing nothing to advance the objective of combatting COVID.

Earlier today, U.S. Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT), the Ranking Member and Chair of the Senate Intellectual Property Subcommittee, introduced a pair of bipartisan bills that the Senators say are aimed at improving the participation Americans from all backgrounds in the patent system and ensuring that the public knows the true owners of patents. If enacted, the Unleashing American Innovators Act (UAIA) would require the Director of the United States Patent and Trademark Office (USPTO) to establish another satellite office within three years somewhere in the Southeastern region of the nation, which the bill specifically defines as Virginia, North Carolina, South Carolina, Georgia, Florida, Tennessee, Alabama, Mississippi, Louisiana, and Arkansas. Of course, given that the main campus of the USPTO is located in Alexandria, Virginia, it would seem unlikely that Virginia would be the final destination of any Southeast Region satellite office. The UAIA would also require the Director to determine within two years whether any additional regional satellite offices are necessary to— in the words of the bill— “achieve the purposes described in section 24 23(b) of the Leahy-Smith America Invents Act… and increase participation in the patent system by women, people of color, veterans, individual inventors, or members of any other demographic, geographic, or economic group that the Director may determine to be underrepresented in patent filings.”

On Thursday, September 9, Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT) sent a letter addressed to Drew Hirshfeld, performing the functions and duties of the Director of the U.S. Patent and Trademark Office (USPTO), discussing the issue of inconsistent statements made by patent applicants pursuant to their disclosure requirements at the USPTO and other federal agencies, especially the U.S. Food and Drug Administration (FDA). The Senators are asking the USPTO to take swift action to ensure that applicants are disclosing all known prior art at both the USPTO and the FDA.

On August 31, at the request of Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT), the United States Patent and Trademark Office (USTPO) provided a report to Congress analyzing infringement disputes between patent and trademark rights holders and states and state entities. The U.S. Copyright Office produced a similar, much lengthier report, also in response to a letter from Tillis and Leahy, studying whether there is sufficient basis for federal legislation abrogating State sovereign immunity when States infringe copyrights. The Senators’ letters were prompted by the March 2020 Allen v. Cooper Supreme Court decision. While the USPTO report came to no conclusions, the Copyright Office found that “the evidence indicates that state infringement constitutes a legitimate concern for copyright owners.”

In March of this year, a bipartisan group of senators asked Drew Hirshfeld, who is Performing the functions and duties of the Director of the U.S. Patent and Trademark Office (USPTO), to “publish a request for information on the current state of patent eligibility jurisprudence in the United States, evaluate the responses,” and provide the senators with a detailed summary of the findings in order to assist them as they consider appropriate legislative action. The letter gave a deadline of March 5, 2022 to submit a report on the topic. Now, a Federal Register Notice (FRN) scheduled to be published July 9 is requesting answers and input from stakeholders to 13 questions/topics to assist in that effort, according to a publicly posted draft of the FRN.

Senators Leahy and Tillis have proposed another patent law amendment for the Endless Frontiers Act (SA 2060). No defense or damages limitation has ever turned on the niceties of recordation of ownership at the USPTO. This would be a sea change in patent law. Something so radical at least should rise or fall based on thorough and thoughtful legislative debate, investigation and committee work, including testimony by experts in real estate law and patent practice.