Posts in Capitol Hill

A Plea to Senator Tillis: Words Matter in Section 101 Reform

In U.S. government, setting public policy is the sole and exclusive domain of Congress. The laws they pass effectuate the public policy positions that Congress alone has the power to set. In law, words are everything. The precise meaning of the words in law determines whether the public policy is implemented as intended by Congress. Altering the meaning of just one word can change the entire public policy set by Congress, even turning the public policy on its head. Anyone following the debate on patent eligibility can attest to how the Supreme Court’s redefinition of the word “any” in 35 U.S.C. § 101 to have an exception called an “abstract idea” caused a significant public policy change and that change destroyed countless startups, especially those in tech. Senator Tillis’ Patent Eligibility Restoration Act of 2022, S.4734, wrongly puts the courts in charge of defining public policy because it leaves key words completely undefined.

Tillis’ Promised Patent Eligibility Bill Would Overrule Myriad, Mayo

Today, Senator Thom Tillis (R-NC), the Ranking Member of the Senate IP Subcommittee, released the first draft of the Patent Eligibility Restoration Act of 2022, which if enacted would, at a minimum, overrule the Supreme Court’s decisions in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)…. This legislation would absolutely be a solution to many of the patent eligibility problems that have plagued the industry for the last decade. Of course, if the tech giants in Silicon Valley think this will hurt them the bill will be killed, period.

A Cautious Welcome: Patent Community Chimes in on Tillis’ Eligibility Bill

This morning, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022, S.4734, which would amend the U.S. Patent Act to clarify the application of 35 U.S.C. Section 101 to certain technologies. While the bill was welcomed by many in the intellectual property (IP) community, since it would abrogate or weaken many of the seminal decisions that have arguably caused confusion on eligibility over the last decade-plus, some have called the bill out as being far from perfect. Questions remain with respect to the text’s language regarding the definition of “technological” and what it means for software patents, for instance, as some commenters note below.

Tillis, Leahy Introduce Legislation Mandating Reports, USPTO Improvements on Patent Quality

Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT) today announced the introduction of the Patent Examination and Quality Improvement Act of 2022, which is aimed at “evaluat[ing] and improv[ing] the patent examination process and the overall quality of patents issued by the USPTO,” according to a press release. Last week, Tillis told IAM that he would be introducing legislation to reform U.S. patent eligibility law, which is still to come. The bill announced today instead focuses on providing clarity around “what constitutes patent quality, the setting of patent quality metrics, and how the quality of work product performed by patent examiners is measured within the office.”

Copyright Office Tells Tillis Deferred Copyright Examination Will Not Achieve Cost Reductions

On August 1, the U.S. Copyright Office sent a report  addressed to Senator Thom Tillis (R-NC) detailing the results of the agency’s study into the feasibility of a deferred registration examination (DRE) option for copyright applicants seeking registration under U.S. law. While the Office recognized the genuine concerns of those seeking the creation of such an option, the report issued by Register of Copyrights Shira Perlmutter concluded that alternative approaches for addressing those issues would achieve better results than the proposed deferred examination option.

Vidal Takes Next Step on Senators’ Call to Curb Inconsistencies in USPTO/FDA Statements

Late last week, United States Patent and Trademark Office (USPTO) Director Kathi Vidal announced in a blog post that the agency had issued a notice in the Federal Register, which was published on Friday, to clarify the duties of disclosure and reasonable inquiry for pharmaceutical patent applicants, as well as parties to Patent Trial and Appeal Board (PTAB) proceedings. The notice was specifically targeted to parties proceeding before both the USPTO and Food and Drug Administration (FDA) and was issued in response to urging by Senators to establish interagency communications aimed in part at eliminating so-called drug patent thickets.

Three Letters Summarize the March-In/ Compulsory Licensing Debate

Health and Human Services (HHS) Secretary Xavier Becerra may consider himself a lucky man (which would probably sound ironic to him at the moment). He just received three letters which aptly summarize the fork in the road he faces in deciding which way to turn in a critical policy decision. On June 23, Senator Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX), joined by 98 of their Democratic Congressional colleagues, sent him the latest in their series of letters urging him to use alleged existing authorities so that copycats can make expensive drugs to lower health care costs. That triggered an immediate rebuttal from six associations representing research universities and hospitals (including the Bayh-Dole Coalition, which I lead) and another from the Licensing Executives Society, USA & Canada, Inc. (LES), representing the licensing profession. It seems appropriate to let the letters speak for themselves, so let’s start with the Congressional letter, urging the Secretary to use tools they allege he already has to cut the Gordian Knot to lower drug costs.

Report Reveals Danger of Proposed Price Fixing to U.S. Biopharma Innovation

Recently published research conducted by Vital Transformation shows legislative provisions similar to those found in the Inflation Reduction Act of 2022, which allows the U.S. Government to “negotiate” drug prices under a set framework based upon the amount of time a drug has spent on the market, would have significant, negative effects on patient access to new therapies because funding would be severely curtailed for research and development. According to Vital Transformation, the reduction of net earnings due to government price fixing would substantially reduce the amount of research and development of small biotech firms, which would negatively impact future drug discovery and development. The model used in the study estimates that with government price fixing “only 6 of 110 previously approved therapies would be considered ‘not at risk’ of being cancelled, or at very least divested.”

Senate Judiciary Committee Advances USPTO-FDA Collaboration Bill Toward Floor Vote

Earlier today, the U.S. Senate Committee on the Judiciary convened a brief executive business meeting to discuss a series of judicial nominees selected by the Biden Administration, as well as a pair of proposed bills. One of those bills, the Interagency Patent Coordination and Improvement Act of 2022, follows various efforts to limit certain patent rights in the pharmaceutical industry and was passed favorably out of the Committee via voice vote toward a full vote on the Senate floor.

This Week in Washington IP: Cybersecurity in Civil Space Operations, Coordinating Patent Data Between the USPTO and the FDA, and Innovative Ideas for Modernizing Congress

This week in Washington IP news, committee hearings at the U.S. House of Representatives focus on several topics related to technology including improvements to civil space procurement activities to promote cybersecurity in space systems, the use of facial recognition technology by U.S. Customs and Border Patrol, as well as technological recommendations advanced by the House Select Committee on the Modernization of Congress. Over in the Senate, the Judiciary Committee will debate a proposed bill that would establish an interagency task force for sharing communication on drug patents between the U.S. Patent and Trademark Office and the U.S. Food and Drug Administration. Elsewhere, the Center for Strategic & International Studies explores how last year’s bipartisan infrastructure law is being leveraged to create a regional clean hydrogen hub in Houston, the Brookings Institution discusses the future of crypto regulation following the stablecoin crash, and the USPTO closes out the week with a regular quarterly meeting of the Trademark Public Advisory Committee.

House IP Subcommittee Drills Down on GAO’s Preliminary Findings that PTAB Judges are Being Influenced by USPTO Leadership

The House Judiciary Committee’s Subcommittee on Courts, Intellectual Property, and the Internet today held Part II in a series of hearings to consider reforms to the Patent Trial and Appeal Board (PTAB) 10 years after it was created by the America Invents Act (AIA). The hearing, titled “The Patent Trial and Appeal Board After 10 Years, Part II: Implications of Adjudicating in an Agency Setting,” coincided with the release of a preliminary report by the U.S. Government Accountability Office (GAO) that was commissioned in June of last year by IP Subcommittee Chair Hank Johnson (D-GA) and Ranking Member Darrell Issa (R-CA) to investigate PTAB decision-making practices. The GAO’s preliminary findings revealed that “the majority of [administrative patent] judges (75 percent) surveyed by GAO responded that the oversight practiced by U.S. Patent and Trademark Office (USPTO) directors and PTAB management has affected their independence, with nearly a quarter citing a large effect on independence.”

This Week in Washington IP: Adjudication Issues at the PTAB, Regulating Government Access to Personal Data, and the USPTO’s Southeast Asia Intellectual Property Roadshow

This week in Washington IP news, the House Committee on the Judiciary’s IP Subcommittee takes a second look at the Patent Trial and Appeal Board after 10 years of existence, with a special focus on issues with adjudicating legal matters in an agency setting. The full House Judiciary Committee also hosts a hearing to explore government access to consumer personal data. Elsewhere, the Information Technology & Innovation Foundation debates ways that cultural changes at federal agencies can improve IT modernization efforts, and the U.S. Patent and Trademark Office hosts a Southeast Asia Intellectual Property Roadshow to educate business owners on how they can leverage their IP rights for business success in that region of the globe.

The PTAB Reform Act Will Make the PTAB’s Problems Worse

Recently, we submitted comments for the record to the Senate Judiciary Committee’s IP Subcommittee in response to its June 22 hearing on the Patent Trial and Appeal Board (PTAB), titled: “The Patent Trial and Appeal Board: Examining Proposals to Address Predictability, Certainty and Fairness.” The hearing focused on Senator Leahy’s PTAB Reform Act, which among other changes, would eliminate the discretion of the Director to deny institution of an inter partes review (IPR) petition based on an earlier filed district court litigation involving the same patents, parties and issues. Here is the net of what we told them:

When it Comes to Patent Reform, Watch What Google Does – Not What it Says

The debate over patent reform is heating up again. Last month, Google published a blog post on patent reform, purportedly aimed at promoting American innovation. In it, Google decried the rising tide of “wasteful patent litigation,” railed against the disfavored practice of “forum shopping” and advocated for pending legislation aimed at making it easier for large companies to challenge the validity of patents owned by smaller rivals — all in the name of promoting a patent system that “incentivizes and rewards the most original and creative innovators.”

SCOTUS Kicks Patent Eligibility Cases to the Curb in Last Move of the Term

The U.S. Supreme Court has denied certiorari in American Axle v. Neapco Holdings, Inc., leaving it up to Congress and the U.S. Patent and Trademark Office (USPTO) to restore any semblance of clarity on U.S. patent eligibility law for now. Many expected that the Court would grant the petition after the U.S. Solicitor General in May recommended granting review. The SG’s brief said that inventions like the one at issue in American Axle have “[h]istorically…long been viewed as paradigmatic examples of the ‘arts’ or ‘processes’ that may receive patent protection if other statutory criteria are satisfied” and that the U.S. Court of Appeals for the Federal Circuit “erred in reading this Court’s precedents to dictate a contrary conclusion.”