Posts in Legislation

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.

Russian businesses now hold the key to pilfering, producing and profiting from western technologies. As of Monday, March 7, the Russian government has legalized intellectual property (IP) theft. With this move, businesses in Russia can now violate IP rights, as they no longer need to compensate patent holders from “unfriendly countries.” The list of “unfriendly countries” includes the United States, Canada, Australia, Switzerland, Norway, Iceland, the United Kingdom, Japan, South Korea, New Zealand, Singapore, Taiwan and all 27 European Union (EU) member countries. Russia has faced growing isolation from the Western world following President Vladmir Putin’s invasion of Ukraine. The United States, EU member countries and others recently initiated sanctions against Russia and have enacted crippling trade limitations. Currently, Russia is sufficiently meeting its supply and demand needs for agriculture, energy and natural resources. However, Russia’s isolation and growing lack of skilled producers have led to a stark decrease in technological production and innovation.

In January of this year, Senator Thom Tillis (R-NC) sent a letter to Matthew Wiener, Acting Chairman of the Administrative Conference of the United States (ACUS), and Todd Rubin, ACUS Counsel for Congressional Affairs, asking that the ACUS “conduct a study on whether Congress should create a unified, stand-alone, and independent Intellectual Property Office.” But Wiener replied to Tillis’ letter on March 7, indicating that ACUS “has neither the expertise nor resources to conduct” such a study. Instead, Wiener suggested asking an entity better positioned to undertake the task, such as the National Academy of Public Administration (NAPA), which Tillis wrote to today.

A bipartisan group of five U.S. senators have introduced a bill to amend Chapter 28 of Title 35 of the U.S. Code to include language that would “combat corrupt Chinese Courts from issuing ‘anti-suit injunctions,’” according to a joint press release issued by the senators today. Senators Thom Tillis (R-NC), Chris Coons (D-DE), Tom Cotton (R-AR), Mazie Hirono (D-HI), and Rick Scott (R-FL) introduced the bill on March 8. An anti-suit injunction is an injunction issued by a foreign court to limit the rights of parties to pursue litigation in U.S. courts.

An IP announcement that may have slipped past you in the last few weeks is that China will now become a part of the Hague System for the International Registration of Industrial Designs. The Act will officially enter into force on May 5, 2022. Does this make a difference to you and your clients? Yes, in a very, very big way. Back in the mid-1990s, I had a key client operating out of Hong Kong, prior to the transfer of sovereignty from the UK back to China. He had, by then, become the world’s largest “maker” and seller of vacuum cleaners. Yet, he had only a small staff, mostly engaged in shipping and monetary transactions, i.e., paying for and getting paid for goods he bought and sold to vendors across the globe located in developing world economies.

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.

The last day of PTAB Masters™ 2022 featured sessions on dealing with parallel litigation at the International Trade Commission (ITC) and district courts in Patent Trial and Appeal Board (PTAB) proceedings; life sciences and inter partes review (IPR); and the future of the PTAB. On the latter topic, speakers contemplated what lies in wait for the U.S. Patent and Trademark Office (USPTO) Director nominee, Kathi Vidal, who is likely to be confirmed, as well as how certain the Restoring America Invents Act is to be passed, and what changes it may include.

On January 20, the Senate Committee on the Judiciary voted 16-6 to advance S. 2992, the American Innovation and Choice Online Act, out of committee and toward a full vote on the floor of the U.S. Senate. If passed, the bill would give the Federal Trade Commission (FTC), the U.S. Attorney General and state attorneys general new powers to bring antitrust enforcement actions against major online platforms that are alleged to be engaging in discriminatory conduct by preferencing their own products and services over competing products and services that are also available on those platforms.

The safe harbor provision set forth in 35 U.S.C. § 271(e)(1) immunizes many types of activities in pursuit of a Food and Drug Administration (FDA) submission from patent infringement claims. Research tools are frequently used in pursuit of an FDA submission, such as drug development, testing and screening. But research tools themselves generally are not subject to FDA or other regulatory approval. Depending on the circumstances, using research tools to submit data to the FDA may not be protected by the safe harbor provision and thus may expose companies to patent infringement claims.

A webinar hosted on Tuesday, January 12, by The Federalist Society’s Regulatory Transparency Project featured former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, as well as Duke University Professor of Law and former USPTO Administrator of the Office of External Affairs Arti Rai, discussing the proposal to the World Trade Organization (WTO) to waive IP rights under the Trade-Related aspects of Intellectual Property Rights (TRIPS) Agreement for certain COVID-19 technologies. While all three panelists agreed that the IP waiver discussion has become a distraction that will not solve the fundamental problems, Iancu and Kappos were especially passionate that the precedent set by the U.S. government’s decision to back the proposal could do very real harm, rather than good.

In the United States and other countries, there is a growing awareness and increasing appreciation of the purpose and value of amicus curiae practice as an aid in adjudicative decision-making. The role of an amicus curiae (“friend of the court”) brief in support of a party, or in support of no party, is to supply, voluntarily, the presiding court or other tribunal in cases of controversy with pertinent information, insights, or arguments in a formal, publicly accessible manner. Toward that end, a well-written amicus brief is one that is useful to the decision-maker(s) in calling attention to relevant or material factual or legal aspects of the issue(s) in contention – aspects that the decision-maker(s) or the party-litigants may not have been aware of or able to develop fully.

Even as Europe and the rest of the world continued to face the unprecedented challenges of the COVID-19 pandemic in 2021, the development of 5G and other Standard Essential Patent (SEP)-enabled technology standards has continued at an unabated pace. While the year has not yet ended, more than 100,000 technical contributions have already been submitted at 3GPP meetings for 2G, 3G, 4G and 5G in 2021 – a near-record yearly contribution count. The invention and standardization of massive, complex communication technologies continues to generate significant numbers of SEPs. According to IPlytics data, the cumulative number of self-declared SEP families has surpassed 72,000 in 2021, indicating a five-fold increase in just 10 years.

In the wake of the development of COVID-19 vaccines, the Biden-Harris Administration has suggested major shifts in U.S. policy concerning patent protection. In May of this year, Ambassador Katherine Tai, the U.S. Trade Representative (USTR) announced the Administration’s support for waiving intellectual property protections for COVID-19 vaccines. Most recently, the National Institutes of Health (NIH) Director Dr. Francis Collins accused Moderna of excluding three NIH scientists as co-inventors of a key patent for the COVID-19 vaccine. This article explores an alternative possibility of the Administration exercising certain rights in the COVID-19 vaccine invention under the 1980 Bayh-Dole Act—one day after the bill’s co-sponsor, Senator Bob Dole, passed away—and whether such an exercise of rights is in line with past precedent or would be a violent disruption to the status quo.