Posts Tagged: "TRIPS agreement"

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.

From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine. More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.

Following four letters sent by Senator Thom Tillis (R-NC) to United State Trade Representative (USTR) Katherine Tai regarding the proposed waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, Tai on November 8 replied to a July 14  letter sent by Tillis and Senator Tom Cotton (R-AR). That letter referred Tai and Commerce Secretary Gina Raimondo to a May 19 letter in which Tillis, Cotton and 14 other senators requested responses to 10 questions on the proposal to waive IP rights for COVID-19 related technology. The May 19 letter had requested Tai and Raimondo’s responses by July 19, 2021.

The implications of the announcement that the Biden Administration will support efforts to waive intellectual property protection for COVID-19 vaccines and therapies is still sinking in. The Wall Street Journal wrote two editorials in three days, the second more blistering than the first. “Biden’s Vaccine IP Debacle” begins: “… [T]his may be the single worst presidential economic decision since Nixon’s wage-and-price controls.” Not to second guess the paper, but President Nixon’s decision only harmed our economy—this one threatens both our economy and our health far into the future.

Over the course of four months, close to 850 million doses of COVID-19 vaccines have been administered in over 100 countries. To the extent the unprecedented pace of research, development and manufacturing to combat the ongoing pandemic is a success, it has many fathers. But it would not have been possible without the participation of the U.S. biopharmaceutical industry and its collaboration with global partners. To ensure that developed and developing countries around the globe maintain and expand access to safe and effective COVID-19 vaccines, therapeutics and diagnostics, it is critical that the U.S. government support ongoing industry collaboration and oppose well-intentioned but counterproductive efforts to waive intellectual property (IP) rights.

Intellectual property protection has played an important role in this pandemic. As some have pointed out, without legal protection for innovative ideas, there may not have been such a rapid response to the pandemic – both in terms of testing/ treatment and, most recently, vaccines. Companies like Moderna, in conjunction with research and funding from the National Institutes of Health (NIH), have spent a decade developing key technology that enabled quicker vaccine development than ever before. Without some intellectual property protections in place that provide strong financial incentives to invest in new ideas, innovation like this may never have come to light. Nevertheless, India and South Africa initiated a proposal in October that is gaining traction among like-minded World Trade Organization (WTO) members. This proposal would temporarily suspend certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) for products related to COVID-19, including vaccines. What began with a handful of nations has now reached a majority, with 57 national sponsors of the proposal, and over 60 WTO members who are in support.

While coronavirus spent the majority of 2020 wreaking havoc on earth, pharmaceutical companies have been busy at work trying to invent a vaccine to combat it. Several companies, such as Pfizer, Moderna and AstraZeneca, have competed neck and neck to be the first to deliver a cure to the world. Renowned pharmaceutical companies have been successful in developing the vaccine, which will be protected under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).

In withdrawing the 2013 statement, the new 2019 guidance by the DOJ, NIST and the USPTO states the obvious, i.e. that there is no difference in the law between F/RAND assured standard essential patents and all other patents. While some would have perhaps liked to break the unitarity approach of the patent system so as to weaken remedies against the infringement of essential patents, a legal system that would apply a different standard to standard essential patents as opposed to other patents would violate U.S. trade obligations.

Australia’s Tobacco Plain Packaging Act (TPPA) was enacted in 2011 and prohibits all use of trademarks (other than word marks) on tobacco product packaging. The law seemingly created a domino effect around the world, with countries including Hungary, Ireland, New Zealand, Norway, and the UK having enacted similar laws since, and many other countries presently considering various approaches to restricting tobacco and other products, including alcohol, snack foods and soda. Most recently, Canada enacted the Tobacco and Vaping Products Act, which places certain restrictions on tobacco products, and is still considering broader plain packaging regulations. Complaints about the law have been pending with the World Trade Organization (WTO) for some time, and, on January 14, the International Trademark Association (INTA) submitted a brief opining in the latest stage of that case.

Enforcement of trademark rights in China is an ongoing issue faced by numerous corporations.  Invalidating or canceling a trademark registration in the Chinese market is time-consuming and costly.  The best way to defend your company’s valuable intellectual property assets is to put in place as many protections as possible.  If your company owns a creative design mark, consider going beyond the standard trademark registration and getting the “super trademark” by obtaining copyright registration for this artistic design element.

Patenting and secrecy are the two major methods of protecting technology that supports competitive advantage. Trade secrets protect a wide range of confidential information, ranging from customer lists to strategic plans and business methods.  While this has been true for decades, the legal landscape in which businesses must choose between them has changed dramatically in recent years, mainly as a result of two forces. The first of these was a series of court rulings that collectively have narrowed the scope of patentable subject matter and have made patents more difficult to enforce. The second was the America Invents Act of 2011 (the “AIA”), which effectively eliminated or reduced certain risks of choosing secrecy, while providing new ways to challenge patents in administrative proceedings.  Considered together, these forces require innovators to reconsider their cost/benefit models for evaluating protection mechanisms. This paper discusses risk factors counsel should weigh when advising clients on these issues. I do not advocate one method over the other, but instead suggest that decisions should be guided by clients’ business needs and priorities rather than by patent eligibility alone.

Plans are being made by the Trump administration to open a probe into deceptive Chinese trade practices by invoking Section 301 of the Trade Act of 1974… Where joint venture tech transfer rules are concerned, however, the Trump administration may well find out that the Chinese government is enabling practices that do violate international treaties. Foreign entities who want to operate in the Chinese market are typically forced to do so as joint ventures with domestic entities and the transfer of intellectual property assets from the foreign entity to the domestic one is often enforced. That policy runs afoul of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Generic drug manufacturers can pose major financial threats to those companies that invent and develop the copied drugs both domestically and internationally… Before TRIPS, most of the world’s developing countries had very weak patent protections, especially for pharmaceuticals. These weaknesses included — but were not limited to — shorter patent terms ranging from 4 to 7 years, narrowly defined patents which allowed for imitations, and greatly reduced monopoly rights of the patent owner by the permissive use of compulsory licenses. This divergence demonstrates a disconnect between the above mentioned weaknesses and the strong protections of industrial countries with their 20-year patent terms and almost unlimited monopoly rights… For pharmaceutical patent owners, these TRIPS amendments try to harmonize the worldwide rights afforded to them by balancing the interests of the rights holder and those of consumers.

President-Elect Donald Trump has announced that he will withdraw the United States from the Trans-Pacific Partnership (TPP) agreement on his first day in office. So ends more than five years of often heated negotiations led by President Barack Obama’s administration as part of an overall strategy to strengthen the US position in the Pacific Rim region… Pulling out of the TPP is a missed opportunity for the US to pursue its IPR agenda in the Pacific Rim economies.