Posts Tagged: "COVID-19"

In April of this year, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post (Part I), we provide a 2021 year in review update on mRNA pioneers Moderna, BioNTech and CureVac, and in Part II, we profile Sanofi and other companies in the mRNA space and offer additional conclusions and outlook for 2022 and beyond.

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.  

Yesterday, Senator Thom Tillis (R-NC), the Ranking Member on the Senate IP Subcommittee, wrote to Ambassador Katherine Tai, the United States Trade Representative who is responsible for negotiating an IP Waiver to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement with the World Trade Organization (WTO). This TRIPS IP Waiver is generated by proposals submitted by South Africa and India and seeks the waiver patent and trade secret protections relating to COVID-19 innovations. This is the fifth such letter Tillis has sent Tai. As noted by Senator Tillis and many commentators, including here on IPWatchdog, the proposed TRIPS IP Waiver is nothing more than an attempt to steal intellectual property rights covering important innovations that took nearly a generation to bring to fruition. And now we have definitive proof.

Experts agree: The COVID-19 vaccines are one of humanity’s greatest achievements. The previous record for vaccine delivery was almost five years; today’s innovators delivered the COVID-19 vaccines in less than one. The achievement is a testament to the dedication of those innovators, as well as the strength of the policy framework that supports their work. Unfortunately, some people want to destroy that framework. Some nations are promoting a dangerous proposal, supported by the administration, to waive intellectual property (IP) protections – such as patents and trade secrets – for COVID-19 vaccines. At the end of November, at a World Trade Organization (WTO) ministerial meeting, they’ll present this proposal as the best way to defeat the pandemic. But what they won’t mention is that their approach will actually threaten ongoing vaccine production, hurt our successful health care innovators, patient safety, economic competitiveness, American leadership, and the discovery pipeline in the process. 

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.

Former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, and former Secretary of Commerce Gary Locke, today released a White Paper calling the Biden Administration’s decision to support a waiver of intellectual property protections for COVID-19-related technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “strategic folly.” The report was produced by the Center for Strategic and International Studies (CSIS). In the paper, titled “The Shot Heard around the World”, the three officials, two of whom served under the Obama Administration, explained that the United States must indeed ramp up its efforts to improve vaccine diplomacy and to distribute more vaccines globally, but that “[w]aiving IP protections would not lead to the manufacture of a single additional dose of a vaccine.” Instead, they proposed a number of alternative solutions to solve the “real problems.”

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.

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.

The lead story in last weekend’s Wall Street Journal made an exciting announcement: “Merck Covid-19 Pill Cuts Risks of Hospitalizations and Death”: “Merck & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people early in the course of the disease in a pivotal study from becoming seriously ill and dying, a big step toward providing the pandemic’s first easy-to-use, at home treatment.” In case its readers missed the significance, the same issue included an editorial, “There May Soon Be a Covid Pill”, stating: “In what is rare good news these days, Merck and Ridgeback Biotherapeutics said Friday that their Covid pill molnupiravir reduced hospitalizations by about half… Since the beginning of the pandemic, doctors have been hoping for an oral antiviral that could prevent recently infected patients from getting sicker… Merck has also signed licensing agreements with generic manufacturers to accelerate the pills availability world-wide. Manufacturers in low-income countries don’t need special expertise and supervision to produce the pills, unlike with Covid vaccines. Molnupirvir can be easily distributed in poorer countries… Evidence also indicates that the drug is effective against different variants and is unlikely to produce viral resistance.” The partnership between Emory University, Ridgeback Biotherapeutics and Merck could turn out to be one of the most significant Bayh-Dole alliances ever, yet just a few months ago all three were under fire. And the critics are renewing their attacks.

Surely there can be no greater national interest to the United States than to allow each and every single person working to solve the COVID-19 pandemic to cross our border without issue, especially those who have already earned visas to work in the United States. However, a series of unfortunate events and policies has resulted in an ironic situation in which, in one example, an attorney from Sweden, who has spent significant periods of time within the United States since 2006, cannot return to the states to sit for the patent bar; aid members and clients of her law firm who are needful of her unique skills, including one colleague who is undergoing medical treatment for a serious health condition; or prosecute several patent applications representing some vital advancements in the fight against COVID-19. U.S. Embassy inaction, which is blocking her ability to take the U.S. patent bar, join her colleagues in the U.S. who have mentored her in this field for a year-and-a-half, and work on these COVID-19 patent solutions, arguably threatens the very chance of those inventions and technologies being properly commercialized to benefit everyone in the United States and beyond.

On Monday of IPWatchdog LIVE in Dallas, a panel on “The TRIPS IP Waiver: Separating Fact & Fiction” was moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, and featured IP leaders Andrei Iancu, Patrick Kilbride, and Chris Israel. The Trade Related Aspects of Intellectual Property (TRIPS) agreement is an international agreement among members of the World Trade Organization (WTO), which sets minimum standards in the international rules governing intellectual property. In 2020, India and South Africa proposed a TRIPS Agreement waiver proposal that would temporarily waive intellectual property rights protections for technologies needed to prevent, contain, or treat COVID-19, including vaccines and vaccine-related products. The proposal has been hotly contested globally, but the Biden Administration said in May of this year that the United States would back it.

June marked the 40th anniversary of the first reported AIDS case. On the anniversary, UNAIDS released a strategy to end HIV/AIDS by 2030, a goal that seemed unthinkable over 40 years ago. Yet since 1981, the innovative scientific community has delivered a series of treatments that revolutionized the outlook for HIV/AIDS patients. Those early days of 1981 were not unlike what we experienced with coronavirus last spring. Hospitals began to see cases of a mysterious pneumonia with few options for how to treat it, just as physicians across the country struggled to identify effective treatments for COVID-19 patients last March. Indeed, Dr. Anthony Fauci – who dedicated 40 years of his career to combatting HIV/AIDS – recalled “the first few years were the darkest years of my medical career, because I was working countless hours taking care of desperately ill young men.”

Believe it or not, a recent op-ed in the Washington Post written by Robin Feldman took the position that pharmaceutical companies should charge prices for their drugs that would surely guarantee that they go bankrupt. An absurd position even for a law professor who is ideologically predisposed to an irrational hatred of patents, but precisely the position Feldman articulated. How someone as smart as a law professor does not understand basic business reality raises important questions about her intellectual honesty—or at the very least raises questions about whether she is truly an expert on this topic.

Scientists, engineers, and everyday people have developed solutions for testing, preventing, and treating the COVID-19 disease. Ordinarily, we wouldn’t think twice about granting patents on these inventions. But, today, when COVID-19 is spreading all over the world and killing millions of people, some world leaders are questioning whether we should be granting the exclusionary rights of patent protection on inventions that help respond to the pandemic. Included in that group is the Biden-Harris Administration, which, in May, announced their support of an “IP waiver” on COVID 19 vaccines. 

In the early days of the vaccination efforts, Americans were anxiously online trying to register for a COVID-19 vaccination appointment. Reports of success at 1:30 am and 2:30 am made the rounds as new appointments dropped onto websites. Also common were stories of vaccine elitism and discussions of which vaccine is “the best.”  News reports continue to show a steady uptick in the percentage of vaccinated Americans. Elsewhere in the world though, the story is very different, and a darker picture is emerging. In Africa, many countries have vaccinated less than 2% of their population. While vaccine distribution is difficult in many regions of the developing world, this is a hurdle that medical assistance groups, such as Doctors Without Borders, are accustomed to handling. The challenges are known. What is most difficult in combating COVID-19 is obtaining the vaccines in the first place. Some argue that IP rights are the key problem and should be waived, while others claim they are the only solution and that waiver would be catastrophic. This article suggests a third option, somewhere between voluntary vaccine donation and a full waiver of IP rights, that may offer a way forward.