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Posts Tagged: "COVID-19"

mRNA IP and Competitive Landscape: 2021 in Review – Part II, Sanofi, Startups, Conclusions and Outlook

This article, originally published on 12/27/2021, was updated on 1/12/2022 and republished on 1/13/2022 to include information that was omitted in error, beginning after “Conclusions and Outlook”.

In Part I of this post, we provided an update on three lead pioneers in the mRNA IP space, Moderna, BioNTech and CureVac. In this post we profile Sanofi, Arcturus, eTheRNA and other mRNA companies and offer conclusions. Sanofi (NASDAQ: SNY), headquartered in Paris, FR, acquired mRNA pioneer Translate Bio in September 2021 for approximately $3.2 billion and mRNA startup Tidal Therapeutics in April 2021 for approximately $470 million. With its acquisition of Translate alone, Sanofi obtained an mRNA pipeline of nine candidates (two in the clinic), hundreds of patents, and undoubtedly valuable mRNA-based technical and regulatory know-how.

SCOTUS, Vaccine Mandates and Patent Law: God Help Us

Is the Supreme Court competent to handle issues dealing with technology? The question is often discussed in private among patent attorneys who find themselves completely befuddled by the wanton disregard and open duplicitous handling of patent laws by the Nation’s High Court. In one decision, the Supreme Court will wax poetically about the need to adhere to precedent, and citing stare decisis, and then overrule well-established, 30-year-old Supreme Court precedent. The whim and fancy – and intellectual dishonesty – of the Supreme Court knows no bounds when it comes to patent law. But now, just how little at least some of the Justices know about basic science – and logic — has become glaringly and unmistakably obvious to everyone, thanks to the recent oral argument held regarding vaccine mandates.

mRNA IP and Competitive Landscape: 2021 in Review – Part I, Update on Moderna, BioNTech, and CureVac

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.

Examining the Moderna-NIH COVID-19 Vaccine Debate in the Context of Bayh-Dole

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.  

Tillis Pushes Tai Again on TRIPS IP Waiver Proposal, as South Africa Asks to Delay Delivery of Vaccines

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.

This is What’s at Stake if WTO Removes Protections for Lifesaving Medicines

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. 

FDA Resists FOIA Request for Vaccine Approval Info as Biden Administration Offers to Share it with the World

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.

Iancu, Locke and Kappos Slam Biden Administration’s Support for COVID IP Waiver in New White Paper

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.”

Tai Tells Tillis Support for COVID-TRIPS Waiver is Not Political but Based on ‘Extraordinary Circumstances’ of the Pandemic

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.

Senator Tillis Letter to Ambassador Tai: TRIPS Waiver (Copyright)

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.

Let No Good Deed Go Unpunished—The Tale of a COVID-19 Breakthrough

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.

U.S. Embassy Failures, COVID-19 Travel Restrictions, Keep Attorney Working on COVID-19 Technology Out of United States

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.

Iancu, Kilbride, Israel Separate Fact from Fiction During IPWatchdog LIVE Panel on TRIPS IP Waiver

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.

The Innovation Ecosystem Behind COVID Vaccines is Now Targeting HIV/AIDS

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.”

Bankrupting Big Pharma Isn’t a Solution

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.