The mRNA IP and Competitive Landscape: Translate BIO; Arcturus; eTheRNA and Other Startups; and LNP Technology (Part II)
In Part I of this three-part series, we focused on three market players: BioNTech, Moderna and CureVac. In this second post, we will focus on Translate BIO, Arcturus Therapeutics, and eTheRNA and discuss certain issues relating to liquid nanoparticle (LNP) delivery technology. Translate Bio, Inc. (NASDAQ: TBIO) is headquartered in Lexington, MA, and as of April 2021, has a market capitalization of over $1.3 billion. According to its website, Translate BIO’s mRNA product pipeline is directed to several indications including cystic fibrosis, primary ciliary dyskinesia, pulmonary arterial hypertension, COVID-19, influenza, viral pathogens, and bacterial pathogens. The company does not presently have any products on the market. However, it has one cystic fibrosis candidate and one COVID-19 vaccine candidate (with Sanofi) that are both in Phase 1/2 clinical trials. Translate BIO also appears to have one infectious disease candidate in the “IND-enabling” Phase (with Sanofi), and three lung candidates, one liver candidate, and two infectious disease candidates (with Sanofi) in the discovery phase.
Changes in the 5G radio access network (RAN) are likely to increase interest in monetizing patents essential to RAN equipment and operations (RAN SEPs). One of these changes is the significant increase in the volumes of equipment like radio units (RUs) expected over the next decade. For example, China alone plans to deploy 6 million 5G cells by 2027, at an average cell spend of $28,500. Other changes likely to spur 5G RAN licensing are the increase of new entrants to the RAN equipment market and the use of open source software and off-the-shelf hardware in new RAN deployments. These latter changes are driven by the new Open RAN model promoted by operators seeking to break vendor lock in and foster equipment democratization and price competition. These changes naturally could pose a threat to the traditional RAN equipment businesses
EPO Opposition Division Upholds NuCana Patent on Gilead’s Sovaldi, Highlighting Potential Flaws of CAFC Ruling in Gilead/Idenix
On April 7, 2021, the European Patent Office (EPO) Opposition Division (OD) issued a comprehensive written decision in the Opposition by Gilead Sciences, Inc. against NuCana plc’s European Patent No. B-2 955 190, upholding amended compound claims that include Gilead’s blockbuster hepatitis C drug, Sovaldi (sofosbuvir). The claims were upheld over various arguments made by Gilead, including an assertion that the NuCana patent did not teach the skilled worker how to make the nucleoside component of Sovaldi (which is a nucleotide phosphoramidate). Gilead alleged, as it did in the myriad of global Idenix litigation cases, that a skilled person in 2003 who tried to make the nucleoside of Sovaldi “would be required to undertake extensive experimentation, if indeed he would be able to succeed at all. This represented an undue burden.”
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.
The Philippines has so far relied on donations and direct purchase to obtain vaccines to address the pandemic. As of March 2021, the Philippines received 2 million Sinovac doses from China and about half a million doses of AstraZeneca vaccines from the COVAX facility. However, these doses could only vaccinate 1% of the country’s more than 110 million people. Concerns regarding access to COVID-19 vaccines are also looming in other developing and least developed countries. It is reported that due to a supposed vaccine hoarding by wealthy countries, low-income countries have minute chances of getting their populations vaccinated against COVID-19 in the coming year. On the contrary, wealthier nations have already been able to secure nearly three times the doses needed to vaccinate their entire populations. As the United Nations Secretary General lamented back in February, progress in COVID-19 vaccinations has been “wildly uneven and unfair.”
Patent categories were established more than 100 years ago. There are dozens of categories that reflect industry at the time: gears, sewing machines, and bicycles, to name a few. While these are certainly useful categories, the patent classification system has not kept up with the times. It leaves out many modern technologies, like inventions that are based on machine learning or blockchain. There are no categories for these innovations, which are reshaping our world in real-time. The problem? When patent classifications don’t actually classify inventions, we have no way of knowing how many inventions in these categories are being registered.
Patent Filings Roundup: Disney Displeasure Cruise; WSOU Investments’ Recordation Problems; and Chinese Company Targets Chinese Counterfeiters in U.S. Court
A slightly higher than average 38 petitions were filed at the U.S. Patent and Trademark Office (USPTO) last week, all inter partes reviews (IPRs), a number again propped up by five more patent filings against the prolific Craig Etchegoyen-led WSOU. That entity’s near-200 patents and 200 lawsuits brought in the district court represent roughly 5% of all 2020 litigation, and they show no signs of slowing their aggressive stance. District court litigation was roughly stable, with a few new campaigns popping up as outlined below. It’s worth noting—not because it’s evidence of any trend or even statistically significant, but just given the rarity—that for the first time since I started writing these updates more than a year ago, the USPTO did not issue any Fintiv trial date or other procedural denials.
The arts and entertainment industry has boosted South Korea’s economy and produced some of the country’s key products and exports. The country’s population of 51 million people was the sixth largest music market in the world in 2020, according to IFPI’s Global Music Report 2021. Also in 2020, South Korea had a $160 million surplus in cultural and arts intellectual property (IP)-related assets trade, according to South Korea’s Maeil Business Newspaper. It was the first time a surplus in such a category was registered. However, entertainment-related IP assets have been big Korean exports for years: in 2019, the country exported $8.62 billion in copyright-protected content, according to Yonhap News Agency. South Korea also has proven itself to be a prolific environment for creating music, film, content, and experiences for fans, and also to be great at making the most of their intangible assets through IP strategies.
Solutions for Promoting Patent Practitioner Diversity at the USPTO in the Battle Against Systemic Racism
A critical battle against systemic racism currently engages the United States. Patent practitioners across the country—from the University of Minnesota Law School (a mere 2.5 miles from the location of the killing of George Floyd) to the U.S. Patent and Trademark Office (USPTO) headquarters in Alexandria, Virginia (another 1,000 miles away)—must cast a critical eye towards our profession to identify systemic barriers in the patent field.
NYIPLA Amicus Brief in Ericsson v. Samsung Advocates the Adjudication of U.S. Patent Rights by U.S. Courts
On April 9, the New York Intellectual Property Law Association (NYIPLA) filed an amicus brief in Ericsson Inc. v. Samsung Electronics Co., Ltd., No. 2021-1565, urging a panel of the U.S. Court of Appeals for the Federal Circuit to balance U.S. interests in adjudicating U.S. patent rights against the rule of comity, with respect to an order by a Chinese court restricting the litigation of certain U.S. patents in U.S. courts. Senator Thom Tillis (R-NC), Judge Paul Michel and former U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu also filed an amicus brief in the case on the same day in support of Ericsson…. Although the NYIPLA did not take a position on the exact scope and content of Judge Gilstrap’s order, it filed an amicus brief to highlight our country’s “strong policy interest in allowing U.S. patent rights to be adjudicated in U.S. courts” and to point out that “[a]llowing China to exercise exclusive dominion over U.S. patent rights and royalty rates and to preclude enforcement of U.S. patent rights within the United States would cause a severe reduction in the value of U.S. patents and jeopardize the very underpinnings of the U.S. patent system.”
Most commentators agree that Google v. Oracle is the most important copyright decision of the last 25 years (since Campbell v. Acuff-Rose Music). But what if the Court got it wrong? The Court has not always done well with issues of technology (the Sony v. Universal “Betamax” case being an exception), and the majority decision in Google v. Oracle appears to be more of the same. For many reasons, the powerful dissent from Justices Thomas and Alito may be the better opinion.
Though the parties have quickly settled their case, the question remains open: was Lil Nas X’s “Satan Shoe” an exercise of free speech or a trademark violation? What we do know is that sneaker giant Nike’s complaint filed in the Eastern District of New York on March 29, 2021 alleged a dispute of biblical proportions against Brooklyn art collective MSCHF Product Studio, Inc. Nike targeted its own Air Max 97 shoe, which it claimed MSCHF and its collaborator Lil Nas X (who was not named in the lawsuit) materially altered to feature an upside down cross, a pentagram, and an injection of human blood into the sole to create the “Satan Shoe” – 666 of them to be exact. The Satan Shoe still displays Nike’s famous Swoosh, which inspired calls to boycott the brand for its alleged association with the controversial shoes. Nike asserted claims of trademark infringement, trademark dilution, false designation of origin, and unfair competition, and sought a temporary restraining order, a permanent injunction, and damages.
Shortly after we posted about Moderna, Inc.’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for two COVID-19 vaccines produced by Moderna and BioNTech (with Pfizer), making these groups the first to ever enter the commercial market with mRNA-based therapies. This little-known and never-before-approved mRNA technology has since been widely administered and represents a primary weapon being used to defeat the pandemic. While this effort carries on, market players are confident that COVID-19 is but one of many indications that the mRNA technology platform might be utilized for, and that approval of the mRNA vaccines could open the door for the approval of other mRNA-based medicines, creating a wide range of new markets. With the anticipated increase in market activity and competition, we will provide an overview of the mRNA IP and competitive landscape in a series of three posts in the context of certain key players’ patent positions, drug pipelines, strategic relationships, and other attributes. These posts are based on publicly available information, are non-exhaustive, and do not identify all market players or potential market players in this space.
Patent Filings Roundup: Acacia Gets Another Fintiv Boost; More Vape IPRs Filed; Adenovirus PGR Challenge; IP Edge Files Dozens of New Complaints
District court complaints rose to 93 this week, while Patent Trial and Appeal Board (PTAB) cases fell to 28 (27 inter partes reviews [IPRs] and a post grant review [PGR]), a number propped up in part by Google filing a number of petitions against serial assertor Express Mobile, LLC and ZTE filing a few more against the perennial WSOU. Additional Facebook petitions were denied against Western District of Texas assertor, Onstream Media Corporation; Google filed a spate of petitions against longtime serial assertor Express Mobile; and there were a not-surprising-but-still-remarkable number of IP Edge complaints filed last week, as seen below, from a wide range of subsidiaries.
It’s hard to believe that, not too long ago, alliances between the public and private sectors were unheard of unless the government was picking up the entire tab. After World War II, the policy was that if the government funded even a small percentage of the research, it would take any resulting inventions away from those who created them to make the discovery readily available to anyone and everyone. While that might sound noble, it was a death knell for commercialization because then, like now, these discoveries required significant private sector effort and investment to turn into commercial products. The result was that not only were few government funded inventions ever developed, but even worse, companies avoided alliances with government funded institutions.