Narrower Patent Means CRISPR Victory for Broad Institute

By: Smitha Gundavajhala

On February 28, 2022, the US Patent and Trademark Office (USPTO) handed down a ruling in one of the most bitterly fought patent turf wars in biotechnology: the battle over the use of CRISPR-Cas9 in humans. The two major groups that were vying for recognition were the Broad Institute, consisting of researchers from Harvard, and MIT and CVC, consisting of researchers from UC Berkeley, the University of Vienna, and Emmanuelle Charpentier. 

CRISPR-Cas9 is a revolutionary gene editing tool that has implications for healthcare, agriculture, and more. CRISPRs are DNA sequences with proteins that act like scissors. Originally derived from bacterial genomes, CRISPR technology has since been extended to apply to eukaryotes, which are multicellular organisms. Examples of eukaryotes include plants, animals, and humans. As one might imagine, the latest evolution in CRISPR technology is immensely lucrative. The technology could be used to prevent viral infections and chronic conditions in humans, as well as to genetically modify produce to carry more nutrients.  Both Broad Institute and CVC stood to lose a great deal in their hard-fought dispute about the CRISPR-Cas 9 patent.

The dispute between these parties was complicated by timelines, the change in US patent law, and the contradictory decisions of different jurisdictions across the world. Jennifer Doudna of UC Berkeley was the first to file a patent application in 2012, a few months before Feng Zhang and the Broad Institute filed their patent application. However, prior to 2013, the USPTO’s rules were different: the agency awarded patents to the entity that was the “first to invent,” rather than the entity that was “first to file.” 

Thus, when Doudna asked USPTO to declare an “interference” between the two patents in 2015, the office had to consider which group was the first to invent by “reducing the concept to practice.” CVC argued that Broad Institute’s patent for gene editing in eukaryotes was a mere extension of CVC’s seminal work on CRISPR-Cas9. In 2017, the Patent Trial and Appeal Board (PTAB) ruled that Broad Institute’s patents were not derived from CVC’s patents. In 2019, PTAB again declined to declare an interference regarding claims to CRISPR-Cas9 technology used in eukaryotes, and confirmed that the Broad Institute’s patents were properly issued.

Ultimately, Doudna’s patent application did not explicitly address CRISPR-Cas9 applications for eukaryotes, and Zhang’s patent application did. Thus, Zhang and the Broad Institute were determined to be the “first to invent” CRISPR-Cas9 gene editing for humans. This year’s USPTO decision represents potential losses of billions in licensing revenue for UC Berkeley and priority of invention for Broad Institute.

However, this turf war is far from over and recognition of the Broad Institute’s and CVC’s patents varies across jurisdictions. Currently, CVC maintains fundamental CRISPR-Cas9 patents in over 80 jurisdictions, including China, Japan, and the European Union. CVC and the Broad Institute also face challenges in other countries: South Korea’s ToolGen and Germany’s Sigma Aldrich still have open interference motions with the Broad Institute. From the looks of it, the international fight for CRISPR-Cas9 patent recognition won’t be over any time soon, even while the dust has seemingly settled in the United States.

Vaccine Patent Waivers: A Major Step Towards Ending the Covid-19 Pandemic?

By: Xiang Li

It has been two years now since the World Health Organization (WHO) declared the existence of the COVID-19 global pandemic on March 11, 2020. Through the concerted efforts of healthcare systems, vaccine manufacturers, governments, and members of the public, the world finally has the upper hand in the uphill battle against the COVID-19 pandemic. However, given how infectious the virus is and the speed at which it evolves to escape sufficient human immune response, it is not yet the time to let our guard down and it is critical to redouble efforts to increase global vaccination rates

Importantly, the inequality in vaccination rates seen between low-income countries and the rest of the world remains a prominent problem. As of March 31, 2022, 79.0% of the populations of “high-income” countries have received at least one dose of the COVID-19 vaccine, and so have 81.2% of the populations of upper middle income countries. Approximately 59.2% of the populations of lower middle income countries have received at least one dose. On the other end of the spectrum, only 14.5% of the population of low-income countries have received at least one dose of the vaccine. The disparity is largely caused by the unaffordability of vaccines to people in low-income countries.

To solve this disparity, the national governments of India and South Africa submitted on October 2, 2020 a communication (IP/C/W/669) to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council of the WTO, proposing that the obligation of TRIPS members to recognize and enforce patent rights should be temporarily waived with respect to patents relating to COVID-19 vaccines, medicines, and equipment necessary for treating and preventing COVID-19. The patent waiver as proposed is not mandatory, it simply allows TRIPS members to waive patent protection in their own countries, if they choose to do so.

The legal basis of adopting a patent waiver lies in Article IX.3 of the Marrakesh Agreement, which establishes the WTO. Specifically, Article IX.3 provides that the Ministerial Conference of the WTO, with the support of three-quarters of WTO members, may waive an obligation imposed by the TRIPS Agreement.

The waiver proposal has gained support from more than 100 low-income countries, but has encountered obstructions from many high-income countries, including European Union countries, the United Kingdom, and Switzerland. On May 5, 2021, the Biden administration announced support for a patent waiver; however, it was not until recently that major parties of the WTO made progress towards the negotiation of the terms of the waiver. 

Specifically, a news report published on March 16, 2022 indicated that the European Union, the United States, India and South Africa have reached a compromise on the terms of the waiver. Notably, only countries that have exported less than 10% of the total global exports of COVID-19 vaccine doses in 2021 are entitled to invoke the waiver to use the patented materials. These criteria effectively exclude the European Union, China, and the United States from invoking the waiver, since these countries account for 39.3%, 33.7%, and 14.2% of global vaccine exports respectively. 

The United States could have taken a stronger stance on waiving intellectual property protections, but it has not — possibly because a waiver suspending domestic patent protection might violate the Takings Clause of the Fifth Amendment of the United States Constitution. The Supreme Court of the United States has recognized that patent rights are subject to the protection of the Takings Clause, just as property rights in a piece of land. At the same time, the United States has a strong interest in preventing China from obtaining the right to invoke the patent waiver, to make sure China cannot use United States’ proprietary technologies to gain an advantage in vaccine development and other related biotechnology.

This recent compromise on the terms of the waiver might be a significant step towards passing the waiver at the WTO, since the European Union (composed of 28 countries, each having a vote) has been the strongest opponent of the waiver, as indicated by its statements made at several WTO meetings. Many scholars and policy makers believe that passing the waiver is a necessary step to provide equal and affordable access to vaccines to people in low-income countries. If the entire world community is vaccinated before the coronavirus can evolve into other highly contagious and potentially even more deadly variants, the world may be able to finally declare victory over the pandemic.

Expanding the Fringe of Patent Infringement

screen-shot-2016-10-18-at-10-19-49-amBy Sebastian Stock

In Akamai Technologies, Inc. v. Limelight Networks, the Federal Circuit broadened potential patent infringement claims by no longer requiring a defendant perform all the steps of a patented method before direct infringement occurs. As the dust settles from Akamai, should courts expect an influx of patent infringement suits.

Akamai Technologies, Inc. began in 2006 when Akamai Technologies, Inc. (“Akamai”) sued Limelight Networks, Inc. (“Limelight”), claiming infringement of claims on its patent related to its content delivery network (“CDN”). A CDN is a platform of proxy servers designed to directly deliver end-user internet content. CDN’s are widely used – they carry nearly half of the world’s internet traffic.

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I ATEN’T DEAD: The Continuing Trademark Saga of B&B Hardware v. Hargis Industries

Trademakr.pngBy Gwen Wei

Does anybody remember how B&B Hardware v. Hargis Industries started anymore?

B&B Hardware is a labyrinthine case grown out of simple roots: in 1993, B&B Hardware (“B&B”) trademarked “Sealtight”. Hargis Industries (“Hargis”) applied for a trademark on “Sealtite” in 1996. When B&B opposed Hargis’s application, Hargis sought to have B&B’s trademark cancelled. B&B retorted with a suit for infringement. This eventually led to a brief wrangle before the Trademark Trial and Appeal Board (“TTAB”), where the board found there was a likelihood of confusion between the two marks. But retelling the full twenty years of its litigious history, as Justice Alito later remarked, could fill a long, unhappy book.  Over the decades, B&B Hardware has devolved into a slapfest as the case was dismissed and refiled and remanded, surging all the way to the Supreme Court and back again. The case’s significance no longer lies in its eventual final verdict—whether B&B or Hargis gets to seal the deal, as it were—but in the precedent that it sets.

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Justices Split on the First Patent Trial & Appeal Board Case

PTO IconBy Don Wang

In 2011 Congress enacted the Leahy-Smith American Invents Act (AIA), which established a new Patent Trial & Appeal Board (PTAB) within the Patent & Trademark Office (PTO) and instituted several new administrative proceedings to review certain issues of patentability. Ever since, patents before the Board have been perishing like Game of Throne wedding guests (or as Judge Rader puts it: PTAB are the “death squads killing property rights”). Unsurprisingly, unhappy patent owners seized their first possible opportunity to challenge various aspects of PTAB proceedings. This led to the Supreme Court hearing of Cuozzo Speed Technologies, LLC v. Lee, No. 15-446. The oral argument was conducted on April 25, 2016, and the transcript can be found here.

There are two questions on appeal, but the Court focuses almost exclusively on the first question: which claim construction standard should be used in a PTAB proceeding, the “broadest reasonable interpretation” standard (BRI) or the “plain and ordinary meaning” standard? The BRI is the claim construction standard applied by PTO during a patent examination.

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