UCB appealed to the United States Court of Appeals for the Federal Circuit, which ruled in Broad’s favor in 2018. The Broad has said that nine of their 21 CRISPR/Cas9 patents in Europe could be affected by the ruling which 'does not involve the actual scientific merits of the patent application, but the interpretation of rules that dictate what happens when the names of inventors differ across international applications. The Broad Institute stands behind the scientific claims and filings it has made to the Patent Office over many years. The best thing, for the entire field, is for the parties to reach a resolution and for the field to focus on using CRISPR technology to solve today’s real-world problems. UC Berkeley in May 2012 (Jennifer Doudna and others, US Patent Application No. Today, the EPO Board of Appeal dismissed the Broad Institute’s appeal of an earlier Opposition Division decision which denied the Broad’s reliance on its U.S. priority provisional application for one patent in Europe based on a technical formality. In April, 2014, the USPTO granted US Patent No. “This is an important, high-profile case,” said Karshtedt, who therefore expects a thorough, lengthy opinion. UC has its back to the wall. 'This prior art became relevant because the opposition division did not acknowledge the patentee's claim to priority from a US provisional application naming more applicants than the subsequent PCT application [Patent Cooperation Treaty application- this is the application that was made to the EPO] from which [the patent] is derived. ToolGen in October 2012 (Jin Soo Kim and others, US Patent Application No. The PTAB rejected CVC’s request that its priority date be May 25, 2012, writing “the CVC inventors’ comments tend to indicate that they did not have possession of a functional CRISPR-Cas9 system in eukaryotic cells” at that time. The Patent Trial and Appeal Board described the important differences between Broad’s work and UCB’s: "Broad provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC's claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment.

September 10, 2020: Decision on motions and interference redeclaration. Broad and collaborators have been allowed and granted eight CRISPR patents in Australia, eight CRISPR patents in Japan, four CRISPR patents in South Africa, three CRISPR patents in Russia, two CRISPR patents in Israel and two CRISPR patents in Singapore.

When will I know if I need to short Editas Medicine or Intellia Therapeutics? Broad’s issued patents are for genome editing and uses in eukaryotic cells -- including cells from animals, humans, and plants.

Broad has worked for more than seven years to ensure that CRISPR tools are made widely available to maximize public benefit. Cas9, for example, is a naturally occurring protein and part of a naturally-occurring bacterial process, but this process, on its own, does not work in mammalian cells. “The Supreme Court won’t touch this,” Noonan said. In addition, Broad has numerous other CRISPR-Cas9 patent applications pending in Europe that are not affected by this formalities issue, as well as granted and pending patents related to CRISPR-Cas12/Cpf1, which are not affected. We continue to urge all institutions to move beyond litigation and instead work together to ensure wide, open access to this transformative technology. 8,697,359 to Broad, MIT, and Dr. Feng Zhang.

The PTAB ruled in 2017 that the claims in Broad’s patents and the claims in UCB’s applications concerned different inventions, and that Broad’s inventions in eukaryotic cells were not drawn from nor obvious over UCB’s work, particularly the experiments in test tubes as in Jinek 2012 -- work that did not include experiments in eukaryotic cells.

Q: Do patents limit the ability to share CRISPR widely? The judges’ questions can offer clues to how they’re leaning. This Patent (which draws priority from a provisional patent application filed in December 2012) contained successful experiments. Update on the June, 2019 interference process. ToolGen in October 2012 (Jin Soo Kim and others, US Patent Application No. The Broad's EPO patent was originally granted based on evidence of their original US patent filings. PTAB leaned heavily on Doudna’s own words about how hard it would be to make CRISPR work in human cells. This meant the USPTO considered the application more quickly and the Broad agreed to respond more quickly to questions raised by the USPTO.

This is a complex patent and licensing landscape that threatens innovation.

The University of California-Berkeley repeats the same false claims that it made in the last interference. In the United States, Broad’s issued patents are for genome editing and uses in eukaryotic cells -- including cells from animals, humans, and plants. ", January 16, 2020: Update on patent process in Europe. This is the same argument that has already failed to persuade the PTAB and Court of Appeals for the Federal Circuit, and the facts have not changed.

The decision does not involve the actual scientific merits of the patent application, but concerns the interpretation of rules that dictate what happens when the names of inventors differ across international applications.

The USPTO has also granted patents directed to CRISPR-Cas9 to UC Berkeley (UCB), University of Vienna and Emmanuelle Charpentier. We take you inside science labs and hospitals, biotech boardrooms, and political backrooms. Broad Institute looks forward to participating in the interference process. By Jon Cohen Feb. 8, 2019 , 2:20 PM. According to GWU’s Karshtedt, “Given that the PTAB decision was lengthy and seems well-reasoned, deference seems likely.”. In 2015, UCB asked the USPTO to declare an “interference” between the claims of its ‘859 application and the Broad 8,697,359 patent, which had recently been issued. Q: Why did Broad receive a CRISPR patent before UCB, even though UCB applied first? UC’s best chance of success is to persuade at least two of the three judges that the patent board misapplied case law in its application of the “obviousness” idea in a way “that was too generous to the Broad,” said patent expert Dmitry Karshtedt of the George Washington University Law School. This agreement included IP from private companies as well as from academic institutions -- including IP that DuPont-Pioneer had licensed from University of California, although UC itself was not part of the discussions. CRISPR research is a large field that involves contributions from many talented scientists around the world. In an important ruling in the current interference between the Broad Institute and CVC (University of California-Berkeley, the University of Vienna, and Emmanuelle Charpentier), the US Patent Trial and Appeal Board (PTAB) ruled on September 10, 2020 that Broad’s priority date precedes CVC’s priority date. New patent win for University of California upends CRISPR legal battle.

(In this case, the Broad, MIT, and Harvard inventions go back to 2011.). This meant the USPTO considered the application more quickly and the Broad agreed to respond more quickly to questions raised by the USPTO. If it’s judges Alan Lourie, who spent decades as a corporate patent lawyer, or Timothy Dyk, also an ex-corporate guy and patent expert, that might be good for UC and therefore Intellia (NTLA), co-founded by Doudna and exclusive licensee of her (yet-to-be-issued) CRISPR patents. The Patent, Trial and Appeal Board ruled in 2017 that the claims in Broad’s patents and in UCB’s applications concerned different inventions, and that Broad’s inventions in eukaryotic cells were not drawn from nor obvious over UCB’s work, particularly the experiments in test tubes as in Jinek 2012, and without work in eukaryotic cells. These include the fundamental claims in EP 2825654B1, as well as others covering certain key therapeutic indications -- including for previously untreatable diseases. The Patent Trial and Appeal Board concluded that when Zhang got CRISPR-Cas9 to work in human and mouse cells in 2012, it was not an obvious extension of … The PTAB accepted the Broad’s request that its priority date be December 12, 2012. UCB’s issued patents are based on studies in cell-free systems and include methods and systems for modifying a target DNA molecule without limitation to uses in eukaryotic cells. UC’s lawyers “won’t whip out a document and say aha!” said biotech patent attorney Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff. The proceeding involves certain patent applications of CVC and the same Broad-issued patents as in the first interference.

The US Patent and Trademark Office had issued more than 570 patents as of September 2020 with claims to CRISPR and/or Cas9 to approximately 900 inventors from more than 200 applicant organizations. Questions? In plain English, that meant the Broad’s patent, on using CRISPR-Cas9 to edit genomes in eukaryotic cells (all animals and plants, but not bacteria), was different from UC’s, which described Doudna’s experiments using CRISPR-Cas9 to edit DNA in a test tube—and it was therefore valid. All rights reserved. 61/613,373); UC Berkeley in May 2012 (Jennifer Doudna and others, US Patent Application No. The ability to precisely edit the genome of a living cell holds enormous potential to accelerate life science research, improve biotechnology, and diagnose and treat human disease. Since then, both institutions have competed for numerous patents with overlapping rights across multiple jurisdictions (see BioNews 967 and 954).

Instead, UC casts baseless claims [see below] at the Broad patents and inventors in the hope of avoiding having to provide any actual evidence of UC’s work in eukaryotic cells.

The best thing, for the entire field, is for the parties to reach a resolution and for the field to focus on using CRISPR technology to solve today’s real world problems. UCB appealed to the United States Court of Appeals for the Federal Circuit, which ruled in Broad’s favor in 2018.

In contrast, the Motions List of the University of California-Berkeley attempts to avoid any evaluation of who actually invented first, because all of the evidence clearly demonstrates that UC was not the first to invent any method of using CRISPR in eukaryotic cells.

61/099,317); Vilnius University in March 2012 (Virginijus Siksnys and others, US Patent Application No. It is deeply unfortunate, for the entire field, that the University of California-Berkeley has chosen this strategy. Updated September 27, 2020communications@broadinstitute.org. That patent centers on using the standard CRISPR-Cas9 system to edit regions specifically 10 to 15 base pairs long.

On June 24, 2019, the Patent Trial and Appeal Board initiated a new interference process involving the UCB patent estate. Persuading the appeals court that the patent board messed up on the law “is an incredibly tough barrier for them to break through,” Sherkow said. A decision from the Boards of Appeal at the European Patent Office has revoked the claim of the Broad Institute to general patents on CRISPR/Cas9 gene editing technology, strengthening the position of its opponent UC Berkeley in Europe. These claims did not succeed in the last interference; they will not succeed now. (Read the order and declaration.) And then it’s over, right? Although we welcome this second action before the PTAB and are confident these patents have been properly issued, we continue to believe it is time for all institutions to move beyond litigation and instead work together to ensure wide, open access to this transformative technology.

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