Friday, January 26, 2018

More on the revocation of an EP patent on CRISPR of Broad

Adam Houldsworth at IAM has a post CRISPR European patent cancellation highlights procedural IP pitfalls which concludes;

Last week’s decision, then, is a stark reminder that even highly valuable patents pertaining to revolutionary technological breakthroughs – including those at the centre of landmark disputes - may be lost as the result of what are possibly mundane procedural errors. Inventions protected via the PCT are often considered to be among the most valuable that an applicant may have as they are the ones deemed worthy of widespread international protection. Given that, it pays to ensure that every possible angle is explored before submission takes place. Broad has already stated that it will be appealing the EPO’s decision, but it may want to look a bit closer to home at what went wrong, too.

While the Broad may not win its appeal, the issue is a bit more than a "mundane procedural error." The Broad, on the facts of "who invented what," may not have had a choice on the naming of inventors, in what Adam described:

In making its PCT filing in 2013 – from which its original EPO grant derived – the Broad Institute claimed priority from 12 of its earlier US applications from 2012. However, the EPO deemed that the institute had not properly obtained the right to claim priority from four of the original US filings. Contrary to European rules on priority rights, Luciano Marraffini of Rockefeller University – who was named in the earlier applications – was not cited as an inventor in the international registration. Only with those four priority claims invalidated, and additional prior art brought into consideration, was the patent found to lack novelty and revoked.

IPKat had noted:

Under US law, [the Broad] observed that it is a requirement for all the inventors that contributed to the subject matter of the invention(s) disclosed anywhere in a provisional application (whether the description, drawings or claims) are named as applicants. They further observed that to be named as an inventor on a patent application, one has to be the inventor or have derived the right from the inventor, and that under US law an inventor can only assign rights to inventions, and the right to claim priority from such inventions, to which she/he has contributed.

Therefore, it was argued, only the inventor-applicants with the right to claim priority from the subject matter of P1 and P2 to which the subsequent PCT application was directed, were listed on the PCT application. Marraffini, the Broad argued, did not have the right to the invention to which the PCT application was directed and therefore was not listed as an applicant for the PCT application.

Adam at IAM had referenced a post, including text by former CJ Michel, which had stated:

The appeal raises questions about the application of basic obviousness precedents and their attendant doctrinal standards and analytic methodologies. Because obviousness lies at the heart of nearly every patent application and litigation, both in the Patent and Trademark Office and the courts, the Federal Circuit's decision could affect all technologies, not only CRISPR, great though it surely is. Specific issues raised that concern such basic standards include:

How specific must the instructions of the prior art be in order to support a conclusion of obviousness?
What nature and level of certainty is required to establish a "reasonable expectation of success"?
How to assess" independent" and/or nearly "simultaneous" invention by others, and exactly what do these terms mean?
How to determine what sort or amount of experimentation constitutes "undue experimentation", and hence leads to a conclusion of non-obviousness?

One point not mentioned was the impact of statements by scientists on the UC/Berkeley side which were suggestive
of the non-obvious task of going to eukaryotes. "Not publishing" on difficulties could be the biggest lesson for scientists. "Just do it."


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