Friday, September 23, 2016

Nature discusses recent events in the CRISPR patent battle

Obviousness in patent law is measured relative to a person having ordinary skill in the art (sometimes designated PHOSITA).

Of the law:

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.

The CRISPR patent battles will, in part, turn on the level of skill.

* Nature wrote of the Doudna (Berkeley) vs. Zhang (Broad) patent dispute:

Berkeley argues that the application of CRISPR–Cas9 to eukaryotic cells was obvious and that “persons of ordinary skill”, such as a postdoc with relevant expertise, could have made the leap. Berkeley points to the swift success of several teams — led by Doudna; Zhang; Church (at Harvard Medical School in Boston, Massachusetts); and genome engineer Jin-Soo Kim at the Institute for Basic Science in Seoul — that applied CRISPR to human cells. The Broad countered that these scientists are all leaders in their field and could hardly be considered ‘ordinary’.

Surprising accusations have been interwoven with the scientific arguments. Berkeley has submitted an e-mail from Shuailiang Lin, who was a visiting student in Zhang’s lab in 2011–12. Lin claims that the lab took inspiration from Doudna and Charpentier’s paper1, rather than working out the system independently. The Broad countered that Lin made this assertion while asking Doudna for a job.

Berkeley asked to subpoena Lin (who has since been employed at the University of California, San Francisco), but USPTO judges denied that request on 14 September. A more complete response from the Broad could come when the two sides file replies to previous motions in late September.

In the meantime, the Broad petitioned the USPTO judges to ignore testimony from two of Berkeley’s scientific witnesses. The law firm that collected their depositions had previously worked for the Broad, and therefore may have been privy to confidential information, the Broad argued. USPTO judges disagreed. “Broad’s request amounts to merely a fishing expedition,” they wrote on 24 August.

One of the most aggressive and risky moves was Berkeley’s decision to subpoena Church, Sherkow says. Berkeley has submitted e-mails from Church congratulating Doudna and Charpentier on their 2012 paper, acknowledging that it inspired his team to try the system in eukaryotic cells. But Church, who has laboured for years to move a different gene-editing system from bacteria to human cells, told Nature in August that such a shift is “anything but obvious”.

The USPTO denied the subpoena on 14 September. Church says that he has not spoken to Berkeley’s lawyers, but was surprised by the judges’ ruling. “I imagined my observations would be considered quite relevant,” he says.

A position of "anything but obvious" would seem to support Broad.

Within the Nature article is a quote: “What is really behind this is not the academic institutions, it is the commercial interests”. One recalls the Merck kGa v. Integra case, wherein the named parties were the commercial interests but the actual inventive entities were academics. [See for example the IPBiz post:
Merck v. Integra and patents on research tools ]

link to Nature:

Some previous IPBiz posts on the CRISPR patent battle:


Post a Comment

<< Home