CRISPR-Cas9: Inventors clash

With UC Berkeley appealing against the US PTAB’s decision in the CRISPR-Cas9 case, what’s next for the groundbreaking gene-editing technology? Kevin O’Connor, partner at Neal Gerber Eisenberg, explains

Is the CRISPR-Cas9 technology proving to be particularly difficult to patent, or is its potential putting a lot of focus on these patent battles?

CRISPR-Cas9 technology is not necessarily difficult to patent. In fact, the US Patent and Trademark Office (USPTO) has already issued dozens of patents relating to CRISPR-Cas9 technology.

Like other nascent technologies, there is a potential for securing claims having greater breadth than more well-developed technologies where a great deal of prior art may be available.

The potential applications of the technology coupled with this potential for securing broad claims—particularly for the early entrants to the field—have increased the focus on these patent battles. Patent battles over platform technology are common in biotechnology—areas such as antibody humanisation and DNA sequencing technology have given rise to similar hotly contested proceedings before the patent office.

In the US, were these patents filed pre-America Invents Act and so subject to the first-to-invent paradigm? Could this have been hashed out more quickly and efficiently under first-to-file?

These patents and applications were subject to examination under pre-America Invents Act (AIA) provisions. In particular, UC Berkeley’s patent application was filed on 15 March 2013 and was subject to examination under pre-AIA provisions.

All of the Broad Institute’s involved patents issued from what is known as a transition application: an application with a filing date on or after 16 March 2013, but which claims priority to an application filed before that date.

Interference proceedings are undoubtedly lengthy, complex, and costly. The AIA replaced interference proceedings with derivation proceedings. Derivation proceedings were intended to more efficiently resolve disputes between two patent applicants claiming the same or substantially the same subject matter. However, very few petitions to institute a derivation proceeding have been filed with the USPTO and even fewer have been actually instituted.

Also, germane to your question, UC Berkeley sought authorisation to file its proposed Motion 1, which would have alleged that examination of the Broad Institute’s patents was erroneously conducted under pre-AIA provisions because the patents contain and/or contained at some time one or more claims that are not supported by the Broad Institute application filed prior to 16 March 2013.

The Patent Trial and Appeal Board (PTAB) did not authorise UC Berkeley to file its proposed Motion 1, so that underlying issue was not decided by the PTAB. UC Berkeley appealed against the PTAB’s refusal to authorise its proposed Motion 1.

One effect of a court or the PTAB determining that the Broad Institute’s patents should have been examined under the AIA provisions is that the Broad Institute could not antedate UC Berkeley’s earlier filing with testimony, a tactic that the Broad Institute employed during examination of its patents under the pre-AIA provisions.

What will be the crux of UC Berkeley’s federal circuit appeal? What do they hope to achieve?

The PTAB’s determination of no interference in fact deprives UC Berkeley of standing in the interference. Thus, the PTAB was not required to decide any of the other issues raised by the parties. The crux of UC Berkeley’s appeal then is to (re)gain standing.

One issue that it will likely ask the Court of Appeals of the Federal Circuit to address is whether substantial evidence supports the PTAB’s determination that one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment.

The technology is also being patented in Europe, which is obviously the next biggest market after the US. Is this a common patent strategy? Secure protection in the biggest markets first, and worry about laying claim to the technology elsewhere later?

Companies often file patent applications around the world, particularly on key aspects of technology. Often the European Patent Office and the USPTO are the first offices to initiate substantive prosecution, usually between 12 and 18 months after the application is filed (at least for biotechnology-related applications).

Typically, this occurs because these patent offices are better staffed than others around the world and not through any effort by the applicant. However, in this instance, the Broad Institute was able to take advantage of a special accelerated examination process in the US.

For a fee, the USPTO’s Track One prioritised examination provides an applicant with a final disposition within about 12 months. The USPTO receives over 600 Track One applications every month, so it is a fairly commonly used option to move examination along even more quickly in the US.

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