In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation, University of Utah Research Foundation v. Ambry Genetics Corp   Leave a comment

 

In a follow-up to the Myriad Supreme Court Decision of June 13, 2013, the Federal Circuit issued what has become known as the “Myriad II” decision on December 17, 2014. The decision is available here. Myriad sought to enjoin Ambry from allegedly infringing six claims of three patents. The claims at issue in Myriad II were not previously considered by the Supreme Court in Myriad.

 

Primer Claims

The composition of matter claims at issue in Myriad II were directed to primers. For example, claim 16 of the ‘282 patent recites:

 

A pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, the sequence of said primers being derived from human chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.

The Federal Circuit panel held that the claims at issue reciting primers were directed to patent-ineligible subject matter. In an opinion drafted by Judge Dyk, the court held that primers necessarily contain the identical sequence of the BRCA strand opposite to the strand to which they are designed to bind. Therefore, the primers were structurally identical to a product of nature. Slip Op at 7.

The court compared the situation to that in In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337 (Fed. Cir. 2014), where the court held that the cloned sheep Dolly was not patent-eligible subject matter because it was identical to a sheep found in nature and did not possess “markedly different characteristics.” The court held that “[a] DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature.” Myriad, 133 S. Ct. at 2116–17 (citing Chakrabarty, 447 U.S. at 309–10). The court held that primers do not have such a different structure and are patent ineligible. Slip Op. at 9.

 

Diagnostic Method Claims

The court also considered whether claims directed to diagnostic methods were patent-eligible. One of the claims at issue was directed to a method for screening the germline of a human subject for an alteration of a BRCA1 gene. The diagnostic method claims comprised steps comparing a germline BRCA1 sequence from a tissue sample with a wild-type BRCA1 sequence.

 

The court held that these claims, like the primer claims, were directed to patent-ineligible subject matter. The court’s rationale for invalidating the method claims was that they were directed to an abstract idea. Slip Op. at 13. The court relied on the two-part Alice test for abstract ideas:

(1) determine if the claim is directed to a patent-ineligible concept

(2) determine what other elements are there in the claim and whether they are enough to transform the claim into a patent-eligible application

Slip Op. at 14.

 

The court held that the Myriad II claims failed both steps of the Alice test. The court also expressed a concern that allowing such diagnostic method claims would preempt the field of research of breast cancer genes.

 

Conclusion

In conclusion, claims directed to primers that have a sequence identical to a sequence found in nature are not patent-eligible. However, claims directed to primers made from modified nucleotides, or that have a sequence that is not found in nature, are presumably patent-eligible since they have “markedly different characteristics” to the corresponding product of nature.

 

Furthermore, claims directed to diagnostic methods that recite “comparing” a germline sequence to a wild-type sequence are not patent-eligible. However, claims that also recite additional steps that narrow the claim enough so that it does not preempt an entire field are more likely to be held patent-eligible. It will also help to recite additional steps that are not seen as conventional and routine.

 

It remains to be seen how this decision will be interpreted by the USPTO in conjunction with the new Myriad Guidelines that were published on December 16, 2014, available here.

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Posted February 5, 2015 by deboraplehn in AIPLA, Myriad, USPTO

A Regulation of Animal Feed   Leave a comment

An article I wrote on the Regulation of Animal Feed was just published in the AIPLA Food and Drug Committee Newsletter:

A Regulation of Animal Feed.

Posted January 17, 2014 by deboraplehn in Uncategorized

AIPLA Annual Meeting, October 24-26, 2013 in Washington D.C.   Leave a comment

I am very excited to be going to the AIPLA Annual Meeting this year!  Please click below for an announcement on the Women in IP blog that I run.

 

AIPLA Annual Meeting, October 24-26, 2013 in Washington D.C..

Posted October 16, 2013 by deboraplehn in AIPLA

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AIPLA Webinar on Myriad Decision Regarding Isolated DNA   Leave a comment

I will be moderating a stimulating AIPLA webinar on Myriad on Wed July 24, 2013.  Our panel will consist of Gregory Castanias of Jones Day, Professor Joshua Sarnoff and Manny Vacchiano from Life Technologies.  Gregory Castanias argued the case for Myriad before the Federal Circuit and also before the Supreme Court.  Professor Joshua Sarnoff wrote an amicus brief on behalf of fifteen law professors in support of the petitioners.  Manny Vacchiano will provide the in-house perspective.

 

I hope you will register.  For more info see:

 

http://www.aipla.org/learningcenter/live_webinars/Pages/Wednesday,-July-24,-2013-Webinar.aspx

Posted July 19, 2013 by deboraplehn in Uncategorized

What Goes Up…Must Come Down: Viagra Patent Invalidated by Canadian Supreme Court   Leave a comment

An article that I wrote about the invalidation of Pfizer’s Canadian patent for Viagra was recently posted on my firm’s Life Sciences Now blog.

 

You may read the article here.

Posted May 15, 2013 by deboraplehn in Uncategorized

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Women in IP Networking Event Announcement   Leave a comment

I have been working with the AIPLA Women in IP Committee to organize their Networking Event on May 23rd.  My firm Drinker Biddle will be hosting the event in Philadelphia.

At 8:30 pm EST everyone will join a conference call from their host city to talk to everyone else, throughout the country.

 

For more information, please see the link below:

 

Women in IP Networking Event Announcement.

Posted May 13, 2013 by deboraplehn in AIPLA

Upcoming Webinar-Forks in the Road: The Many Paths of Success in IP Law   Leave a comment

I have been working with the AIPLA Women in IP Committee to help organize their upcoming Free webinar which will take place on Tuesday November 13, 2012 from 3-4 pm EST.

 

Please see the link below for details.

 

Upcoming Webinar-Forks in the Road: The Many Paths of Success in IP Law.

Posted November 8, 2012 by deboraplehn in AIPLA

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