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.

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..

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.

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.

The American Intellectual Property Law Association (AIPLA) is trying something new for its 2013 Mid-Winter Institute which will be held in Tampa, Florida on January 30-February 2, 2013.  For a description of the program see the  AIPLA 2013 Mid-Winter Institute flyer.

The focus of the meeting will be on why Intellectual Property is THE business asset of the 21st Century.  IP attorneys and company executives will work side by side to present how they work together to face the challenges presented by today’s economy and protect IP in the global marketplace.

Here are some of the advantages of attending the meeting, alone or with a client:

• attend the sessions and think through best practices and procedures to determine how to best maximize IP protection
• learn directly from business executives and leaders why IP protection is so important to companies today
• the conference will provide an intense primer on IP protection, including patent, copyright, trademark, as well as trade secret protection
• this is a great opportunity to network with in-house or law firm attorneys and to learn from each other how to best maximize IP protection
• learn how a working knowledge of IP has benefited business executives, CEOs and CTOs straight from the source
• learn how IP matters to Angel and Venture investors
• learn about global IP issues in biotechnology, chemistry, high-tech fields and other technical areas
• learn how start-ups can best maximize the value of their IP and attract investors

If you want to receive more information from the AIPLA on the 2013 Mid-Winter Institute as it becomes available, click here.  I am one of the organizers and will attend the Mid-Winter Institute.  I look forward to seeing you there!

Click the link to the AIPLA Women in IP Law blog for an announcement on the 2012 AIPLA Annual Meeting in Washington D.C:

2012 AIPLA Annual Meeting in Washington D.C. Announcement.

We have received some good feedback on our latest webinar and would like to continue the discussion on the Women in IP blog and on the AIPLA Women in IP LinkedIn Group.  If you would like to submit questions or make comments to the questions anonymously, please email me at debora.plehn-dujowich@dbr.com or Yelena Morozova at morozova.yelena@gmail.com.  We will post the questions or comments on the Women in IP blog anonymously.

Registration is now open to all attendees, not just Women in IP members.  I am the moderator and one of the organizers of this webinar.  It promises to be very informative and will teach great networking skills.  Please check it out!

FREE Women in IP Webinar on September 18th Open to All Attendees.

I am going to be the moderator for this AIPLA Women in IP webinar on September 18th, sponsored by Drinker Biddle:

Upcoming Free Webinar for Women in IP Law Committee Members on September 18th-Engaging the Room YOUR Way.

The webinar by the AIPLA Women in IP Law Committee: “Overcoming Client Development Challenges for Women Lawyers” was a great success. We have planned our next webinar: “Engaging the Room YOUR Way” with Karen B. Kahn, Managing Partner of Threshold Advisors, LLC for September 18, 2012. However, we need your support to make this and future webinars happen. Please contact Yelena Morozova (yxm@cll.com) or Debora Plehn-Dujowich (Debora.Plehn-Dujowich@dbr.com) about sponsorship opportunities. As a sponsor, your firm name would be prominently displayed in all webinar announcements and your firm would be thanked during the webinar itself.  Thank you. Below is a short description of the webinar:

Does the avalanche of invitations to seminars, conferences, charity events, and holiday parties excite you or fill you with dread?

Hundreds of lawyers report that they find going to these events to be sheer torture and a waste of time. Many times, you don’t have a real choice – you have to go to certain events as part of your job and/or family responsibilities. Instead of focusing on the negative, can you find ways to make these events fun and productive? For example you can earn CLE credit and expand your relationship network at the same event. With many seminars, conferences and holiday events looming on the horizon, we are pleased to present a practice webinar that provides specific instruction about how attendance at gatherings can lead to the acquisition of new knowledge, relationships, opportunities and actual enjoyment.

For more information, check out the AIPLA Women in IP blog here.