Patent Law Practice Center

AMP v. USPTO: The Latest Developments

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing the latest developments in the AMP v. USPTO case and what the Plaintiffs next move may be.

After the CAFC issued a decision in AMP v. USPTO on July 29, 2011, there was much speculation as to what would be the next move in this compelling case.  A petition for an en banc rehearing or a petition to the Supreme Court to grant a writ of certiorari seemed likely, but instead each party petitioned for a rehearing by the same three-judge panel.  Last week, the CAFC denied both of these without providing any further comments.  However, these petitions provide some insights as to how the parties’ positions on standing as well as the merits are evolving, and are summarized below.

Plaintiffs’ Petition for Panel Rehearing

On August 25, 2011, the Plaintiffs, represented by the ACLU and PubPat, filed a petition for a panel rehearing on both substantive issues and issues of standing.  As to the substantive issues, the Plaintiffs took issue with the majority’s reasoning that isolated DNA does not occur in nature. (more…)

AMP v. USPTO: Myriad wins this battle, but will the war continue?

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing Friday’s Court of Appeals for the Federal Circuit decision in the AMP v. USPTO case.  He highlights the key points of the decision and why this decision should come as a relief to anyone in the biotechnology industry.

After nearly four months of consideration[1], the Court of Appeals for the Federal Circuit issued a decision in the controversial AMP v. USPTO case on Friday, July 29, 2011.  Weighing in at just over a hundred pages total, the decision includes a majority opinion by Judge Lourie, a concurrence by Judge Moore and a dissent by Judge Bryson.  The main point of contention between the three opinions relates to the patent-eligibility of the composition claims, particularly the claims which recite isolated long DNA sequences.

Standing

The first issue considered by the CAFC was whether the Plaintiffs had standing to sue.  The Plaintiffs were a motley crew of doctors, patients, scientific organizations and advocacy groups.  This wide breadth of Plaintiffs was one of the unusual aspects of this case.  Some Plaintiffs, such as cancer patients, claimed standing based on the fact that they could not afford the costs of the genetic tests or obtain a second opinion, due to Myriad being the exclusive provider for this test in the United States.  The Court quickly dismissed this reasoning, stating that “we fail to see how the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.”  Citing MedImmune, the Court succinctly stated: “[s]imply disagreeing with the existence of a patent or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court’s requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

(more…)

Advanced Patent Prosecution Workshop: Chemical & Pharmaceutical Claim Drafting

Last week, I attended PLI’s Advanced Patent Prosecution Workshop 2011 in New York where an esteemed panel of experts offered hands-on claim drafting and amendment writing techniques.  The program was organized into four technological sections: Biotechnology, Chemical/Pharmaceutical, Electrochemical and Electronics/Computers. I attended the Chemical/Pharmaceutical segment where Michael Davitz, Partner at Axinn, Veltrop & Harkrider and Practice Center Contributor, discussed Chemical and Pharmaceutical Claim Drafting.  Here are some highlights from his presentation….

• Development of a Patent Portfolio – patent portfolio is developed in the context of a business plan and where in the life cycle the product is.
• Generic Player – differentiate product from innovator and create difficulty for competitors, other generics.
• Innovator – at what stage is the development? Integrate FDA and patent filing strategies and develop patents with an eye towards forcing infringement.
• Strategies for Early-stage and Late-stage Products
• Developing a Portfolio of both Listed and Unlistable Patents
• Start with the end-game and plan backwards (more…)

Advanced Patent Prosecution Workshop: Claim Drafting & Amendment Writing

Yesterday, I attended PLI’s Advanced Patent Prosecution Workshop 2011 in New York where an esteemed panel of experts offered hands-on claim drafting and amendment writing techniques.  The program was organized into four technological sections: Biotechnology, Chemical/Pharmaceutical, Electrochemical and Electronics/Computers. I attended the Chemical/Pharmaceutical segment whereJohn Todaro of Merck & Co. discussed advanced issues in drafting of patent specifications.

Here are some highlights from his presentation….

-Draft the claims or Summary of the Invention first, because of the primary role of the patent specification in claim construction

-General Considerations in Drafting the Specification:

1. Distinguish invention from the prior art
2. Define claim terms
3. Provide broadest possible claim scope, while complying with section112 requirements
4. Consider ex-US patent law issues

–Control the length of the application – too long = excess fees. Cost issue is important, think about when drafting the application. (more…)

Supreme Court Grants Certiorari In Prometheus V. Mayo (Again)

On Monday, the United States Supreme Court agreed to consider whether to set limits on when inventors can patent medical diagnostic tests.  Our friends at Foley & Lardner sent in this article discussing the history of the case, the issues being considered by the Court and the potential impact this case may have on intellectual property in the personalized medicine space.

On June 20, 2011, the United States Supreme Court granted Mayo’s petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), a case addressing patent eligibility under 35 U.S.C. § 101 of certain method claims relevant to personalized medicine. While the issue under consideration here does not relate to whether isolated genes and other alleged “products of nature” are patent-eligible, the Court in Prometheus will likely address whether and how one can claim methods that take advantage of correlations between an individual’s personal health/genetic make-up and possible health care options.

As discussed in postings on Foley’s Personalized Medicine Bulletin and PharmaPatents blogs, Mayo Collaborative Services filed a second petition for certiorari with the Supreme Court after the Federal Circuit upheld the claims (for a second time) on remand after the Supreme Court’s decision in Bilski v. Kappos (2010). Representative claims in Prometheus include: (more…)