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.”

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Liability For Joint Infringement: Application Of Existing Case Law And A Call For En Banc Review

Prior to the Federal Circuit’s April 13, 2011 decision in the Mckesson Technologies Inc. v. Epic Systems Corp. case, many patent experts would have agreed that joint infringement liability has been a settled area of patent law.  However, the Court’s divided ruling demonstrates that might not be the case at all.  Our friends at Foley & Lardner sent in this article discussing the Court’s decision and what companies should consider doing  to ensure that it’s highest-value inventions are properly protected.

On April 12, 2011, the U.S. Court of Appeals for the Federal Circuit issued its decision in McKesson Technologies Inc. v. Epic Systems Corp., No. 2010-1291, slip op. (Fed. Cir. April 12, 2011). In this long-anticipated decision, a sharply divided panel composed of Judges Newman, Bryson, and Linn determined that a patentee who was unable to attribute the performance of all of the steps of the asserted method claims to a single entity had failed to prove direct infringement. The Court’s decision is notable in that it produced three opinions: a majority opinion, a concurrence suggesting that en banc consideration of the question of joint infringement might be warranted, and a vigorous dissent arguing that the majority—in its application of the “single entity rule”—had ignored controlling precedent. This opinion provides a useful discussion and application of the recent cases addressing liability for alleged joint infringement as well as a preview of a case that the Court might decide to review en banc. (more…)

AMP v. U.S.P.T.O.: Oral Argument at the Federal Circuit

Yesterday, the much anticipated oral argument in the AMP v. USPTO aka the Myriad Case took place at the Court of Appeals for the Federal Circuit.  Fortunately for us, Ryan B. Chirnomas, Partner at Westerman, Hattori, Daniels & Adrian attended the argument and has passed along this article summarizing the day’s events.

On April 4, 2011, the Appellant, Appellee and the U.S. Government presented oral argument before the Court of Appeals for the Federal Circuit in AMP v. USPTO, which deals with gene patenting.  The parties in this case are the Association for Molecular Pathology, along with many other medical organizations, doctors and patients on one side, and the U.S.P.T.O., Myriad Genetics, Inc., and the University of Utah Research Foundation on the other side.  Many amicus briefs have been filed as well.  The argument was heard by a panel consisting of Judges Bryson, Lourie and Moore, and was attended by approximately 200 people.   Due to the complexity of the subject matter and the presence of Government, the Court granted each side approximately 30 minutes of argument, instead of the usual 15 minutes.

Interestingly, although the parties seemed eager to discuss the merits, approximately half of the time for the Appellant and Appellee was spent discussing the issue of jurisdiction and standing.  In particular, Judge Moore seemed very interested in this issue.  The Appellants, led by Myriad, argued that there was no immediate controversy between the parties, since Myriad had not contacted any of the parties in over ten years.  However, Judge Moore questioned whether those parties previously threatened by Myriad were still refraining from making and using the claimed subject matter due to a continuing fear of litigation over the past decade.  (more…)

Federal Circuit: Foreign Application Not Priority in Interference When it Only “Envisions” Invention

Written by Gene Quinn (of IPWatchdog and Practice Center Contributor)

Last week the United States Court of Appeals for the Federal Circuit issued a ruling in Goeddel v. Sugano, which might be one of a dying breed should patent reform actually pass.  The case dealt with an appeal from an interference proceeding where the Board awarded priority based on a Japanese application.  The Federal Circuit, per Judge Newman, explained that it was inappropriate to say that the Japanese application demonstrated a constructive reduction to practice because the application merely would allow the skilled reader to “envision” the invention covered in the interference count.  If patent reform passes (and yes that could really happen) cases like Goeddel would become a thing of the past, although priority determinations like this one in Goeddel will certainly not go away.

Goeddel was a consolidated appeal from two decisions of the Board of Patent Appeals and Interferences of the United States Patent and Trademark Office in two related patent interference priority contests between the party Haruo Sugano, Masami Muramatsu, and Tadatsugu Taniguchi (together “Sugano”) and the party David V. Goeddel and Roberto Crea (together “Goeddel”).  The Board held that Sugano is entitled to the benefit of the filing date of its initial Japanese application, and awarded Sugano priority as to the counts of both interferences. (more…)

In the Wake of MedImmune: What We Have Learned

The following guest post comes from Lisa A. Dolak, Professor of Law at Syracuse University and Practice Center Contributor.

In its 2007 decision in MedImmune, Inc. v. Genentech, Inc., the Supreme Court held that “Article III’s limitation of federal courts’ jurisdiction to ‘Cases’ and ‘Controversies,’ reflected in the ‘actual controversy’ requirement of the Declaratory Judgment Act, 28 U.S.C. § 2201(a)” does not require “a patent licensee to terminate or be in breach of its license agreement before it can seek a declaratory judgment that the underlying patent is invalid, unenforceable, or not infringed.”  Although MedImmune was decided in the context of a non‑breaching licensee’s action against its licensor-patentee, it altered the patent enforcement/licensing landscape more generally, specifically, by expanding the circumstances under which the district courts have the power to entertain declaratory judgment claims.

The Supreme Court held that the Federal Circuit had erred in holding that jurisdiction could not lie under the circumstances because the license agreement insulated MedImmune from a “‘reasonable apprehension of suit’”.   In the three and a half years since MedImmune was decided, the Federal Circuit has had the opportunity to apply its teachings in a variety of contexts.  The following summary highlights the key lessons from those Federal Circuit decisions. (more…)