The Clones War: Chapter Two – Myriad Files Their Brief on Appeal

The following guest post was written by Birch, Stewart, Kolasch & Birch Partner Mark J. Nuell, Ph.D.

Myriad Genetics has filed their brief in their appeal of the decision in Assoc. of Med. Pathology et al. v. Myriad Genetics et al. This case is one having effect on patent-eligibility of claims directed to purified natural products and to sequence-based diagnostic methods.  Myriad’s brief is a paper of advocacy, and it is persuasive of an asserted lack of jurisdiction.  Thus, the Federal Circuit might not even reach the questions of patentability of isolated DNA and of nucleic acid (sequence)-based diagnostic methods.  But, should the Federal Circuit choose to consider those questions, it appears that claims to “isolated DNA” meet the standard for patent-eligibility.  Despite their arguments to the contrary, some of Myriad’s diagnostic method claims are likely to fail to meet the standard, as falling within the scope of abstract ideas or laws of nature.  The other method claims that are challenged, although they can be interpreted to include a “transformative” step and so include a strong clue in favor of patent-eligibility under Bilski v. Kappos, might be deemed ineligible for patent protection because the “transformative” steps represent mere data-gathering steps. (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…)