Myriad Decision Invoked in Appeal of Suit To Invalidate Embryonic Stem Cell Patent Claims

On June 13, the U.S. Supreme Court struck down patent claims of Myriad Genetics to genomic DNA in the BRCA1 and BRCA2 genes on the ground that those patents claimed mere “products of nature.”  Only occasionally mentioned in the commentary on that decision was the possible extension of this decision from human genomic DNA to other naturally occurring biological substances, such as molecules or proteins.  (The CLB blog’s coverage, here, did mention that uncertainty.)

On July 2, the first step may have been taken toward such an extension of the Myriad rationale.  On that date, two public interest groups, Consumer Watchdog and the Public Patent Foundation, filed a brief with the Court of Appeals for the Federal Circuit in Consumer Watchdog v. Wisconsin Alumni Research Foundation.  In that brief, they argue that patent claims on human embryonic stem cells, held by the Wisconsin Alumni Research Foundation (WARF) are invalid under the Myriad decision because they are “products of nature.”  Here is their press release, here is their brief for download, and here is the Genome Web story about the brief.

The Public Patent Foundation filed the brief as counsel for Consumer Watchdog in an appeal from a “Decision on Appeal” of the Board of Patent Appeals and Interferences (now known as the Patent Trial Appeal Board) in an inter partes re-examination of certain patents.  On July 17, 2006, Consumer Watchdog had filed a request for inter partes re-examination of patent 7,029,913 (“the ‘913’ patent”) that had issued on April 18, 2006 to Professor James Thomson and been assigned to WARF.   Consumer Watchdog argued that three claims of the patent for in vitro cultures of human embryonic stem cell lines had been obvious in light of the prior art.  Any person of ordinary skill in the art of deriving and maintaining embryonic stem cell lines for any mammal would have found the process used to derive these human stem cell lines obvious or, at least, obvious to try.

The Examiner granted Consumer Watchdog’s request for re-examination but then held that the claims were allowable. The  Patent and Trademark Office Board first agreed with Consumer Watch that the claims were obvious and, on April 29, 2010, reversed the Examiner.  WARF filed a Request to Reopen Prosecution, with some amendments to the application, supported by new evidence.  The Examiner determined that these claims were patentable in spite of the earlier objections from the Board. On January 22, 2013, the Board affirmed the Examiner’s latest decision, leading to this appeal.

Most of the argument in the brief is directed to Consumer Watchdog’s earlier argument of obviousness, but the first four pages of the 17 pages of argument take up the Myriad issue.  The brief argues that the claims are only for “replicating in vitro cell culture[s] of pluripotent human embryonic stem cells derived from a pre-implantation embryo,” which have characteristics that the brief maintains all embryonic stem cells have. Thus, the brief urges, these are just “products of nature” and thus, following Myriad, not patentable subject matter  under Section 101.  Several of the those four pages are dedicated to arguing that the Federal Circuit should consider this argument even though it was not raised below.

Jake Sherkow’s June 13 blog post with his first thoughts on Myriad warned that among other questions, the decision left unanswered “What about other patents directed to “isolated and purified” natural products?”. Well, less than three weeks later, that very issue is being raised with another very high profile biological patent.

Of course, the Court of Appeals for the Federal Circuit may not resolve that question.  It may decide not to consider this issue because it was not raised below (even though Consumer Watchdog’s lawyers, the Public Patent Foundation, including Daniel Ravicher, also litigated the Myriad case).  It may decide not to consider the issue because it feels compelled to rule for the appellant on the obviousness claims.

And if does consider the issue, it may resolve it narrowly.  It seems to me quite plausible that human embryonic stem cells, grown in petri dishes in manufactured culture medium and in a man-made environment, are not the same thing as human embryonic stem cells inside a blastocyst (which are usually called inner cell mass cells and not embryonic stem cells). This is especially true as the cultured cells can be kept alive indefinitely without differentiating, something that does not happen in nature.

A stronger question would probably be one both Jake and I have written about – what about a biological molecule secreted, let’s say, by a fungus that a pharmaceutical company notices has therapeutic properties?  Consumer Watchdog v. WARF seems unlikely to resolve that question – but it does make clear that the Supreme Court’s Myriad opinion is going to spawn such questions.  That’s good for patent lawyers and patent law scholars. Whether it is good for anyone else remains to be seen.

Hank Greely