Thanks to recent advances in cloning technology, treating degenerative diseases with replacement tissue that matches a patient’s genetic makeup exactly is no longer science fiction. Just last month, for example, two research groups reported successfully generating embryonic stem cells using nuclei from adult patients.[1] Of course the road between basic research and a successful therapy that can be used in patients is a long, expensive, and unpredictable one, with no guarantees that one will even arrive at the desired destination. Consequently, companies investing in this type of research have often relied on patent protection to ensure an upside to making the long term investment risks. Since the Supreme Court’s decision in the Myriad Genetics case,[2] however, patent protection in the biotechnology space has become less certain.
In Myriad Genetics, the Court held that under 35 U.S.C. § 101, a “naturally occurring DNA segment is a product of nature and not patent eligible” even if it is claimed in an “isolated” form.[3] The rationale of the Myriad Genetics case is not limited to nucleic acid inventions, but generally applicable to anything found in the natural world. The U.S. Patent & Trademark Office (PTO), for example, issued new guidelines for examiners in March, instructing that when claims are directed to a law of nature or a natural product, they are ineligible for protection unless they recite something “significantly different” than is found in nature.[4] In particular, eligibility will turn on whether the claims include elements that impose meaningful limits on their scope, recite a particular application or use, include a particular machine or transformative step, or add an element that is “more” than something that is routine or well understood.[5]On May 8, 2014, the Federal Circuit upheld a decision by the Patent Trial and Appeal Board rejecting all of the Roslin Institute’s pending claims on clones on § 101 grounds. The Roslin Institute’s most famous clone is undoubtedly Dolly the sheep, the first animal to be cloned from an adult somatic cell in the mid-1990s.
Exemplary claims at issue in this case are below:
- 155. A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
- 164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.[6]
Under current PTO examination guidelines, an examiner would be hard pressed to find anything in the claims that would render a cloned animal “significantly different” than naturally-occurring animal from which it is derived.
Roslin’s “chief innovation” of sufficiently preserving donor DNA worked to its disadvantage in the patent cotext. By definition, a clone is genetically identical to its donor, so cannot “possess ‘markedly different characteristics from any [farm animal] found in nature.’”[7] And there is no dispute that a donor animal is not the handiwork of man, but of Nature herself.
Anyone is “free to copy any unpatentable article, such as a live farm animal, so long as they do not infringe a patented method of copying.”[8] Roslin had not, in these applications, claimed a particular process for generating clones, but had claimed the clones themselves. As a result, it could not recoup its investment in the painstaking work that had been required to generate a clone in the first place.
At oral argument in February, Roslin argued that there are phenotypic differences inherent between a clone and its donor that arise inevitably as a result of the steps required to generate the clone.[9] Moreover, any clone is time-shifted relative to its donor.[10] Neither argument was persuasive to Judges Dyk, Moore or Wallach, because, critically, the language of the claims did not capture those distinctions.[11]
The panel also rejected Roslin’s argument that a clone is different from its naturally occurring donor because while they possess identical nuclear DNA, they differ in regard to their source of mitochondrial DNA. A clone’s mitochondrial DNA comes not from the somatic donor cell, but from a different animal’s oocyte. Again, however, Roslin’s arguments hinged on unclaimed distinctions, and were not sufficient to preserve their claims.[12]
The good news is that the Federal Circuit left the door open, just a bit, to allow for the patenting of clones. “[H]aving the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies.”[13] It will be interesting to see what sort of creative claim drafting this opening prompts, and whether claiming the types of distinctions identified by Roslin results in claims that meet the (likely evolving) standard for definiteness under 35 U.S.C. § 112 (1).[14]
Regardless, patent practitioners, the PTO and the courts will continue to grapple with the edicts of Supreme Court decisions, like Myriad Genetics, that affect the scope of eligible subject matter under the patent laws.
