In a unanimous panel decision, the Federal Circuit affirmed the
finding of the USPTO Patent Trial and Appeal Board (PTAB) that
claims directed to cloned cattle, sheep, pigs, and goats are
directed to non-patent eligible subject matter under 35 USC §
101. The court in effect held that while methods of making a clone
may be patentable, the clone generally is not.
The patent application at issue was 09/225,233, assigned to the
Roslin Institute of Edinburgh, Scotland. The court identified
claims 155 and 164 as representative:
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.
The inventors are the same inventors who made Dolly the sheep
(the first mammal cloned from an adult somatic cell). The Federal
Circuit noted that the inventors were granted a patent on their
cloning methods (U.S. 7,514,258), which were not at issue in this
case.
In a decision rendered February 7, 2013, the PTAB affirmed the
Examiner's § 101 rejection finding the claimed subject
matter "constituted a natural phenomenon that did not possess
'markedly different characteristics than any found in
nature.'" The Board also affirmed the Examiner's
multiple rejections under 35 USC §§102 and 103.
The Federal Circuit's 12 page opinion was authored by Judge
Dyk, with Judges Moore and Wallach joining. Although the claims on
appeal were rejected under 35 USC §§ 101, 102 and 103,
the court did not reach the issues of anticipation and obviousness,
disposing of the case solely under § 101. The decision opened
with a brief recap of the Supreme Court decisions in
Myriad, Chakrabarty, and Funk Bros.,
collectively being characterized as making it "clear that
naturally occurring organisms are not patentable." In Funk
Bros., "the mixture of bacteria . . . was unpatentable
because its 'qualities are the work of nature' unaltered by
the hand of man." In Chakrabarty, "the modified
bacterium was patentable because it was 'new' with
'markedly different characteristics from any found in nature
and one having the potential for significant utility.'"
Lastly, in Myriad, "claims on two naturally
occurring, isolated genes . . . were invalid under §
101,″ because the "genes themselves were unpatentable
products of nature." Thus, according to the court, only
discoveries that possess "markedly different characteristics
from any found in nature" . . . are eligible for patent
protection.
Roslin argued that the clones are patent eligible, because they
are "the product of human ingenuity" and "not
nature's handiwork, but [their] own." However, the court
found that "Dolly herself is an exact genetic replica of
another sheep and does not possess 'markedly different
characteristics from any [farm animals] found in
nature.'" The court explained that Roslin's
chief innovation was the preservation of the donor DNA such that
the clone is an exact copy of the donor. Therefore,
Dolly's genetic identity to her donor parent is what renders
her unpatentable.
The court left open the possibility that "having the same
nuclear DNA as the donor mammal may not necessarily result in
patent ineligibility in every case," but emphasized that the
claims at issue "do not describe clones that have markedly
different characteristics from the donor animals of which they are
copies." Future court decisions will likely provide
guidance regarding how "markedly different" a clone must
be from its donor to render it patent eligible.
If you have any questions about the court's decision or how it
may impact your business, please feel free to contact one of our
biopharma specialists at the firm.
This article is intended to provide information of general interest to the public and is not intended to offer legal advice about specific situations or problems. Brinks Gilson & Lione does not intend to create an attorney-client relationship by offering this information and review of the information shall not be deemed to create such a relationship. You should consult a lawyer if you have a legal matter requiring attention. For further information, please contact a Brinks Gilson & Lione lawyer.
