Supreme Court Holds Patent Claims
Unpatentable
The United States Supreme Court ruled in Mayo Collaborative Services v. Prometheus
Laboratories, Inc. (Case No. 10-1150), that claims for measuring patient
drug levels and correlating those levels with a need to adjust dosage, is
unpatentable subject matter tantamount to an attempt to patent a law of
nature.
Claims from Prometheus’s U.S. Patent No. 6,355,623, one of
the patents-in-suit, required administering the drug to a subject, determining
the blood level of the drug in the subject, and then establishing a
correlation without actually requiring an adjustment to the dosage.
The
district court had granted summary judgment of invalidity, holding that the
Prometheus patents at-issue effectively claim natural
laws or natural phenomena, and as such were not patentable. On appeal, the
Federal Circuit reversed the district court, stating that the claimed
processes specify the steps of: (1) “administering a [thiopurine] drug” to a
patient; and (2) “determining the [resulting metabolite] level.” The Federal Circuit explained that these
steps involve the transformation of the human body or of blood taken from the
body, thus, satisfying the “machine or transformation test,” and therefore
constituted patentable subject matter under §101.
The
Supreme Court noted that the patent claims purport to apply natural laws
describing the relationships between the concentration in the blood of
certain thiopurine metabolites and the likelihood that the drug dosage will
be ineffective or induce harmful side-effects. However, the Supreme Court
held that the process claims at- issue
were not patentable because the steps in the claimed processes (apart from
the natural laws themselves) involve well-understood, routine, conventional
activity previously engaged in by researchers in the field. The Supreme Court further noted that
“upholding the patents would risk disproportionately tying up the use of the
underlying natural laws, inhibiting their use in the making of further
discoveries.”
Federal
Circuit Affirms Order Compelling Arbitration
In Promega Corp v. Life Tech (Case No.
2011-1263), the Federal Circuit affirmed the district court’s order
compelling arbitration.
In
1996, Research Genetics entered into a license agreement with Promega. The
Agreement required Promega to pay Research Genetics an initial fee and
running royalties. Under the
Agreement, Promega had the right to sublicense the licensed patents. The
Agreement included an arbitration clause which provided that “[a]ll
controversies or disputes arising out of or relating to this Agreement, or
relating to the breach thereof, shall be resolved by arbitration.”
Research
Genetics through several mergers became Life Technologies. Life Technologies notified Promega that it had
been paying less than it was required to pay under the Agreement. After negotiations between the parties
failed to resolve the issue, Life Technologies sought arbitration. Rather than submit to arbitration, Promega
filed suit, which the district court dismissed in view of the arbitration
clause.
The
Federal Circuit stated that the district court’s determination that the
parties have contractually bound themselves to arbitrate is reviewed de novo, and its factual findings for
clear error. The Federal Circuit further noted that the Federal Arbitration Act
(“FAA”) mandates enforcement of valid, written arbitration provisions.
Promega
raised several arguments as to why it should not be compelled to arbitrate:
(1) the arbitration clause at-issue was permissive rather than mandatory; (2)
the real party-in-interest was not a party; (3) the arbitration clause does
not encompass the dispute over Promega’s alleged failure to pay royalties
because the parties intended arbitration to apply only to small disputes
between non-competitors; (4) compelling arbitration would be unjust and
unfair because the agreed upon arbitration procedures did not permit
third-party discovery which would be needed to resolve the dispute; (5) arbitration
is inappropriate because Promega’s claims of patent infringement against Life
Technologies and AB remain pending in the district court; and, (6) various
equitable defenses to arbitration; namely, laches, waiver, unjust enrichment
and estoppel.
The
Federal Circuit found none of Promega’s arguments convincing and noted that
the FAA establishes that, as a matter of federal law, “any doubts concerning
the scope of arbitrable issues should be resolved in favor of arbitration,
whether the problem at hand is the construction of the contract language
itself or an allegation of waiver, delay, or a like defense to
arbitrability.” Accordingly, the district court’s order compelling arbitration
was affirmed.
Federal
Circuit Affirms Certain Means-Plus-Function Language Was Indefinite
In Ergo Licensing v. Carefusion 303 (Case
No. 2011-1229), the Federal Circuit affirmed the district court’s
determination that certain means-plus-function claim terms were indefinite.
The
patent-in-suit described an infusion system used to meter and simultaneously
delivers fluids from multiple fluid sources into a patient’s body. The claims
recited a “programmable control means” and a “control means.” The only structure disclosed in the
specification corresponding to these means was a “control device.”
Ergo argued
that “control device” is synonymous with computer, and that one skilled in
the art would understand a control device to be a general-purpose computer. The Federal Circuit disagreed, stating that
the specification fails to disclose a corresponding algorithm, and that computer-implemented
means-plus-function terms are limited to the algorithms disclosed in the
specification. The Federal Circuit stated that there was no algorithm
described for the function of “controlling the adjusting means,” and that the
specification merely provides functional language and did not contain any
step-by-step process for controlling the adjusting means. As a result, the
Federal Circuit held that the district court correctly determined that the
“control means” terms were indefinite for failure to disclose corresponding
structure.
Federal
Circuit Reverses And Remands Rejection To The PTO
In In re Staats (Case No. 2010-1443), the
Federal Circuit reversed and remanded a rejection by the Board of Patent
Appeals and Interferences (“Board”). The Board had rejected claims of a
reissue application as being broadening beyond the two-year time limit set
forth in 35 USC § 251.
Section 251
provides, in pertinent part, a two-year time limit to broaden the scope of
claims in a reissue application:
No reissued patent shall be granted enlarging the scope of
the claims of the original patent unless applied for within two years from
the grant of the original patent.
Staats timely
filed a first broadening reissue application relating to the first embodiment
described in the specification. While
the first broadening reissue application was pending, Staats filed a second
broadening reissue application as a continuation of the first broadening
reissue application. This application, however, was filed outside the original
two-year period. Similar to the first
broadening reissue application, the second broadening reissue application
only addressed errors related to the first embodiment.
Subsequently,
while the second broadening reissue application was pending, and well outside
of the two-year period, Staats filed a third broadening reissue as a continuation
of the second broadening reissue application. During prosecution of the third
broadening reissue application, Staat added broadened claims directed toward
the second embodiment that was described in the specification, but which
embodiment had not been previously claimed.
The patent
examiner rejected the third reissue application under Section 251 finding
that the new broadened claims were “not related in any way to what was
covered in the original broadening reissue.”
The Federal
Circuit, following In re Doll, 419
F.2d 925 (C.C.P.A. 1970), stated that an applicant is “not barred from making
further broadening changes” after the two-year period in the course of the
prosecution of the reissue application, and that subsequently filed
continuation applications relate back to a previously filed application under
Section 120 if each successive continuation application was filed while its
parent application was still pending. As such, the Federal Circuit held that the time limit for filing a
broadening reissue application is satisfied provided the first broadening
reissue application has been timely filed within the two-year statutory time
period, so that the applicant can present new, broadened claims.
Greenblum & Bernstein Hosting Biosimilars Workshop
Greenblum & Bernstein is hosting a pre-conference
workshop titled: Biosimilars In America: IP Strategy and Due Diligence at the
10th EGA International Symposium on Biosimilar Medicines that will take place
April 19-20, 2012 in London. |
