In 2009, I filed an amici brief on behalf of myself and
several other law professors in
Prometheus v. Mayo, which was the
first time the Federal Circuit heard the case.
In the decision below, the district court held that the interaction of a
synthetic, non-naturally occurring pharmaceutical compound with the human body
is a “natural phenomenon.” In our brief,
we basically argued that the interaction of a synthetic compound with the human
body is not a natural phenomenon, but that if the definition of “natural
phenomena” is interpreted so broadly as to encompass the interaction of human-made
drugs with the human body, then by implication drug method of treatment claims
seemed vulnerable to invalidation under 101 for encompassing patent ineligible
subject matter.
Nonetheless, the Federal Circuit and the Supreme Court
invalidated the Prometheus claims based on an assumption that the interaction
of the pharmaceutical agent (the metabolic breakdown product of a drug) with
the human body is a natural phenomenon. In
the Supreme Court’s decision, Mayo v.
Prometheus, Justice Breyer seemed cognizant of this concern, and
affirmatively stated that drug method of treatment claims should not be
threatened by the holding in Mayo. Still, I have continued to wonder how
secure drug method of use claims are post-Mayo,
particularly given the expansive interpretation of the Mayo/Alice by the district court’s and the Federal Circuit in
decisions such as Ariosa (discussed
in a previous post).
Thus, it came as no surprise when I saw a September
23, 2015 Report and Recommendation from a magistrate judge in the District of
Delaware recommending invalidation of a drug method of treatment patent for patent
ineligibility on a motion to dismiss under Rule 12(b)(6). The case, Endo
Pharmaceuticals v. Actavis, is an
ANDA litigation brought by Endo Pharmaceuticals against Actavis in connection
with a Generic Oxymorphone ER Tablets. The Report and Recommendation is available here.
The patent is US Patent Number 8,871,779, and
representatives of claim one recites:
1. A method of treating pain in a renally impaired patient,
comprising the steps of:
a. providing a solid oral controlled release dosage form,
comprising: i. about 5 mg to about 80 mg of oxymorphone or a pharmaceutically
acceptable salt thereof as the sole active ingredient; and ii. a controlled
release matrix;
b. measuring a creatinine clearance rate of the patient and
determining it to be (a) less than about 30 ml/min, (b) about 30 mL/min to
about 50 mL/min, (c) about 51 mL/min to about 80 mL/min, or (d) above about 80
mL/min; and
c. orally administering to said patient, in dependence on
which creatinine clearance rate is found, a lower dosage of the dosage form to
provide pain relief;
wherein after said administration to said patient, the
average AUC of oxymorphone over a 12-hour period is less than about 21 nghr/mL.
The magistrate judge applied the Mayo/Alice two-part test for patent eligibility. The first step is to determine whether the
claims at issue are “directed to a patent-eligible concept,” in this case a
natural law. The magistrate judge notes
that the “Mayo court provided a broad
definition for a law of nature: ‘[a] patent that… describes a relationship that
is the consequence of entirely natural processes sets forth a natural law.’” The judge went on to conclude that “the
connection between the severity of renal impairment and the bioavailability of
oxymorphone” was the relevant natural law to which the claims are directed.
The second step is to determine whether the claims “add
enough” to the “natural law” to render the claim patent eligible. The magistrate judge essentially determined
that the “providing,” “measuring,” and “administering” steps were analogous to
the steps in the claims held to be patent ineligible in Mayo, and thus did not provide “enough” extra.
The claims at issue in Mayo
essentially recited a method of performing a diagnostic test and determining
the optimal dosage of drug for a patient.
The claim did not recite a step of actually administering the optimized
dosage to a patient, and many have held out the hope that in the future a claim
that included this additional step of actually applying the information derived
from the diagnostic test would be found patent eligible.
But note that Endo’s claim does expressly recite
administering a lower dosage of drug to a patient based on the results of the
diagnostic test, i.e., the claim does include the extra step that many thought
would have rendered the claims in Mayo patent
ineligible. But, at least in the view of
this magistrate judge, the inclusion of this extra step was not sufficient to
render the claim patent eligible. And
given the sweeping language of Mayo, particularly
as interpreted by the Federal Circuit in Ariosa,
it is not hard to see how the magistrate judge came to this conclusion.
It is important to note that the Endo claim is not a
straightforward method of treatment claim, i.e., “a method of treating disease X
by administering drug Y,” and does not necessarily indicate that the magistrate
judge would have ruled such a claim patent ineligible. The decision does explicitly note that “oxymorphone
is ‘widely used’ for acute and chronic pain relief, the showing that the
utilization of oxymorphone is not the invention.” Thus, the magistrate judge seemed to imply
that in a case where the “invention” is the discovery of a new pharmaceutical
agent for the treatment of some medical condition a method of treatment claim could
still be patent eligible under Mayo.
It seems inevitable that before long we will be seeing a
decision involving an allegation that a more conventional method of treatment
claim is patent ineligible. It will be
interesting to see how the courts handle that case, and also how the district
court judge in Endo v. Actavis (and
perhaps the Federal Circuit eventually) responds to the magistrate judge’s
recommendation.
3 comments:
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