Eli Lilly and Company v. Teva Pharmaceuticals USA, No. 05-1044 (Fed. Cir. 7/13/2005), 05-1044.
| Decision Date | 13 July 2005 |
| Docket Number | No. 05-1044.,05-1044. |
| Parties | ELI LILLY AND COMPANY, Plaintiff-Appellee, and MASSACHUSETTS INSTITUTE OF TECHNOLOGY and INTERNEURON PHARMACEUTICALS, INC., Involuntary Plaintiffs, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant. |
| Court | U.S. Court of Appeals — Federal Circuit |
Before MAYER, LOURIE, and BRYSON, Circuit Judges.
Opinion for the court filed by Circuit Judge BRYSON. Circuit Judge MAYER dissents.
Teva Pharmaceuticals USA, Inc., seeks review of a decision by the United States District Court for the Southern District of Indiana, in which the court found that Teva infringed U.S. Patent No. 4,971,998 ("the '998 patent") and that the patent was not invalid. Eli Lilly & Co. v. Teva Pharms. USA, Inc., IP 02-0512-C-B/S (S.D. Ind. July 29, 2004). We affirm.
The '998 patent covers a method of treating premenstrual syndrome ("PMS") by administering fluoxetine, a drug belonging to a class of compounds known as Selective Serotonin Re-Uptake Inhibitors ("SSRIs"). SSRIs increase the amount of the neurotransmitter serotonin in the synaptic gaps of neurons by inhibiting the reuptake of serotonin. Reuptake is the process by which serotonin is removed from the receiving neuron and returned to the neuron from which it was sent. Fluoxetine causes the serotonin from the receiving neuron to remain in the synaptic gap for longer than it normally would, thereby increasing the chance that the serotonin will be recognized by the receptors of the receiving neuron.
The symptoms of PMS typically occur during the two weeks before the beginning of a woman's menstrual period. That two-week period is commonly known as the luteal period. Drugs relating to PMS treatment typically fall into one of two categories with respect to dosing: (1) dosing limited to the luteal period only; or (2) continuous dosing, which extends indefinitely beyond the luteal period.
The '998 patent is entitled "Methods for Treating the Premenstrual or Late Luteal Phase Syndrome." Claim 2 of the '998 patent is the only claim in suit. It reads:
A method of treating disturbances of mood, disturbances of appetite, or both, associated with pre-menstrual syndrome, comprising administering to a woman prior to the onset of her menstrual period, a composition consisting essentially of approximately 5 mg to approximately 120 mg of fluoxetine.
Eli Lilly and Company is the secondary licensee of the '998 patent, which is assigned to Massachusetts Institute of Technology ("MIT") and licensed to Interneuron Pharmaceuticals. Lilly received approval from the Food and Drug Administration ("FDA") to market fluoxetine under the tradename Sarafem for the treatment of Premenstrual Dysphoric Disorder, a particularly severe form of PMS. In connection with its request for FDA approval, Lilly listed the '998 patent in the FDA's Orange Book as covering Sarafem and its use. When Teva filed an Abbreviated New Drug Application with the FDA seeking approval for the generic version of Sarafem to be administered by continuous dosing, Lilly filed suit against Teva for infringement of the '998 patent. Lilly joined MIT and Interneuron Pharmaceuticals as involuntary plaintiffs. In response, Teva raised the defenses of noninfringement and patent invalidity.
On July 21, 2003, the district court issued a claim construction order. Thereafter, Teva stipulated to infringement of claim 2 for purposes of a trial on the issue of validity. Following a bench trial, the district court found that the '998 patent is not invalid for either anticipation or obviousness. The court then entered a final judgment that the '998 patent was not invalid and was infringed. Teva appeals, contending that the district court erred as a matter of law in its claim construction and committed legal and factual errors on the issue of obviousness.
Teva challenges the district court's construction of the claim limitation requiring the composition to be administered "prior to the onset of [a woman's] menstrual period." The district court construed that phrase to mean treatments administered "prior to the onset of a woman's menstrual period, including those that go on continuously thereafter." Teva argues that the district court erred by construing the claim to include dosing regimens "that go on continuously thereafter." Instead, Teva contends, the district court should have construed the term to refer to dosing "limited to administration during part or all of the 14 days prior to her menstrual period and up to 3 days after," i.e., dosing limited essentially to the luteal phase only.
We disagree with Teva's proposed claim construction. The district court's interpretation is consistent with both the claim and the specification, which do not limit the dosing to the luteal phase. The claim language does not provide that dosing should take place within a certain time frame. Rather, the claim simply states that the recited composition should be administered "prior to the onset of [the woman's] menstrual period." '998 patent, col. 7, line 10. The specification also does not suggest a discrete time period for dosing, but states only that dosing should begin "prior to the expected onset of [a woman's] menstrual period." Id., col. 5, ll. 14-15; see id., col. 6, ll. 51-52 (providing, as an example, the administration of fluoxetine "starting two weeks prior to the expected onset of a subject's menstrual period").
In support of its argument that the dosing period is limited to the luteal phase. Teva relies on language from the specification stating that the dosing period for fluoxetine "will generally begin 1 to 14 days prior to menstruation and may continue for several days (e.g., 3 days) after onset of menstruation." Id., col. 2, ll. 47-49; see id., col. 5, ll. 17-19. That statement, however, is preceded by the statement that "[t]he length of time during which [fluoxetine] will be given varies on an individual basis." Id., col. 2, ll. 45-46; see id., col. 5, ll. 15-16. Hence, the specification is not as restrictive as Teva suggests and does not support limiting the dosing scheme to exclude any regimen that includes administration of the drug outside the luteal phrase.
Teva argues that the prosecution history supports construing the claim to permit dosing only during the luteal phase. Teva points to the prosecution history of a parent patent application, U.S. Patent Serial No. 111,771 ("the '771 application"), and asserts that the applicants added a luteal phase dosing limitation to the claims in that application in order to overcome a rejection. Teva's argument lacks merit because the prosecution history merely reflects the applicant's statement that dosing should occur "prior to and during the late luteal phase." That characterization of the timing requirement indicates that dosing should take place during the luteal phase, but it does not suggest that administration of the drug must terminate at any time. Hence, the prosecution history does not carry the weight Teva attributes to it.
Finally, Teva argues that the district court's claim construction is incorrect because in the case of continuous dosing no monthly treatment regime can be said to "begin prior to the onset of [a woman's] menstrual period." The claim language is broad, and we agree with the district court that it does not exclude a regime of continuous dosing. The language of the claim would plainly cover a treatment regime that began, for example, 20 days before the onset of the woman's menstrual period and continued for eight days after the end of the period, with a two-day hiatus before the beginning of the next treatment cycle. That being so, it would be highly artificial to hold that the claim would cease to apply if the treatment regime were extended to include administration of the composition during the two-day hiatus period. Although it is awkward to characterize a continuous treatment regime as having a beginning point each month, the claim by its terms merely requires that the treatment occur "prior to" the onset of menses, and that plainly occurs in the case of continuous treatment. We therefore affirm the district court's construction of the disputed claim term, at least insofar as it applies to a regime of continuous coverage. Teva does not contest a finding of literal infringement under the district court's claim construction. Accordingly, we affirm the judgment of infringement.
Teva challenges the district court's conclusion that the '998 patent is not invalid for obviousness. Teva's argument is based on three main assertions: (1) there was evidence of contemporaneous invention; (2) two prior art publications would have motivated persons of ordinary skill in the art to use fluoxetine to treat PMS; and (3) a person of ordinary skill in the art would have had a reasonable expectation of success in using fluoxetine to treat PMS. Teva also argues that the district court applied the wrong legal standard in its obviousness analysis.
Teva contends that the district court confused the...
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