`
`IN THE SUPREME COURT OF THE UNITED STATES
`___________
`
`No. A-_____
`___________
`ELI LILLY AND COMPANY, APPLICANT
`
`v.
`
`ERFINDERGEMEINSCHAFT UROPEP GBR
`___________
`
`APPLICATION FOR AN EXTENSION OF TIME
`WITHIN WHICH TO FILE A PETITION FOR A WRIT OF CERTIORARI
`TO THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`_________
`
`Pursuant to Rules 13.5 and 30.2 of this Court, counsel for
`Eli Lilly and Company respectfully requests a 30-day extension of
`time, to and including June 5, 2019, within which to file a peti-
`tion for writ of certiorari to review the judgment of the United
`States Court of Appeals for the Federal Circuit in this case. The
`Federal Circuit entered its judgment on October 10, 2018. App.,
`infra, 1a-2a. It denied a petition for rehearing on February 5,
`2019. Id. at 3a-4a. Unless extended, the time for filing a
`petition for a writ of certiorari will expire on May 6, 2019. The
`jurisdiction of this Court would be invoked under 28 U.S.C.
`1254(1).
`In a long line of decisions culminating in Halliburton
`1.
`Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946), this Court
`has made clear that a patent claim is invalid if it describes its
`point of novelty in purely functional terms -- that is, in terms
`of what it accomplishes, rather than what it is. Purely functional
`
`
`
`2
`
`
`claims “discourage” innovation because they preempt future inven-
`tions by “extend[ing]” the patent monopoly “beyond the discovery”
`itself. Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245,
`257 (1928). The rule ensures fair notice of the scope of the
`invention and adequate disclosure of how to make and use it. See
`3 Donald S. Chisum, Chisum on Patents § 8.04[3], at 406-407 (2018
`ed.).
`In Halliburton, the Court applied the rule against purely
`functional claiming to invalidate a combination claim -- i.e., a
`claim that unites existing components in a novel way -- describing
`all “means” for performing a certain function, including those
`means not yet discovered. 329 U.S. at 12-13. In response, Con-
`gress enacted 35 U.S.C. 112, ¶ 6 (now 35 U.S.C. 112(f)), as part
`of the 1952 Patent Act. That provision narrowly permits means-
`plus-function claiming for combination claims, but only if “the
`broad literal language of such claims” is limited to “the actual
`means shown in the patent specification” for performing the func-
`tion. Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S.
`17, 28 (1997). By its terms, Section 112, ¶ 6, does not reach
`single-step claims such as the one at issue here.
`2.
`In 2001, applicant sought FDA approval for Cialis®, a
`drug to treat erectile dysfunction. In May 2001, following pre-
`clinical evaluations, applicant proposed evaluating new indica-
`tions for tadalafil, the active ingredient in Cialis. Those in-
`dications included a new treatment for benign prostatic hyper-
`plasia (BPH), a condition in which the benign growth of the pros-
`tate gland in older males causes constriction of the neighboring
`
`
`
`3
`
`
`urethra and results in lower urinary tract symptoms, such as dif-
`ficulty urinating. App., infra, 9a.
`At the time, BPH was treated by surgery or the use of alpha-
`receptor blockers, which were not particularly effective and
`caused severe side effects. App., infra, 6a. Applicant spent
`over $150 million on research and an extensive drug development
`process involving multiple clinical studies of tadalafil that con-
`tinued through at least 2009. See C.A. App. 13914-13918, 13920-
`13939, 14002-14003. On October 6, 2011, applicant obtained FDA
`approval to market tadalafil for low-dose, once-daily treatment of
`BPH, and also for the concurrent treatment of BPH and erectile
`dysfunction. App., infra, 9a.
`A few months later, respondent, a non-practicing German as-
`sociation with only a handful of employees, filed the patent ap-
`plication that ultimately became U.S. Patent No. 8,791,124. Re-
`spondent’s patent claims priority to an application dated July 9,
`1997. App., infra, 5a-6a.
`Respondent’s patent is directed to a method for preventing or
`treating BPH -- namely, by administering an inhibitor of a specific
`enzyme, phosphodiesterase V (or PDE V). Claim 1 of that patent
`encompasses “[a] method for prophylaxis or treatment of [BPH] com-
`prising administering to a person in need thereof an effective
`amount of an inhibitor of [PDE] V excluding a compound selected
`from [a particular] group” identified in that claim. App., infra,
`10a. That is the very method for treating BPH used by Cialis,
`which was already on the market when respondent filed the appli-
`cation that matured into its patent.
`
`
`
`4
`
`
`Respondent filed suit against applicant in the Eastern
`3.
`District of Texas, asserting that applicant had infringed claim 1
`of its patent in violation of 35 U.S.C. 271. As is relevant here,
`the district court recognized that the claim included functional
`language, but it determined that the claim did not fall within
`Section 112, ¶ 6. C.A. App. 53-65.
`The district court construed the phrase “inhibitor of [PDE]
`V” as “a selective inhibitor of PDE5, which is at least 20 times
`more effective in inhibiting PDE5 as compared to PDE1 through
`PDE4.” C.A. App. 147; see id. at 71. As construed by the court,
`the claim captures billions of compounds, described solely in terms
`of what they do, rather than what they are. App., infra, 20a.
`The court nevertheless held that the claim was “sufficiently def-
`inite” as a matter of law. C.A. App. 128, 133-134.
`At trial, applicant argued, inter alia, that claim 1 was
`invalid because it failed to satisfy the written-description and
`enablement requirements in Section 112, ¶ 1 (now Section 112(a)).
`The jury returned a verdict for respondent, finding claim 1 not
`invalid and infringed and awarding respondent damages. App., in-
`fra, 11a-13a.
`Following the jury verdict, applicant renewed its motion for
`judgment as a matter of law, arguing, inter alia, that the claim
`was invalid for failing to comply with the written-description and
`enablement requirements of Section 112, ¶ 1, and that the claim
`was indefinite under Section 112, ¶ 2. The district court denied
`
`
`
`5
`
`
`
`
`
`
`
`that motion, rejecting applicant’s argument that the claim imper-
`missibly describes its point of novelty “using functional lan-
`guage.” App., infra, 16a, 82a.
`3.
`The court of appeals affirmed in a summary order. App.,
`infra, 1a-2a. In so doing, it rejected applicant’s argument that
`the claim used purely functional language that did not satisfy the
`requirements of Section 112.
`4.
`The court of appeals subsequently denied a petition for
`rehearing. App., infra, 3a-4a.
`5.
`Counsel for applicant respectfully requests a 30-day ex-
`tension of time, to and including June 5, 2019, within which to
`file a petition for a writ of certiorari. This case presents
`complex issues concerning the continued viability of the rule
`against functional claiming. The undersigned counsel did not rep-
`resent applicant below and needs additional time to review the
`record and underlying opinions. In addition, the undersigned
`counsel is preparing petitions for writs of certiorari in several
`other cases. Additional time is therefore needed to prepare and
`print the petition in this case.
`Respectfully submitted.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`KANNON K. SHANMUGAM
`Counsel of Record
`PAUL, WEISS, RIFKIND,
` WHARTON & GARRISON LLP
`2001 K Street, N.W.
`Washington, DC 20006
`(202) 223-7300
`
`
`
`
`
`
`
`
`
`
`April 22, 2019
`
`
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