In Re '318 Patent Infringment Litigation: Janssen Pharmaceutica v. Teva and Myland and Dr. Reddy's Laboratories and Barr and Purepac and Alphapharm (CAFC 2008-1594, 2009-1070) precedential

The specification for the '318 patent was only just over one page in length, and it provided almost no basis for its stated conclusion that it was possible to administer "an effective Alzheimer's disease cognitively-enhancing amount of galanthamine." Id. col.1 ll.47-48.

The district court found the specification lacking.

The district court found that the '318 patent was neither anticipated nor obvious. However, the district court concluded that the '318 patent was invalid for lack of enablement on two distinct grounds. The district court found that the specification did not demonstrate utility because relevant animal testing experiments were "not finished . . . by the time the '318 patent was allowed" and the specification provided only "minimal disclosure" of utility. '318 Patent Infringement Litig., 578 F. Supp. 2d at 723, 735; see also id. at 736-37 & n.39. The district court alternatively found that the specification and claims did not "teach one of skill in the art how to use the claimed method" because the application "only surmise[d] how the claimed method could be used" without providing sufficient galantamine dosage information. Id. at 736. The district court entered judgment in favor of the defendants that the '318 patent was invalid for lack of enablement.

Appeals court enablement case law foundation. The CAFC tied enablement to utility in order to reach its legal conclusion, and skirt the requisite factual inquiry required in determining enablement.

The enablement requirement is stated in 35 U.S.C. § 112.⁵ Enablement is determined as of the effective filing date of the patent's application. Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339 (Fed. Cir. 2003).

⁵ The statute states:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. - 35 U.S.C. § 112, ¶ 1 (emphases added).

Enablement is closely related to the requirement for utility.⁶ As we noted in

Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1358 (Fed. Cir. 1999),

The enablement requirement of 35 U.S.C. § 112, ¶ 1 requires that the specification adequately discloses to one skilled in the relevant art how to make, or in the case of a process, how to carry out, the claimed invention without undue experimentation. The utility requirement of 35 U.S.C. § 101 mandates that any patentable invention be useful and, accordingly, the subject matter of the claim must be operable. If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement.

(emphasis added, citations and footnote omitted). See also 3 Donald A. Chisum, Chisum on Patents § 7.03(6) (2007). The Supreme Court in Brenner v. Manson, 383 U.S. 519 (1966), discussing the utility requirement, stated that inventions must have "substantial utility" and "specific benefit exist[ing] in currently available form." Id. at 534-35.

⁶ The utility requirement is stated in 35 U.S.C. § 101:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. - (emphases added).

The utility requirement prevents mere ideas from being patented. As we noted in Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997), "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. . . . Tossing out the mere germ of an idea does not constitute enabling disclosure." See also In re Fisher, 421 F.3d 1365, 1373 (Fed. Cir. 2005) (inventions fail to meet the utility requirement if their "asserted uses represent merely hypothetical possibilities, objectives which the claimed [inventions] . . . could possibly achieve, but none for which they have been used in the real world").

The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research. Again as the Supreme Court stated in Brenner, "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." 383 U.S. at 536. A process or product "which either has no known use or is useful only in the sense that it may be an object of scientific research" is not patentable. Id. at 535. As we observed in Fisher, inventions do not meet the utility requirement if they are "objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end." 421 F.3d at 1373. Allowing ideas, research proposals, or objects only of research to be patented has the potential to give priority to the wrong party and to "confer power to block off whole areas of scientific development, without compensating benefit to the public." Brenner, 383 U.S. at 534 (footnote omitted).

Typically, patent applications claiming new methods of treatment are supported by test results. But it is clear that testing need not be conducted by the inventor. In addition, human trials are not required for a therapeutic invention to be patentable. Our predecessor court, the United States Court of Customs and Patent Appeals, held in In re Krimmel that patent applications need not "prove that compounds or other materials which [the applicant] is claiming, and which [the applicant] has stated are useful for 'pharmaceutical applications' are safe, effective, and reliable for use with humans." 292 F.2d 948, 954 (CCPA 1961). As we observed in In re Brana, "[w]ere we to require Phase II testing [human trials] in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue . . . potential cures." 51 F.3d 1560, 1568 (Fed. Cir. 1995); see also Scott v. Finney, 34 F.3d 1058, 1063-64 (Fed. Cir. 1994).

Extensive testing is not required for patentability. In this case, though, there was no test result basis for the patent.

Janssen conceded that the specification's summarization of prior art animal testing did not establish utility, but argued "that the specification here establishes utility by analytic reasoning." Not good enough.

Thus, at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. See Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005) ("If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to 'inventions' consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor' would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.").

Affirmed.

Judges DYK and Mayer formed a majority, while Judge Gajarsa would have thrown the matter back to the district court for more cogitation.

[T]he district court did not undertake the required legal analysis to determine whether an ordinarily skilled artisan reading the patent would understand it to reveal a credible utility for the invention. In addition, the district court failed to make the factual findings necessary to support the ultimate legal conclusion regarding enablement. See Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1149 (Fed. Cir. 2004) ("Enablement is a matter of law that we review without deference; however, this Court reviews the factual underpinnings of enablement for substantial evidence.").

In general terms, an inventor may look at the prior art differently than those before her, arrive at a novel and nonobvious insight, and submit a patent application that compiles the prior art findings that led her to the insight in such a way as to render obvious in hindsight what was wholly nonobvious at the time she filed her application. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) ("The question is not whether the combination was obvious to the patentee but whether the combination was obvious to a person with ordinary skill in the art."); Grain Processing Corp. v. Am. Maize-Products Co., 840 F.2d 902, 907 (Fed. Cir. 1988) (In considering obviousness, "[c]are must be taken to avoid hindsight reconstruction by using 'the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.'" (quoting Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1012 (Fed. Cir. 1983))). As a result, the proper focus when assessing enablement is on what is disclosed in the patent, not what is taught in the prior art. See In re Ziegler, 992 F.2d 1197, 1201 (Fed. Cir. 1993) ("The how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention." (emphases added)).

According to the majority, even though the district court failed to make the appropriate findings or conduct the proper legal analysis, we need not vacate here because "the record would not support a finding of utility." I respectfully disagree. The record clearly includes evidence that may support a finding of utility, which the majority discounts in order to reach its erroneous conclusion.

Finally, I disagree with the majority opinion's emphasis on the sufficiency of the evidence presented by Janssen.

Because the district court erred as a matter of law and failed to make certain required factual findings, we cannot defer to the district court's legal conclusion or fact-findings, and thus, it is particularly problematic for the majority to require Janssen to demonstrate on appeal that its patent is valid.