Finnegan, Henderson, Farabow, Garrett & Dunner, LLP US: Statutory Basis for Judicial Application of a Utility Requirement April 4, 2012 Howard W. Levine

2 2 The utility requirement of 35 U.S.C. § 101 has its origin in the U.S. Constitution, which empowers Congress to authorize the granting of patents “to promote the progress of … useful arts.” U.S. Const. art. I, § 8, cl. 8. “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.” 35 U.S.C. §101.

3 3 “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U. S. ____ (2012). To meet the utility requirement, courts have required that an invention must be operable—that is, “capable of being used to effect the object proposed.” Mitchell v. Tilghman, 86 U.S. 287, 396 (1873).

4 4 “If a claim describes a structure or process that is impossible to achieve, the claim is considered inoperative.” Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1573 (Fed. Cir. 1992).

5 5 The long-standing rule at the PTO is that an invention is presumed operable as disclosed without further evidence where the invention does not contravene established scientific principles and “conforms to the known laws of physics and chemistry.” In re Chilowsky, 229 F.2d 457, 462 (CCPA 1956). The inoperability standard for utility “applies primarily to claims with impossible limitations,” and the bar should not be set too high. CFMT, Inc. v. YieldUp Int’l Corp., 349 F.3d 1333, 1339 (Fed. Cir. 2003).

6 6 Thus, rejections under section 101 for lack of utility are usually limited to inventions deemed scientifically impossible or inherently unbelievable. –cold fusion (In re Swartz, 232 F.3d 862 (Fed. Cir. 2000)) –perpetual motion machine (Newman v. Quigg, 877 F.2d 1575, modified, 886 F.2d 329 (Fed. Cir. 1989)) –a flying machine with a flapping action (In re Houghton, 433 F.2d 820 (CCPA 1970)) –control of aging (In re Eltgroth, 419 F.2d 918 (CCPA 1970)) –accumulating ether electric energy (In re Perrigo, 48 F.2d 965 (CCPA 1931))

7 7 “[I]t is not a requirement of patentability that an inventor correctly set forth, or even know, how or why the invention works.” Newman, 877 F.2d at “[I]t is axiomatic that an inventor need not comprehend the scientific principles on which the practical effectiveness of his invention rests.” Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1570 (Fed. Cir. 1983). “Notably absent from this test [for whether an invention is ready to be patented] is a requirement that an inventor have complete confidence that his invention will work for its intended purpose.” Robotic Vision Sys., Inc. v. View Eng’g, Inc., 249 F.3d 1307, 1312 (Fed. Cir. 2001).

8 8 Where an undertaking is not inherently unbelievable and does not involve implausible scientific principles, there is no requirement that an applicant submit clinical evidence to prove the utility of an invention. In re Cortright, 165 F.3d 1353, (Fed. Cir. 1999).

9 9 A heightened showing of utility is also not required of patents in the pharmaceutical field. In re Brana, 51 F.3d 1560, (Fed. Cir. 1995). The utility requirement for obtaining a patent is not to be confused with the regulatory requirements for obtaining approval to market a particular drug for human consumption. Id. “Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development.” Id. at 1568.

10 “Early filing of an application with its disclosure of novel compounds which possess significant therapeutic use is to be encouraged. Requiring specific testing... in order to satisfy the how-to-use requirement of § 112 would delay disclosure and frustrate, rather than further, the interests of the public.” In re Bundy, 642 F.2d 430, 434 (CCPA 1981).

11 PTO Examiner may challenge utility only if he believe it is not credible. An applicant’s facial disclosure of utility at the PTO “must be taken as in compliance with the enabling requirement of the first paragraph of § 112 unless there is reason to doubt the objective truth of the statements contained therein.” In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971). Only if the PTO adequately explains why it doubts the truth of the statements in the disclosure does “the burden then shift[] to the applicant to provide suitable proofs indicating that the specification is indeed enabling.” In re Wright, 999 F.2d 1557, 1562 (citing Marzocchi, 439 F.2d at ).

12 Post-filing evidence and data may be used to establish the truth of the asserted practical utility as set forth in the patent’s specification –Marzocchi, 439 F.2d at 221, –In re Wands, 858 F.2d 731, 739 (Fed. Cir. 1988) –Gould v. Quigg, 822 F.2d 1074, 1078 (Fed. Cir. 1987) –In re Jolles, 628 F.2d 1322, 1327 (CCPA 1980) –In re Watson, 517 F.2d 465, (CCPA 1975) –In re Krimmel, 292 F.2d 948, (CCPA 1961) –In re Dodson, 292 F.2d 943, 947 (CCPA 1961)

13 PTO’s own rules establish that post-filing evidence can be used to establish utility of claimed invention In chemical and biotechnical applications, evidence actually submitted to the FDA to obtain approval for clinical trials may be submitted [to the PTO].... To overcome a prima facie case of lack of enablement, applicant must demonstrate by argument and/or evidence that the disclosure, as filed, would have enabled the claimed invention for one skilled in the art at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. MPEP § at (8th ed. rev. 7, July 2008) (first emphasis in original).

14 Thus, the utility set forth in the specification must be true But, the specification need not contain proof that the asserted utility is correct Post-filing evidence can be used to support utility if challenged

15 General rule is that lack of utility difficult to establish in infringement suits: –“To violate § 101 the claimed device must be totally incapable of achieving a useful result....” Brooktree, 977 F.2d at –“If a party has made, sold, or used a properly claimed device, and has thus infringed, proof of that device’s utility is thereby established. People rarely, if ever, appropriate useless inventions.” Raytheon Co. v. Roper Corp., 724 F.2d 951, 959 (Fed. Cir. 1983). –“[L]ack of practical utility cannot co-exist with infringement.” Phillips Petroleum Co. v. U.S. Steel Corp., 673 F. Supp. 1278, 1328 (D. Del. 1987), aff’d, 865 F.2d 1247 (Fed. Cir. 1989) (citing Raytheon, 724 F.2d at 959).

16 What protects public against the patenting of “research plans” and ensures that only real inventors are awarded patents?

17 Written description requirement of 35 U.S.C. § 112: “The specification shall contain a written description of the invention.” –corroborates the “conception of the invention” –conception is “the formation, in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is thereafter to be applied in practice” –“[T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).

18 –“We have made clear that the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement.” Id. at –“Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id. at 1351.

19 Eli Lilly and Co. v. Actavis Elizabeth LLC, 435 Fed. Appx. 917 (Fed. Cir. 2011) –Lilly’s Strattera® product for the treatment of attention- deficit/hyperactivity disorder (ADHD) –United States Patent No. 5,658,590 (the '590 patent), assigned to Lilly, claimed using atomoxetine (the active ingredient in Strattera®) to treat ADHD –Generic drug manufactures (defendants) challenged the patent as lacking utility under 35 U.S.C. § 101 because those skilled in the art would not believe atomoxetine would actually work to treat ADHD –Defendants argued “that in view of the absence of experimental data in the specification, the disclosed utility must be deemed incredible.” Id. at 925.

20 What did patent specification teach ? –“The '590 patent describes the use of tomoxetine to treat ADHD in humans, and states that ‘tomoxetine is a notably safe drug, and its use in ADHD, in both adults and children, is a superior treatment for that disorder because of improved safety.’” Id. at 923. –“The patent refers to the two recognized types of ADHD, inattentive type and hyperactive-impulsive type, and states: ‘Treatment with tomoxetine is effective in patients who are primarily suffering from either component or from the combined disorder.’” Id. –“The method of the present invention is effective in the treatment of patients who are children, adolescents or adults, and there is no significant difference in the symptoms or the details of the manner of treatment among patients or different ages.” Id.

21 The defendants did “not dispute that the '590 patent describes the utility of tomoxetine for treatment of ADHD, and that the utility is correctly described.” Id. Lilly had agreed “that human test data were not available at the time the patent application was filed, because human tests were prohibited without FDA authorization.” Id. One of the inventors testified “about his uncertainty whether this treatment of ADHD would be effective.” Id.

22 District court held patent was invalid for lack of utility under 35 U.S.C. § 101 –“The [district] court held that utility was not established because experimental data showing the results of treatment of ADHD were not included in the specification.” Id. at 923. –“The [district] court held that ‘[it] cannot conclude that a person of skill in the art would have recognized the method of treatment's utility in view of the specification and prior art.’” Id.

23 But, far from being patent defeating, this circumstance has been recognized by the Supreme Court as the hallmark of a nonobvious and patentable invention. United States v. Adams, 383 U.S. 39, (1966) (disbelief by experts after invention made known to them is evidence of patentability).

24 Federal Circuit reversed: –“[1] the utility of tomoxetine is accurately stated in the specification; [2] there is no allegation of falsity in the disclosed utility, and [3] the patent examiner did not require the presentation of additional data.” Eli Lilly v. Actavis, 435 Fed. Appx. at 925.

25 Clinical trials with atomoxetine for ADHD had been initiated before the patent application was filed The Manual of Patent Examining Procedure instructs examiners to give presumptive weight to the utility for which human trials have been initiated

26 “Before a drug can enter human clinical trials, the sponsor, often the applicant, must provide a convincing rationale to those especially skilled in the art (e.g., the Food and Drug Administration) that the investigation may be successful. Such a rationale would provide a basis for the sponsor's expectation that the investigation may be successful. In order to determine a protocol for phase I testing, the first phase of clinical investigation, some credible rationale of how the drug might be effective or could be effective would be necessary. Thus, as a general rule, if an applicant has initiated human clinical trials for a therapeutic product or process, Office personnel should presume that the applicant has established that the subject matter of that trial is reasonably predictive of having the asserted therapeutic utility.” MPEP § (8th ed. 2008).

27 In re ’318 litigationEli Lilly v. Actavis DrugGalantamineAtomoxetine ConditionAlzhemimer’sADHD Other viable treatmentsNoYes Dosage informationNone givenOperative recipe Status of testingAnimal testing not complete until after patent issued Human testing initiated and results obtained before patent issued Utility foundNoYes

28 “In the case of atomoxetine, however, the norepinephrine relationship was known, safety for antidepressant activity had been established, the specification contained a full description of the utility, experimental verification had been obtained before the patent was granted, and the examiner had not requested additional information. There was no evidence that the disclosure is ‘on its face, contrary to generally accepted scientific principles.’” Eli Lilly v. Actavis, 435 Fed. Appx. at 926 (internal citations omitted).

29 “As stated in Brana, 51 F.3d 1566–67: ‘Even if one skilled in the art would have reasonably questioned the asserted utility, i.e., even if the PTO met its initial burden thereby shifting the burden to the applicants to offer rebuttal evidence, applicants proffered sufficient evidence to convince one of skill in the art of the asserted utility.’” Id. at 926