By Peter Reap, J.D., LL.M.
The Patent Trial and Appeal Board erred in finding that all claims of a patent claiming a method of "arresting or regressing" a condition known as penile fibrosis, owned by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center ("LAB"), unpatentable as obvious, the U.S. Court of Appeals for the Federal Circuit has decided. The obviousness finding of the PTAB was based on the Board’s incorrect construction of two claim limitations and the dispute between LAB and erectile dysfunction drugmaker Eli Lilly and Company ("Lilly"), IPR2014-00752, was remanded to the Board (Los Angeles Biomedical Institute at Harbor-UCLA Medical Center v. Eli Lilly and Company, February 28, 2017, Bryson, W.). Decided together with this case, but in a separate opinion, the Federal Circuit considered Lilly’s appeal of another inter partes review decision made by the Board, IPR2014-00693, in which Lilly had argued that all of the claims of the same patent were unpatentable as anticipated. The Board’s ruling that the claims were not anticipated was affirmed because substantial evidence supported the lack of anticipation, the Federal Circuit held (Eli Lilly and Company v. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, February 28, 2017, Bryson, W.).
LAB’s U.S. Patent No. 8,133,903 ("the ’903 patent") claims a method of "arresting or regressing" a condition known as penile fibrosis. The method entails the long-term, daily administration of drugs known as type 5 phosphodiesterase ("PDE5") inhibitors. The drugs function by inhibiting the enzymatic action of PDE5, which is found in the human penis. Penile fibrosis is characterized by the buildup of excess collagen. It includes two conditions: penile tunical fibrosis, which results from the buildup of excess collagen in the tunica albuginea, and corporal tissue fibrosis, which results from a buildup of excess collagen in the corpora cavernosa. The two fibrotic conditions can cause erectile dysfunction, although they do not always do so.
In 2013, LAB filed an infringement action against Lilly, alleging that Lilly’s marketing of the drug Cialis induced infringement of the ’903 patent. Lilly subsequently filed multiple petitions requesting that the PTAB conduct inter partes review of the ’903 patent. In this appeal, the Board instituted inter partes review on the petition in which Lilly contended that all the claims of the ’903 patent were unpatentable as obvious in light of three references. The cited references were: Francesco Montorsi et al., The Ageing Male and Erectile Dysfunction, 20 World J. Urology 28-53 (2002) ("Montorsi"); International Patent Application No. WO 01/80860 (published Nov. 1, 2001) (John S. Whitaker et al., applicants) ("Whitaker"); and Hartmut Porst et al., Daily IC351 Treatment of ED, 12 Int’l J. Impotence Research (Supp. 3) S76, B13 (2000) ("Porst").
The ’903 patent claims priority from Provisional Application No. 60/420,281, which was filed on October 22, 2002. The Board rejected LAB’s argument for the earlier priority date and determined that the specification of the provisional application did not disclose the dosage limitation of "up to 1.5 mg/kg/day."
The Board ultimately concluded that the combination of references satisfies each of the limitations of the ’903 patent, as construed, and that the combination provides a reasonable expectation of success in treating erectile dysfunction. On appeal, LAB argued that the Board erred: (1) in denying LAB’s claim of priority to the October 2002 filing date of the inventors’ provisional application; (2) in construing the three disputed claim terms; (3) in deciding that claim 1 of the ’903 patent would have been obvious based on incorrect claim constructions; and (4) by failing to adequately consider the prevailing beliefs in the field and the unexpected results achieved by the inventors.
Priority. In order for a patent to be entitled to priority based on an earlier application or chain of applications, each previous application in the chain must comply with the written description requirement of 35 U.S.C. § 112(a), the court noted. The ’903 patent is not entitled to the priority date of the provisional application because of a lack of adequate written description, according to the Federal Circuit. Because proof of priority requires written description disclosure in the parent application, not simply information and inferences drawn from uncited references, the Board correctly held that LAB’s expert’s calculation did not satisfy the requirements for priority and that the ’903 patent was therefore not entitled to the October 2002 priority date of the provisional application.
Claim construction—term 1. The broadest reasonable interpretation of the phrase "an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis" is its plain meaning: an individual with penile tunical fibrosis and/or corporal tissue fibrosis, the appellate court said. The Board’s construction ("an individual hav[ing] symptoms that may be associated with penile fibrosis, such as [erectile dysfunction], but not that the patient be specifically diagnosed as having penile tunical fibrosis or corporal tissue fibrosis") reads that limitation out of the claim. That is because erectile dysfunction can have causes other than penile fibrosis, and because penile fibrosis does not necessarily result in erectile dysfunction, the appellate court explained.
The Board’s construction would make the patent claims applicable to individuals with erectile dysfunction not caused by penile fibrosis. The Board’s construction was therefore not the broadest reasonable interpretation of the disputed claim language; rather, it was overly broad. Given the relationship between erectile dysfunction and penile fibrosis, it was unreasonable to use the symptom of erectile dysfunction as a proxy for penile fibrosis.
Claim construction—term 2. The limitation "arresting or regressing the at least one of the penile tunical fibrosis and corporal tissue fibrosis" requires halting the progression of, or reversing, penile fibrosis. Lilly contended that the phrase "arresting or regressing the [penile fibrosis]" has no patentable weight. However, the phrase is more than a statement of the intended result of administering the PDE5 inhibitor within the dosage limits, with the frequency, and for at least the minimum period prescribed in the patent, the Federal Circuit concluded.
Because the ’903 patent claims specify only a maximum dosage level and a minimum treatment period, it is different from cases in which the claims contain express dosage amounts as material claim limitations, and in which efficacy is inherent in carrying out the claim steps. Therefore, "arresting or regressing" the fibrosis adds an efficacy requirement that is not otherwise found in the claim language, the court held.
Claim construction—term 3. Claim 1 of the ’903 patent contains a limitation providing for a "continuous long-term regimen" in addition to the limitation providing for administering a PDE5 inhibitor in an amount "up to 1.5 mg/kg/day for not less than 45 days." The 45-day requirement makes clear that the "continuous long-term regimen" must be at least 45 days in length. LAB argues that the term "continuous long-term regimen" adds a requirement that the drug concentration in the patient’s body attain a "constant level," i.e., maintain a "steady state" plasma concentration. The Federal Circuit rejected this argument. The patent never mentions the "steady state" of a drug or other agent, it noted.
Obviousness. LAB contended that the Board’s findings were insufficient to establish obviousness under the correct constructions of "an individual with at least one of a penile tunical fibrosis and corporal tissue fibrosis" and "arresting or regressing the at least one of a penile tunical fibrosis and corporal tissue fibrosis." The Federal Circuit agreed.
The Board concluded that the references on which it relied rendered obvious the treatment of erectile dysfunction via the claimed method, but it did not determine whether those references showed that it would have been obvious to use long-term continuous treatment with a PDE5 inhibitor to treat individuals with penile fibrosis and to achieve the arrest or regression of that condition.
Because the Board’s obviousness analysis was based on an erroneous construction of the claim language and an overly broad interpretation of Whitaker, and because the Board did not address certain record evidence, the case was remanded for the Board to make new findings as to whether there was an apparent reason to combine the prior art references and whether that combination would have rendered obvious the long-term administration of PDE5 inhibitors to treat penile fibrosis.
The Board also made no findings as to whether any reference or combination of references rendered obvious the claim limitation "arresting or regressing the at least one of a penile tunical fibrosis and corporal tissue fibrosis," because the Board erroneously concluded that arresting or regressing fibrosis is an inherent effect of any regimen exceeding 45 days regardless of the dosage, the appellate court noted. On remand, the Board should make the findings necessary to determine whether the references render the "arresting or regressing" limitation obvious.
The Board’s order was vacated, and the case remanded.
In this separate, related case, at the behest of Lilly, the PTAB instituted inter partes review of the claims of the ’903 patent for anticipation by Whitaker. Following trial, the Board held that Whitaker did not anticipate the ’903 claims because it did not disclose the limitation requiring the administration of a PDE5 inhibitor "at a dosage up to 1.5 mg/kg/day for not less than 45 days."
Lilly’s argument on appeal amounted to saying that Whitaker’s definition of "chronic administration" anticipates daily administration for 45 days or more because a person of skill would understand that erectile dysfunction (in the absence of therapy) can last longer than 45 days, the court observed. As the Board stated, however, that, "at best, is an obviousness argument." Whitaker’s definition of "chronic administration," which is "regular administration for an extended period, preferably daily for three or more days, and still more preferably daily as long as the patient suffers from erectile dysfunction (in the absence of therapy)," does not expressly teach daily treatment for at least 45 days, the court held.
Whitaker may "suggest" long-term daily treatment by noting the beneficial effects of daily treatment, but that is not enough. To anticipate, a reference must do more than "suggest" the claimed subject matter. Thus, substantial evidence supported the Board’s finding that Whitaker does not disclose the claimed treatment regimen with sufficient clarity to satisfy the demanding standard for anticipation, the court ruled.
Attorneys: Mark J. Feldstein (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP) for Eli Lilly and Company. Ewa M. Davison (Fenwick & West LLP) for Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center.
Companies: Eli Lilly and Company; Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
MainStory: TopStory Patent FedCirNews
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