CAFC sides with L.A. Biomedical Research over Eli Lilly in two IPRs challenging penile fibrosis patent

EDITORIAL NOTE: Reported below are two separate cases decided by the Federal Circuit between L.A. Biomedical Research Inst. at Harbor-UCLA Med. Ctr. and Eli Lilly & Co. While the decisions relate to the same patent they are appeals taken from different IPR proceedings. The first decision relates to IPR2014-00752, challenging claims 1-5 of U.S. Patent No. 8,133,903 (‘903 patent) as being obvious. The second decision relates to IPR2014-00693, challenging claims  1-5 of ‘903 patent as being anticipated.

CAFC says PTAB incorrectly invalidated patent as obvious

L.A. Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., No. 2016-1518, 2017 U.S. App. LEXIS 3582 (Fed. Cir. Feb. 28, 2017) (Before Newman, Bryson, and Moore, J.) (Opinion for the court, Bryson, J.) (Opinion concurring in part, dissenting from the judgment filed by Newman, J.).

A divided panel of the Federal Circuit held that the Patent Trial and Appeal Board (“Board”) incorrectly invalidated as obvious all claims of a patent owned by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (“LAB”) and remanded for further proceedings.

LAB’s patent claims a method of “arresting or regressing” a condition known as penile fibrosis, which results in a buildup of excess collagen in the penis. This condition can cause erectile dysfunction but does not always do so, and several conditions other than penile fibrosis can also cause erectile dysfunction. LAB’s claimed method recites long-term, daily administration of a drug known as PDE5, which, at the time of filing, was commonly used for the on-demand treatment of erectile dysfunction in drugs such as Viagra and Cialis.

LAB sued Eli Lilly & Company (“Eli Lilly”), alleging Eli Lilly’s marketing of the drug Cialis induced infringement of LAB’s patent. Eli Lilly subsequently requested that the Board conduct inter partes review of the patent. The Board agreed to do so and ultimately found the patent to be obvious in light of three prior art references.

On appeal, LAB challenged the Board’s denial of LAB’s claim of priority to the filing of a provisional application, the Board’s construction of three claim limitations, the Board’s finding of obviousness based upon these claim constructions, and the Board’s failure to adequately consider LAB’s arguments of unexpected results achieved by the inventors.

The Court upheld the Board’s denial of LAB’s claim of priority to the provisional application’s filing date, agreeing with the Board that the provisional application lacks adequate written description to support the dosage level claimed by the patent.

The Court then found the Board’s construction of certain claim terms to be overly broad, stating the Board’s construction “would make the patent claims applicable to individuals with erectile dysfunction not caused by penile fibrosis.” The Court also found that the Board improperly dismissed LAB’s argument that “a person of skill in the art would not have been motivated to combine the references to treat individuals with fibrosis-related erectile dysfunction because, according to LAB, the results would have been expected to be detrimental.”

Because the Board’s obviousness determination relied on an erroneous claim construction and because the Board failed to make factual findings as to whether there was motivation to combine the prior art references to treat penile fibrosis and whether a person of ordinary skill in the art would have had a reasonable expectation of success from such a combination, the Court vacated the Board’s decision and remanded to the Board for further determination.

Judge Newman concurred in part and dissented from the judgment, and would have instead affirmed the Board’s decision. Judge Newman found that it was known prior to filing that penile fibrosis is a cause of erectile dysfunction and that erectile dysfunction is relieved by treatment with PDE5 inhibitors. Judge Newman stated that even though other conditions are known to cause erectile dysfunction, the evidence showed that “when penile fibrosis was present it was affected by the PDE-5 inhibitors, [and] the Board found that this effect was inherent in the use of these products to treat erectile dysfunction.” Quoting Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999), Judge Newman explained that “‘if granting patent protection on the disputed claim would allow the patentee to exclude the public from practicing the prior art, then that claim is anticipated, regardless of whether it also covers subject matter not in the prior art.’”

A broadest reasonable interpretation of claim scope should not encompass treatments that eliminate a specifically claimed condition or patient population. Likewise, a motivation to combine references could not arise from a too-broad claim construction, and when negative teachings are dismissed without proper factual findings.

Unanimous panel upholds PTAB, prior art did not anticipate

Eli Lilly & Co. v. L.A. Biomedical Research Inst. at Harbor-UCLA Med. Ctr., No. 2016-1547, 2017 U.S. App. LEXIS 3581 (Fed. Cir. Feb. 28, 2017) (Before Newman, Bryson, and Moore, J.) (Opinion for the court, Bryson, J.).

A unanimous panel of the Federal Circuit upheld the Patent Trial and Appeal Board’s (“Board”) holding that the prior art failed to anticipate a patent owned by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (“LAB”).

LAB’s patent claims a method of “arresting or regressing” a condition known as penile fibrosis, which results in a buildup of excess collagen in the penis. This condition can cause erectile dysfunction but does not always do so. LAB’s claimed method recites long-term, daily administration of a drug known as PDE5, which, at the time of filing, was commonly used for the on-demand treatment of erectile dysfunction in drugs such as Viagra and Cialis.

LAB sued Eli Lilly & Company (“Eli Lilly”), alleging Eli Lilly’s marketing of the drug Cialis induced infringement of LAB’s patent. Eli Lilly subsequently requested that the Board conduct inter partes review of the patent. The Board agreed to do so and found that the patent was not anticipated because the prior art failed to disclose the dosage amount and dosage duration claimed in LAB’s patent. (The Board did find the patent to be obvious in light of three prior art references, which LAB appealed in a related case, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly & Co., No. 2017-1518, 2017 U.S. App. LEXIS 3582 (Fed. Cir. Feb. 28, 2017).)

On appeal, the Court agreed with the Board that Eli Lilly’s argument “‘at best, [wa]s an obviousness argument,’” as it relied heavily on the understanding of a person of skill at the time, and various assumptions that a person of skill would make, regarding how long a patient would suffer from erectile dysfunction in the absence of therapy. The Court additionally noted that Eli Lilly’s argument said “nothing about how long erectile dysfunction would last with the . . . chronic treatment with PDE5 inhibitors, rather than on-demand use.” (emphasis in opinion).

The Court held that “[t]o anticipate, a reference must do more than ‘suggest’ the claimed subject matter,” and thus substantial evidence supports the Board’s finding that the prior art does not anticipate LAB’s patent.

Practitioners should ensure that a reference relied on for an anticipation argument expressly discloses each limitation of the claim at issue. As the Court stated, a mere suggestion of the claimed subject matter is not enough.

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