July 2014
A Proper Obviousness Analysis Must Consider the Entire Scope of the Claims
| Judges: Prost (author), Reyna, Chen (dissenting-in-part) |
| [Appealed from M.D.N.C., Judge Eagles] |
In Allergan, Inc. v. Apotex Inc., Nos. 13-1245, -1246, -1247, -1249 (Fed. Cir. June 10, 2014), the Federal Circuit reversed the district court’s findings with respect to validity, holding that the asserted claims of two patents directed to methods of treating hair loss were obvious and vacating the district court’s grant of an injunction.
Allergan, Inc. (“Allergan”) and Duke University (collectively “Appellees”) sued Apotex Inc., Apotex Corp., Sandoz, Inc., Hit-Tech Pharmacal Co., Inc., Actavis, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively “Appellants”) for infringement under 35 U.S.C. § 271(e)(2)(A) after Appellants submitted an ANDA to the FDA to market a generic version of Allergan’s Latisse® product. The active drug product in Latisse® is bimatoprost, a synthetic prostaglandin F-2-alpha (“PGF”) analog, which is used to promote eyelash hair growth. Appellees asserted infringement of U.S. Patent Nos. 7,388,029 (“the ’029 patent”) and 7,351,404 (“the ’404 patent”), both of which claim methods of treating hair loss using certain PGF analogs.
After a bench trial, the district court found that the asserted claims were not invalid for anticipation, obviousness, insufficient written description, or lack of enablement and, moreover, were infringed by Appellants and granted a permanent injunction. Appellants appealed.
“The district court reached its conclusion of nonobviousness by looking only at properties of the C1-amide group and, particularly, bimatoprost. In doing so, the district court erred by failing to take into account the full scope of the ’029 patent claims.” Slip op. at 16.
On appeal, the Federal Circuit reviewed the district court’s findings related to claim construction, anticipation, and obviousness. Regarding claim construction, the Federal Circuit affirmed the district court’s construction of the term “treating hair loss” in the asserted claims of the ’029 patent. The Court noted that the “specification provides an express definition for the term: ‘Treating hair loss’ includes arresting hair loss or reversing hair loss, or both, and promoting hair growth.” Slip op. at 7 (emphasis added) (citation and internal quotation marks omitted). But the Court rejected Appellants’ argument that the use of “and” required that the method must both arrest or reverse hair loss, as well as also promote hair growth. Explaining that even if the patentee’s definition contained some ambiguity, the Court nevertheless found “[m]ost compelling[]” the patent examples’ descriptions of the use of the claimed composition to, e.g., “promote hair growth.” Id. Thus, in light of the specification as a whole, the Court held that the proper construction of “treating hair loss” included a method of promoting hair growth without also arresting or reversing hair loss.
The Federal Circuit next held that the asserted claims of the ’029 and ’404 patents were not anticipated by either of two references relied on by Appellants. The Court turned first to International Patent Application No. PCT/US98/02289 (“Johnstone”), which discloses methods for stimulating hair growth using a broad genus of prostaglandin analogs. The Court noted that Johnstone was cited by the examiner during prosecution of the ’029 patent, after which the patentee filed a claim amendment to expressly exclude the compounds disclosed in Johnstone, namely, those with a double carbon bond at a particular position. The Court then held that the district court did not clearly err in finding that Johnstone’s disclosure was too sparse and ambiguous to teach compounds outside the ’029 patent claims’ proviso and, thus, did not anticipate.
The Court turned next to U.S. Patent No. 5,688,819 (“the ’819 patent”), which discloses the use of certain PGF analogs, including bimatoprost, to treat glaucoma through administering eyedrops, but does not refer to hair growth, treating hair loss, or topical application of any compound. Because the asserted claims involve topical application of a drug product, the Court framed the issue as whether “promoting hair growth through topical application of bimatoprost on the skin is necessarily present or inherent in the method of applying eyedrops containing bimatoprost.” Id. at 12. While acknowledging that inherent anticipation can be found based on a trace amount, the Court held it was not clear error for the district court to find that “it was at least possible to administer eyedrops in a way as to reduce the flow of liquid to the eye to close to zero.” Id. at 13-14. Accordingly, the Court affirmed that the ’819 patent did not anticipate the asserted claims of the ’029 and ’404 patents.
In contrast, the Federal Circuit reversed the district court’s decisions on obviousness. The Court first held that the asserted claims of the ’029 patent were obvious over Johnstone and the ’819 patent, concluding that the district court legally erred by “failing to take into account the full scope of the ’029 patent claims.” Id. at 16. According to the Court, the district court incorrectly focused on whether specific compounds containing a C1-amide group, like bimatoprost, were rendered obvious when the proper analysis should focus on whether “any compounds within the broad genus claimed by the ’029 patent, including those that did not have the C1-amide groups, were obvious at the time of the invention.” Id. at 17. The Court noted that the district court’s reasoning was especially problematic because it relied on the variant receptor-binding characteristics of PGF analogs with a C1-amide group without explaining how this finding necessarily applied to the reasonable expectation of success for the full scope of the compounds claimed.
The Court next concluded that the district court compounded its error by not giving proper weight to the full disclosure of the prior art. The Court held that while Johnstone did not “clearly and unequivocally disclose” the full scope of the ’029 patent claims for anticipation purposes, it did, however, “suggest” it. Id. at 19. Moreover, the Court explained, Johnstone’s disclosure of an alternative preference did not teach away from the broad scope of the ’029 patent. As the Court reasoned, “following Johnstone, there was nothing left for a chemist to do” because Johnstone taught a new utility (hair growth) for compounds that had been characterized in the ’819 patent. Id. at 20-21.
The Court also rejected the district court’s conclusion that any difference in the chemical activity of PGF analogs was sufficient to teach away from the claimed invention because hair growth is generally an “unpredictable and mysterious” art. Id. at 21. The Court explained that once Johnstone taught that PGF analogs could be used to grow hair, “the correct question . . . was whether there was anything ‘unpredictable and mysterious’ about a PGF analog that could treat glaucoma growing hair.” Id. And, according to the Court, “[w]hile success in employing the disclosed compounds to treat hair loss may not have been guaranteed, Johnstone’s teaching provided sufficient guidance as to what parameters would lead to a reasonable expectation of success.” Id. at 22.
The Federal Circuit next held that the ’404 patent was obvious over Johnstone and four publications (“the Brandt references”) alleged by Appellants to disclose bimatoprost’s ability to promote eyelash hair growth. As a preliminary question, the Court analyzed whether the Brandt references qualified as potentially invalidating prior art. Regarding the two earlier Brandt references, the Court concluded that, while they were undisputedly prior art under 35 U.S.C. § 102(b), these references did not expressly refer to bimatoprost and, thus, one of ordinary skill in the art would be unaware that the results were associated with bimatoprost.
Turning to the two later-published and “more fulsome” Brandt references, the Federal Circuit held that these references qualified as prior art under 35 U.S.C. § 102(a) as they (1) were published before the invention date of the ’404 patent and (2) did not represent the work of the inventors. Id. at 25-26. Regarding the invention date, the Court concluded that the district court improperly found corroboration for an earlier priority date of the ’404 patent’s invention of topical application to promote eyelash growth. The Court held that this was clear error because the documentary evidence did not relate to the claimed invention, and the only corroborating evidence was the oral testimony of a coinventor, which the Court “must treat with skepticism.” Id. at 27-28. Regarding the Brandt references being the inventors’ own work, the Court held that, even if Appellees had not waived the argument by presenting it first in closing arguments and post-trial briefing, Appellees had not produced any evidence that the inventors were responsible for directing the work described in the references.
Finally, the Federal Circuit held that, when combined with Johnstone, the two later-published Brandt references rendered the ’404 patent obvious. Noting that the district court’s decision was limited to reciting that the Brandt references were not prior art, the Court nevertheless concluded that, in light of Johnstone’s disclosure of topical application of a PGF analog to treat hair loss and the Brandt references’ disclosure of bimatoprost’s effect in growing eyelash hair in nearly 50% of patients, a person of ordinary skill in the art would have a substantial motivation to use topical application of bimatoprost to grow eyelash hair with a reasonable expectation of success. Thus, according to the Court, a remand was not necessary given the overwhelming weight of the evidence.
Judge Chen dissented from the majority’s analysis of obviousness relating to the ’029 patent. In Judge Chen’s view, in light of the presumption of validity, Johnstone’s teachings are simply too vague and equivocal to justify invalidating the ’029 patent. Judge Chen noted that, “[i]n light of the particularly heavy burden to show obviousness over a reference disclosed during prosecution and discussed by the examiner, Appellants have not shown that Johnstone now somehow teaches or suggests the very structural feature that the patentee claimed to distinguish the Johnstone compounds.” Chen Dissent at 4. Judge Chen also disagreed with the majority’s combination of Johnstone with the ’819 patent, which concerns treatment methods for glaucoma. According to Judge Chen, Appellants failed to establish by clear and convincing evidence that a person of ordinary skill in the art would look to the ’819 patent for solutions in the hair growth field. Accordingly, Judge Chen would have held that the ’029 patent claims were not rendered obvious by Johnstone and the ’819 patent.
