Allergan, Inc. v. Apotex, Inc. (Fed. Cir.)

by Robins Kaplan LLP

Case Name: Allergan, Inc. v. Apotex, Inc., No. 2013-1245, -1246, -1247, 2014 U.S. App. LEXIS 10710 (Fed. Cir. June 10, 2014) (Circuit Judges Prost, Reyna and Chen presiding; Opinion by Prost, C.J.; Dissent-in-part by Chen, J.) (Appeal from M.D.N.C., Eagles, J.)

Drug Product and Patent(s)-in-Suit: Latisse® (bimatoprost ophthalmic solution); U.S. Patents Nos. 7,388,029 (“the ’029 patent”) and 7,351,404 (“the ’404 patent”)

Nature of the Case and Issue(s) Presented: By the mid-1980s, it was established that naturally occurring prostaglandin analogues (PGF) could alleviate intraocular pressure (IOP), which is associated with the eye disease glaucoma. Bimatoprost is a PGF that received FDA approval in 2001—and marketed as Lumigan®--as an eye drop to treat glaucoma. Hair loss treatment was another area in which certain PGFs proved useful. One such PGF, latanoprost, also received FDA approval for use in glaucoma treatment. The formulator that studied latanoprost, Dr. Johnstone, filed a patent application on the use of latanoprost and other PGFs to promote hair growth in February 1997.

Defendants appeal from a final judgment of the district court finding the patents-in-suit valid and infringed. The Federal Circuit reversed the district court’s findings with respect to the validity of each patent.

Why Defendants Prevailed: The issue of infringement hinged on the district court’s construction of the claim term “treating hair loss” in the ‘’029 patent. All parties, as well as the district court, agreed 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.” Defendants argue that use of “and” in the lexicographic definition provides that the method for treating hair loss must both arrest or reverse hair loss, as well as also promote hair growth. Under that view, defendants’ generic Latisse would not infringe because Latisse only promotes hair growth. The district court agreed with Allergan that the use of the word “includes” in the lexicographic definition plainly means that the patentee intended to define treating hair loss to include the possibility of one or all of arresting hair loss, reversing hair loss, or promoting hair growth. This is evidenced by the various examples in the patent that illustrate all three types of treatment. Because there is nothing in either the specification or the claims suggesting that the patentee would have excluded these examples from the scope of the claimed methods, the Federal Circuit affirmed the district court’s construction and finding of infringement.

Next, defendants assert that the ’029 patent is invalid as anticipated by (i) Dr. Johnstone’s patent publication concerning the use of latanoprost to promote hair growth; and (ii) an earlier Allergan patent on the use of bimatoprost  to treat glaucoma. The Federal Circuit did not agree because the Johnstone application expressly discloses PGF structures in which the alpha chain includes a double bond. The ’029 claims expressly exclude such a structure. With respect to Allergan’s prior-art patent, it did not refer to hair growth or treating hair loss, nor did it disclose topical application of any compounds. At issue, therefore, was 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. Because the district court’s findings—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 and there was no express teaching in the prior-art patent that described how fluid from the eye drop could transfer to the skin—were not clearly erroneous, the Federal Circuit affirmed.

The district court had found that the ’029 patent was not obvious because there was no motivation to combine the Johnstone application with Allergan’s prior-art patent due to “pharmacological differences” between the compounds that each reference discloses. Here, the Federal Circuit disagreed. “The district court reached its conclusions of non-obviousness 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.” The Federal Circuit also said that the district court took an “overly cramped view” of what the prior art taught and found that the Johnstone application did suggest the possibility of using a PGS structure that would include a single bond, merely without adequate explanation within the reference itself. The Federal Circuit further found that the district court’s findings on secondary considerations “suffer from the same infirmity of lacking a nexus with the scope of the ’029 patent’s claimed invention.” The finding of non-obviousness was therefore reversed.

The ’404 patent obviousness analysis concerned four references known as the Brandt references, and whether they would render the ’404 patent obvious in light of the Johnstone application. The Brandt references were published clinical trials that allegedly disclose the ability of bimatoprost to promote eyelash hair growth. The first two Brandt references are indisputably prior art. Those references do not, however, expressly refer to bimatoprost. With respect to the other two Brandt references, the district court found that the ’404 patent was invented prior to their publication date and therefore, those references were not prior art. The Federal Circuit reversed the district court’s finding that the ‘’404 patent pre-dated any of the Brandt references. It held that the district court committed clear error in finding corroboration of an earlier priority date in documents that collectively did not include any description of the claimed invention of the ’404 patent, and in relying on corroborating evidence of conception from the self-serving oral testimony of a co-inventor. In light of the Brandt references’ disclosure of bimatoprost’s effect in growing eyelash hair, a skilled artisan would have had substantial motivation to follow Johnstone’s application and use topical application of bimatoprost to grow eyelash hair. The asserted claims of the ’404 patent were therefore also obvious.

In partial dissent, Judge Chen would not have found the ’029 patent obvious by the Johnstone application, either alone or in combination with the Allergan prior-art patent. In his view, “Johnstone’s teaching are simply too vague and equivocal to justify invalidating the patent.” Judge Chen stressed the presumption of validity of an issued patent and also noted that the Patent Office considered the Johnstone application during the prosecution of the ’029 patent application and found that it did not render the claims obvious.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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