Allergan, Inc. v. Apotex, Inc.

Patents-in-suit relating to the “unpredictable and mysterious” art of hair growth were infringed and enforceable.

April 16, 2013

GENERICally Speaking

Case Name: Allergan, Inc. v. Apotex, Inc., Civ. No. 1:10-cv-681, 2013 U.S. Dist. LEXIS 13987 (M.D.N.C. Jan. 24, 2013) (Eagles, J.)

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

Nature of the Case and Issue(s) Presented: Scientists have been researching hair growth agents for decades with little success, and the field of hair growth biology is unpredictable. Bimatoprost was identified in the early 1990s during research on prostaglandins in connection with efforts to develop drugs to treat osteoporosis. Scientists at Allergan studied bimatoprost but for the purpose of developing a new glaucoma treatment. During those clinical trials, scientists observed a significant number of reports of the adverse effect of eyelash growth. The ’029 patent claims a method of treating hair loss by repeatedly administering to a mammal certain compounds systemically or topically. The ’404 patent claims a method of stimulating eyelash growth by applying an effective amount of bimatoprost.

Allergan holds the NDA for Latisse. Defendants sought to make and sell generic versions of the drug by filing ANDAs containing paragraph IV notices as against both patents. Allergan filed suit claiming patent infringement. Defendants counterclaimed seeking a declaratory judgment that the patents were invalid on the basis of anticipation, obviousness and failure to meet the statutory conditions set out in 35 U.S.C. § 112. The Court found that the patents were infringed, valid, and enforceable.

Why Allergan Prevailed:  Defendants conceded that their products consisted of .03% bimatoprost, and their proposed labels instruct patients to apply their products in order to promote hair growth by increasing lash length, thickness, and darkness. Moreover, defendants’ products are the material part of the patented invention, and they have no substantial non-infringing use. Defendants also knew of the potential for infringement of the patents when they filed their ANDAs. In light of this, the Court found that Defendants’ ANDA products would induce infringement and be liable for contributory infringement.

With regard to anticipation, Defendants contend that either of the Johnstone PCT or the ’819 prior art patent anticipate the ’029 patent. The Johnstone PCT, like the ’029 patent, teaches the use of prostaglandins as hair growth agents. However, the Johnstone PCT lacks motivation to modify the prostaglandins taught therein in order to obtain the prostaglandins claimed in the ’029 patent. In particular, the prostaglandin in the Johnstone PCT consists of an alpha chain that is unsaturated and does not “clearly and unequivocally disclose” the use of saturated prostaglandin F compounds, as required by the ’029 patent. The ’819 prior art patent claims the application of compounds, including bimatoprost, to the eye to treat glaucoma. Defendants concede that the ’819 patent does not disclose hair growth or the application of bimatoprost to the skin, but they argue that it inherently anticipates the ’029 patent. This argument was rejected because there was no evidence in the prior art patent that bimatoprost necessarily grew eyelashes. “The mere fact that bimatoprost, when applied through an eye drop, may contact the skin and cause eyelash growth does not mean that such an effective application is inherent in the ’819 patent.”

Defendants further contended that the ’404 patent was anticipated in view of various presentations to Brandt, the ’029 patent, and the ’819 patent. The ’404 patent inventors were able to date their conception back behind the filing date of their patent application based on corroborating evidence regarding the same. As such, the Brandt presentations were no longer considered prior art for purposes of anticipation. As noted above, the ’819 patent was not an anticipatory reference because it did not inherently teach the application of an effective amount of bimatoprost to stimulate eyelash growth. This left the Defendants’ contention that the ’029 patent anticipated the ’404 patent because it is a small genus of which a person of ordinary skill in the art would at once envisage the species—the ’404 patent. The Court disagreed, “The ’029 patent expressly depicts the structures of approximately one hundred compounds, yet it does not expressly depict or describe the structure of bimatoprost.”

Turning to obviousness, Defendants contended that the Johnstone PCT’s teaching that glaucoma drugs grow hair would have motivated a person of ordinary skill to test the ’819 patent’s glaucoma drugs for effectiveness in hair growth. The Johnstone PCT and the ’819 patent, however, were too limited and too different from the ’029 claims to make obvious the hair growth properties of the ’029 compounds to a person of ordinary skill in the art. Although the ’819 patent discloses bimatoprost as a glaucoma drug, it does not supply the missing link that Defendants seek; namely, the motivation to use bimatoprost to grow hair. The reason being that it was understood to be pharmacologically different than other prostaglandin analogs. The court further found that “these pharmacological differences are especially significant in the hair growth field,” which was considered “unpredictable and mysterious.” For the same reasons, the prior art did not render the ’404 patent obvious.

The Court denied Defendants’ Section 112 defenses. Defendants contended that the ’029 filed to meet the written description required because the specification did not support the claimed provisos concerning the molecular and substituent structure of the claimed compounds. According to the Court, there was adequate support in the specification for those provisos. The court also found that both patents were enabled. The ’029 patent was enabled because it provided sufficient information for a person of ordinary skill to make and use the compounds without undue experimentation; namely, the patent taught how to chemically synthesize the prostaglandin F analogs claimed in the patent and also described a telogen conversion assay used to determine if a compound could treat hair loss. Finally, because Defendants did not mention any contention that the ’404 patent was invalid for lack of enablement, any argument to that effect had been waived.

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