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Duke University v. Sandoz, Inc.

United States District Court, D. Colorado

September 18, 2019

SANDOZ, INC., Defendant.


          Marcia S. Krieger, Senior United States District Judge.

         THIS MATTER comes before the Court pursuant to the Plaintiffs’ Motion to Bifurcate (# 42), the Defendant’s (“Sandoz”) response (# 51), and the Plaintiffs’ reply (# 64); and Sandoz’s Motion for Summary Judgment (# 47), the Plaintiffs’ response (# 68), and Sandoz’s reply (# 74).[1]


         The Court summarizes the pertinent facts here and elaborates as necessary in its analysis.

         According to the Plaintiffs’ Complaint (# 2), Plaintiff Duke University (“Duke”) is the owner of U.S. Patent No. 9,579,270 (“the ‘270 Patent”), covering “Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins.” Duke has licensed its rights under the ’270 Patent to Plaintiff Allergan Sales, LLC (“Allergan”). Allergan markets a product based on the ‘270 Patent under the brand name Latisse. Sandoz manufactures and markets its own product, a generic version of Latisse, which the Plaintiffs allege infringes on Claims 22 and 30 of the ‘270 Patent. Based on these facts, the Plaintiffs assert claims for induced and contributory patent infringement. Sandoz has asserted several counterclaims, some of which allege that the Plaintiffs have engaged in anticompetitive by filing previous patent infringement lawsuits, and another of which alleges patent misuse.[2]

         The Plaintiffs now move (# 42) to bifurcate Sandoz’s antitrust and patent misuse counterclaims from the patent infringement claims to stay this matter as to those counterclaims until the infringement issues have been resolved.

         Separately, Sandoz moves (# 47) for summary judgment on all of the Plaintiffs’ infringement claims, contending that those claims are precluded under the doctrine of collateral estoppel, arising from rulings made in prior infringement lawsuits between the parties.


         A. Motion for Summary Judgment

         To adequately address Sandoz’s collateral estoppel motion, it is necessary to discuss, in some detail, the ‘270 Patent, its predecessors, and the history preceding this litigation. The ‘270 Patent describes a method for growing hair by topically applying a chemical compound known as a prostaglandin. Prostaglandins are molecules that bind to certain receptors on cells in a living body and change how such cells function. The human body produces a variety of prostaglandins; the general type at issue here is known as prostaglandin F or PGF. Within the general category of PGF are many variants, some naturally-occurring and some synthesized. These variants are referred to as PGF analogs. Analogs differ from one another by virtue of various molecules that can attach to base structure of the prostaglandin and which change its pharmacological properties. For example, the prostaglandin is much like a charm bracelet to which different charms can be attached at different points.

         PGF analogs were the subject of research in the 1980s as a treatment for glaucoma (among other things), and by the end of the 1990s, several inventors had obtained patents covering the use of PGF analogs for glaucoma treatment. Most notably, Dr. Murray Johnstone obtained a patent for treating glaucoma via eyedrops containing a PGF analog that described using various esters, carboxylic acids, or other molecules at the “C1 location”[3] (i.e. a specific type of charm at a specific location on the charm bracelet), that caused the prostaglandin to bind with cells at a site called the FP receptor. Among the things Dr. Johnstone also noticed and reported in his patent application was that when the eyedrops came in contact with the skin of the eyelid – that is, when the drug was applied topically – some patients experienced increased growth and thickening of the eyelashes as a side effect. Shortly thereafter, Allergan had obtained a patent (“the ‘819 patent”) for a glaucoma treatment that differed from Johnstone’s, in that Allergan’s method disclosed an amide group, rather than an acid or ester, at the C1 location. The compound in the ‘819 patent is known as “bimatoprost.” The ‘819 patent did not make any mention of topical application of bimatoprost to the skin, nor did it indicate that hair growth was a possible side effect.

         Eventually, inventors realized the commercial potential of using PGF analogs to stimulate eyelash growth for cosmetic purposes. This triggered another round of patent applications specifically directed at using PGF analogs for hair growth purposes, rather than as a glaucoma treatment. Duke’s assignor obtained U.S. Patent Nos. 7,388,029 (“the ‘029 patent”) – the predecessor to the ‘270 Patent at issue here – and Allergan obtained another patent, both of which covered topical application of bimatoprost (among others) for the purpose of growing hair. On the strength of these patents, Allergan began marketing a bimatoprost solution for eyelash growth under the brand name Latisse. When several manufacturers obtained approval to market generic competitors to Latisse, Allergan filed the first of several patent infringement suits.

         In the first suit, which the parties refer to as Latisse I, Allergan sued the generic drugs’ manufacturers, including Sandoz, for infringement of various claims of the ‘029 patent. The trial court in Latisse I made numerous findings, but the one most germane to the dispute here concerned the generic manufacturers’ arguments that the combination of the then-existing teachings of Johnstone (that topical application of PGF analogs used to treat glaucoma are known to cause eyelash growth) and the ‘819 patent (that bimatoprost is type of PGF analog that can effectively be used to treat glaucoma) would have allowed a person of ordinary skill in the art to reach the conclusions of the ‘029 patent (that topical application of bimatoprost would be an effective method to stimulate eyelash growth), such that the ‘029 patent would be deemed invalid as obvious.[4] Allergan, Inc. v. Apotex, Inc., 2013 WL 286251 (M.D.N.C. Jan. 24, 2013).

         That trial court found that Johnstone and the ‘819 patent “are too limited and different from the ‘029 claims to make obvious the hair growth properties of the ‘029 compounds”. The court noted that Johnstone’s hair-growing compounds did not have an amide group at ¶ 1 like the ‘029 patent’s compounds did. It further found that the ‘819 patent, which did disclose compounds with an amide group at ¶ 1, “does not supply the missing link” because, at the time, “C1 acids were thought to be required for activity at the FP receptor [to produce hair growth], and bimatoprost has an amide rather than an acid at the C1 position.” The court stated that “bimatoprost was thought to exert activity on a receptor other than the FP receptor, and therefore was distinguishable from the Johnstone compounds.”[5] The court pointed out that there were three PGF analogs being marketed as glaucoma treatments at the time, and each of the three had different hair growth side effects, with some promoting hair growth and others inhibiting it. Thus, the court found, “a person of skill in the art would not have reason to use bimatoprost as a topical hair growth agent based on bimatoprost’s identity as a prostaglandin analog alone.” (The court also found ...

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