Allergan, Inc. v. Apotex Inc.

754 F.3d 952

ALLERGAN, INC., and Duke University, Plaintiffs–Appellees,

v.APOTEX INC., Apotex Corp., Sandoz, Inc., and Hi–Tech Pharmacal Co., Inc., Defendants–Appellants.

Allergan, Inc., and Duke University, Plaintiffs–Appellees,

v.Watson Pharmaceuticals, Inc., now known as Actavis, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc., Defendants–Appellants.

Nos. 2013–1245, 2013–1246, 2013–1247, 2013–1249.

United States Court of Appeals, Federal Circuit.

June 10, 2014.

Rehearing and Rehearing En Banc Denied Sept. 12, 2014.

Jonathan E. Singer, Fish & Richardson P.C., of Minneapolis, MN, argued for plaintiffs-appellees. With him on the brief were Deanna J. Reichel; and Juanita R. Brooks, of San Diego, CA. Of counsel was Jeffrey T. Thomas, Gibson, Dunn & Crutcher, LLP, of Irvine, CA.

Deanne M. Mazzochi, Rakoczy Molino Mazzochi Siwik LLP, of Chicago, IL, argued for defendants-appellants Apotex Inc., et al. With her on the brief were William A. Rakoczy, Paul J. Molino, and Andrew M. Alul, for Apotex Inc., et al; Meredith Martin Addy, Thomas Filarski, and Brandon C. Helms, Steptoe & Johnson LLP, of Chicago, IL, for Sandoz Inc.; Steven Roth, Hi–Tech Pharmacal Co., Inc., of Amityville, NY, and Thomas J. Vetter, Lucas & Mercanti, LLP, of New York, NY, for Hi–Tech Pharmacal Co., Inc.; and Gary E. Hood, Robyn H. Ast and Mark T. Deming, Polsinelli PC, of Chicago, IL for Watson Pharmaceuticals, Inc., et al. Of counsel were Luke T. Shannon and Harven V. Deshield, Rakoczy Molino Mazzochi Siwik LLP, of Chicago, IL.

Before PROST,^* Chief Judge, REYNA and CHEN, Circuit Judges.

Opinion for the court filed by Chief Judge PROST. Opinion dissenting in part filed by Circuit Judge CHEN.

PROST, Chief Judge.

Apotex Inc., Apotex Corp., Sandoz, Inc., Hit–Tech Pharmacal Co., Inc., Actavis, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively “appellants”) appeal from a final judgment of the U.S. District Court for the Middle District of North Carolina finding that appellants had infringed claims of U.S. Patent Nos. 7,388,029 (“'029 patent”) and 7,351,404 (“'404 patent”) and had failed to establish they were invalid. For the reasons stated below, we reverse the district court's findings with respect to the validity of each patent.

Background

Plaintiff-appellee Allergan, Inc. (“Allergan”) has U.S. Food and Drug Administration (FDA) approval to sell Latisse®, a 0.03% bimatoprost ophthalmic solution, as a topical solution to treat hypotrichosis (i.e., hair loss or reduction) of the eyelashes by stimulating hair growth.

Bimatoprost is a synthetic prostaglandin F–2–alpha (“PGF”) analog. Prostaglandins are naturally occurring molecules that bind to receptors on the surface of cells. When prostaglandins bind to a cell's receptors, they generate signals that change the way that the cell functions, for example, by controlling cell growth. Because of the ability of prostaglandins to control cell properties, they are significant targets for pharmaceutical research in a variety of areas. PGF is a particular type of prostaglandin that binds with the FP receptor.

The chemical structure of naturally occurring PGF is illustrated below:

IMAGE

The structure includes a “cyclopentane ring” of carbon atoms, which is illustrated above as the pentagonal structure at the left of the diagram. Two chains of atoms are attached to the ring. The top chain is called the “alpha chain,” and the chain below it is called the “omega chain.”

By the mid–1980s, it was established that naturally occurring PGF could alleviate intraocular pressure (IOP), which is associated with the eye disease glaucoma. To develop an effective treatment and minimize side effects, scientists worked on synthesizing and testing more selective derivatives and analogs of PGF. A particular kind of PGF analog, 17–phenyl PGF analogs, proved to be particularly useful in the treatment of glaucoma. Bimatoprost is one such synthetic 17–phenyl PGF analog, which emerged in the course of research by Allergan scientists. In 2001, Allergan received FDA approval to sell Lumigan®, a 0.03% bimatoprost ophthalmic solution—identical to Latisse®—as an eyedrop to treat glaucoma, which it continues to market.

Hair loss treatment was another area in which certain PGF analogs proved useful. In the 1990s, Dr. Murray Johnstone performed studies on latanoprost, another kind of 17–phenyl analog. Latanoprost optical solution also received FDA approval for use in glaucoma treatment, and it continues to be marketed as Xalatan®. Dr. Johnstone observed that in the course of treating glaucoma patients with latanoprost eyedrops, a substantial fraction of them grew much longer and denser eyelash hair. Dr. Johnstone filed a patent application on the use of latanoprost and other 17–phenyl PGF analogs to promote hair growth in February 1997.

The work that led to the '029 patent, the first of the two patents asserted by appellees in this case, was conducted by researchers at Proctor & Gamble led by Dr. Mitchell DeLong. Dr. DeLong and his team studied the effects of a wide range of prostaglandin compounds in mice. In the course of their studies they observed that administration of PGF compounds that were selective for the FP receptor resulted in growth of longer and thicker hair. On March 21, 2000, Dr. DeLong and others filed a provisional patent application on the topical application of compounds that bind the FP receptors to treat hair loss. The '029 patent claims priority to this provisional application. During prosecution, in 2003, the parent application of the '029 patent was assigned to Duke University, and the patent issued on June 17, 2008.

The second patent asserted by appellees in this suit is the '404 patent, which is assigned to Allergan. The '404 patent arises from observations made during the clinical trials for Lumigan®. As had been observed for latanoprost, glaucoma patients treated with bimatoprost eyedrops spontaneously grew longer and thicker eyelash hair. See '404 patent col.11 ll.5–62. The '404 patent covers the treatment of eyelash hair loss through topical application of bimatoprost, and it claims priority to a provisional application filed on February 4, 2002.

Allergan and Duke University (collectively “appellees”) sued each of the appellants under 35 U.S.C. § 271(e)(2)(A) after they submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking to market a generic version of Allergan's Latisse® product. Appellees asserted claims 1, 8, 14, 18, and 20 of the '029 patent and claim 14 of the '404 patent. After a bench trial in the consolidated Hatch–Waxman action, the district court held, inter alia, that the asserted claims of the '029 and '404 patents are not invalid for anticipation, obviousness, insufficient written description, or lack of enablement, and, moreover, that appellants infringed. Allergan, Inc. v. Apotex, Inc., Nos. 1:10–CV–681, 1:11–CV–298, 1:11–CV–650, 2013 WL 286251, at *1 (M.D.N.C. Jan. 24, 2013). The district court subsequently enjoined appellants, along with any persons or entities who are in privity with appellants or to whom appellants transfer the ANDA, from commercial manufacture, use, offer to sell and/or sale of the proposed products until the latest of the expiration dates of the '029 and '404 patents. Allergan, Inc. v. Apotex, Inc., No. 1:10–CV–681 Permanent Inj. and Final J. 2–3, ECF No. 231.

This appeal followed, in which appellees raise issues of claim construction for the '029 patent, as well as the invalidity of the asserted claims of the '029 and '404 patents. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

Discussion

I. Claim Construction

Claim construction is an issue of law that we review de novo. Lighting Ballast Control LLC v. Philips Elecs. N. Am. Corp., 744 F.3d 1272, 1276–77, (Fed.Cir.2014) (en banc); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454–55 (Fed.Cir.1998) (en banc). In construing a claim term, we look at the term's plain and ordinary meaning as understood by a person of ordinary skill in the art. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed.Cir.2005) (en banc). There is an exception to this general rule when a patentee sets out a definition and acts as her own lexicographer. Thorner v. Sony Computer Entm't Am., LLC, 669 F.3d 1362, 1365 (Fed.Cir.2012).

Appellants raise a single claim construction issue on appeal concerning the '029 patent. The '029 patent's asserted claims are directed towards a method of “treating hair loss.” Appellants challenge the district court's construction of this term as “ ‘arresting hair loss, reversing hair loss, or both and promoting hair growth’ meaning that the invention may arrest hair loss, reverse hair loss, or promote hair growth in the alternative.” 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.” '029 patent col.3 ll. 29–30. Appellants argue, however, that use of the conjunctive “and” in the inventor's own lexicography expressly provides that the method for treating hair loss must both arrest or reverse hair loss, as well as also promote hair growth. Appellants argue that under their proposed construction, a generic version of Latisse® would not infringe because Latisse® treats hair loss by lengthening, thickening, and darkening existing healthy hair—which appellants argue means only the promotion of hair growth.

The district court agreed with the appellees that the use of the word “includes” in the definition of “treating hair loss” 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. Appellees argue that this comports with the plain meaning of “treating hair loss,” which would be understood in the art as including treatments that exclusively promote hair growth....