Insite Vision Inc. v. Sandoz, Inc.
| Decision Date | 09 April 2015 |
| Docket Number | No. 2014–1065.,2014–1065. |
| Parties | INSITE VISION INCORPORATED, Inspire Pharmaceuticals, Inc., Pfizer Inc., Plaintiffs–Appellees v. SANDOZ, INC., Defendant–Appellant Sandoz GmbH, Sandoz Industrial Products S.A., Defendants. |
| Court | U.S. Court of Appeals — Federal Circuit |
Dominick A. Conde, Fitzpatrick, Cella, Harper & Scinto, New York, N.Y., argued for plaintiffs-appellees. Also represented by David E. De Lorenzi, Gibbons P.C., Newark, NJ. Plaintiffs-appellees Inspire Pharmaceuticals, Inc., Pfizer Inc. also represented by Margaret A. Scoolidge, Fitzpatrick, Cella, Harper & Scinto, New York, N.Y.; Dennis C. Aeling, Costa Mesa, CA.
Brian Robert Matsui, Morrison & Foerster LLP, Washington, DC, argued for defendant-appellant. Also represented by Deanne E. Maynard ; David Clarence Doyle, James Webb Huston, Mark Andrew Woodmansee, San Diego, CA; Matthew D'Amore, New York, N.Y.
Before PROST, Chief Judge, NEWMAN and LINN, Circuit Judges.
In this Hatch–Waxman Act litigation, Sandoz, Inc. (“Sandoz”) appeals the district court's decision in InSite Vision, Inc. v. Sandoz, Inc., No. 11–3080, 2013 WL 5975015 (D.N.J. Oct. 4, 2013), which held that Sandoz had not shown that the claims of U.S. Patents No. 6,861,411 (the “'411 patent”) ; No. 6,239,113 (the “'113 patent”) ; No. 6,569,443 (the “'443 patent”) ; and No. 7,056,893 (the “'893 patent”) (collectively “the patents-in-suit”) asserted by Insite Vision, Inc. (“Insite”); Inspire Pharm., Inc. (“Inspire”); and Pfizer, Inc. (“Pfizer”) (collectively “plaintiffs”) are invalid as obvious. This court agrees that Sandoz failed to show that the asserted claims in the patents-in-suit would have been obvious to a person of ordinary skill in the art and therefore affirms.
The '411 patent issued from U.S. Patent Application No. 09/200,199 (the “'119 application”), which was filed on November 25, 1998, claiming priority to a provisional application filed on December 2, 1997. It is owned by Pfizer. Insite owns the '113, '443 and '893 patents (the “ISV patents”). The ISV patents claim priority to an application filed on March 31, 1999. Inspire is the exclusive sub-licensee of the '411 patent and the exclusive licensee of the ISV patents.
The '411 patent discloses methods of treating eye infections
by the topical administration of azithromycin to the eye. '411 patent col.1 ll.8–10. The patent states that prior to the invention, azithromycin was commonly administered orally for the treatment of antibacterial infections, but was not known to be effective when topically administered to the eye. Id. at col.1 ll.22–27. Claim 1 of the '411 patent is representative and recites:
1. A method of treating an ocular infection
, comprising topically administering to an eye of an animal in need of such treatment an ocular infection-treating amount of azithromycin.
The ISV patents disclose various formulations and methods of using topical azithromycin
as a gel eyedrop for treating eye infections. Claim 1 of the '113 patent ; claim 16 of the '443 patent ; and claim 1 of the ' 893 patent are representative and recite:
1. A process for treating an eye, which comprises: topically applying an aqueous polymeric suspension of an azalide antibiotic, wherein said suspension comprises water, 0.01% to 1.0% of an azalide antibiotic, and 0.1 to 10% of a polymeric suspending agent.
'113 patent claim 1;
16. A topical ophthalmic composition comprising an aqueous polymeric suspension comprising water, 0.01% to 1.0% of an azalide antibiotic and 0.1 to 10% of a polymeric suspending agent, wherein said topical ophthalmic composition has an osmotic pressure of from 10 to 400 mOsM and wherein said composition does not contain constituents that are physiologically or ophthalmically harmful to the eye.
'443 patent claim 16;
1. A composition comprising water, a polymeric suspending agent and an azalide antibiotic, wherein said composition has a pH of about 6.0 to 6.6.
'893 patent claim 1.
Inspire markets a topical azithromycin
solution, which is approved by the Food and Drug Administration (“FDA”) and is distributed under the name “Azasite ®.” The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) lists all four of the patents-in-suit for Azasite ®.
Sandoz filed an Abbreviated New Drug Application (“ANDA”) for its generic version of Azasite
® seeking approval prior to the expiration of the patents-in-suit. The ANDA included a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2012) () stating that the claims of the patents-in-suit were invalid and/or not infringed. Pursuant to § 355(j)(2)(B), Sandoz notified plaintiffs of the Paragraph IV certification. In response, plaintiffs sued Sandoz for infringing dependent claims 3 and 5 of the '411 patent, which depend from claims 1 and 2; dependent claims 6–9 of the '113 patent, which depend from claims 1–3; independent claims 16 and 44 of the '443 patent ; and dependent claims 4, 6, 7, 9–12, 30, 36 and 40 of the '893 patent, which depend directly or indirectly from claims 1 or 23 (collectively, the “asserted claims”) under 35 U.S.C. § 271(e).
After claim construction, Sandoz stipulated to infringement but contested the validity of the asserted claims under 35 U.S.C. § 103(a) (2006).1 InSite, 2013 WL 5975015, at *2. Before trial, Sandoz moved to amend the pre-trial order to include as an exhibit the file history of the European counterpart of the '411 patent (the “EPO file history”). The district court denied that motion because it concluded that the late proffer was prejudicial. A bench trial then ensued. The district court ruled that Sandoz had failed to show by clear and convincing evidence that the asserted claims would have been obvious to a person of ordinary skill in the art and, therefore, upheld the validity of all of the patents-in-suit. Id. at *49. Sandoz appeals, contending that the district court “mis-framed” the obviousness inquiry by adopting plaintiffs' characterization of the problem facing a person of ordinary skill in the art at the time of the invention as the development of “improved topical treatments for ocular infections
,” id. at *20, rather than the narrower problem argued by Sandoz of topically administering azithromycin to treat conjunctivitis. Sandoz also appeals the district court's refusal to admit into evidence the late-proffered EPO file history. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
“Following a bench trial on the issue of obviousness, we review the court's ultimate legal conclusions de novo and the underlying factual findings for clear error.” Tyco Healthcare Grp. LP v. Ethicon Endo–Surgery, Inc., 774 F.3d 968, 974 (Fed.Cir.2014) (citing Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346, 1354 (Fed.Cir.2013) ). “A factual finding is clearly erroneous if, despite some supporting evidence, we are left with the definite and firm conviction that a mistake has been made.” Ferring B.V. v. Watson Labs., Inc.–Fla., 764 F.3d 1401, 1406 (Fed.Cir.2014) ().
“In review of an order denying a motion to amend, a subject [that] is not unique to patent law, we look to the law of the regional circuit court.” Optivus Tech., Inc. v. Ion Beam Applications S.A., 469 F.3d 978, 985 (Fed.Cir.2006) (quoting Kalman v. Berlyn Corp., 914 F.2d 1473, 1480 (Fed.Cir.1990) ). In the Third Circuit, a motion to amend a pretrial order is reviewed for abuse of discretion. Petree v. Victor Fluid Power, Inc., 831 F.2d 1191, 1194 (3d Cir.1987).
A patent is invalid “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103(a) (2006). As patents are “presumed valid,” § 282, a defendant bears the burden of proving invalidity by “clear and convincing evidence,” Takeda Pharm. Co. v. Zydus Pharm. USA, Inc., 743 F.3d 1359, 1366 (Fed.Cir.2014) (citing Microsoft Corp. v. i4i Ltd., ––– U.S. ––––, 131 S.Ct. 2238, 2242, 180 L.Ed.2d 131 (2011) ).
Obviousness is a question of law, based on underlying factual determinations including: “the scope and content of the prior art”; “differences between the prior art and the claims at issue”; “the level of ordinary skill in the pertinent art”; and “[s]uch secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc.” Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007).
The district court began its obviousness analysis by addressing a dispute between the parties regarding the proper “framing” of the obviousness question. InSite, 2013 WL 5975015, at *19. Plaintiffs argued that the proper question to be considered by the court was whether it would have been obvious to a person of ordinary skill in the art at the time of the invention to develop a topical ophthalmic formulation containing azithromycin
. Sandoz argued for a narrower question: whether it would have been obvious that topical azithromycin could be used to treat conjunctivitis.
The district court agreed with the plaintiffs and found no reason to limit the question to...
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