Novartis Pharm. Corp. v. Accord Healthcare, Inc.

38 F.4th 1013

NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiff-Appellee

v.ACCORD HEALTHCARE, INC., Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories, Ltd., Emcure Pharmaceuticals Ltd., Heritage Pharmaceuticals Inc., Glenmark Pharmaceuticals Inc., USA, Glenmark Pharmaceuticals Limited, Hetero USA, Inc., Hetero Labs Limited Unit-V, Hetero Labs Limited, Mylan Pharmaceuticals, Inc., Prinston Pharmaceutical Inc., Strides Global Pharma Private Limited, Strides Pharma, Inc., Torrent Pharma Inc., Torrent Pharmaceuticals Ltd., Zydus Pharmaceuticals (USA) Inc., Cadila Healthcare Ltd., Apotex Inc., Apotex Corp., Sun Pharmaceutical Industries, Ltd., Sun Pharmaceutical Industries Inc., Sun Pharma Global FZE, Defendants

HEC Pharm Co., Ltd., HEC Pharm USA Inc., Defendants-Appellants

2021-1070

United States Court of Appeals, Federal Circuit.

Decided: June 21, 2022

Jane M. Love, Gibson, Dunn & Crutcher LLP, New York, NY, argued for plaintiff-appellee. Also represented by Paul E. Torchia, Robert Trenchard.

Paul Skiermont, Skiermont Derby LLP, Dallas, TX, argued for defendants-appellants. Also represented by Sarah Elizabeth Spires; Mieke K. Malmberg, Los Angeles, CA.

Before Moore, Chief Judge, Linn and Hughes, Circuit Judges.

Dissenting opinion filed by Circuit Judge Linn.

Moore, Chief Judge.

HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (collectively, HEC) petition for rehearing of our prior decision in this case, 21 F.4th 1362 (Fed. Cir. 2022), in which we affirmed a final judgment of the United States District Court for the District of Delaware. The district court determined that claims 1–6 of U.S. Patent No. 9,187,405 are not invalid and that HEC infringes them. Because the '405 patent fails to disclose the absence of a loading dose, the district court clearly erred in finding that the negative claim limitation "absent an immediately preceding loading dose" added during prosecution to overcome prior art satisfies the written description requirement of 35 U.S.C. § 112(a). We grant HEC's petition for panel rehearing, vacate our prior decision, and reverse the district court's judgment that Novartis' claims are not invalid for inadequate written description.

BACKGROUND

The '405 patent discloses methods of treating relapsing-remitting multiple sclerosis (RRMS) using the immunosuppressant fingolimod. E.g. , '405 patent at claim 1, 8:56–60. Each claim of the '405 patent requires administering fingolimod "at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen." Id. at claim 1. A loading dose is a "higher-than-daily dose ... usually given as the first dose." J.A. 27 ¶ 63 (internal quotation marks omitted). The patent's specification does not mention loading doses, much less the absence of a loading dose. Instead, it describes administering fingolimod at regular intervals (e.g., once daily, multiple times per day, or every other day). '405 patent at 11:20–38.

Novartis owns the '405 patent and markets a drug under the brand name Gilenya that purportedly practices the patent. HEC filed an abbreviated new drug application (ANDA) with the Food and Drug Administration seeking approval to market a generic version of Gilenya. Novartis sued HEC in the District of Delaware, alleging that HEC's ANDA infringes all claims of the '405 patent.¹

After a four-day bench trial, the district court found that HEC's ANDA infringes and that the claims are not invalid, either as anticipated by Kappos 2006 or for inadequate written description of the no-loading-dose or daily-dosage limitations. HEC appeals as to written description. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

DISCUSSION

"Whether a claim satisfies the written description requirement is a question of fact that, on appeal from a bench trial, we review for clear error." Allergan, Inc. v. Sandoz Inc. , 796 F.3d 1293, 1308 (Fed. Cir. 2015) (quoting Alcon Rsch. Ltd. v. Barr Labs., Inc. , 745 F.3d 1180, 1190 (Fed. Cir. 2014) ). Under the clear error standard, we defer to the district court's findings "in the absence of a definite and firm conviction that a mistake has been made." Scanner Techs. Corp. v. ICOS Vision Sys. Corp. N.V. , 528 F.3d 1365, 1374 (Fed. Cir. 2008) (cleaned up). Inadequate written description must be shown by clear and convincing evidence. Hynix Semiconductor Inc. v. Rambus Inc. , 645 F.3d 1336, 1351 (Fed. Cir. 2011) (citing ICU Med., Inc. v. Alaris Med. Sys., Inc. , 558 F.3d 1368, 1376 (Fed. Cir. 2009) ).

A

To satisfy the written description requirement, a patent's specification must "reasonably convey[ ] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co. , 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Such possession must be "shown in the disclosure." Id. It is not enough that a claimed invention is "an obvious variant of that which is disclosed in the specification." Lockwood v. Am. Airlines, Inc. , 107 F.3d 1565, 1572 (Fed. Cir. 1997). Disclosure is essential; it is "the quid pro quo of the right to exclude." Kewanee Oil Co. v. Bicron Corp. , 416 U.S. 470, 484, 94 S.Ct. 1879, 40 L.Ed.2d 315 (1974) ; see also Enzo Biochem, Inc. v. Gen-Probe Inc. , 323 F.3d 956, 970 (Fed. Cir. 2002) ("[D]escription is the quid pro quo of the patent system.").

For negative claim limitations, like the no-loading-dose limitation at issue here, there is adequate written description when, for example, "the specification describes a reason to exclude the relevant [element]." Santarus, Inc. v. Par Pharm., Inc. , 694 F.3d 1344, 1351 (Fed. Cir. 2012) ; Inphi Corp. v. Netlist, Inc. , 805 F.3d 1350, 1355 (Fed. Cir. 2015) (same); Nike, Inc. v. Adidas AG , 812 F.3d 1326, 1348 (Fed. Cir. 2016) (same), overruled on other grounds by Aqua Prods., Inc. v. Matal , 872 F.3d 1290, 1301 (Fed. Cir. 2017) (en banc). A reason to exclude an element could be found in "statements in the specification expressly listing the disadvantages of using" that element. Santarus , 694 F.3d at 1351. Another reason could be that the specification "distinguishes among" the element and alternatives to it.

Inphi , 805 F.3d at 1357 ; see also In re Johnson , 558 F.2d 1008, 1017–19 (C.C.P.A. 1977) (reversing rejection for inadequate written description where specification disclosed several species of a genus and claims recited genus but excluded two species of lost interference count).

The common denominator of these examples is disclosure of the element. That makes sense because "the hallmark of written description is disclosure." Ariad , 598 F.3d at 1351 ; see also Lockwood , 107 F.3d at 1571 ("It is the disclosures of the applications that count."). Silence is generally not disclosure. See Seabed Geosolutions (US) Inc. v. Magseis FF LLC , 8 F.4th 1285, 1288 (Fed. Cir. 2021) ("[S]ilence does not support reading the claims to exclude gimbaled geophones." (citations omitted)); MPEP § 2173.05(i) (9th ed. Rev. 10.2019, June 2020) ("The mere absence of a positive recitation is not a basis for an exclusion."). If it were, then every later-added negative limitation would be supported so long as the patent makes no mention of it. While a negative limitation need not be recited in the specification in haec verba , there generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives. Consistent with our precedent in Santarus, Inphi and Nike , the written description requirement cannot be met through simple disregard of the presence or absence of a limitation.

While a written description's silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation.² For example, if the record established that in a particular field, the absence of mention of a limitation necessarily excluded that limitation, written description could be satisfied despite the specification's silence. See Tronzo v. Biomet, Inc. , 156 F.3d 1154, 1159 (Fed. Cir. 1998) ("[M]issing descriptive matter must necessarily be present in the ... specification such that one skilled in the art would recognize such a disclosure." (citing Cont'l Can Co. USA v. Monsanto Co. , 948 F.2d 1264, 1268 (Fed. Cir. 1991) )); see also In re Robertson , 169 F.3d 743, 745 (Fed. Cir. 1999) ("To establish inherency [for purposes of anticipation], ... evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill." (internal quotation marks and citation omitted)). When the specification is itself silent regarding a negative limitation, testimony from a skilled artisan as to possibilities or probabilities that the recited element would be excluded would not suffice, lest such testimony could effectively eliminate the written description requirement. If silence were generally sufficient, all negative limitations would be supported by a silent specification. If, however, a patent owner could establish that a particular limitation would always be understood by skilled artisans as being necessarily excluded from a particular claimed method or apparatus if that limitation is not mentioned, the written description requirement would be satisfied despite the specification's silence.

B

The district court found that because there is no recitation of a loading dose in the specification, the no-loading-dose limitation is supported. J.A. 26 ¶ 61. The district court further found that the no-loading-dose limitation is disclosed in the specification because "[t]he Prophetic Trial describes giving a ‘daily dosage of 0.5 ... mg’ fingolimod to treat RRMS, started ‘initially.’ The...