In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this statutory section continues a pattern that has existed since the 1952 Patent Act was enacted. It is not for lack of petitions for certiorari, which have included during the Court's denials in Amgen v. Sanofi; Janssen Biotech, Inc. v. Abbott Laboratories; CoreValve Inc. v. Edwards Lifesciences AG; and Ariad v. Eli Lilly & Co. Last week, the Court's refusal to consider this section recurred with its denial of certiorari in Actavis Laboratories FL, Inc. v. Nalproprion Pharmaceuticals, Inc.
To recap, the case arose in ANDA litigation over Nalproprion Pharma's Contrave® extended-release tablets of the combination of naltrexone hydrochloride and buproprion hydrochloride, for treatment of obesity, as claimed in Orange Book-listed U.S. Patent Nos. 7,375,111; 7,462,626; and 8,916,195. The District Court found that Defendant Actavis had not established that one claim (claim 11) of the '195 patent was invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) with regard to the claim limitation reciting USP dissolution methods ("USP1" versus "USP2"):
Claim 11 of the '195 patent:
A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is ad- ministered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution pro- file in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37° C. of:
a) between 39% and 70% of naltrexone re- leased in one hour;
b) between 62% and 90% of naltrexone re- leased in two hours; and
c) at least 99% in 8 hours;
wherein about 16 mg of said sustained re- lease formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180 mg of said sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.
The claims expressly recited the USP 2 Paddle Method, but Actavis argued that the specification disclosed only the UPS 1 Basket Method. The District Court based its decision on the skilled worker not having a doubt that the inventors had possession of the invention based on the nature of the dissolution method disclosed in the specification. The Court held that disclosure of a "substantially equivalent method" was sufficient to satisfy the requirement.
The Federal Circuit, in an opinion by Judge Lourie, joined by Judge Wallach, affirmed the District Court on its written description determination over Chief Judge Prost's dissent. The majority's written description decision was based in part on the "peculiarity" of the structure of claim 11, which is directed to a method for treating obesity using specific amounts of the two drugs and reciting the method for determining the dissolution profile of what the majority termed "resultant in vitro parameters," which were not the "operative steps to treat overweight or obesity." The majority found no clear error in the District Court's holding that "irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it." The majority noted that this determination by the District Court was supported by more credible testimony from Nalproprion Pharma's expert and "untrustworthy, self-serving statements by Actavis's expert." The majority stated that it refused to disturb the District Court's weighing of witness credibility in the performance of its "fact-finding function." The majority further recognized (in the face of the Chief Judge's dissent) that "[w]hile as a general matter written description may not be satisfied by so-called equivalent disclosure," under these facts the District Court had not clearly erred.
The Chief Judge's dissent on the written description question was based on the majority's reliance on "substantially equivalent disclosure" to support claim language not having clear and explicit support in the specification. The Chief Judge characterized the majority's decision as "add[ing] what appears to me to be a new rule to this court's long-standing written description jurisprudence." She set forth three reasons for her disagreement with the majority:
First, the USP 2 clause is limiting. Second, the majority's "substantially equivalent" rule is inconsistent with this court's precedent. Third, the district court clearly erred in finding that the '195 patent's written description includes a disclosure "substantially equivalent" to USP 2.
Important to the Chief Judge's reasoning, inter alia, were arguments from the prosecution history where the patentee appeared to rely on the dissolution profile (and the manner of determining it) to distinguish the claims from the prior art. The Chief also disagreed with the District Court's (and the majority's) disregard for Defendant's expert testimony and found his assertion that the USP1 an USP2 methods would not have produced the same dissolution profile results to have been relevant to the written description issue before each court.
In its certiorari petition, Actavis submitted this Question Presented:
Whether § 112 requires a patent's specification to contain a written description of all of the limitations of a patent's claims, not just a "substantially equivalent" disclosure.
Actavis argued that the statutory requirement for a written description was "straightforward" and meant what it said: that the specification was required to set forth a written description of "the invention" (emphasis on petition), which, of course, is what is claimed. Actavis contended that the Federal Circuit majority had broken with "longstanding precedent, [and] adopted a new rule: now disclosing something 'substantially equivalent' can suffice." This inquiry is "amorphous" and contrary to the statutory language and (of necessity) Federal Circuit precedent. Almost pandering to Supreme Court prejudices, the petition argued that "[r]equiring a patent to contain sufficient written description support ensures that a patent-holder cannot assert a broader monopoly than what 'the inventor actually invented,'" citing Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), and that "[a]n adequate written description is also necessary 'to inform the public during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not,'" citing Permutit Co. v. Graver Corp., 284 U.S. 52, 60 (1931).
According to Actavis, this decision, if permitted to stand (which is has been), overturns the certainty provided by the Federal Circuit's prior precedent on Section 112(a), substituting a "substantially equivalent" standard for one where "an obvious variant of that which is disclosed in the specification," which was previously excluded, can now suffice, citing Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). In addition to the doctrinal error Actavis asserts, the petition also maintains that the decision "disrupt[s] the settled expectations of the inventing community" that the Supreme Court (somewhat ironically) advised against in Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 739 (2002). And on a practical level, Actavis reminded the Court that this case is an excellent vehicle for review, wherein only one claim is at issue, there is no dispute on the facts, and the alternative outcome would permit Actavis to "bring its generic to market forthwith, instead of being blocked for another full decade."
The petition reminded the Court of the fundamental basis ("a bedrock principle") of the written description requirement, having been part of U.S. patent law "practically since the Founding," setting forth an explication of the history of this requirement to support its statement. The importance of properly applying the requirement includes that "it ensures that an inventor does not claim patent protection for something broader than what he or she has invented by the time of filing the patent application, exemplified in the Court's decisions including O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853), and Federal Circuit decisions including Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991), and Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1379 (Fed. Cir. 2009). A second benefit of the requirement is to the public, wherein "the description effectuates the patent bargain: what the inventor claims, and secures a monopoly over, he or she must describe," citing Gill v. Wells, 89 U.S. (22 Wall.) 1, 25-26 (1874) and Ariad.
"The decision below creates a new rule that hopelessly muddies what previously was clear and cannot be reconciled with the court of appeals' previous decisions" according to Actavis's petition. These decisions cited in the petition include Lockwood; Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997); Lucent Techs., Inc. v. Gateway, Inc., 543 F.3d 710 (Fed. Cir. 2008); PowerOasis, Inc. v. TMobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558 F.3d 1368 (Fed. Cir. 2009); Vas-Cath; and D Three Enters., LLC v. SunModo Corp., 890 F.3d 1042, 1052 (Fed. Cir. 2018). This is not the same as imposing an in haec verba requirement according to Actavis; the panel majority's error Actavis emphasized that the Federal Circuit departed from years of consistent decisions to the contrary by "accepting a disclosure that was 'substantially equivalent'—i.e., different but close enough."
Actavis also challenged the basis for the majority's decision -- that the disputed, assertedly unsupported claim term -- did not related to a "operative claim step." There is no basis in the statutory language for this distinction, Actavis argued, nor in "this Court's clear precedent," citing Supreme Court precedent in Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S. 915, 921 (2014); Warner-Jenkinson, Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997); and Water-Meter Co. v. Desper, 101 U.S. 332, 337 (1880), and the Federal Circuit (and its predecessor Court, the C.C.P.A.) in In re Sabatino, 480 F.2d 911, 913 (C.C.P.A. 1973); Exxon Chem. Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1557 (Fed. Cir. 1995); and Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 851 F.3d 1270, 1273 (Fed. Cir. 2017).
And yet, to no avail. Whether the Federal Circuit's decision below will lead to the dire consequences envisioned by Petitioners or is cabined by the facts and circumstances of the case before the Federal Circuit is uncertain. But what seems certain is that the Supreme Court has not been, and perhaps cannot be, presented with a case that has been able to overcome a seeming institutional reticence against deciding questions presented regarding Section 112(a).