By Kevin E. Noonan —

The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by the different conclusions in Classen Immunotherapies, Inc. v. Biogen IDEC and Momenta Pharmaceuticals, Inc. v. Amphastar Inc.  The issue once again came before the Court in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., in a decision handed down earlier this month; the decision provides another example of the Court setting forth the contours of the scope of the safe harbor.

The case involved a district court's determination that U.S. Patent No. 7,575,886 was not infringed by Teva nor by Amphastar and additional defendants in companion cases decided together.  The claims at issue were directed to enoxaparin, an anticoagulant drug marketed since 1993 under the brand name Lovenox.  Momenta marketed the first generic version of the drug and sought to block additional generic entrants by asserting the '866 patent, which claimed methods for ensuring that each batch of the drug met quality standards.  Teva imported batches of the drug made abroad and Momenta alleged infringement based on the provisions of 35 U.S.C § 271(g):

Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent.  In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product.  A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—
    (1) it is materially changed by subsequent processes; or
    (2) it becomes a trivial and nonessential component of another product.

The District Court rejected this contention, because the asserted claims were directed to methods for analyzing the product for quality control purposes and not methods of making the drug.  In addition, the District Court found that Teva's use of the analytical methods claimed in the '866 patent fell within the safe harbor provisions of 35 U.S.C § 271(e)(1).

The situation was different with regard to Momenta's infringement allegations against Amphastar, inter alia, because Amphastar manufactured enoxaparin in the U.S.  In this case, the District Court held that Amphastar's activities fell within the safe harbor provisions of the Hatch-Waxman Act.

The Federal Circuit affirmed the District Court's decision as to Teva (relating to infringement under § 271(g) but vacated the lower court's grant of summary judgment in Amphastar's favor, in an opinion by Judge Wallach joined by Judge Moore and in part by Judge Dyk, who also dissented in part.  The portion of the decision related to (non)infringement under § 271(g) was straightforward:  the '866 patent claims did not encompass methods of "making" the enoxaparin.  Momenta argued that the quality control methods in the '886 patent claims were "a crucial interim step" in making the drug, because batches were chosen for "further process[ing]" into the finished drug product based on the results of these testing methods.  Saying that these arguments were "not without merit," the Federal Circuit nevertheless held that the District Court's decision of non-infringement was "more consonant with the language of the statute, as well as with this court's precedent, to limit § 271(g) to the actual 'ma[king]' of a product, rather than extend its reach to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made," based on an "ordinary meaning" interpretation of the statutory language.  The Court cited Bayer AG v. Housey Pharm., Inc., 340 F.3d 1367, 1373 (Fed. Cir. 2003), and American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931), in support of their interpretation of the word "make."

Turning to Amphastar's § 271(e)(1) defense, the Federal Circuit turned to the purpose of the statute according to the legislative history:

[Section 271(e)(1)] provides that it is not an act of patent infringement for a generic drug maker to import or to test a patented drug in preparation for seeking FDA approval if marketing of the drug would occur after expiration of the patent . . .  .  This section does not permit the commercial sale of a patented drug by the party using the drug to develop such information . . .  .  The information which can be developed under this provision is the type which is required to obtain approval of the drug. . .  .  The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement [emphasis in opinion].

The opinion notes that while the contours of the safe harbor have been deemed broad (citing, inter alia, Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005), Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir. 2011), and AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1027 (Fed. Cir. 1997)), the safe harbor is not without boundaries.  These exceptions include research tools not subject to FDA approval (Proveris Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1265–66 (Fed. Cir. 2008)) and information "routinely reported" to the FDA post-approval (citing Classen).  Even though the Federal Circuit had earlier affirmed denial of Momenta's motion for preliminary injunction on the grounds that the movant was unlikely to prevail, this decision was not the "law of the case" nor was this panel bound by the earlier panel's decision, and that, in any event, courts had the ability to reconsider and come to a different conclusion.  Here, the majority held that they were considering a fuller record than had been available at the preliminary injunction stage.  That record was enough to convince the Court that the FDA submissions relied upon by Amphastar were sufficiently "routine" that they fell outside the scope of the § 271(e)(1) safe harbor.

The opinion contrasts the routine nature of the submissions made based on the use of Momenta's method with "non-routine submissions that may occur both pre- and post-approval, such as the submission of investigational new drug applications ('INDs'), new drug applications ('NDAs'), supplemental NDAs, or other post-approval research results."  Because Amphastar's submissions using Momenta's patented technology were routine they were not "reasonably related to the development and submission of information" as required by the statute to qualify for the safe harbor, and the District Court's decision to the contrary was clearly erroneous in the majority opinion.  This decision is based in part on the panel's apprehension that deciding in Amphastar's favor would "result in manifest injustice" because it would be the first case to have § 271(e)(1) encompass "activities related to ongoing commercial manufacture and sale."

In a footnote the opinion sets out the views of the government as amicus, wherein "the government argued that the routine use of a patented testing process in the commercial manufacture of a drug is not 'reasonably related to the development and submission of information to [the] FDA' and thus not shielded from liability by § 271(e)(1).'"  While the decision is consistent with these sentiments, there is nothing in the opinion indicating that the government's views formed any basis for the opinion.

Judge Dyk dissented in part, over the question of whether Teva infringed under § 271(g).  The grounds of his dissent are based in part on his disagreement with the majority's interpretation of Bayer v. Housey, which he believes is too limited and does not apply in this case.  Specifically, the dissent contends that the patented method is used in the manufacturing process itself and becomes a part thereof, and thus should be encompassed in the "making" requirement contained in the statutory language.  The dissent does not attempt to set forth any definitive rubrics on the question, which Judge Dyk recognizes must be considered on a "case-by-case" basis.  Rather his dissent is based on his opinion that the majority misapplied the law in this instance, based at least in part on his understanding of the manufacturing process, complexity of the enoxaparin drug product and the need to rely on the patented testing methods to produce batches of the drug that conform with the standards set out by the FDA for the approved drug (which Judge Dyk characterizes as being "an integral part of the manufacturing of the enoxaparin drug product").  He finds legal support for his opinion in Bio-Tech. Gen. Corp. v. Genentech, Inc., 80 F.3d 1553, 1561 (Fed. Cir. 1996), and logical force in his perception that the majority's interpretation would lead to the "anomalous result[]" that "[p]atents on purification methods or the quality control method at issue here, which may be integral to the regulatory or commercial viability of a product, but which do not create or transform a product, combine components, or confer new properties, could be freely infringed simply by outsourcing those processes abroad."  Congress could not have intended this result according to Judge Dyk and thus he dissents.

Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2015)
Panel: Circuit Judges Dyk, Moore, and Wallach
Opinion by Circuit Judge Wallach; concurring in part and dissenting in part opinion by Circuit Judge Dyk