By Andrew Williams —

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are "solely for uses reasonably related to the development and submission of information" to the FDA.  Even though the plain language of the statute appears to indicate that the exemption to infringement would be narrow, the Supreme Court and the Federal Circuit have been gradually expanding its scope.  Earlier this week, the Federal Circuit continued this expansion in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc.  Not only does the safe-harbor provision apply to post-filing activity, as previous cases have indicated, but the safe harbor can also be sought by NDA holders that happen to practice someone else's patents for the purposes of FDA submissions.

The relevant part of 35 U.S.C. § 271(e)(1) reads:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

The Supreme Court began the expansion of this provision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005).  That case arose from a Federal Circuit appeal, in which that court held that the safe harbor did not apply to preclinical testing because it is too far removed, or "back down the chain of experimentation," for the development of submitted information to the FDA.  The Supreme Court could not find support in the statute to exclude "certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included."  Id. at 202.  Thereafter, preclinical data enjoyed the safe harbor.

With regard to post-FDA filing activity, the Federal Circuit initially indicated that it was not a "phase of research" entitled to the exemption.  In Classen Immunotherapies, Inc. v. Biogen IDEC, presumably unrelated to the present case, a majority of the merits panel (then-Chief Judge Rader joined by Judge Newman) held that "routine" post-approval submissions are outside the safe harbor (over a vigorous dissent by Judge Moore).  In the following case, Momenta Pharm. v. Amphastar Pharm., the roles were reversed, with Judge Moore finding herself in the majority (with Judge Dyk), and then-Chief Judge Rader filing a dissent.  In this case, the Federal Circuit interpreted the statutory language broadly, stating that the "language unambiguously applies to submissions under any federal law, providing that the law 'regulates the manufacture, use, or sale of drugs.'"  Therefore, according to current Federal Circuit jurisprudence, the safe harbor is not limited to pre-approval activities (Momenta); it is not limited to information that is actually submitted to the FDA, provided the FDA requires that records be maintained for possible inspection (Momenta); and it is okay if the information has alternative uses, such as for fund raising or other business purposes (Abtox, Inc. v. Exitron Corp.).

In the present case, the patent at issue (U.S. Patent No. 6,584,472) was directed to "a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing that new use."  The representative method claim (claim 36) depends from claim 33 cancelled during reexamination:

33.  [cancelled during reexamination]  A method for creating and using data associated with a commercially available product, wherein the method comprises the steps of:
    accessing at least one data source, comprising together or separately, adverse event data associated with exposure to or use of the product and commercial data regarding marketing, sales, profitability or related information pertaining to the product;
    analyzing the accessed data to identify (i) at least one new adverse event associated with exposure to or use of the product, (ii) at least one new use for the product responsive to identification of the at least one new adverse event, and (iii) the potential commercial value of the at least one new use for the product; and
    commercializing the newly identified product information based upon the analyzed data.

36.  The method of claim 33, wherein the commercializing step comprises formatting the data relating to at least one new adverse event associated with exposure to, or use of the product, or documenting same, such that a manufacturer or distributor of the product must inform consumers, users or individuals responsible for the user, physicians or prescribers about at least one new adverse event associated with exposure to or use of the product.

There were also kit claims, claim 59 of which is representative:

59.  A proprietary kit comprising (i) product and (ii) documentation notifying a user of the product of at least one new adverse event relating to the product, wherein determination of the new adverse event is based upon the data provided by the method of claim 36.

And if these claims appear to have patent eligibility issues, the Court pointed out that 35 U.S.C § 101 issues were not raised on appeal.

Elan had filed an NDA for metaxalone, a muscle relaxant, which it markets under the brand-name Skelaxin.  In 2001, Elan learned that some third party studies called into question the designation of the metaxalone tablets.  Elan responded by conducting additional clinical studies showing that the bioavailability of Skelaxin was significantly increased when administered with food.  As a result, Elan filed a supplemental NDA (sNDA), and sought patent protection using this data, the claims of which were subsequently invalidated in another litigation.  Classen sued Elan, alleging infringement of the '472 patent for studying the effects of food on bioavailability, using the data to identify a new use, and commercializing the new use.  Elan argued that all of this activity was protected by 271(e)(1).

With regard to the clinical studies, the Federal Circuit held that "Elan's clinical study and its FDA submissions" were well within the scope of the protection.  Elan had developed this information for submission to the FDA in order to change the product label, and the Court found this to be anything but "routine."  This addressed any potential concerns of the impact of the Classen case.  With regard to the patent filings and kits being developed, the Federal Circuit found that the District Court did not determine whether these post-filings activities would fall within the exemption.  Therefore, the case was vacated and remanded.

Important in this decision, the Federal Circuit pointed out that the mere disclosure or use of the information would not be an "act of infringement."  Also, the Court provided "the following observation" about the cases.  First, filing a patent application is generally not an act of infringement.  "It is the act of approaching an agency of the government in order to obtain a limited privilege and to fulfill a public."  Second, the use of such information "submitted to the FDA on the product label after sNDA approval generally cannot be an infringement."  In fact, the opposite is true — it is required by law that this information be submitted to the FDA.  But, the Court left open the question whether there was any use or commercializing which would not be exempt.  For those answers, we will have to stay tuned.

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)
Panel: Chief Judge Prost, Circuit Judge Lourie, and District Judge Gilstrap (sitting by designation)
Opinion by Circuit Judge Lourie