Hatch-Waxman Watch: Safe Harbor Edition

by McDonnell Boehnen Hulbert & Berghoff LLP

Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute.  Both of the cases relied heavily on the Federal Circuit case Momenta Pharm. v. Amphastar Pharm., 686 F.3d 1348 (2012).  In fact, one of the cases was the Momenta case back at the Massachusetts District Court.  The other case was in the Southern District of New York, and in that case, the dismissal occurred at the pleadings stage.  Because both cases looked to 35 U.S.C. § 271(e)(1), it is useful to review this provision, which 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 Federal Circuit Momenta case interpreted this 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 (see 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 (see Momenta); and it is OK if the information has alternative uses, such as for fund raising or other business purposes (see Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030 (Fed. Cir. 1997)).  It is with this understanding that the lower courts proceeded.

Momenta Pharma., Inc. v. Amphastar Pharma., Inc., C.A. No. 11-11681-NMG

Momento PharmaceuticalsLast week, the U.S. District Court for the District of Massachusetts granted a summary judgment motion of non-infringement in favor of Amphastar (see Memorandum & Order).  This case involved generic versions of Aventis' product Lovenox (enoxaparin).  However, the patent-in-suit was owned by Momenta, another generic company, and related to methods for comparing generic enoxaparin to the branded version.  As a reminder, the procedural posture in front of the Federal Circuit was as an appeal of a preliminary injunction.  Because the Court found that the alleged infringing activity was protected by 35 U.S.C. § 271(e)(1), it vacated the injunction.  In fact, the Federal Circuit suggested that "the district court may want to consider whether Momenta's admission . . . makes this case amenable to summary judgment of non-infringement."  Nevertheless, the lower court stayed the case pending a petition for en banc appeal, and a petition for certiorari to the Supreme Court in Classen Immunotherapies, Inc. v. Biogen IDEC, another safe harbor case.  After both of those petitions were denied, the District Court lifted the stay, and Amphastar moved for summary judgment the next day.

AmphastarMomenta's position regarding whether the safe-harbor provision applied in this case apparently did not change significantly.  First, it argued that the FDA did not mandate the use of its patented test, and therefore its use by Amphastar was entirely voluntary.  However, as the District Court pointed out, the Federal Circuit "explicitly" held that the safe harbor "'does not mandate the use of a non-infringing alternative when one exists."  Second, Momenta argued that the required record-keeping was not a "submission," and therefore fell outside the statute.  However, again, the Court noted the Federal Circuit's "express" holding that the FDA's requirement for maintaining records that might be inspected was sufficient to satisfy this requirement.  Finally, Momenta alleged that the use of this information during manufacturing was for commercial purposes, and therefore not "solely" for uses related to satisfying Federal Law.  However, the Federal Circuit found this argument to not be consistent with precedent, citing the Abtox case.  Therefore, the Massachusetts court simply applied the holding of Momenta to grant the summary judgment motion.

Momenta also argued that Amphastar was liable under 35 U.S.C. § 271(g), which states in part: "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."  This section of the statute is generally directed to importation of a product made by a U.S. patented method practiced abroad, and in this case, there was no allegation that Amphastar manufactured the drug product outside the U.S.  Instead, Momenta argued that the language of the statute does not require that the patented process be practiced inside or outside the U.S.  This ignores, however, another section of that provision that states it only applies when "there is no adequate remedy under this title for infringement."  Because 35 U.S.C. § 271(a) applies to the making or use of a patented invention within the U.S., the Court reasoned that 35 U.S.C. § 271(g) does not apply in this case.

At about the same time that Amphastar filed its Summary Judgment motion, Teva filed a motion to dismiss a similar action based on the same patents.  In almost an identical opinion, the Massachusetts District Court also dismissed this case (see Memoradum & Order).

Teva Pharma. USA, Inc. v. Sandoz Inc., Case No. 09 Civ. 10112 (KBF)

Teva #2The U.S. District Court for the Southern District of New York also dispensed of two cases last week because of the Hatch-Waxman safe harbor provision (Mylan was defendant in the second case), but this time both cases were at the pleading stage.  Interestingly, Momenta was a co-defendant with Sandoz.  Therefore, the parties of this case were basically a mirror image of the Momenta v. Teva litigation that was dismissed in Massachusetts.  In other words, both parties were able to take advantage of the safe-harbor provision in the different litigations (or both parties were burned by it).

Sandoz #2The products in question were generic versions of glatiramer acetate, which is sold under the name Copaxone to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.  Glatiramer acetate is a mixture of polypeptides, and much like with Lovenox/enoxaparin in the Momenta case, the ANDA filers needed to demonstrate that their active ingredient was the same as the branded product.  Specifically, the ANDA filers needed to show that the polypeptides in their products have the same molecular weight characteristics as those in Copaxone.  Teva is the exclusive licensee to four patents that claim polypeptide markers and methods for using these markers to measure these molecular weight characteristics.

Because the fact pattern was so similar to Momenta, the defendants moved to dismiss for failure to state a claim.  The District Court did not, however, start with Momenta, but rather it underwent a similar analysis as the Momenta court.  First, it started with the text of statute, and it found the meaning to be plain and unambiguous.  As a result, the District Court did not need to consult the legislative history.  If it did, it might have discovered that the intent of Congress was that the statute was only meant to apply to pre-approval activity, as Chief Judge Radar explained in detail in the Momenta dissent.

The District Court then compared the case to Momenta, and found that the two cases had "striking similarities."  The Court concluded that the holding of Momenta and its fact pattern support dismissal in this case.  "Momenta allows for the elective use of patented technology as long as it serves to produce information required under federal law."  Teva had not alleged that Sandoz or Mylan activity was any different.

Instead, Teva attempted to differentiate this case by relying on another Federal Circuit case, Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008).  In that case, Innovasystems was making and selling a product that could be used by generic drug manufactures to calibrate drug delivery devices.  Innovasystems had argued that when its product was used by its customers (the generic drug manufacturers), they were protected by the safe harbor provision, and therefore Innovasystems should also be protected.  The Federal Circuit rejected this argument, and pointed out that the "patented invention" of Innovasystems was not the type of "patented invention" to which § 271(e)(1) refers.  It was important that Innovasystems was selling the patented invention to others, and not developing information for submission to the FDA.  The District Court concluded that the present case was analogous to Momenta, and that Proveris was inapposite to the present facts.  Therefore,  the Court held, "without an exclusion for plaintiffs' patented product not being the type of "invention" that can fall within § 271(e)(1), plaintiffs failed to state a claim" for the relevant counts in the complaints (see Opinion & Order).


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McDonnell Boehnen Hulbert & Berghoff LLP

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