U.S. Supreme Court Asked to Review Hatch-Waxman “Safe Harbor” LOVENOX Method Patent Case

By Kurt R. Karst –      

In a widely anticipated move, Momenta Pharmaceuticals, Inc. and Sandoz Inc. have petitioned the U.S. Supreme Court to review the August 3, 2012 judgment of the U.S. Court of Appeals for the Federal Circuit, in which a divided (2-1) Federal Circuit panel ruled that the scope of the Hatch-Waxman “safe harbor” provision at 35 U.S.C. § 271(e)(1) is broad and exempts from infringement any commercial activity where FDA requires that a record of that activity be maintained, even if no record is ever submitted to the Agency.  The Supreme Court case, Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., has been assigned Docket No. 12-1033. 

As we previously discussed, the case involves a generic version of LOVENOX (enoxaparin) and U.S. Patent No. 7,575,866 (“the ‘866 patent”) assigned to Momenta that generally relates “to methods for analyzing heterogeneous populations of sulfated polysaccharides” such as enoxaparin.  Momenta sued generic drug sponsor Amphastar in the U.S. District Court for the District of Massachusetts for patent infringement alleging that Amphastar infringed the ‘886 patent by manufacturing for commercial sale enoxaparin using the patented method.  Relying on the Federal Circuit’s decision in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), the District Court ruled that Amphastar’s activity fell outside of the “safe harbor” provision at 35 U.S.C. § 271(e)(1).  In Classen, which concerned whether a vaccine license holder was required to report to FDA certain adverse event information, the Federal Circuit held that 35 U.S.C. § 271(e)(1) “does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.” 

On appeal, the Federal Circuit disagreed with the District Court and vacated an injunction in the case.  The Federal Circuit explained that its decision is not inconsistent with Classen “because the information submitted is necessary both to the continued approval of the ANDA and to the ability to market the generic drug,” and that in this case, “the submissions are not ‘routine submissions’ to the FDA, but instead are submissions that are required to maintain FDA approval. . . ,” thereby bringing them within the scope of the 2171(e)(1) safe harbor.   

During the pendency of the Federal Circuit’s consideration of Momenta, the U.S. Supreme Court had been asked to review the Classen decision.  See GlaxoSmithKline v. Classen Immunotherapies, Inc. (Docket No. 11-1078).  Ultimately, the Supreme Court decided not to hear the case, but not before the U.S. Solicitor General filed an amicus brief urging the Court to deny certiorari.  According to the U.S., although the Federal Circuit “erred in stating that section 271(e)(1)’s safe harbor encompasses only activities undertaken to obtain the FDA’s pre-marketing approval of generic products . . . there is no longer any practical need for theis Court’s intervention in light of the Federal Circuit’s subsequent decision in Momenta.”  Moreover, states the U.S., if “postapproval studies involve the use of patented inventions solely for uses reasonably related to the development and submission of information to the FDA, the plain language of Section 271(e)(1) precludes any claim for patent infringement.”  (Thus, if the U.S. Solicitor General is asked to file a brief in the Amphastar/Sandoz appeal, it is not difficult to discern what that brief will say.)

Amphastar and Sandoz present the following question to the U.S. Supreme Court:

Whether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as “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.

According to Petitioners, the Federal Circuit’s Classen and Momenta decisions are irreconcilable and fundamentally wrong:

Both Classen and the ruling below give the wrong scope to the safe harbor provision and together they leave its meaning in an intolerable state of uncertainty.  The Federal Circuit has shown no willingness to correct its interpretation or to provide the needed certainty.  In the absence of guidance from this Court, future panels will have two purportedly binding precedents from which to choose.  District courts are left adrift with two conflicting compasses, each purporting to be definitive.  Companies attempting to chart their own courses have no idea whether they are free to use patented inventions or whether such use will subject them to infringement liability.  The pharmaceutical industry cannot wait for the Federal Circuit to get it right (or wrong) a third or fourth time.

Absent review, the ruling below will undermine pharmaceutical industry investment in life-saving and life-enhancing innovations.  Each drug the pharmaceutical industry brings to market requires enormous investment. That investment is predicated on the protection provided by the patent laws: protection for innovators, during a patent’s term, from unlicensed, commercial competition from their own invention.  The court of appeals’ sweeping interpretation of Section 271(e)(1) calls into question the value of a great many pharmaceutical patents.

Regardless of whether or not the U.S. Supreme Court decides to take up the Momenta case, a final decision could have significant implications on the budding biosimilars industry where method patents play an important role.  Indeed, it is possible that FDA could require, as a condition of approval, that all biosimlar sponsors for a particular product use a particular analytic method that is under patent by a reference product sponsor.  As the law currently stands, the Section 271(e)(1) safe harbor would appear to exempt infringement in such circumstances.