Federal Circuit Addresses Quality Control Testing in Infringement and Safe Harbor Determination | Practical Law

Federal Circuit Addresses Quality Control Testing in Infringement and Safe Harbor Determination | Practical Law

In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., the US Court of Appeals for the Federal Circuit held that two generic drug manufacturers' use of a patented process to determine whether generic drug compound batches meet certain quality standards do not infringe under 35 U.S.C. Section 271(g). The court also held that the district court erred in concluding that one of the generic manufacturer's activities fell within the 35 U.S.C. Section 271(e)(1) infringement safe harbor.

Federal Circuit Addresses Quality Control Testing in Infringement and Safe Harbor Determination

by Practical Law Intellectual Property & Technology
Published on 12 Nov 2015 • USA (National/Federal)
In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., the US Court of Appeals for the Federal Circuit held that two generic drug manufacturers' use of a patented process to determine whether generic drug compound batches meet certain quality standards do not infringe under 35 U.S.C. Section 271(g). The court also held that the district court erred in concluding that one of the generic manufacturer's activities fell within the 35 U.S.C. Section 271(e)(1) infringement safe harbor.
On November 10, 2015, in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., the US Court of Appeals for the Federal Circuit:
  • Affirmed-in-part the US District Court for the District of Massachusetts' holdings that neither Teva Pharmaceuticals USA Inc. nor Amphastar Pharmaceuticals Inc. infringed Momenta Pharmaceuticals, Inc.'s process patent under 35 U.S.C. Section 271(g) because using the claimed quality control testing process for a particular compound is not making the compound using the process.
  • Vacated and remanded the district court's grant of summary judgment holding that Amphastar's activities fell within the 35 U.S.C. Section 271(e)(1) infringement safe harbor.
    ( (Fed. Cir. Nov. 10, 2015).)
Momenta is a generic drug manufacturer and was the first company to market a generic version of the anticoagulant enoxaparin. Momenta sued both Teva and Amphastar for infringement of US Patent No. 7,575,886 (the '866 patent), which is directed to a process for ensuring that a batch of generic enoxaparin meets certain quality standards. Teva Pharmaceuticals imports its product from an Italian company. Amphastar manufactures its product in the US.
The district court granted summary judgment in favor of Teva and Amphastar holding that:
  • Teva's conduct did not infringe under 35 U.S.C. Section 271(g), which prohibits selling products within the US that have been made by a process patented in the US.
  • Teva and Amphastar were not liable for infringement because their conduct fell within the 35 U.S.C. Section 271(e)(1) safe harbor, which generally allows a party to use a patented invention solely for uses reasonably related to developing and submitting information to the FDA.
On appeal, the Federal Circuit affirmed the district court's infringement determination under section 271(g) but vacated and remanded its holding that Amphastra's activities fell within the section 271(e)(1) safe harbor.
The Federal Circuit explained that Teva's and Amphastar's enoxaparin products are not "made by" Momenta's patented process within the meaning of section 271(g) because:
  • Limiting section 271(g) to the actual making of a product is more consistent with the language of the statute than extending it to include methods of testing an intermediate or final product since:
    • dictionaries define forms of the word "make" to involve the creation or bringing into existence of something;
    • Federal Circuit precedent equated "made" in the statute with "manufacture", which dictionaries define as involving the creation or bringing into existence of something; and
    • US Supreme Court precedent approved of a "manufacture" definition that means giving raw or prepared materials new qualities or properties.
  • The quality control testing does not create or give new properties to the enoxaparin in the batches that are selected for further processing. Instead the testing is conducted on enoxaparin samples extracted from an enoxaparin batch, which may then be selected for incorporation into the finished product.
  • Federal Circuit precedent has held that a product was not "made by" a US patented process under section 271(g) where the patented process was:
    • not used in the actual synthesis of the drug product; or
    • used to merely determine whether the intended product has been already made.
  • All the claims of the '886 patent are directed to a method of analyzing a sample, which indicates that the claimed invention requires the sample to already have been made.
  • The FDA "manufacture" definition does not control section 271(g).
In addressing the section 271(e)(1) safe harbor, the Federal Circuit pointed out that:
  • It does not apply to information that may be routinely reported to the FDA after marketing approval.
  • Amphastar's quality control activities:
    • generate information on each enoxaparin batch that is routinely recorded and retained as required by regulation; and
    • is part of its post-approval, commercial production process.