Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto)

July 5, 2016 12:05 PM

Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a preliminary injunction against the biologics license applicant entering the market unless it has given the patentee notice after receiving the requested FDA license and then waiting 180 days. “We hold that the commercial marketing provision is mandatory and enforceable by injunction even for an applicant” who “did launch the statutory process for exchanging patent information and channeling patent litigation.” “We conclude that an applicant must provide a reference product sponsor with 180 days' post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”

A full version of the text is available in PDF form.

Rapid Litigation Management v. Cellzdirect, Inc. (No. 2015-1570, 7/5/16) (Prost, Moore, Stoll)

July 5, 2016 10:40 AM

Prost, C. J. Vacating summary judgment of invalidity under 35 U.S.C. § 101 because the claims were not directed to a patent-ineligible law of nature as the district court held. “The district court identified in these claims what it called a “natural law”—the [hepatocytes] cells' capability of surviving multiple freeze-thaw cycles. We need not decide in this case whether the court's labeling is correct. It is enough in this case to recognize that the claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims of the '929 patent are directed to a new and useful laboratory technique for preserving hepatocytes. This type of constructive process, carried out by an artisan to achieve “a new and useful end,” is precisely the type of claim that is eligible for patenting.” “The inventors certainly discovered the cells' ability to survive multiple freeze-thaw cycles, but that is not where they stopped, nor is it what they patented. … They employed their natural discovery to create a new and improved way of preserving hepatocyte cells for later use.” “Repeating a step that the art taught should be performed only once can hardly be considered routine or conventional. This is true even though it was the inventor's discovery of something natural that led them to do so.”

A full version of the text is available in PDF form.