Source: https://www.orangebookblog.com/2012/02/index.html
Timestamp: 2019-04-20 06:30:38+00:00

Document:
American Conference Institute will be holding its 16th Advanced Forum on Life Sciences Collaborative Agreements and M&A in New York on February 27th and 28th.
In addition, ACI is offering a post-conference Life Sciences M&A/Strategic Alliances Due Diligence Master Class on February 29th.
In a precedential decision today, the Federal Circuit held for the first time that an ANDA applicant who files a Section viii statement with respect to a method-of-use patent and, accordingly, does not seek approval of its ANDA product for the patented use, cannot be found liable for infringement of the patent under 35 U.S.C. § 271(e)(2). Thus, the Federal Circuit dismissed AstraZeneca's § 271(e)(2) infringement claims against ANDA applicants for generic versions of CRESTOR (rosuvastatin calcium) pursuant to Fed. R. Civ. P. 12(b)(6).
As explained more fully in our post on the district court decision in this case, AstraZeneca sued numerous generic companies who filed ANDAs for generic CRESTOR, alleging infringement of U.S. Patent Nos. 6,858,618 (claiming a method of treating heterozygous familial hypercholesterolemia ("HeFH")) and 7,030,152 (claiming a method of lowering the cardiovascular disease risk for individuals with elevated C-reactive protein). The ANDA applicants, however, had filed Section viii statements with respect to both patents, seeking approval of their ANDA products for only unpatented uses (namely, the treatment of homozygous familial hypercholesterolemia ("HoFH") and hypertriglyceridemia).
It shall be an act of infringement to submit--(A) an application [i.e., an ANDA] under section 505(j) of the Federal Food, Drug, and Cosmetic Act [codified at 21 U.S.C. § 355(j)] for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.
[W]e again reject the contention that filing an ANDA for a drug having any patented use automatically constitutes infringement under § 271(e)(2). As we held in Warner-Lambert, a patented method of using a drug can only be infringed under § 271(e)(2) by filing an ANDA that seeks approval to market the drug for that use.
AstraZeneca attempted to distinguish Warner-Lambert from this case on the basis that in Warner-Lambert the patent-in-suit claimed an off-label use, but the court found that distinction "irrelevant for purposes of § 271(e)(2)." What matters instead is "the scope of approval sought in the ANDA."
Today's decision preserves the labeling carve-out and Section viii statement as a viable route to FDA approval of generic drugs. A contrary decision would have dramatically limited the utility of the Section viii route.
In a press release today, the FDA announced the publication of three draft guidance documents on biosimilar product development "to assist industry in developing such products in the United States." FDA is seeking public comment on the draft guidance documents.
Scientific Considerations in Demonstrating Biosimilarity to a Referenced Product--intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product.
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product--provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product.
Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009--provides answers to common questions that may arise in the early stages of product development.

References: § 271
 § 271
 § 355
 § 271
 § 271
 § 271