Description
48
Top Food and Drug Cases, 2015 & Cases to Watch, 2016
enjoyed by innovator biologic drug makers as to when the
biosimilar applicant can enter the marketplace.
PRODUCT HOPPING
“Product Hopping” describes the introduction of product
enhancements aimed at minimizing generic substitution.
In New York v. Actavis PLC,8 the U.S. Court of Appeals
considered the legal limits of “product hopping” for the
first time at the appellate level. The district court granted
an injunction, and the Second Circuit affirmed, ruling that
Actavis likely violated Section 2 of the Sherman Act by
removing twice-daily Alzheimer’s medicine, Namenda
IR, from the market prior to generic entry.
This case was appealed and the parties subsequently settled, (the petition for a writ of certiorari being withdrawn). While Actavis has been settled, the question under consideration has not. In Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Ltd.,9 the plaintiffs brought monopolization claims against the defendants for product hopping, which the district court dismissed on summary judgment.
The case has now been appealed to the Third Circuit, and the Federal Trade Commission has filed an amicus brief. Food and Drug Law Institute acid is unpatentable as a law of nature. It is important to note that other jurisdictions, such as the European Patent Office, do not impose these same restrictions on patent eligible subject matter. For example, the EU patent related to the U.S. patent at issue in Ariosa survived opposition in Europe.12 It remains to be seen whether Sequenom will petition for certiorari and, if so, whether the Supreme Court will grant review.
It seems Ariosa will further the chilling effect of Mayo on innovations in genetic and diagnostic testing. The unfavorable patent climate and long recognized difference in regulatory approval time between FDA and the European Medicines Evaluation Agency continue to be concerning for the life science industry and for innovation in the United States. ENDNOTES 1 135 S. Ct.
2218 (2015). 2 131 S. Ct. 2653 (2011). 3 No.
15-cv-3588, --- F. Supp. 3d --- (S.D.N.Y.
Aug. 7, 2015). 4 703 F.3d 149 (2d Cir. 2012). 5 No.
1:15-cv-07055, Complaint for Declaratory and Injunctive Relief filed on September 8, 2015. 6 See Janet Woodcock’s list of front burner priorities for 2016 at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM477299.pdf. In Ariosa Diagnostics Inc. v. Sequenom Inc, the Federal Circuit continued to apply Mayo Collaborative Services v. Prometheus Laboratories, Inc.11 and denied Sequenom’s petition for en banc rehearing, thus affirming the holding that the claimed method of detecting paternally inherited nucleic 787 F.3d 638 (2d Cir.
2015). 9 10 794 F.3d 1347 (Fed. Cir. 2015). 8 PATENTABILITY AND LAWS OF NATURE 7 No.
12-3824, slip op. (E.D. Pa.
Apr. 16, 2015), appeal docketed, No. 15-2236 (3d Cir.
May 14, 2015). 10 788 F.3d 1371 (Fed. Cir. 2015). 11 132 S.
Ct. 1289 (2012). 12 Appeal Case No. T 146/07 – 3.3.08, decided December 13, 2011.
http://www. epo.org/law-practice/case-law-appeals/pdf/t070146eu1.pdf. .
This case was appealed and the parties subsequently settled, (the petition for a writ of certiorari being withdrawn). While Actavis has been settled, the question under consideration has not. In Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Ltd.,9 the plaintiffs brought monopolization claims against the defendants for product hopping, which the district court dismissed on summary judgment.
The case has now been appealed to the Third Circuit, and the Federal Trade Commission has filed an amicus brief. Food and Drug Law Institute acid is unpatentable as a law of nature. It is important to note that other jurisdictions, such as the European Patent Office, do not impose these same restrictions on patent eligible subject matter. For example, the EU patent related to the U.S. patent at issue in Ariosa survived opposition in Europe.12 It remains to be seen whether Sequenom will petition for certiorari and, if so, whether the Supreme Court will grant review.
It seems Ariosa will further the chilling effect of Mayo on innovations in genetic and diagnostic testing. The unfavorable patent climate and long recognized difference in regulatory approval time between FDA and the European Medicines Evaluation Agency continue to be concerning for the life science industry and for innovation in the United States. ENDNOTES 1 135 S. Ct.
2218 (2015). 2 131 S. Ct. 2653 (2011). 3 No.
15-cv-3588, --- F. Supp. 3d --- (S.D.N.Y.
Aug. 7, 2015). 4 703 F.3d 149 (2d Cir. 2012). 5 No.
1:15-cv-07055, Complaint for Declaratory and Injunctive Relief filed on September 8, 2015. 6 See Janet Woodcock’s list of front burner priorities for 2016 at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM477299.pdf. In Ariosa Diagnostics Inc. v. Sequenom Inc, the Federal Circuit continued to apply Mayo Collaborative Services v. Prometheus Laboratories, Inc.11 and denied Sequenom’s petition for en banc rehearing, thus affirming the holding that the claimed method of detecting paternally inherited nucleic 787 F.3d 638 (2d Cir.
2015). 9 10 794 F.3d 1347 (Fed. Cir. 2015). 8 PATENTABILITY AND LAWS OF NATURE 7 No.
12-3824, slip op. (E.D. Pa.
Apr. 16, 2015), appeal docketed, No. 15-2236 (3d Cir.
May 14, 2015). 10 788 F.3d 1371 (Fed. Cir. 2015). 11 132 S.
Ct. 1289 (2012). 12 Appeal Case No. T 146/07 – 3.3.08, decided December 13, 2011.
http://www. epo.org/law-practice/case-law-appeals/pdf/t070146eu1.pdf. .
