Description
FOOD AND DRUG LAW INSTITUTE
Top Food and Drug Cases
2015
& Cases to Watch
2016
EDITED BY GREGORY J. WARTMAN
. Top Food and Drug Cases, 2015 & Cases to Watch, 2016
CASES TO WATCH IN 2016
by Gianna J. Arnold and Joey Tsu-Yi Chen
We present herein a range of cases to watch having myriad
implications in the food and drug community. These cases
seem to indicate that 2016 may well be a busy year from a
legal perspective.
FIRST AMENDMENT PROTECTION OF SPEECH
Reed v. Town of Gilbert1
Key decisions in 2015 continue to place FDA’s regulation
of off-label promotion within the cross-hairs of First
Amendment challenges.
In Reed, the U.S. Supreme Court struck down a town ordinance restricting the public display of temporary advertising signs based on categorical content as an unconstitutional violation of free speech. The Supreme Court applied its precedent in Sorrell v. IMS Health, Inc.,2 which invalidated a state law restricting the sale, disclosure, and use of pharmacy records containing prescriber-identifying information is improper contentbased regulation. Accordingly in Reed, the Court held that the town ordinance violated the First Amendment because it drew distinctions based solely on the message or ideas conveyed on the signs. Although Reed does not involve food and drug law, it could have implications in the food and drug community going forward in 2016.
For example, state labeling laws requiring special labeling of foods (e.g., genetically engineered foods) may be subject to heightened judicial scrutiny for content-based regulation of commercial speech. Amarin Pharma, Inc. v. U.S.
Food & Drug Administration3 In Amarin, the federal district court granted a preliminary injunction barring the government from prosecuting Amarin for engaging in truthful and non-misleading speech promoting the off-label use of its drug, Vascepa. The court held that under United States v. Caronia,4 speech that is truthful and non-misleading based on information presently known cannot be misbranding under the FDCA.
The case was settled on March 8, 2016, but the repercussions will be felt as case law continues to develop in this area. Food and Drug Law Institute 47 Other cases have cited Amarin in similar First Amendment challenges to the restriction on off-label promotion. In Pacira Pharmaceuticals, Inc. v.
FDA,5 Pacira filed suit after it received a warning letter from the FDA claiming that its off-label promotion of the non-opioid anesthetic, Exparel, constituted misbranding. Relying on Amarin, Pacira argued that it was permitted to promote its drug so long as its claims were scientifically supported and the speech was non-misleading. Three months later, the parties settled. Although Pacira never made it to trial, it was closely followed by many and has been viewed as a victory for the life sciences industry inasmuch as it appeared to signal FDA’s weakened position regarding off-label promotion of approved drugs.
After these recent developments in First Amendment law, the Center for Drug Evaluation and Research has made re-evaluation of FDA’s regulation of drug advertising and promotion a “front burner priority” for 2016.6 BIOLOGICS PRICE COMPETITION AND INNOVATION ACT OF 2009 (BPCIA) In Amgen Inc. v. Sandoz Inc.,7 the Federal Circuit addressed two issues of first impression relating to the BPCIA.
The Court held that the biosimilar applicant does not need to disclose its abbreviated biologics license application (ABLA) and manufacturing information to the reference product sponsor. The Court further held that the biosimilar applicant must provide notice of commercial marketing to the reference product sponsor, and that effective notice can only be given after FDA licenses the ABLA product. Amgen limits the information available to biologic drug makers regarding a competitor’s application for a biosimilar product while extending the statutory exclusivity period A Saul Ewing LLP partner, Gianna J. Arnold draws from her education and experience in science, business, and law to provide strategic counseling for innovation based companies with an aim to enhancing corporate value. .
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. .
In Reed, the U.S. Supreme Court struck down a town ordinance restricting the public display of temporary advertising signs based on categorical content as an unconstitutional violation of free speech. The Supreme Court applied its precedent in Sorrell v. IMS Health, Inc.,2 which invalidated a state law restricting the sale, disclosure, and use of pharmacy records containing prescriber-identifying information is improper contentbased regulation. Accordingly in Reed, the Court held that the town ordinance violated the First Amendment because it drew distinctions based solely on the message or ideas conveyed on the signs. Although Reed does not involve food and drug law, it could have implications in the food and drug community going forward in 2016.
For example, state labeling laws requiring special labeling of foods (e.g., genetically engineered foods) may be subject to heightened judicial scrutiny for content-based regulation of commercial speech. Amarin Pharma, Inc. v. U.S.
Food & Drug Administration3 In Amarin, the federal district court granted a preliminary injunction barring the government from prosecuting Amarin for engaging in truthful and non-misleading speech promoting the off-label use of its drug, Vascepa. The court held that under United States v. Caronia,4 speech that is truthful and non-misleading based on information presently known cannot be misbranding under the FDCA.
The case was settled on March 8, 2016, but the repercussions will be felt as case law continues to develop in this area. Food and Drug Law Institute 47 Other cases have cited Amarin in similar First Amendment challenges to the restriction on off-label promotion. In Pacira Pharmaceuticals, Inc. v.
FDA,5 Pacira filed suit after it received a warning letter from the FDA claiming that its off-label promotion of the non-opioid anesthetic, Exparel, constituted misbranding. Relying on Amarin, Pacira argued that it was permitted to promote its drug so long as its claims were scientifically supported and the speech was non-misleading. Three months later, the parties settled. Although Pacira never made it to trial, it was closely followed by many and has been viewed as a victory for the life sciences industry inasmuch as it appeared to signal FDA’s weakened position regarding off-label promotion of approved drugs.
After these recent developments in First Amendment law, the Center for Drug Evaluation and Research has made re-evaluation of FDA’s regulation of drug advertising and promotion a “front burner priority” for 2016.6 BIOLOGICS PRICE COMPETITION AND INNOVATION ACT OF 2009 (BPCIA) In Amgen Inc. v. Sandoz Inc.,7 the Federal Circuit addressed two issues of first impression relating to the BPCIA.
The Court held that the biosimilar applicant does not need to disclose its abbreviated biologics license application (ABLA) and manufacturing information to the reference product sponsor. The Court further held that the biosimilar applicant must provide notice of commercial marketing to the reference product sponsor, and that effective notice can only be given after FDA licenses the ABLA product. Amgen limits the information available to biologic drug makers regarding a competitor’s application for a biosimilar product while extending the statutory exclusivity period A Saul Ewing LLP partner, Gianna J. Arnold draws from her education and experience in science, business, and law to provide strategic counseling for innovation based companies with an aim to enhancing corporate value. .
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. .
