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Healthcare Biologics and Severability Will the ACA and the BPCIA Survive the Latest Challenge?

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The Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) is looking alive and well after last week’s Supreme Court oral argument on the Affordable Care Act (“ACA”).

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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Healthcare, Biologics, and Severability: Will the ACA—and the BPCIA—Survive the Latest Challenge?

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<div class="li-text-orange">Joe Palmore co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Chambers USA describes him as “an outstanding oral advocate,” who is “calm, focused, effective and doesn’t back down,” and has “complete command of the facts.” Joe “writes great briefs” (Chambers USA), with one client recounting that “the Court mirrored the language he thoughtfully chose in its ultimate order” (Legal 500).Joe has argued 13 cases in the U.S. Supreme Court. Law360 called one of them (Thole v. U.S. Bank) a “landmark ruling” that “made huge waves in the ERISA litigation arena” and named another (Atlantic Richfield Co. v. Christian) one of the “biggest environmental law decisions” of the year. Joe’s oral argument before the Supreme Court on the preemptive scope of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) in CTS Corp. v. Waldburger was described in the National Law Journal as “brilliant” and a “template for anyone arguing a statutory case before these nine justices in the future.”Joe’s practice extends to federal and state appellate courts across the country, where he has handled appeals on issues as varied as antitrust, class actions, communications, false advertising, intellectual property, contract disputes, and securities. Joe has secured important victories in the Second Circuit, where he clerked. For example, he prevailed in a securities class action for an online marketplace and a fraud case against an investment bank. A <a href="/resources/news/210426-no-circuit-split.html" target="_self">Reuters columnist</a> called one of Joe’s Second Circuit wins a “major ruling” that “put significant qualifiers” on constitutional standing to sue in data breach cases.Joe also has a successful track record in the Ninth Circuit, including winning for a software company in a securities class action, a beverage company defending against an antitrust suit and an equipment manufacturer embroiled in a dispute over U.S. discovery for foreign litigation. One of Joe’s victories in the Federal Circuit was described by another practitioner as having “saved from the fire tens of thousands of patents that would have gone up in smoke.” Joe frequently appears before New York state appellate courts, having argued and won appeals in the New York Court of Appeals and the Appellate Division, First Department. He has also handled appeals in other state appellate courts, including those of California, Massachusetts, New Jersey, and Kentucky.Before joining Morrison Foerster, Joe served as an Assistant to the Solicitor General at the U.S. Department of Justice. During his nearly five years in the Solicitor General’s Office, Joe represented the United States in the Supreme Court on a range of civil, criminal, and regulatory cases. He received the Attorney General’s Award for Exceptional Service—the Department of Justice’s highest honor for employee performance—and the Environmental Protection Agency General Counsel’s medal.Before working for the Justice Department, Joe spent three years as Deputy General Counsel at the Federal Communications Commission, where he oversaw all litigation involving constitutional, statutory, and administrative-law challenges to the agency’s actions and presented oral argument in the D.C. Circuit and other federal courts of appeals. His FCC experience includes virtually all aspects of communications regulation, including broadcast, cable, wireless, wireline, and Internet.Joe clerked for Justice Ruth Bader Ginsburg of the U.S. Supreme Court, Judge John Gleeson of the U.S. District Court for the Eastern District of New York, and Judge Dennis Jacobs of the U.S. Court of Appeals for the Second Circuit in New York. Joe earned his J.D. from the University of Virginia School of Law, his M.A. in legal history from the University of Virginia, and his A.B. magna cum laude from Harvard University.Joe is a Fellow in the American Academy of Appellate Lawyers, selected for his distinction as an appellate lawyer. He is also a board member of the Historical Society of the District of Columbia Circuit; a master in, and former officer of, the Coke Appellate Inn at Court; a member of the Technology Litigation Advisory Committee of the U.S. Chamber Litigation Center; and a former co-chair of the Federal Communications Bar Association’s judicial practice committee.He is recommended annually by Chambers USA, Legal 500, and Best Lawyers for appellate law.</div><h4>Supreme Court Arguments</h4><ul class="li-text-orange"><li class="li-text-orange"><a href="/resources/video-audio/250121-mclaughlin-chiropractic-assoc-v-mckesson" target="_self">McLaughlin Chiropractic Assoc. v. McKesson Corp.</a> (28:16) Whether the Hobbs Act’s grant of exclusive jurisdiction to courts of appeals to review FCC orders bars collateral review of the merits of FCC orders in private-party litigation</li><li><a href="/resources/video-audio/200113-thole-v-u-s-bank.html" target="_self">Thole v. U. S. Bank, N. A.</a> (28:15) Whether Article III of the Constitution requires a plaintiff to demonstrate individual financial loss or the imminent risk of financial loss to assert a fiduciary duty claim against a pension plan</li><li><a href="/resources/video-audio/191203-atlantic-richfield-v-christian.html" target="_self">Atlantic Richfield Co. v. Christian</a> (28:10) Whether state-law pollution clean-up remedies are barred by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)</li><li><a href="/resources/video-audio/140423-cts-corp-waldburger.html" target="_self">CTS Corp. v. Waldburger</a> (16:22) Whether the U.S. Court of Appeals for the Fourth Circuit correctly interpreted the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) to apply to statutes of repose as well as to statutes of limitations</li><li><a href="/resources/video-audio/140122-abramski-v-united-states.html" target="_self">Abramski v. United States</a> (26:01) Involving the materiality of a false statement made when purchasing a firearm</li><li><a href="/resources/video-audio/131113-fernandez-california.html" target="_self">Fernandez v. California</a> (42:27) Whether the Fourth Amendment prohibits a warrantless search of a residence when the defendant has previously objected to a search but is no longer present and the co-tenant consents</li><li><a href="/resources/video-audio/121031-florida-harris.html" target="_self">Florida v. Harris</a> (16:55) Whether a drug-detection dog’s alert to the exterior of a vehicle provides an officer with probable cause to conduct a warrantless search of the interior of the vehicle</li><li><a href="/resources/video-audio/130320-horne-department-agriculture.html" target="_self">Horne v. Department of Agriculture</a> (26:50) Involving jurisdictional requirements for Takings Clause claims</li><li><a href="/resources/video-audio/121127-us-airways-inc-mccutchen.html" target="_self">US Airways v. McCutchen</a> (21:18) Involving the limits on equitable relief available in suits against ERISA plans by beneficiaries and participants</li><li><a href="http://www.mofo.com/resources/video-audio/111011-pacific-operators-offshore-valladolid.html">Pacific Operators Offshore v. Valladolid</a> (25:36) Involving the territorial limits on compensation available under the Outer Continental Shelf Lands Act</li><li><a href="/resources/video-audio/120111-roberts-v-sea-land-services.html" target="_self">Roberts v. Sea-Land Services</a> (27:53) Involving benefit calculations under the Longshore and Harbor Workers’ Compensation Act</li><li><a href="/resources/video-audio/110322-borough-duryea-guarnieri.html" target="_self">Borough of Duryea v. Guarnieri</a> (19:16) Whether state and local government employees may sue their employers for retaliation under the First Amendment’s Petition Clause when they petition the government on matters of private concern</li><li><a href="/resources/video-audio/101208-chase-bank-usa-mccoy.html" target="_self">Chase Bank USA v. McCoy</a> (17:23) Whether Regulation Z of the Truth in Lending Act requires a creditor to give cardholders advance notice any time they raise the interest rate for default</li></ul><h4>Representative Appellate Arguments</h4><ul class="li-text-orange"><li><a href="/resources/video-audio/250318-divx-v-harman-int-l" target="_self">DivX v. Harman Int’l </a>(2:13:08) (New York Appellate Division, First Department) Secured victory on all appeal and cross-appeal issues in commercial dispute</li><li class="li-text-orange"><a href="/resources/video-audio/231005-klin-v-cloudera-inc" target="_self">Klin v. Cloudera, Inc.</a> (12:34) (9th Cir.) Secured affirmance of dismissal of securities fraud suit for failure to allege falsity</li><li><a href="/resources/video-audio/221013-wamai-v-industrial-bank-of-korea" target="_self">Wamai v. Industrial Bank of Korea</a> (10:51) (2d Cir.) Secured affirmance of forum non conveniens dismissal of fraudulent conveyance claims against foreign bank</li><li><a href="/resources/video-audio/211210-andrew-cohen-v-apple-inc" target="_self">Cohen v. Apple Inc.</a> (19:10) (9th Cir.) Successfully defended dismissal of state-law claims as preempted by Communications Act</li><li><a href="/resources/video-audio/210901-veroblue-farms-usa-inc-v-canaccord-genuity-llc" target="_self">VeroBlue Farms USA Inc. v. Canaccord Genuity LLC</a> (14:17) (2d Cir.) Successfully defended dismissal of fraud claim against investment bank</li><li><a href="https://www2.ca3.uscourts.gov/oralargument/audio/22-1379_22-1380_McLarenv.UPS.mp3" target="_blank">McLaren v. The UPS Store Inc.</a> (0:41 & 46:04) (3d Cir.) Secured reversal of order remanding cases to state court</li><li><a href="/resources/video-audio/211030-cho-v-blackberry-ltd.html" target="_self">Cho et al. v. BlackBerry Limited et al.</a> (16:12) (2d Cir.) Successfully defended dismissal of named plaintiffs’ individual securities claims on res judicata grounds in putative securities class action</li><li><a href="/resources/video-audio/200409-richardson-v-the-ups-store.html" target="_self">Richardson v. The UPS Store, Inc.</a> (35:34) (Massachusetts Supreme Judicial Court) Secured win on question certified by federal district court on meaning of Massachusetts notary statutes</li><li><a href="/resources/video-audio/180705-firefighters-retirement-consulting-services-group.html" target="_self">Firefighters’ Retirement System, et al. v. Consulting Services Group</a> (15:34) (5th Cir.) Secured reversal of district court and dismissal with prejudice of accounting malpractice suit as time-barred</li><li><a href="/resources/video-audio/190418-altayyar-v-etsy.html" target="_self">Altayyar v. Etsy, Inc.</a> (08:42) (2d Cir.) Secured dismissal of securities fraud case</li><li><a href="/resources/video-audio/180112-raytheon-company-indigo-systems-corporation.html" target="_self">Raytheon Company v. Indigo Systems Corporation</a> (12:49) (Fed. Cir.) Defeated attempt to upend jury verdict of no-liability in long-running trade secrets case</li><li><a href="/resources/video-audio/190102-first-advantage-v-lexisnexis.html" target="_self">First Advantage LNS, Inc., et al. v. LexisNexis Risk Solutions, Inc.</a> (1:29:50) (New York Appellate Division, First Department) Secured victory for LexisNexis in significant contract dispute</li><li><a href="/resources/video-audio/171207-nikon-corporation-asml-us.html" target="_self">Nikon Corporation v. ASML US, Inc.</a> (33:50) (9th Cir.) Secured U.S. discovery for use in foreign patent litigation</li><li><a href="/resources/video-audio/161020-odunbaku-v-odunbaku.html" target="_self">Odunbaku v. Odunbaku</a> (00:11) (New York Court of Appeals) Secured a unanimous ruling for client seeking child support and established important procedural protections for litigants in New York’s family courts</li><li>Bank v. Uber Technologies, Inc. (2d Cir.) Obtained dismissal of a Telephone Consumer Protection Act suit on the ground that the call was political speech</li><li><a href="/resources/video-audio/160719-helping-hand-tool-environmental-protection.html" target="_self">Helping Hand Tools et al. v. U.S. Environmental Protection Agency et al.</a> (32:09) (9th Cir.) Secured a victory in a case that set an important precedent for regulation of greenhouse gas emissions from combustion of renewable biofuels</li><li><a href="/resources/video-audio/160506-immersion-corp-htc-corp.html" target="_self">Immersion Corp. v. HTC Corp.</a> (00:07) (Fed. Cir.) Securing reversal of district court, successfully defended the timeliness of Immersion’s patent application and, by extension, those of tens of thousands of patent owners whose patents were at risk of invalidation</li><li>Nelson Coniglio, et al. v. Bank of America, NA (11th Cir.) Secured reversal of default judgment against Bank of America</li><li><a href="/resources/video-audio/150915-gregory-berry-lexisnexis-risk-information.html" target="_self">Gregory Berry v. LexisNexis Risk & Information</a> (28:30) (4th Cir.) Defended settlement of one of the largest class actions ever certified from objector challenges</li><li><a href="/resources/video-audio/150325-gnc-corporation-marketing-sales-practices.html" target="_self">In re: GNC Corporation; Triflex Products Marketing and Sales Practices Litigation</a> (15:42) (4th Cir.) Secured dismissal of false-labelling claim against GNC</li><li><a href="/resources/video-audio/091016-core-communications-inc-fcc.html" target="_self">Core Communications, Inc. v. FCC</a> (23:01) (D.C. Cir.) Successfully defended FCC’s intercarrier compensation rules</li><li><a href="/resources/video-audio/080313-star-wireless-llc-fcc.html" target="_self">Star Wireless LLC v. FCC, et al.</a> (16:40) (D.C. Cir.) Defeated challenge to imposition of monetary forfeiture for violation of wireless auction anti-collusion rules</li></ul>