Brian Burgess

Brian Burgess is a partner in Goodwin’s Litigation department and Appellate and Supreme Court Litigation practice, co-chairs the firm’s FDA Litigation practice (which was honored by LMG in 2022 and 2023 as the FDA Litigation & Enforcement Firm of the Year) and is a member of the firm’s Life Sciences Disputes group. His work focuses on appellate matters and complex civil litigation in federal courts, and he has experience in a wide range of areas including antitrust law, administrative law (with a particular focus on FDA litigation), constitutional law, environmental law, and intellectual property. Brian has argued appeals in numerous courts, including twice in the US Supreme Court.

Brian has been recognized in Chambers USA: America’s Leading Lawyers for Business as an “Up and Coming” attorney in the Nationwide Appellate Rankings, where he is noted in particular for “expertise in advising life sciences clients in disputes work.” Clients laud Brian for providing “timely and helpful advice across a variety of issues” and describe him as “a tremendous up-and-coming litigator” with “the unique skill of taking complicated controversial topics and making them simple, understandable and logical.” Another client notes that Brian is “a phenomenal lawyer with an impressive command of a variety of issues” and describes him as “a good writer and a strong oral advocate” with “tremendous drive.” Brian has also been named to Benchmark Litigation’s “40 & Under Hot List” for seven consecutive years, from 2017-2023 and is a recommended lawyer for appellate by the Legal 500. In 2020, Brian was named a "DC Rising Star" by the National Law Journal.  In 2024, Brian was recognized by Best Lawyers in America for his work in FDA Law.

Prior to joining Goodwin, Brian served as a law clerk to Associate Justice Sonia Sotomayor of the Supreme Court of the United States. He previously worked in the Department of Justice as a special assistant to the Solicitor General.

Brian has handled complex litigation matters in the Supreme Court; in the First, Second, Third, Fourth, Fifth, Sixth, Seventh, Ninth, DC and Federal Circuits; in several state appellate courts; in bankruptcy court; in the International Trade Commission; and in numerous federal and state trial courts.

Brian has briefed and argued several significant recent appeals:

• Argued appeal in DC Circuit behalf of pharmaceutical company as intervenor defending against challenge to FDA approval of section 505(b)(2) application premised on a challenge to the FDA’s classification of a product as a drug rather than a biologic.  Court rejected challenge to client’s approval.  See Ipsen BioPharms, Inc. v. Becerra, --F.4th --, 2024 WL 3529399 (D.C. Cir. 2024). 
• Argued appeal in DC Circuit as intervenor in defense of Department of Transportation orders approving client’s participation in the Maritime Security Program, with court adopting client’s jurisdictional position.  See Matson Navigation Co. v. U.S. Dep’t of Transp., 77 F.4th 1151 (D.C. Cir. 2023).
• Led successful appeal in New Mexico Supreme Court on issue of personal jurisdiction for a pharmaceutical company in an antitrust litigation initiated by the New Mexico Attorney General, resulting in vacatur and remand.
• Led successful appeal in the Third Circuit of adversary judgment in bankruptcy adversary action regarding the scope of a channeling injunction for asbestos claims under 11 U.S.C. 524(g), resulting in vacatur and remand. See In re: W.R. Grace & Co., 13 F. 4th 279 (3d Cir. 2021).
• Successfully defended class-action settlement in antitrust litigation in the Second Circuit on appeal raising issue of first impression concerning the authority of claims administrators to opt customers out of class actions. See In re Aggrenox Antitrust Litig., 812 F. App’x 26 (2d Cir. 2020).
• Successfully represented the National Mining Association in the DC Circuit in defense of the decision by the Environmental Protection Agency not to finalize new “financial responsibility” requirements for the hardrock mining industry under Section 108(b) of CERCLA. Presented oral argument on behalf of coalition of industry intervenors. See Idaho Conservation League v. Wheeler, 930 F.3d 494 (D.C. Cir. 2019).
• Persuaded the US Supreme Court to grant certiorari in two matters in the 2019 Term, led merits briefing, and presented oral argument. Secured 7-2 decision for a habeas petitioner, in a decision holding that restrictions on second or successive habeas petitions are not applicable to timely motions for reconsideration under Rule 59(e). See Banister v. Davis, 140 S. Ct. 1698 (2020).
• Successfully defended judgment for BarBri, Inc. in affirmance of claims brought by a bar-exam competitor under the Sherman Act and RICO. Brian co-authored motion to dismiss briefing in litigation in the Southern District of New York, and then led successful appellate effort in the Second Circuit. See LLM Bar Exam, LLC v. BarBri, Inc., 922 F.3d 136 (2d Cir. 2019).
• Successfully defended post-trial JMOL for DCo LLC in the Ninth Circuit in wrongful death action based on alleged asbestos exposure. See Jack v. DCo LLC et al., 837 F. App’x 421 (9th Cir. 2021).
• Persuaded the Washington Court of Appeals to grant interlocutory review and then reverse the denial of clients’ motion for summary judgment in product liability case involving the prescription drug metoclopramide. The decision rejected an effort by the plaintiff to expand the scope of a drug company’s duty to warn under state law to extend beyond the warnings provided with a product’s package insert. See Sherman v. Pfizer, Inc., P.3d, 2019 WL 1923583 (Wash. App. 2019).

Brian's FDA litigation matters include:

• Led litigation on behalf of pharmaceutical company as intervenor defending against challenge to approval of section 505(b)(2) application premised on a challenge to the FDA’s classification of a product as a drug rather than a biologic.  Successfully obtained summary judgment upholding client’s approval.  See Ipsen Biopharm., Inc. v. Becerra, No. 22-cv-860 (D.D.C.).
• Leading litigation on behalf of pharmaceutical company as intervenor defending approval of ANDA product in challenge premised labeling requirements.  Successfully opposed preliminary injunction. See Vanda Pharms. Inc. v. FDA, No. 23-cv-280 (D.D.C.)
• Led challenge on behalf of e-cigarette manufacturer to challenge an FDA marketing denial. See Breeze Smoke, LLC v. FDA, 18 F. 4th 499 (6th Cir. 2021). 
• Led litigation on behalf of pharmaceutical company as intervenor defending award of 180-day exclusivity for application to market generic buprenorphine film against forfeiture challenge by competitor. See Alvogen, Inc. v. Becerra et al., No. 21-cv-672 (D.D.C.).
• Represented pharmaceutical company in action challenging FDA award of NCE exclusivity. See Sandoz v. Becerra et al., No. 21-cv-600 (D.D.C.)
• Represented pharmaceutical company in challenge to approval of 505(b)(2) application brought by competitor asserting that NCE exclusivity barred receipt of application and approval. See Genus Lifesciences, Inc. v. Becerra et al., No. 20-cv-211 (D.D.C.).
• Co-authored brief in D.C. Circuit on behalf of a pharmaceutical company defending approval of its new drug application against a competitor’s exclusivity challenge. The D.C. Circuit upheld FDA’s approval of our client’s application in a decision that set an important precedent on the scope of three-year exclusivities for new clinical investigations. See Otsuka Pharm. Co. v. Price, 869 F.3d 987 (D.C. Cir. 2017).

Brian’s other significant matters include:

• Leading litigation efforts by the Association of American Railroads and the American Short Line & Regional Railroad Association in challenge to regulations adopted by the California Air Resources Board targeting the railroad industry.
• Led merits briefing in several matters in the US Supreme Court. Co-authored brief and served as second-chair in Supreme Court litigation concerning the test for whether an artistic design feature can qualify for a copyright. Brian represented the copyright owner, which designed original artwork appearing on clothing. The Supreme Court held by a vote of 6-2 that the designs were copyright-eligible. Star Athletica, LLC v. Varsity Brands, Inc., 137 S. Ct. 1002 (2017). Also co-authored merits brief in Washington v. United States on behalf of a group of Tribes, in which the Supreme Court affirmed a lower-court injunction requiring the State to replace culverts that blocked salmon passage in violation of tribal fishing rights protected by treaty.
• Co-authored briefs in the Second Circuit on behalf of a major banking client in a putative class-action alleging violations of the Racketeering Influenced and Corrupt Organizations Act based on the rates charged for lender-placed insurance. Successfully obtained interlocutory review and reversal of adverse judgment resulting in an order to dismiss all claims. See Rothstein v. Balboa Insurance Company, 794 F.3d 256 (2d Cir. 2015).
• Leading briefing and motions practice in antitrust actions filed against a leading pharmaceutical company asserting theories of monopolization, including allegations of “sham” petitioning and “product hopping.”
• Has defended a leading pharmaceutical manufacturer in several putative class actions challenging patent litigation settlements on antitrust grounds, initiated after the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013). Co-authored numerous appellate briefs and district court motions Supported trial team in landmark defense victory in multiple billion dollar HIV drug litigation.
• Co-authored several briefs in opposition to petition for certiorari in the Supreme Court, including a brief in a First Amendment challenge to a transit authority’s advertising policy, a brief concerning the rules for claim construction in patent litigation, and a brief in a Sixth Amendment sentencing case in opposition to the Michigan Attorney General.
• Successfully led arbitration on behalf of insurance client in defense against breach of contract in settlement agreement entered in connection with an asbestos bankruptcy.

Brian is a member of the Edward Coke Appellate Inn of Court in Washington, DC, and is a regular participant at Georgetown Law School’s Supreme Court Institute.

In 2024, Brian was recognized by The Best Lawyers in America Best Lawyers for his work in FDA Law. Brian was recognized for his work in Appellate by The Legal 500 2021-2024. Brian was also recognized in Chambers USA as “Up and Coming” in Nationwide Appellate Litigation in 2021 and 2022. Brian has been named to Benchmark Litigation’s “40 & Under Hot List” for eight consecutive years, from 2017-2024. In 2020, Brian was also named a "D.C. Rising Star" by the National Law Journal.

Brian’s recent publications include:

• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S. 2023-2024 ed.,” published by Thomson Reuters, January 2024
• Co-Author, “Federal Court of Appeals Rejects HHS Stance on Section 340B Contract Pharmacies,” Goodwin Alert, February 2023
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S.,” published by Thomson Reuters, December 2022
• Co-Author, “Federal District Court Ruling May Jeopardize Insurance Coverage of More Than 50 Recommended Procedures, Screenings, and Treatments,” Goodwin Alert, September 2022
• Co-Author, “First Circuit,” US Courts Annual Review, Global Competition Review, 2020, 2021 & 2022
• Co-Author, “Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations,” Goodwin Alert, April 2021
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 ed.,” Thomson Reuters, February 2021
• Co-Author, “Congress Enacts Amendments Affecting the Regulation of Generic Drugs and Biosimilars,” Goodwin Alert, January 2021
• Author, “Federal Circuit Narrows Venue for Patent Infringement Suits Under the Hatch-Waxman Act,” Goodwin Alert, November 2020
• Co-Author, “U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights,” Goodwin Alert, April 2020
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed.,” published by Thomson Reuters, November 2019
• Co-Author, “Will New Jersey’s Bet On Sports Gambling Pay Off?,” Law360, January 2018

Brian’s recent speaking engagements include:

• Speaker, “Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions,” 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA, October 2023
• Speaker, “Legal Challenges to the Inflation Reduction Act: An Update on Pending Challenges and Reactions to Oral Argument in Dayton Area Chamber Of Commerce et al. v. Becerra et al.,” Goodwin Webinar, September 2023
• Speaker, “FDA Approval is Coming: Part 1 – Securing Exclusivities and Maximizing Patent Term,” Goodwin Webinar, November 2022
• Speaker, “Interchangeable Biosimilars – Emerging Legal Issues and Trends,” FDLI Annual Conference, June 2022
• Speaker, “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” FDLI’s Enforcement, Litigation, and Compliance Conference, December 2021
• Speaker, “Trends and Developments,” PLI Fashion and Retail Law, May 2018
• Panelist, “Sanctuary Cities Litigation,” IMLA's 82nd Annual Conference, October 2017
• Speaker, “TC Heartland's Impact on Hatch-Waxman,” Goodwin Webinar, June 2017
• Speaker, “SCOTUS Series - TC Heartland LLC v. Kraft Foods Group Brands LLC,” American University College of Law, March 2017