Life Sciences

Regulatory Counseling and Litigation 

• Assisted an Indian pharmaceutical manufacturing company with an OIG self-disclosure involving government pricing of an FDA-regulated product. The company turned to our team based on our experience with the FDA and CMS elements of the project. We drafted documents and interacted with the government for the company. We specifically reviewed the company’s pricing and government reporting compliance policies, advised on enhancing these policies, drafted a disclosure to the OIG explaining the compliance lapse involving the price reporting to CMS, discussed the conflict between CMS regulations and the FDA’s authorized generic drug regulations, and assisted with OIG negotiations. We also drafted compliance policies for the company that addressed CMS- and FDA-authorized generic drug price reporting issues.
• Representing private equity clients on acquisitions and sale of FDA-regulated biopharmaceuticals, medical devices, foods and dietary supplement products.
• Representing pharma and medical device clients with FDA response and engagement on enforcement actions.
• Represented a pharmaceutical client on its acquisition of a diabetes medical device asset.
• Conducted risk assessment of a client’s third-party screening strategy and helped the client redesign the program.
• Helped a client successfully respond to an FDA OCI subpoena.
• Counseled defense and life sciences clients regarding mandatory disclosure obligations and multiple voluntary disclosures to the VA, the GSA and the Department of Defense.

Corporate and Business 

• Served as lead corporate and acquisitions counsel to a private equity sponsor in connection with the sale and purchase of portfolio companies in the contract research organization and nutraceutical industries in deals ranging in size from $50 million to $250 million.
• Served as outside general counsel to a large privately held distributor of dietary supplements and health products with respect to general business matters.
• Served as lead counsel to a privately held company developing cancer therapeutics with respect to approximately $90 million in equity and debt offerings and its strategic licensing transactions.
• Served as outside general counsel to a privately held company developing cancer therapeutics with respect to contract negotiations associated with its clinical trials and other general business matters.
• Served as lead U.S. acquisitions counsel for a publicly traded multinational company in its acquisition of a privately held foreign medical device business for approximately 180 million euros.
• Represented a developer, manufacturer and marketer of medical products in its acquisition from a medical device manufacturer of its blow-fill-seal business.
• Represented a biotech research company in numerous merger and acquisition transactions and collaboration arrangements, including the sale of a product division to a medical device company, an exclusive collaboration and license agreement with a biotechnology company, and the sale of a business unit to a foreign purchaser.
• Represented one of the world’s largest pharmaceutical companies in evaluating a potential multibillion-dollar acquisition of a European biotechnology company.
• Represented a cancer therapeutics company in its $400 million sale to a global biopharmaceutical company.
• Represented a medical device company in its $350 million sale transaction.
• Representing an endoscopic medical device company in connection with its equity and debt financings and its strategic licensing transactions.
• Assisted in the representation of a $22 million convertible note financing for a biopharma manufacturer.
• Assisted in the representation of a $3.5 billion equity sale of a biotechnology firm to a major biopharma firm.
• Assisted in the representation of a $30 million tranched syndicated preferred stock investment in a biopharma manufacturer.
• Served as lead corporate and acquisitions counsel to a Fortune 1000 medical device company in multiple acquisitions ranging in size from $100 million to $500 million.
• Served as lead corporate and acquisitions counsel to a Fortune 500 life sciences company in numerous national and multinational acquisitions, joint ventures and equity investments ranging in size from $20 million to $200 million.
• Served as lead corporate and acquisitions counsel to a global provider of clinical, commercial and consulting services to companies in the pharmaceutical, biotech and life sciences industries in acquisitions ranging in size from $5 million to $50 million.
• Advised a dietary supplement distributor during its review of the company’s advertising SOPs.
• Advised a medical company with reporting obligations in its going-private transaction. Retained an investment banker for a fairness opinion, formed a special committee with newly appointed independent directors to assess the fairness of proposed and alternative transactions, drafted current reports on Form 8-K, advised the company on going-private transactions under Rule 13e-3, and drafted Schedule 13e-3, merger agreement and ancillary documents.

Litigation

• Representing Cardinal Health, one of our long-standing clients, in many of the company’s deal activities and litigation matters as well as in a variety of specialty areas.
• Represented a healthcare services company and its employee pharmacists in a wrongful death action arising from an alleged prescription error involving drug look-alike products and sound-alike names.
• Represented a manufacturer of portable mechanical ventilators in a wrongful death case alleging that the unit failed to emit audible or visual alarms.
• Represented a medical device manufacturer in connection with an internal investigation and litigation involving the theft of trade secrets and successfully obtained orders for preliminary injunctions, which were granted by federal courts in two jurisdictions.
• Served as lead counsel for a medical device distributor in federal court in a breach-of-contract action involving a wholesale distribution agreement. The case was settled on favorable terms following a preliminary injunction hearing.
• Served as lead counsel for a medical device distributor in federal court in a breach-of-contract and tort action stemming from a distribution agreement with a group purchasing organization. The lawsuit resolved on favorable terms following motion practice.
• Defeated a putative nationwide class action to recover alleged economic losses consisting of billions of dollars paid by consumers and third-party payers for a prescription hormone drug marketed for 40 years without FDA approval on the basis that it was generally recognized as safe and effective and thus was not a “new drug.” The plaintiffs claimed that the drug was marketed illegally and through false advertising that misled them to believe it was approved. Asked to take over the defense months after filing, we successfully moved to vacate an order of the Judicial Panel on Multidistrict Litigation (MDL), transferring the case to a product liability MDL (In re Prempro MDL 1507); amended the answer to plead new defenses; successfully moved to dismiss the case with prejudice on grounds of primary jurisdiction and preemption; and successfully opposed reconsideration.

Employment 

• Defending a major international pharmaceutical company in multiple lawsuits, Equal Employment Opportunity Commission charges, investigations and other administrative matters across several states. Claims range from whistleblower allegations, wage and hour claims, age discrimination, gender discrimination, race discrimination, and retaliation to alleged FMLA violations. In federal court, we defended the company in a whistleblower lawsuit alleging retaliation under the False Claims Act and other counts. The plaintiff, a former pharmaceutical sales representative, alleged retaliatory termination due to her reports of alleged off-label marketing and alleged kickbacks and false claims. We obtained dismissal of the wrongful discharge, breach of contract and punitive damages claims.
• Defended a major international pharmaceutical company against wage and hour claims in a lawsuit.
• Representing a manufacturer of FDA-registered products in connection with a whistleblower complaint regarding alleged OSHA and related safety violations.

Intellectual Property 

• Representing Johnson & Johnson on patent prosecution matters, spanning a wide array of therapeutics and medical devices. In addition to patent prosecution, we provide all forms of counseling related to patents and technology, including the purchase, sale and licensing of technology as well as corporate acquisitions. Our portfolio management includes monitoring competitor products and patents and providing advice regarding product clearance and patent enforcement.
• Developed multiple patent portfolios, including one drug from inception to pharmaceutical launch, over a 15-year period for a biopharmaceutical company. The intellectual property estate contributed to the acquisition of the company for nearly $500 million.
• Developed patent portfolios from conception to product launch of a licensed biologic drug, and developed and prosecuted the patent strategy for a licensed biologic compound.
• Working as the founding IP counsel for a number of early-stage life sciences companies. Our involvement at the early stage of a life sciences company involves the critical step of IP in-licensing, often from a major university, and the establishment of the company’s IP strategy.
• Have handled numerous licensing negotiations and have developed a wide variety of IP strategies for early-stage life sciences companies. We also have a very strong life sciences patent prosecution group, comprising a number of former scientists and engineers, many of whom hold advanced degrees, who are now patent agents and patent attorneys.
• Negotiated and drafted numerous inbound license agreements for early-stage life sciences clients that are developing a wide variety of technologies pertaining to biologics, nucleic acids, small molecules, antibodies, genetics, vaccines, immunotherapies, protein therapies, blood purification, medical devices, diagnostics, gene therapies and bioinformatics.
• Defended a subsidiary of one of the world’s largest research-based pharmaceutical companies regarding an alleged infringement of patents concerning hepatitis C virus technology in an action brought by a multinational biotechnology firm.
• Assisting a multinational pharmaceutical company in strategic business-making decisions by providing freedom to operate, patent validity and patentability assessments and in evaluating potentially infringing competitor products.
• Assist a multinational pharmaceutical company with its in-licensing of various platform technologies and biological products, including gene therapy assets, monoclonal antibodies, chimeric antigen receptor T-cell therapies and nucleic acids.
• Secured a jury verdict for the University of Pennsylvania in a patent infringement suit involving nucleic acids that code for amyloid precursor protein with the Swedish mutation.
• Conducted due diligence on a patent portfolio and are providing counseling to a life sciences company on freedom to operate the technology and deal terms of the licensing transaction.