Regulatory Counseling and Litigation

Ms. Lin is heavily involved in the firm's regulatory counseling and litigation practice. She concentrates primarily on the statutory and regulatory issues in obtaining FDA approval of generic drugs, under the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act (FDCA) and biosimilars, under the Public Health Service Act (PHSA) and Biologics Price Competition and Innovation Act (BPCIA). She routinely helps clients develop and implement regulatory approval strategies, including issues connected with patent certifications, drug labeling carve-outs, regulatory exclusivities, and other matters related to obtaining approval and managing post-marketing issues.

Ms. Lin also has extensive experience with presenting scientific data and/or legal arguments in administrative submissions to the U.S. Food and Drug Administration or U.S. Patent and Trademark Office, including, among other things, controlled correspondence, citizen petitions, and comments to proposed regulations and policies.

Ms. Lin also has experience in several regulatory disputes arising under the Administrative Procedure Act, including actions brought against the FDA. A sample of significant representations include:

• Teva v. FDA, et al. (D.D.C.): Represented Sandoz as an intervenor defendant in Administrative Procedure Act suit filed by Teva challenging FDA's 'protein' definition and refusal to transition Copaxone (glatiramer acetate) as a drug regulated under the FDCA to a biologic regulated under the PHSA. Member of litigation team that obtained a decision in favor of FDA and Sandoz on a Motion for Summary Judgment.

• Otsuka v. Burwell, et al. (D. Md.): Represented Apotex as an intervenor defendant in Administrative Procedure Act suit filed by Otsuka to block FDA's approval of generic versions of Abilify (aripiprazole) prior expiration of orphan exclusivity for a pediatric indication. Member of litigation team that successfully defeated a motion for preliminary injunction and obtained a decision in favor of FDA and Apotex on a Motion for Summary Judgment.

Ms. Lin also frequently provides legal and strategic advice on competitive issues related to product lifecycle management, including potential settlements of Hatch-Waxman or BPCIA litigations.

Legislative Counseling and Other Relevant Experience

Ms. Lin also has experience assisting corporations and industry trade groups with protecting the interests of the generic drug and biosimilar pharmaceutical industry by evaluating federal and state legislative proposals affecting the pharmaceutical sector, including amendments to the Hatch-Waxman Act, the BPCIA, and patent reform under the America Invents Act (AIA). Ms. Lin has experience with legislative analysis, drafting white papers, and preparation of presentations and materials for meetings with Congressional members and staff in both the U.S. Senate and House.

Ms. Lin has worked with several clients to prepare and file amicus curiae briefs in the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court on a diverse number of issues affecting the pharmaceutical industry.

Previous Experience

Prior to joining RMMS, Ms. Lin served as a patent attorney for Fresenius Kabi USA (formerly known as APP Pharmaceuticals). While at Fresenius Kabi, she worked on a wide-range of intellectual property matters, including those involving pharmaceutical products and medical devices, and was responsible for assisting with the development of global IP strategies.

Ms. Lin also previously was an associate at Winston & Strawn LLP, where she was involved in numerous Hatch-Waxman patent litigation cases.