Carolyn A. Blessing

Carolyn Blessing concentrates her practice in IP Pharmaceutical matters, Hatch-Waxman litigation and FDA regulatory counseling. She represents pharmaceutical and biotechnology companies in all aspects of federal intellectual property litigation, and she has significant experience counseling generic pharmaceutical companies in federal intellectual property litigation, and counseling food, drug and cosmetic companies in connection with regulatory issues.

Before attending law school, Carolyn gained practical experience working as a neurobiologist for a major pharmaceutical company. While there, she participated in the investigation of multiple sclerosis treatments that focused on promoting and enhancing remyelination. During her undergraduate studies, she conducted senior thesis research and authored a literature study on nuclear Actin Related Proteins (ARPs) and organized and led a project to characterize novel ARP proteins in yeast cells. Additionally, she interned in a pharmaceutical laboratory where she designed and conducted a study of the cross-resistance of test mammalian cancer cell lines to nucleoside based drugs.

Carolyn’s representative experience includes:

Pharmaceutical Litigation and Counseling

Carolyn represents and counsels pharmaceutical and biotechnology companies in all stages of litigation, including pre-litigation activities, Paragraph IV Certifications, filing, fact and expert discovery, claim construction, motion practice, pre-trial, trial, post-trial and appellate phases. She has extensive experience developing invalidity and noninfringement strategies, working with fact and expert witnesses to prepare declarations and reports, taking and defending depositions, and directing and crossing fact and expert witnesses at trial.

Carolyn has had a lead role in matters involving many different pharmaceutical compounds and dosage forms, including oral, transdermal and parenteral formulations; extended- and modified-release formulations; polymorphic drug substances; analytical testing of active pharmaceutical ingredients and final dosage forms; process chemistry; pharmacokinetics; drug delivery systems; bioequivalence studies; and methods of treatment. Her experience includes litigation involving many well-known products, including:

• Bridion® (parenteral formulation for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery)
• Corlanor® (oral formulation used for the symptomatic management of stable heart-related chest pain and heart failure not fully managed by beta blockers)
• Vraylar® (oral formulation for an atypical antipsychotic, which is used in the treatment of schizophrenia, bipolar mania and bipolar depression)
• Viberzi® (oral formulation for the treatment of irritable bowel syndrome)
• Januvia®, Janumet®, Janumet XR® (oral formulations for the treatment of type 2 diabetes in adults)
• Otezla® (oral formulation for the treatment of certain types of psoriasis and psoriatic arthritis)
• Trintellix® (oral formulation for the treatment of depression), Gilenya® (oral formulation for the treatment of multiple sclerosis)
• Eliquis® (oral formulation for the treatment of deep vein thrombosis and pulmonary embolism)
• Sensipar® (oral formulation for the treatment of secondary hyperparathyroidism)
• Myrbetriq® (oral formulation for treating overactive bladder)
• Daliresp® (oral formulation for treating COPD), Axiron® (testosterone metered transdermal solution)
• Trokendi XR® (extended-release capsules for treating certain types of seizures)
• Tygacil® (injectable antibiotic IV infusion)
• Pristiq® (treatment of depression)
• Asacol HD® (treatment of ulcerative colitis)

Regulatory Counseling

Carolyn provides counseling in connection with regulatory issues in the pharmaceutical, food, beverage and cosmetics industries. She has particular experience counseling companies in the cosmetics industry regarding regulatory requirements associated with FDA and USDA compliance, including compliance with the requirements of the Modernization of Cosmetics Regulation Act (MoCRA).

Representative Completed Matters

• Represented generic drug manufacturers in paragraph IV Hatch-Waxman patent infringement litigation concerning five patents related to an oral formulation for the treatment of depression (Trintellix®), resulting in a district court verdict where two patents were not infringed, allowing permitting client entry into the market five and a half years prior to expiry of latest expiring Orange Book patent; on appeal, the Federal Circuit affirmed the judgment
• Represented generic drug manufacturer in paragraph IV Hatch-Waxman patent infringement litigation concerning two patents relating to a testosterone metered transdermal solution (Axiron®) and one patent relating to an applicator device, resulting in a district court verdict where all asserted formulation claims were found invalid and all asserted device claims were not infringed; on appeal, the Federal Circuit affirmed the judgment in its entirety
• At previous firm, represented a major pharmaceutical company in a Hatch-Waxman litigation concerning nine patents relating to one of their blockbuster brand-name drugs, resulting in a district court verdict where all asserted claims were found valid and enforceable and where defendants infringed all asserted claims