Add a bookmark to get started

Nicole Endejann

N. Nicole Endejann

Partner
About

Nicole focuses on intellectual property matters, including developing product exclusivity strategies, strategic patent prosecution and counseling, due diligence, and transactional support. Her clients include those in the pharmaceutical, biologic, nutraceutical, cosmetic, medical device, and other health and life sciences fields.

Nicole conducts IP due diligence and counsels on transaction documents involving IP, such as license agreements, collaboration agreements, and mergers and acquisitions. She also advises such clients on the interplay of FDA and patent law on pharmaceutical, nutraceutical, dietary health supplement, and medical device products. Nicole also provides strategic counseling on best practices for the creation and management of robust, value­ driven intellectual property portfolios.

Bar admissionsNew JerseyOhioPennsylvaniaUnited States Patent and Trademark Office
CourtsUnited States District Court for the Northern District of Ohio

EXPERIENCE

Product Exclusivity Strategies

  • Advised companies on the creation and expansion of exclusivity strategies to protect therapeutic products through the interplay of patents, regulatory data and marketing exclusivity, trade secrets and other proprietary rights.
  • Formulated strategies to maximize exclusivity for repurposed or repositioned drugs and biologics, including patent strategy and regulatory data exclusivity.
  • Conducted eligibility assessments for patent listings in the Orange Book.
  • Analyzed eligibility for and prepared patent term extension applications for drugs, biologics and medical devices.
  • Advised on the interplay of FDA and patent law for drugs, biologics and medical device products.

Patent Prosecution and Strategic Counseling

  • Advised a private company focused on licensing, developing and commercializing product candidates for the central nervous system (CNS), including epilepsy and psychiatry.
  • Counseled a private pharmaceutical company developing breakthrough therapies for immunological and neurological conditions.
  • Advised a public drug discovery company developing small molecule therapies in immune-inflammatory conditions.
  • Counseling a private biopharmaceutical company developing topical, targeted therapies for rare genetic dermatological diseases.
  • Advised a public specialty pharmaceutical company focused on medical and aesthetic dermatology, including developing a topical product for the treatment of seborrheic keratosis and warts, as well as topical and oral products to treat alopecia and vitiligo with Janus Kinsae inhibitors.
  • Counseled a private biopharmaceutical company with multiple, ongoing late-stage clinical development programs in neurosciences and dementia, rare diseases, dermatology and endocrinology.
  • Advised a public biotechnology company developing small molecule and enzyme-based therapeutics for restoring neurological function in patients with spinal cord injuries, multiple sclerosis and other neurological disorders.
  • Counseled a clinical stage biopharmaceutical company developing highly selective and reversible endogenous human cell signaling technologies targeting orphan diseases in the areas of fibrosis and inflammation.
  • Advised a public biotechnology company focused on the development of small molecule oncology products.
  • Counseled a biopharmaceutical company focused on the development of peptide-based therapeutics for the treatment of diabetes.
  • Advised a private company developing peptide-based therapeutics for pregnancy and immune-related disorders.
  • Counseled a specialty pharmaceutical company focused on the development of therapeutics  for neonatal and pediatric patients.
  • Counseled a public health care company focused on the development of oligoribonucleotide-based therapeutics, including siRNA and various ophthalmic therapeutics and diagnostics.

IP Due Diligence and Transactions

  • Advised a large pharma company on numerous patent landscapes in the fields of mRNA vaccines and delivery technologies.
  • Served as IP counsel to a clinical-stage biopharmaceutical company in a collaboration and license agreement to develop first-in-class treatments for epilepsy with a US$50 million upfront and up to US$1.7 billion in potential development, regulatory and commercial milestone payments.
  • Served as intellectual property counsel to a global health care company in its equity investment valued at more than US$1 billion.
  • Advised a private biopharmaceutical company, conducting IP due diligence in support of strategic alliances, collaborations and partnerships with academic institutions and pharmaceutical companies to augment its late-stage clinical development programs in neurosciences and dementia, rare diseases, dermatology, and endocrinology.
  • Counseled a public specialty pharmaceutical company focused on medical and aesthetic dermatology.
  • Conducted IP due diligence in support of licensing efforts.
  • Advised a private specialty biopharmaceutical company in the dermatology industry and navigated through the IP due diligence process that led to an acquisition by a global multi­ specialty health care company worth up to US$275 million.
  • Advised a drug discovery and development company in the neurologic space and navigated through the IP due diligence process that led to a US$345 million license agreement with a worldwide biotechnology company.
  • Counseled a biopharmaceutical company in the molecular imaging field and navigated through the IP due diligence process that led to an acquisition of the company by a global pharmaceutical company worth up to US$800 million.
  • Counseled a venture capital firm as part of a US$46 million financing that included conducting IP due diligence on a clinical stage pharmaceutical company developing antibiotics for drug­ resistant bacteria.
  • Counseled a big pharma health care venture capital fund, conducting IP due diligence on a Swedish biotechnology company focused on immunotherapy for the treatment of chronic diseases.
  • Advised a venture capital firm as part of a US$15 million financing that included conducting IP due diligence on a pharmaceutical company developing novel antibiotics for drug-resistant bacteria.
  • Advised a venture capital firm as part of a US$30 million financing that included conducting IP due diligence on a specialty pharmaceutical company developing therapeutic products and medical devices for neurological and psychiatric diseases.
  • Conducted internal IP due diligence reviews and audits on behalf of pharmaceutical, biopharmaceutical and medical device companies in preparation for partnering, financing and public offerings.
  • Provided assistance to venture capital and investment funds in evaluating potential investment opportunities with biotechnology and pharmaceutical companies in relation to private placements/public financing transactions.
  • Provided assistance to venture capital and investment funds in evaluating potential investment opportunities with biotechnology and pharmaceutical companies in relation to private placements/public financing transactions.
  • Provided counsel on and prepared nondisclosure agreements, consulting agreements, license agreements and collaboration/joint venture agreements for bio-pharmaceutical companies.
Education
  • J.D., University of Akron School of Law
  • B.S., Ohio Northern University

Memberships And Affiliations

  • Member, American Intellectual Property Law Association
  • Member, Ohio Pharmacists Association

Connect