Partner

Dr. Teresa Nicoletti

Sector

Health & Life Sciences ,

Services

Intellectual Property ,

Dr Teresa Nicoletti is both a lawyer and PhD-qualified scientist with 25 years' experience in the health and life sciences sector. She has gained particular prominence in Australia as the leading lawyer in the regulation of medicinal cannabis (Federal and State).

Teresa's practice provides broad advice to clients across their businesses, and draws on her unique mix of commercial, regulatory, scientific and legal expertise to obtain the best outcomes for her clients. She represents clients regularly in dealings with the TGA, State and Territory health and food authorities, the APVMA, ACCC, HCCC, medical and pharmacy boards, AHPRA, VCAT and NCAT.

Expertise

Teresa’s expertise includes:

Therapeutic goods regulation (medicines, medical devices and biologicals)
Regulation of medicinal cannabis (Federal and State)
Regulation of cosmetics, foods, agrochemicals and industrial chemicals
Reimbursement of pharmaceuticals, medical devices and medical services
Commercial products supply and distribution
Health disciplinary proceedings and medical malpractice
Patent litigation, freedom to operate, oppositions, validity advice and term extensions
Product liability, safety and recalls
Industry Code of Conduct complaints and appeals
Competition and Consumer law

Recent Projects

Advising various companies on Commonwealth and State/Territory regulatory regimes for medicinal cannabis cultivation, production, manufacture and supply.
Advice on the Federal and State regulatory regimes for patient access to medicinal cannabis products.
Ongoing advice about the regulation of therapeutic goods, particularly the merits of decisions by the TGA; section 60 and AT appeals; ongoing advice about application of the legislation and guidelines; and proper administrative process.
Advice to an originator company regarding price implications arising from the listing of a generic competitor, including advice on applicable statutory provisions and negotiations with the Department of Health to achieve a commercially acceptable.
Advice to various originator companies in relation to alleged disclosures by the Department of Health of confidential information in risk-share deeds.
Acting for an originator against a generic company alleging misleading and deceptive conduct in relation to various claims made in promotional material.
Ongoing negotiation and drafting of commercial agreements for the supply and distribution of pharmaceutical products (3PL and 4PL).

Professional Memberships / Accreditation & Activities

Ranked Lawyer (Band 1), Life Sciences, Chambers Asia-Pacific
Recognised Lawyer, Life Sciences Practice, Biotechnology Law and Health & Aged Care Law, The Best Lawyers in Australia
Recommended Lawyer, Intellectual Property, The Legal 500 Asia-Pacific Legal
Partner of the Year, Health, Lawyers Weekly Partner of the Year Awards, 2016, 2017 and 2022
Judging Panel’s Highly Commended Award, Women Lawyers Association of NSW Achievement Awards, 2017