Heather Morehouse Ettinger, Ph.D.

Heather counsels life sciences clients on a variety of intellectual property matters. She excels at due diligence studies, loss of exclusivity analyses, and agreement drafting in connection with buy- and sell-side transactions and collaborations for her clients, which range from preclinical biotechnology companies to large clinical pharmaceutical companies. Heather regularly advises on Hatch-Waxman issues, biosimilars strategy, and litigation and post-grant proceedings, such as inter partes reviews. She also manages the worldwide prosecution of numerous life sciences patent portfolios.

Heather has extensive experience counseling clients in intellectual property matters in areas including gene editing, immunotherapies, regenerative medicine, rare diseases, pharmaceutical formulations, genetically modified plants and seeds, enzyme and other large-molecule technology, and small-molecule chemistry. She routinely works with the firm’s corporate team to counsel international corporations in preparing their intellectual property portfolios for U.S. cross-border securities transactions.

Heather is a registered patent attorney with the U.S. Patent and Trademark Office. In addition to earning her J.D., Heather has a Ph.D. in biological and biomedical sciences and a bachelor’s degree in biology.

Heather has served as lead IP counsel for the following:

• A specialty pharmaceutical company in its acquisition agreement involving an upfront payment of approximately $412 million for the rights to develop, manufacture, and commercialize a leading oncology asset.
• A pharmaceutical company in its license agreement involving an upfront payment of $7.5 million and potential milestone payments of up to $217.5 million for worldwide rights to develop, manufacture, and commercialize a PDE4D inhibitor.
• A global specialty pharmaceutical company in its acquisition of a treatment for severe frostbite from a clinical-stage biotechnology company.
• A global specialty pharmaceutical company in the complex negotiation of exclusive U.S. rights of a novel, monoclonal antibody fragment for critical care conditions from a global drug development company.
• A major pharmaceutical company in the complex negotiation and sale of the rights to small molecules for the treatment of liver diseases for $120 million.
• The U.S. tax inversion transaction with Pozen Inc. to create Aralez Pharmaceuticals Inc. (The Americas M&A Atlas Awards, Pharma & Devices Deal of the Year, 2016).
• A major pharmaceutical company in the sale of its oncology portfolio, which totaled $2.4 billion.
• A life sciences investment firm in its $70 million purchase of RNA company preferred stock.
• A major pharmaceutical company in its $32 billion acquisition of another pharmaceutical company. Handled review of freedom-to-operate and patent exclusivity for more than 20 commercial and pipeline products that focus on rare disease treatments.

Heather has conducted due diligence and transaction drafting for the following:

• A global specialty pharmaceutical company in the acquisition of a medical device kit for decontaminating chemical warfare agents from a global biopharmaceutical company for an up-front payment of $75 million, with an additional $5 million milestone payment.
• A major pharmaceutical company in its acquisition of a license to develop and commercialize a preclinical autoimmune drug candidate.
• A major pharmaceutical company on its $6.5 billion acquisition of a biotechnology company focused on treatment for hereditary angioedema (HAE). Also counseled on royalty provisions, trademark coverage, ownership issues, and patent exclusivity.
• A major pharmaceutical company in its $5.2 billion acquisition of a pharmaceutical company that specializes in treatments for rare diseases.
• A major pharmaceutical company in its acquisition of an ophthalmology company.
• A major pharmaceutical company’s acquisition of molecules for the treatment of degenerative eye diseases.
• A major consumer care company in its acquisition of a top-selling line of female health products.
• A drug company’s partnership with a cancer biotech company.
• A drug company’s partnership with a medical device company.
• A major pharmaceutical company’s acquisition of a company focused on kidney fibrosis treatments.
• A major pharmaceutical company’s acquisition of a company that owned late-stage compounds for rare hepatic conditions.
• A complex patent portfolio covering genetically engineered enzymes in the biofuels area.

Heather’s critical IP strategy and litigation experience includes the following:

• Successfully defended a major pharmaceutical company in trade secret litigation involving ophthalmology clinical trials.
• Led strategic planning and litigation for pharmaceutical companies in abbreviated new drug application (ANDA) litigation.
• Manage and prosecute patent portfolios for small and large therapeutic molecules, medical devices, and genetically modified plants.
• Prepare noninfringement and invalidity opinions in the biotech, antibody therapies, and genetically modified plant technologies.

• International Asset Management: “Strategy 300” (2021)
• Super Lawyers: “Rising Star” (2013-2014)