Biopharma intellectual property that is patentable subject matter -- The novelty requirement -- Nonobviousness -- Formal standards of patentability for biopharma inventions -- Restriction and double patenting -- Inequitable conduct: what it is and how to avoid it -- How to write a biopharma patent application -- How and when to file biopharma patent applications -- Identifying the inventors -- Protecting ip rights of nonprofit institutions -- How to prosecute a biopharma patent application -- Post-grant procedures -- Extending the life of a biopharma patent -- Licensing biopharma patents -- Patent infringement -- Statutory infringement of pharmaceutical patents under the Hatch-Waxman Act -- Approval of biologics and the prospect of follow-on biologics -- Assertion of patent infringement in the international trade commission -- Regulatory exclusivities for pharmaceutical products -- Trademark issues relating to pharmaceuticals -- Protection of ip rights by trade secrets -- How to obtain biopharma patents in Canada, China, the European Union, India, and Japan -- Biopharma patent-related regulatory approval provisions in Canada, China, the European Union, India, and Japan -- How to enforce biopharma patents in Canada, China, the European Union -- India, and Japan
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