Eli Lilly and Company v Douglas Pharmaceuticals Limited

Eli Lilly and Company (Lilly) brought proceedings against Douglas Pharmaceuticals Limited (Douglas) in the Federal Court of Australia, alleging that Douglas had infringed Lilly's Australian Patent No 2014201911 (the Patent). The Patent relates to a method of treating type 2 diabetes by administering a specific dosage regimen of dulaglutide, the active ingredient in Lilly's pharmaceutical product Trulicity. Douglas sought to register a generic version of dulaglutide, and Lilly contended that Douglas's proposed product and its proposed labelling would infringe the Patent.

The primary legal issues before the Court were whether Douglas's proposed product and labelling would infringe Lilly's Patent. Specifically, the Court had to determine if Douglas's proposed product, when used according to its proposed labelling, would constitute a method of treatment falling within the scope of Lilly's patent claims. This involved a detailed analysis of the patent claims and the proposed use of Douglas's generic product.

Justice Murray found that Douglas's proposed product, when used in accordance with its proposed labelling, would infringe Lilly's Patent. Her Honour reasoned that the proposed labelling instructed users to administer dulaglutide in a manner that fell squarely within the method of treatment claimed in the Patent. The Court applied the principles of patent infringement, focusing on whether the alleged infringing act fell within the scope of the patent claims. The Court concluded that Douglas's proposed actions would directly infringe the patent.

Consequently, the Court made orders permanently restraining Douglas from infringing Lilly's Patent.