Case Study 1 - Amgen
Evaluate Amgen’s patenting strategy. What are its strengths, what are its weaknesses?
Amgen is a multinational biopharmaceutical company, one of the world's largest biotechnology firms in the world. Amgen's first product was its breakthrough with recombinant human erythropoetin (EPO) as a treatment for anemia. It was crucial for the company to do all within its power to protect its intellectual property (IP). For this purpose Amgen's patent strategy included filling for three separate patents which would cover all its bases including the final product, starting material and the process.
The first and most important patent the company filed was for the final product, recombinant human EPO. This patent is the
Moreover they could have possibly changed their technique just enough to make their invention novel and eligible for better protection.
The final product patent was denied as there was already a competing company, Genetic's Institute (GI), with a patent for EPO. GI had already succeeded in isolating small amounts of EPO from human Urine in 1984. Although the company was not capable of producing commercial quantities, they still had the patent and Amgen should have known. Had Amgen obtained this crucial information in time they could have changed their strategy and challenged GI without the costly legal battles.
The process patent was denied most probably because genetic engineering was the only feasible method for manufacturing human proteins and was therefore hard to prove that a new process was substantially different and deserving of a patent. In addition in 1985 the federal circuit ruled against "In re Durden" and claimed that producing a product with a novel and unobvious starting material by a known process is obvious and therefore doesn't warrant a patent. The USPTO demined multiple patents based on the case.
Amgen should have taken into account the above information and adapt its patents strategy accordingly saving themselves from legal battles and substantial expenses which can determine the success of a new company.
Should Rathmann execute the royalty-free cross-license?
Following the patent outcome, GI offered