Amgen’s Epogen
1) Describe Amgen’s patenting strategy. Evaluate its strengths and weakness
Amgen first went after product patent, the strongest type of patent. But Amgen knew that it would be very difficult to get the product patent because it did not pass the test of “non-obviousness in the light prior art”. Therefore they also went after process patent. Now to increase the protection, Amgen also patented the starting material that is needed to produce EPO protein i.e. host cell and its vector.
Strengths of product patent:
• Provide best possible protection i.e. firm has the right to exclude others from making, selling, using or importing
Weakness of product patent:
• Hard to obtain for biotech companies because most of these products have already been discovered and isolated.
Strengths of process patent:
• Since “first-scale doctrine” does not apply to process patents, people who have bought the patented product could not resell the invention
• Process patents can be written quite broadly so therefore you can cover a lot of ground in one patent
Weakness of process patent:
• By writing broad claims you can get in trouble when it comes time to defend your patient. In addition to that, it can also be difficult for someone skill in the art to reproduce the patient claims and this can invalidate your patient
• After Durden’s case, it’s difficult for biotech companies to obtain process patent
Weakness of patenting starting material:
• This patient did not prevent foreign manufacturing from using these starting materials and then importing the final product to USA
2) Should Amgen execute the royalty-free cross license?
YES: Why?
• They will be able to get to market without any legal problems and start bringing in revenue. This will stabilize Amgen’s stock price
• Avoid expensive fees of courts and lawyers
• Genetics Institute has the product patent, which is much more powerful than Amgen’s process patent
• Since Amgen has the only patent on starting
Amgen first went after product patent, the strongest type of patent. But Amgen knew that it would be very difficult to get the product patent because it did not pass the test of “non-obviousness in the light prior art”. Therefore they also went after process patent. Now to increase the protection, Amgen also patented the starting material that is needed to produce EPO protein i.e. host cell and its vector.
Strengths of product patent:
• Provide best possible protection i.e. firm has the right to exclude others from making, selling, using or importing
Weakness of product patent:
• Hard to obtain for biotech companies because most of these products have already been discovered and isolated.
Strengths of process patent:
• Since “first-scale doctrine” does not apply to process patents, people who have bought the patented product could not resell the invention
• Process patents can be written quite broadly so therefore you can cover a lot of ground in one patent
Weakness of process patent:
• By writing broad claims you can get in trouble when it comes time to defend your patient. In addition to that, it can also be difficult for someone skill in the art to reproduce the patient claims and this can invalidate your patient
• After Durden’s case, it’s difficult for biotech companies to obtain process patent
Weakness of patenting starting material:
• This patient did not prevent foreign manufacturing from using these starting materials and then importing the final product to USA
2) Should Amgen execute the royalty-free cross license?
YES: Why?
• They will be able to get to market without any legal problems and start bringing in revenue. This will stabilize Amgen’s stock price
• Avoid expensive fees of courts and lawyers
• Genetics Institute has the product patent, which is much more powerful than Amgen’s process patent
• Since Amgen has the only patent on starting