Patent Claim Analysis: Teva v. Sandoz

Today I am going to discuss patent claims involved in the case Supreme Court case Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. 

Case Background: Teva sued Sandoz for patent infringement of Copaxone, a drug used to treat the neurological disorder Multiple Sclerosis. In defense, Sandoz claimed that Teva's patent claims were indefinite in that the term "molecular weight" had three possible meanings, and was not defined. The district court ruled that the claims regarding molecular weight were definite, and that Sandoz had infringed on Teva's patents. Sandoz appealed this decision and the appellate court found that Teva's molecular weight claims were indeed indefinite, and therefore the claims were invalid.

Patent at Issue: The patent at hand is U.S. Patent No. 5,800,808: Copolymer-1 Improvements in Compositions of Copolymers.

The claims of the the '808 patent follow as:

1. A method of manufacturing copolymer-1 

  1. comprising reacting protected copolymer-1 with hydrobromic acid 
  2. to form trifluoroacetyl copolymer-1
  3. treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution 
  4. to form copolymer-1, 
  5. and purifying said copolymer-1, 
  6. to result in copolymer-1 
  7. having a molecular weight of about 5 to 9 kilodaltons.
This patent describes a method of manufacturing copolymer-1 with a molecular weight of 5-9 kilodaltons. The reactions uses the starting materials of protected copolymer-1 and hydrobromic acid. This initial reaction forms trifluoroacetyle copolymer-1. Trifluoroacetyl copolymer-1 is treated with piperidine solution to form copolymer-1. The resulting copolymer-1 is purified and results in a molecular weight of 5-9 kilodaltons. 

The Supreme Court ruled that though Sandoz had infringed Teva's patents, there is a lack of support regarding whether Teva's claims are definite. 


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