Intellectual Property Law:

Please write a case commentary on Cubist Pharmaceuticals v. Patent Re-examination Board of the State Intellectual Property Office of the People’s Republic of China.

Cubist Pharmaceuticals, Inc v. PRB was an administrative case of dispute over invalidation of a patent for an invention relating to a method of administration of antibiotics. Claim 1 in dispute is directed to a Swiss-type use and reads: “Use of daptomycin in the manufacture of a medicament for treating a bacterial infection while it does not result in muscle toxicity in a patient in need thereof, wherein a dose for said use is 3 to 75 mg/kg of daptomycin at a dosage interval of once every 24 hours to once every 48 hours.”

The contribution of the invention lies in the discovery that the toxicity disappeared when daptomycin was administrated at the dose and at a dosage interval as defined. Thus, there are two distinguishing elements: 1) (a bacterial infection while) it does not result in muscle toxicity (toxicity decrease element); and 2) a dose for said use is 3mg/kg to 75mg/kg of daptomycin at a dosage interval of once every 24 hours to once every 48 hours (dosage regime element). 

The issue in this case are first whether the toxicity decrease element has limitation on the use; and second, whether the dosage regime element confers novelty to the claim. The relevant law is Article 25(3) of the Patent Law concerning Non-Patentable Subject Matter. 

Please see attached document: ‘Cubist.Pharmaceuticals.Inc.v.PRB.docx’.

The focus of this essay should be on your opinion on the judicial decision, specifically whether you agree with the factors considered in assessing novelty of invention relating to medical use of substance

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