Generic Drugs and Patents

The legal games that are played over patents and pharmaceuticals are dizzying, and the impact of patents is present throughout all phases of a drug s development. At the outset of this chapter were mentioned the ideas of cocrystals and polymorphs. These concepts 

Formulating a drug as a cocrystal can improve the pharmacokinetic behavior of a drug. Cocrystals are patentable, so a company can claim ownership of that form of a drug. A hypothetical example demonstrates the potential impact of patents of cocrystals. 

Because of the incredible success of Zantac, generic manufacturers were eager to enter the market with a generic version of ranitidine. Since the patent on Form 1 was set to expire in 1995, a generic manufacturer could conceivably enter the market with a Form 1 formulation without waiting for expiration of the Form 2 patent in 2002. Around 

Novopharm was not finished. Novopharm was ultimately able to reproducibly manufacture Form 1. Novopharm filed an ANDA in 1994 to market Form 1 of ranitidine. Glaxo sued Novopharm. Glaxo s argument 

Form 2 impurities. The court ruled in favor of Novopharm. Novopharm was allowed to develop a generic formulation of Form 1 of ranitidine with a target market date of 1995, the expiration date of the Form 1 patent. 

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