Pharma Patent Primer

An analysis of pharmaceutical patenting reveals the various trends in the types of patents being granted. The earliest product patents focused on chemical compounds, which later gave way to biological products such as antibiotics. Now the emphasis is on genetically engineered products and hybrids of successful drugs. The international pharmaceutical companies claim that the cost of conducting innovative research often consumes their profits owing to the huge generic market, which produces cheaper alternatives. However the generic product is required to be bioequivalent to the original and generic companies are also carrying out innovative research.

The recent patents granted to Indian generic manufacturers such as Ranbaxy, Cipla, Nicholas Piramal and Dr Reddy’s include a large number of product patents alongside the expected process patents. The product patents mainly involve novel forms of classes of compounds known to be effective in the treatment of various disorders. The process patents provide easier techniques for manufacturing a particular product. The new methods also have the benefit of being more economical than the original method.

As an increasing number of highly successful drugs come off patent, it is seen that the parent companies try to defend their patent rights by various delaying tactics such as applying for secondary patents on particular intermediates or forms of the key compound that are not truly innovative. Recent cases of interest include Ranbaxy versus Pfizer on atorvastatin (Lipitor) and Natco versus Novartis on imatinib mesylate (Gleevec). The cost of the branded drug is usually much higher than that of its generic counterpart and this causes problems in developing countries. Big companies often have strangleholds on particular markets for a certain drug (Bayer with Ciprofloxacin-Cipro) and during epidemics this can create problems as availability runs low and prices remain high.

The non-generic companies claim that high prices are required to sustain the costs of research and development. Patent analysis however reveals that discoveries of entirely new compounds are rare and most of the product patents focus on novel derivatives or substituents of the known compounds not differing much from those granted to generic manufacturers. Combination products consisting of several successful drugs are increasingly being developed.

This article has three case studies on Ciproflaxcin, Imatinib Mesylate and Atorvastatin.

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