Legal Forum: Patenting Strategies to Delay Biogeneric Competition - Innovator biotechnology companies may extend patents for a drug's formulation, manufacturing method, and other critical factors. - B

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Legal Forum: Patenting Strategies to Delay Biogeneric Competition
Innovator biotechnology companies may extend patents for a drug's formulation, manufacturing method, and other critical factors.


BioPharm International
Volume 19, Issue 11

Another strategy includes obtaining patent protection on adverse drug reactions (ADRs) using pharmacogenomics. ADRs include side effects, allergic reactions, and unusual and unpredictable reactions. The innovator company is required by the FDA to document ADRs for marketed products. Because of this regulatory requirement, the data must be collected, and is available solely to the innovator company. If the innovator company can discover novel drug–drug and drug–food interactions, and negative interactions between drugs and certain phenotypes, genotypes, and pre-existing conditions, then methods of obtaining and using this information to avoid ADRs could be patented.

The challenge of this strategy is to identify genetic differences that influence drug metabolism and response, and to correlate that data with drug efficacy and safety information. The goal is to identify patients who are likely to suffer drug related adverse events and to ensure appropriate dosing by identifying the patient's rate of drug metabolism. Thus, the patents would be to ensure the safer use of the innovator's drug by avoiding these interactions.

The innovator company could patent compositions of isolated therapeutic proteins, and of course the nucleic acid sequences encoding them, that are responsible for these differences, as well as methods for obtaining the pharmacogenomic data and methods for diagnosis and treatment of subjects based on the data. Thus, a generic company could be prevented from using the pharmacogenomic data obtained by the innovator company to recommend appropriate dosing of the biogeneric, thereby delaying the entry of the biogeneric until the pharmacogenomic patent expired.

The major patenting issues for patent protection in pharmacogenomics are utility, enablement, and written description. However, because of ADR data for the particular biologic drug, these issues should be minimal, and the innovator company should be able to obtain patent protection fairly readily.

A patent strategy that considers the particular details of the marketed therapeutic protein, the methods of manufacturing the protein, patent term extensions, and ADRs could increase the market exclusivity of a biologic. After the initial patent applications are filed and the product has been further developed, the patent strategy of the companies should include filing applications on the approved product itself, and claim the product characteristics required for FDA approval, the final manufacturing process, ADRs, as well as patent-term extensions.

Narinder Banait is an attorney at Fenwick & West LLP, 801 California Ave., Mountain View, CA 94041, 650.335.7818, fax 650.938.5200,


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