Patent protection of pharmaceutical products is recognized as a necessary mechanism to prevent competitor copycat products. Sheer population alone makes China and India attractive markets for sale of products.
When intending to market a pharmaceutical product in these countries, a company typically files a patent application with the intent to secure granted patent claims to the product. There are, however, several considerations a patent practitioner should be aware of when advising a company whether to file in India or China and when preparing patent applications for filing in the countries. These considerations are addressed in this article. First, patent rules in the U.S. and Europe are provided to give context to the considerations in India and China.
Like most countries, China and India follow a patent “examination system”, whereby a patent application is examined by a patent examiner at the national patent office to ascertain whether the claims presented in the application satisfy the country’s legal standards for patentability. The patent examiner will issue a written report outlining any basis found for a lack of patentability.
The patent applicant has an opportunity to respond to the written report, which may include amending the claims in a way that is supported in the application as originally filed. The written exchanges between the examiner and the patent applicant can continue multiple rounds, typically until claims are found to be patentable (allowable) or the examiner issues a final rejection, which can be appealed by the applicant.
In the U.S., claims recognized as eligible for patent protection are to:
- a new drug compound,
- a new composition or formulation comprising a new drug or a known drug,
- methods of treatment using the compound or composition, and
- a new dosage regimen.
Typically a company with a pharmaceutical product will seek all types of claims, unless, of course, the product is based on a known drug, in which case claims to the drug compound are not sought.
In Europe, claims to a new drug compound, to a new composition with a new or a known drug, and to a dosage regimen are permitted. For policy reasons, Europe does not permit claims to methods of treatment, although claims to a “use” of a compound or composition (such as for making a medicine) are permissible. These “use” type of claims are termed first medical use and second medical use or “Swiss” claims.