The pharmaceutical and biotechnology industries are responsible for new drugs introduced into the market to treat patients suffering from different diseases. Before a new drug reaches the market, a lot of time and money is spent in research and development of the drug. For every new drug that reaches the marketing stage there may be hundreds of new drugs not approved by the FDA. Because a pharmaceutical company often attempts to research many drugs prior to getting one approved, every new drug that does reach the market must also cover the costs of the drugs that did not make it.
Patents allow a drug manufacturer to license the drug to other companies so that the drug inventing company can recoup the costs of research and development, while also being rewarded for creating the inventive product.
In the US, the process to obtain a patent in the pharmaceutical or biotechnology industries is the same as it would be for any other field. The patent, once issued, protects the right of inventorship of the product and is valid for 20 years from the filing date of the earliest US application to which priority is claimed, excluding provisional patent applications.
Another factor to consider when applying for a patent for a new drug is that the application should disclose the synthesis of the new drug in such a manner that it is possible for another person, with ordinary skill in the field, to be able to replicate the drug in a similar manner. Lack of sufficient disclosure of the product can form the basis for refusing the application or invalidating the patent. The purpose of such a requirement is that the invention should be described in such terms that the invention can be communicated to the persons interested in the drug in a meaningful way.
Patents are very important to the pharmaceutical and biotechnology industries since they not only help them to recoup the expenses on research and development of the drugs which they develop but also allow them to make a profit on the drugs that are finally approved. The patenting of products allows the inventor to make a profit on their invention and this in turn is the reason that pharmaceutical and biotechnology companies are willing to invest the considerable sum of money required to bring a new product to the market.
In the US, to obtain a utility patent, one can apply for a provisional patent application or a non-provisional patent application. A Provisional Utility Patent application is optional, but establishes a filing date of the invention. Further, a provisional application does not mature into an issued patent unless the applicant files a regular non-Provisional Utility Patent application within one year. A provisional application includes a description and drawings of the invention, but does not require formal patent claims. There is no examination of the application, and the application is held in confidence at the USPTO.
The provisional patent application has the advantage of preserving a “filing date” of the invention. This means that a later filed non-provisional application by the inventor can claim the same right to priority date as that of the provisional application. The priority date governs the date when the inventor is deemed to have begun protecting his patent rights, and any invention by another after the priority date cannot be held against the inventor.
A non-Provisional Patent application is a complete patent application that is examined by the patent office. The non-provisional application requires a detailed description, formal drawings, an inventor declaration and any other information disclosure statements. It is important that the non-provisional application is crafted well as this document can eventually yield into a patent.
The time period to obtain a patent after filing the non-provisional application is between two to four years. Further, obtaining a patent is not cheap, the total process can cost tens of thousands of dollars in legal fee alone. However, once a drug is finally approved by the FDA, the time and fees required to obtain a patent become complete worthwhile
The Law Offices of Rohit Chhabra provides an affordable legal fee structure to clients who are interested in obtaining a US patent. His firm’s website address is http://www.GetMeAPatent.com
