Chemical and pharmaceutical companies protect their investment in research and development and the future of the companies by securing patents on their inventions. Success or failure of the company often depends on the strength of the patent or in its ability to resist competition. Recently, the United States Patent and Trademark Office proposed changes to the way patents will be processed with a view to reduce patent Examiner's work load. These changes could drastically limit the company's ability to secure strong patents.
Under the current practice, if the company is not happy with the Examiner's refusal to grant a patent, the company can file one, two, or more continuation patent applications so that additional exchanges can take place between the applicant and the Examiner. If the proposed rule changes are made permanent, and it is widely expected they will be, the patent applicant will have opportunity to file only one continuation application, which means only a limited number of exchanges are possible. If such exchanges do not result in patent grant, the applicant may have to narrow the scope of invention by further distancing the invention from a known drug formulation; or in some cases, lose its patent entirely. When the patent applicant tries to amend or narrow the application, he may face several legal hurdles. For example, the Examiner may refuse saying that the originally filed application does not contain the language that applicant wants to use for amending the application.
To avoid such an unfavorable result, the patent application must have been prepared in such a way that the Examiner cannot refuse the amendment. To illustrate this, consider the following situation where the applicant describes his invention which is a drug formulation containing a drug in an amount from 1 to 50%. The Examiner rejects the application since a formulation containing 7% drug is known.
If the patent application had disclosed only 1 to 50% drug, the inventor cannot amend the application to say 8 to 50% to avoid the known formulation. On the other hand, if a cascade of fall back positions had been built into the application at the time of patent filing, such as 5 to 30%, 10 to 20%, and 12 to 15%, then he can amend the application by defining 10 to 30% or 10 to 20% drug so as to cover his invention which may contain 11% drug. In the absence of a fall back position, the applicant will have to forego the entire patent.
A patent application is a serious legal document and should be prepared with great care. This requires knowledge of the industry, for example, what has been done before and what the competition might try to get around the patent. In the wake of the proposed rules, the importance of writing a good patent application cannot be overemphasized.
Dr. Xavier Pillai specializes in < hef="http://www.leydig.com">patent matters involving chemistry, pharmaceuticals, biotechnology, and polymers; see http://www.leydig.com.
