FDA Regulatory Filings and IP
At the recent PharmaBiotechIP summit, a speaker discussed a problem that really struck a cord with the audience – that the language used in FDA regulatory filings can have a serious impact on patent applications. In communications with the FDA, the authors of regulatory documents like to use words such as “conventional”. The term “conventional” helps to assure the FDA that there is nothing unusual for them to worry about. I can see how this makes sense. If something is conventional it is not unique and hence in need of additional scrutiny.
Therein lies the problem for the intellectual property side of the house. We want IP to be unique, innovative, and special. In fact, we want it to be so special that it would not have been obvious to other people reasonably well versed in whatever industry or technology that we are dealing with. For FDA approval to go smoothly, you have to declare that the product is, in many ways, like other products. For the patent filing process to go smoothly, you have to show that the product is, in most ways, unlike any other product. If you are a patent examiner trying hard not to award a patent to something obvious, you might think to look at the regulatory filings related to the same drug that a company is trying to patent. If the company expresses the view that it conventional, you can easily read obvious.
This sounds very much like a Publication Clearance problem. Typically, with a Publication Clearance process, a company tries to insure that nothing contained in a technical or scientific publication will jeopardize intellectual property rights. The Regulatory – IP conflict is very much the same. Companies need to insure that what is written in a published document, in this case an FDA filing, does not inhibit the ability to gain patent protection later. A well thought out Publication Clearance system, modified for the particular workflow of regulatory filings, should help to provide this level of oversight. Like all publications, the document has to go out on time but needs to be reviewed to insure that it is correct in many ways.
So, why continue to risk patent approvals because of the wording of an FDA document? An easy solution exists by way of the same process necessary to release other publications.
Therein lies the problem for the intellectual property side of the house. We want IP to be unique, innovative, and special. In fact, we want it to be so special that it would not have been obvious to other people reasonably well versed in whatever industry or technology that we are dealing with. For FDA approval to go smoothly, you have to declare that the product is, in many ways, like other products. For the patent filing process to go smoothly, you have to show that the product is, in most ways, unlike any other product. If you are a patent examiner trying hard not to award a patent to something obvious, you might think to look at the regulatory filings related to the same drug that a company is trying to patent. If the company expresses the view that it conventional, you can easily read obvious.
This sounds very much like a Publication Clearance problem. Typically, with a Publication Clearance process, a company tries to insure that nothing contained in a technical or scientific publication will jeopardize intellectual property rights. The Regulatory – IP conflict is very much the same. Companies need to insure that what is written in a published document, in this case an FDA filing, does not inhibit the ability to gain patent protection later. A well thought out Publication Clearance system, modified for the particular workflow of regulatory filings, should help to provide this level of oversight. Like all publications, the document has to go out on time but needs to be reviewed to insure that it is correct in many ways.
So, why continue to risk patent approvals because of the wording of an FDA document? An easy solution exists by way of the same process necessary to release other publications.
This articles lot of useful information and helpful for patent applications.FDA assure that easy solution.