Legal Eye: Patenting a better pain reliever

It is no wonder that these industries have sought to extend intellectual property protection rights to prevent others from cashing in on their superstars.

A little theory

If you make the proverbial "better mousetrap" (or pain reliever), patent law can protect your rights. Patent law is designed as a compromise to encourage innovation and to reward the innovator. The compromise is straightforward: you agree to publicize your invention (in minute detail), and in return you obtain a 20-year monopoly. 

During this 20-year period, you have the exclusive right to make economic or professional use of the patent. This means that you decide on nearly everything, from production and use to sale of the patented technology and any products made by your patented technology.

A matter of time

Did I say a 20-year monopoly? Well, that applies to most patents. But holders of pharmaceutical patents may extend the patent for up to another five years by obtaining Supplementary Protection Certificates. 

To be fair, pharmaceutical companies can find themselves in a time crunch. Patent law requires you to file for a patent before your invention becomes public information. Thus, pharmaceutical companies must file for patents prior to commencing the governmental product-approval process. This entire process of certifying that a drug is safe and may be sold to the public can take years. Supplementary Protection Certificates extend the patent by the amount of time from applying for the patent to obtaining product approval, but not by more than five years. 

Holding a patent does not mean that no one may touch your pharmaceutical product for 25 years. In fact, in limited situations, competitors are specifically allowed to use or reference your patented product.

Research exception    

The research exception allows use of a patented product to take actions necessary for governmental product approval for sale of a medicinal product. Specifically, it allows a company to conduct research on its competitors' patented medicinal products. Because of the length of the product-approval process, research-exception proponents argue that the only way to bring a new product to the market immediately after the expiration of a patent is if the research is done in advance.

The generics debate

Pharmaceutical companies creating original drugs and those creating generic products have been engaged in a multi-front, global legal wrangle over the years. With the amount our ageing society spends on medicinal products, the stakes are high. In the US, one of the favorite defenses used by makers of generic products is that of patent misuse. In other words, the patent holder is improperly restricting access to the patented product for any of a number of reasons, including by charging too much. In Europe, the generic debate is conducted on other grounds. The EU has developed a "data and marketing exclusivity" period during which product-approval authorities will not consider an application for or allow sale of a generic product. In Poland, the data-exclusivity period is currently six years. But, starting from 2013, the combined periods will extend, in total, to 11 years.

Judith Gliniecki is the managing partner of Rymar and Partners.