Abstract: In the pharmaceutical industry, patents protect a drug-maker’s right to exclusively produce a drug or issue a license for its production by another entity. In either instance they have the ability to control distribution and, more importantly, the cost. This exclusivity exists until the time the
patent term expires, at which point other manufacturers can begin producing a generic versions of the drug. Production of generic drugs significantly cuts the market share of brand name drug as well as drives down the overall cost of the drug. This makes patent protection a big concern for pharmaceutical companies spending years and billions of dollars in drug development. Once a patent is issued for a drug there is still a chance that the validity of the patent may be challenged. One such way a purported infringer or competitor can challenge a patent’s validity is through an inter partes review (IPR) Process allowed by the United States Patent and Trademark Office (USPTO). Until recently the use of this process by generic drug-makers to invalidate patents has had no success. However, a recent decision by the Patent Trial and Appeal Board (PTAB) gave generic drug-makers their first break when they invalidated the patent for the multiple sclerosis drug Gilenya. The following will review the IPR process and examine the decision by the PTAB to invalidate the Gilenya patent under 35 U.S.C §103.