Branded drug companies release new drugs protected by composition of matter patents for the active ingredients in their products. Some of these patents are based on unique findings and can hold up for two decades. Down the road, companies may choose to file for supplementary patents to protect newly found formulas or methods of manufacturing.
On the other hand, some of these patents are granted in error or based on overly-general means. That is where generic pharmaceutical companies step in. Generic drug manufacturers challenge branded company patents, typically based on the fact that the patents are invalid or the generic version does not infringe on the patent.
Traditionally, patent challenges were handled in court through litigation. Litigation is expensive and can take years to resolve. Neither party wants to dredge through the cost and time attributed to the process. A new process called inter partes review has surfaced for patent challenges, giving drug companies a cheaper and faster alternative to litigation. This more streamlined pathway for challenging patents ends in a 50 percent success rate for generic companies according to a new study.
What is the outcome?
This new study shows that generic drug companies are successful half of the time when challenging patents through the inter partes review process. According to the study by researchers at the Program On Regulation, Therapeutics, And Law, generic pharmaceutical manufacturers have challenged 198 patents over the past five years. Cases are resolved within a year. A much faster rate than litigation.
Generic drug companies are embracing inter partes review with relatively high rates of success. Since 2011, 43 percent of the challengers succeeded in overturning all disputed patent claims. Although proceedings look promising, it is especially important to retain legal counsel experienced in both patent litigation and prosecution for inter partes review. Issues are often technical in nature and require an understanding of both sides.
Giving generic drug companies a better way to challenge patents can be beneficial to companies and to the general public. The process drives medical innovation and price competition, slowing down the ever-rising cost of healthcare.