Calcium Channel Blocker Patent Protection Disputed

When new drugs are introduced to the market, U.S. and international laws allow for a period of protection during which strong patents allow the company that invented the drug to be the sole producer and distributor. Despite a vocal minority that is critical of this process, widespread opinion is that this system, or one very much like it, is needed to help pharmaceutical companies recoup the price of researching, developing, and testing new drugs - a process that can cost billions of dollars.

After this initial period of protection, drug patents expire, and any appropriate pharmaceutical company is free to produce generic versions of the drug. Recently, a number of companies have been feuding over interpretations of these patents, with third party groups looking to manufacture generic drugs before the inventing company believes the patent is expired.

The newest entry into this legal arena involves two companies - Teva and Apotex - and a potent high blood pressure drug, Coreg (carvedilol). Coreg is a calcium channel blocker that has shown great effectiveness at treating hypertension in many different patient populations. This case is slightly different, though. The original drug was not manufactured by either of these companies. Rather, Coreg was first brought to market by GlaxoSmithKline, and is currently eligible for third party manufacturing. As an example of the growing contention in the pharma industry, this lawsuit was brought by Teva against Apotex because Teva says it owns patents, not on the drug itself, but on various processes used to produce the drug.

While courts have been generally strong in defending the patent rights of originating pharma companies, the outcome is much less clear in this case. What is clear, though, is that the market for generic drugs is becoming more hotly contested and defended as a growing number of manufacturers compete to produce lower cost medications.