Protection From Harm?

There is little doubt that the protection of the patent system has been instrumental in the continued innovation in science and technology by allowing the inventor (or filer of the patent) to reap the benefits of their effort and creativity. The realm of public health is no stranger to these benefits, with such innovation having furthered the frontier of medical treatments and pharmaceuticals. However, stringent patent protection has come at a cost to public health, a cost potentially greater than the benefits it confers. 

The recent case of Occlutech GmbH v AGA Medical Corporation & Ors in the United Kingdom highlights this conflict. This patent infringement case had extended to trials in Sweden, the German Supreme Court, and the Court of Appeal of the Hague in the Netherlands. At the heart of the case lay the accusation that Occlutech had infringed upon one of AGA’s patents relating to a dumbbell shaped collapsible medical device for delivery through a channel of the body. Occlutech specifically manufactured these medical devices to help treat septum defects, while AGA sought an injunction for these devices (click here to read more). In the final judgment from the courts, all four nations had come to the consensus that Occlutech’s device did not infringe upon AGA’s patent – however, the bulk of the decision rested upon the definition of a term, “clamp”, in AGA’s patent application.

The case highlights a problem that plagues the patent system in its application to public health. Smaller, more specialized companies that do not possess the assets to purchase licensing agreements to utilize patents filed by larger corporations may see their practice or ideas shut out of the market through injunctions. In effect, the availability of potentially life-saving technologies may be delayed or prevented from reaching the market simply because of patent infringement. The court must balance the interests of companies to ensure there is an incentive to continue research, with the protection and promotion of public health. We have seen a similar instance in India, where the government issued its first compulsory license to a local pharmaceutical (Natco Pharma) for a foreign company’s drug (Bayer’s Nexavar) (For more information on the Natco case, click here). Briefly, the government chose to air on the side of public health – by respecting the patent that has been filed but forcing the company to allow a local company to synthesize the drug at a more affordable cost. In the case at hand, Occlutech was a smaller company that specialized in the production of occlusion devices for septum defects – their technology allowed doctors to fix this heart defect in a manner that was minimally invasive and non-surgical. There is little doubt that in reducing the need for surgery, such a technology would be greatly beneficial for the public.

On the other hand, the patent system has valuable uses. Just as larger companies are allowed to profit, smaller companies often rely on patents for profit as well – profit that is much more vital for the company’s stability and viability. The development of new drugs and technologies from conception to clinical use is extremely expensive and time-consuming, and without an exclusive right conferred by the patent, such costs would be insurmountable.  Furthermore, the patent system encourages the sharing of such information, as patent information is made public. This allows information to be made public to researchers and additional companies, allowing them improve on existing technologies. With that said, such reasons do not amount to an appropriate justification for denying public access to more beneficial technologies. I do not believe that had Occlutech infringed upon AGA’s patent, that an injunction (thereby denying the technology from reaching the market) would have been an appropriate response to protect AGA’s intellectual property rights.

I believe the ideal method is one that strikes a middle ground. This may take the shape of compulsory licenses (as seen with Natco), research exceptions, or parallel imports. What the courts ought to consider, however, is the implications of its decision on public health. Though commercial interests are vital, it cannot come at the expense of delaying or denying medical treatments for society.

Byron Tse is a JD candidate at the Western University Faculty of Law.