Life Sciences – Just Another Way to Say “Intellectual Property”?
There is no corner of the American economy more deeply dependent on intellectual property rights than the life sciences. Of course, we all know that patents have long been central to the success of pharmaceutical and medical device manufacturers, and the unanimous decision in the Prometheus case this past month has brought additional scrutiny to a market segment often misunderstood in the popular press. That said, for players in the life sciences space, patents are only one of many ways that intellectual property shapes their business. In fact, the trademark, unfair competition and copyright laws can be just as critical, and a strategic understanding of their value can provide companies with real ownable distinction in the market.
What is a product with “ownable distinction?” It is the opposite of a generic commodity, and it is the holy grail in the life sciences. It is what distinguishes you from your competition, in a way that you can own and keep to yourself. A patent is the most obvious form of ownable distinction, but it is short lived and as important for what it communicates as for what it does. After all, when a product like ADVIL is no longer covered by patent protection, and anyone can sell generic ibuprofen, why do consumers still purchase the original product? Is it because they trust the innovation of the original manufacturer? Inevitably, exclusivity communicates a basket of associations to consumers that outlasts the exclusivity itself, and the brand can continue to carry those associations for many years to come.
Branding in the life sciences space, of course, is often enormously complicated. Consumer confusion can be fatal, rather than merely inconvenient, and companies spend untold millions to find the perfect name for their new products. Once a drug comes off patent protection, often the only things that provide continuing market relevance are (a) the trademark, and (b) trade dress in the packaging (if the product is sold over the counter). But while many companies are sensitized to the necessities of FDA clearance, it is easy to forget that traditional trademark laws are just as important. Even when the FDA approves a name, it can still be subject to a successful infringement suit and an injunction. More subtlety, the grey market (and counterfeit market) for drugs manufactured abroad means that a careful analysis of the interplay between the U.S. Customs Service, the Tariff Act and the Lanham Act is a necessary part of any brand protection strategy.
Over the next several months, we will have a number of opportunities to discuss the ways in which intellectual property protection intersect in unique ways with the complexities of the life sciences market. As we do, keep in mind that these are often not mutually exclusive choices. A proper IP strategy in the world of life sciences recognizes the need for patents, the copyrightable subject matter used in web pages and on social media platforms, the branded products themselves, the look and appearance of packaging and pills and the claims made in your marketing practices. There may be no segment of the American economy more innovative than the life sciences, but for that reason it is critical that we remember the role that intellectual property plays in keeping it that way.
