Implications of ACLU Decision
The decision, as it stands, could have far-reaching implications in the world of biotech patenting. The expansive language and generalized analysis in the decision could be interpreted to invalidate thousands of biotech patents that currently protect biologic products or diagnostic methods. Moreover, since most biotech inventions rely to some extent on genetic information or its analysis, the decision casts a shadow of uncertainty over the entire industry.
However, panic is premature. Once appealed, the Federal Circuit is likely to reverse or limit the decision. Indeed, it would be difficult to reconcile some of the language of the ACLU decision with long-standing (and recently reaffirmed) decisions by the Federal Circuit and Supreme Court. Appellate courts are also typically cautious about taking action that goes directly against long-standing industry practice.
However, everyone in the biotech and pharmaceutical communities should take notice of the trend toward limiting patent scope in the industry. Various decisions, from Bilski to Ariad, all emphasize that patents should be awarded for precise, focused, and complete inventions. The days of sweeping patent coverage for fundamental inventions may well have passed. If the ACLU decision stands, even patents on specific biotech products may be unavailable.
Does this catastrophic scenario mean the industry will collapse? No. While biotech patents are being questioned, new forms of protection for biotech products are being developed. The recent healthcare reform legislation includes a 12-year exclusivity provision for innovator biologics. Such protection is very different from a patent but certainly provides significant commercial incentive and value. Congress clearly understands the importance of protecting biotech products. We believe that the courts understand this too.
At the end of the day, it is likely that the worst of the ACLU decision will be reversed or redirected. Some aspects of it, perhaps setting heightened standards for defining a product as “manipulated by the hand of man” and, therefore, distinguished from products of nature, may well survive.
However, more practical and product-orientated patent policies may very well promote development in biotechnology. And there’s nothing like a common enemy to stimulate collaboration within an industry. If this ACLU decision can act as the biotech industry bad guy and stimulate greater innovation, what seems like a doomsday ending might turn out to be a new beginning.