The Biotechnology Innovation Organization (“BIO”) (formerly: Biotechnology Industry Organization) is the principal trade association representing the biotechnology industry domestically and abroad. BIO has more than 1,000 members, which span the for-profit and non-profit sectors and range from small start-up companies and biotechnology centers to research universities and Fortune 500 companies. Approximately 90% of BIO’s corporate members are small or mid-size businesses that have annual revenues of under $25 million, and that count their patents among their most valuable business assets. BIO’s members depend heavily on robust patent rights and a fair system for adjudicating their validity.
Biotechnology businesses and entrepreneurs have huge reliance interests in the validity of their patents. BIO members commonly devote a decade of effort and in excess of 2 billion dollars to develop innovative products that address unmet medical needs, increase crop yields, and provide real-world tools in the fight against disease, hunger, and pollution. Without the promise of effective and predictable patent rights, these investments would be far more difficult—if not
impossible—to undertake. And unlike typical products in, for example, the ecommerce, enterprise software, or mobile communications industries, biotechnology products tend to be protected by only a handful of patents. A biotech company literally faces the loss of its entire business if but a few, or even just one, of its patents are invalidated. BIO’s member companies are extremely sensitive to even the slightest procedural imbalances that exist in the proceedings of the Patent Trial and Appeal Board (PTAB) of the United States Patent and
Trademark Office (PTO), including the ability to amend claims in inter partes review (IPR). Accordingly, the question of who has the burden of proof, and what must be proved, before a claim amendment can be entered in IPR is of great importance to BIO’s membership.