Momenta backs shorter data exclusivity period

As the debate over protecting biotech intellectual property heats up, everyone is taking sides. Most biotechs are fighting for patent protection for biologics of at least 7 to 12 years, arguing that it's expensive to make biologics and companies need to be able to recoup their costs (and of course make profits). But Cambridge, MA-based developer Momenta Pharmaceuticals is not happy with the Senate's proposal for 12 years of IP protection. In fact, the company has been lobbying Congress and its industry counterparts to restrict the data exclusivity period to five years. Why would a drug developer push for limited data protection? Just like those arguing for longer protection, it has vested interests in doing so.

As Mass High Tech reports, the company says it has a technology platform that can help determine and reproduce exactly how a biologic was made. Biotechs and industry advocates have argued that given that biologics are made from living organisms, it's difficult and risky to develop biosimilars as they can never be exact copies of the original drugs. But Momenta sees things differently. "One of the things I find most disappointing is that the biotech industry is not debating the actual science," Momenta CEO Craig Wheeler tells MHT. "For an industry that is built on innovation, to say something can't be done, that is the wrong way to go. It's two-faced." 

Analysts say Momenta stands to benefit from the development of a clear regulatory pathway for biosimilars regardless of the final decision on patent protection. Momenta's technology makes the company a very attractive M&A target, analyst Simos Simeonidis of Rodman and Renshaw told investors in a note. "Big pharma companies, and some of the major generics companies, would be interested in keeping all to themselves both the technology and the internal capabilities and know-how of Momenta," he wrote (as quoted by MHT).

- read more at Mass High Tech

Related Articles:
NYT: Biosimilar bills are neither a threat nor boon
Examining the generic biologics debate
Obama offers "generous compromise" on biosimilars
FTC: 12-14 years too much protection for biologics