1 May 2011Americas

Covering all the bases: An interview with BIO President Jim Greenwood

Reform of the US patent system has been a long time coming. Year after year, it seems, US legislators get close to a consensus on satisfactory improvements to the patent system, only for their efforts to be scuppered by last-minute amendments, or other priorities, or just plain old disagreements. But this year, it might be different. A bill was approved earlier this year by the US Senate with broad bipartisan support. A similar bill is scheduled to be considered by the full House of Representatives in mid-June.

Assuming for now that the bill does get through in some form, what benefits would it bring to the biotechnology and life sciences industries? “BIO supports legislation that removes subjective elements of the patent system and provides a more reliable set of rules,” Greenwood says. “If patent reform is done in this way, the net effect will be positive.”

Specifically, provisions to allow the US Patent and Trademark Office (USPTO) discretion to set its fees and keep collected fees should increase its resources and make it more effective, while harmonisation with the global norm on first-to-file will “bring us closer to a time when the same examination doesn’t have to be done in 15 countries”. Additionally, provisions to tackle the big-business bugbear of false patent marking suits will be welcome.

Here and now

While patent reform may finally be coming, no one will take anything for granted until it’s signed and sealed. In the meantime though, the biotechnology industry is living with the ramifications of the last major legislative reform in the US: healthcare. Since the legislation passed in March of last year, the US Food and Drugs Administration (FDA) has been preparing guidance so that companies will be able to make applications for biosimilars.

Greenwood says: “Many companies have announced their intention to get into this space, and many of those are innovative companies.” Innovator companies such as Amgen, Inc., Biogen and Merck & Co have indicated in media statements that they are considering entering the biosimilars market to compete against other biologic companies.

Alongside this, the political discourse continues to focus on how to trim the federal budget and reduce the deficit. One of President Obama’s specific suggestions in that regard was to change the data exclusivity protection term for biosimilars from 12 (as decided in the heathcare reforms) to seven years, Greenwood says.

“That was interesting to us because, although it’s not likely to happen, it shows that not everyone in the Administration has conceded the point yet.” Alongside this, the Administration is negotiating a pacific trade agreement, and one of the key questions is whether that agreement should follow current US law. “There’s apparently some hesitancy,” Greenwood says.

While it is probably too early to fully assess the impact of healthcare reform on the biotech industry in the US, Greenwood is yet to be convinced that it’s been positive overall.

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