Speakers on both sides of the debate discussed their concerns with the Biologics Price Competition and Innovation provision of President Obama’s landmark healthcare legislation during a session held at the BIO International Convention in Washington, DC on Monday.
Mark Bowditch of Sandoz was hesitant about the bill from the perspective of a generic applicant. Most troubling to him is that the law requires a biosimilar applicant to disclose the full contents of its application to the reference product sponsor in order to verify that the application is sufficiently similar to the reference product.
“Fundamentally, having to provide your entire application is very disturbing to biosimilar applicants,” said Bowditch. “You may have no intention of challenging the basic patent, but you still have to give up your most sensitive information to your bitterest enemy.”
On the other hand, innovator companies seem concerned about the bill’s stipulation that the biosimilar application can only be reviewed by one outside and one in-house counsel who have not been engaged in patent prosecution related to the reference product.
“We’ve always negotiated the scope of the protective order [which normally governs prosecution limits],” said Bart Newland, vice president and chief IP counsel at Biogen Idec.
Some have proposed that innovator companies hire special in-house counsel just for the purpose of reviewing biosimilar applications, but Newland said he hopes that doesn’t become necessary.
“This could create a lot of tension,” added Bowditch.
Edward Murray, managing counsel of IP litigation at Merck, said that the new law will present problems for choosing outside counsel, since the line between innovator companies and biosimilar applicants is not as clearly drawn.
In the small molecule world, most law firms have developed an allegiance to representing either innovator companies or generics, but many large brand-name pharmaceutical companies are interested in developing biosimilars as well. This could create serious conflicts for firms, since an innovator client may suddenly ask its outside lawyer to represent it in the role of a generic.
The bill also includes several opportunities for gamesmanship with respect to timing issues. One audience member was concerned that biosimilar applicants might wait until the very end of the 12-year exclusivity period the legislation grants to biologics to file an application. This would allow the applicant to launch its product even if the innovator company ultimately wins a patent infringement or validity challenge, since an injunction would not be issued against the biosimilar product until there is a final decision on appeal, which could take years.
“You raise a very valid point,” said Bowditch in response to this argument.
No one has yet used the new biosimilars pathway, but the panellists said they expect to see a biosimilar application launched soon.
“The strategies people will use are just not yet clear,” said Murray.
