The rubber has hit the road in the debate over legislation, approved in March, to create a regulatory pathway for generic versions of cell-based drugs known as biosimilars. The U.S. Food and Drug Administration has yet to issue rules on the new law, which would give the “innovator companies” — those who produce the name-brand biologics — 12 years of data exclusivity before their drug patents can face competition.
Attorneys are giving their clients a flurry of advice about how to protect their patents and are holding their breath to see what approach the FDA takes in its rule-making. “Our advice (to companies with name-brand biologics) is to think about creating a broad patent portfolio, not only to cover the sequences of molecules, but more importantly, also protecting the method of formulation, the dosing, the delivery methods,” said Jonathan Sparks, a Boston-based attorney in the life sciences practice at McCarter & English LLP. “You need to create a picket fence around the product.”
Sparks and his colleagues Cristin Cowles and Maria Laccotripe Zacharakis are now writing an article about the implications of the biosimilar legislation that they hope will be published in the journal Nature Biotechnology.
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