Here's interesting post from the Patent Doc Blog that argues that there are incentives for producers of innovator drugs to NOT file patents to block information access to biosimilars producers in the future.
The writer argues that instead of filing patents innovator drug producers could file the bare minimum information with the FDA to get their drug approved. Because biologic drugs are so complex, this degree of stealth would prevent knowledge flow to biosimilar producers who wanted to copy their drug. Thus, the innovator would not disclose the cell used to produce the drug, or any optimization of that cell line.
The bloggist argues that this would produce obstacles for the biosimilar follower and would also avoid litigation under the biosimilars statute. The innovator could thus avoid protracted biosimilar patent infringement lawsuits.
It is an interesting post. But if non-filing is this easy, why doesn't someone do it now? It would save time and money. It may protect from a biosimilar follower but does it protect from a fellow innovator?
Posted by Bruce Lehr Dec 20th 2011.
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