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Where were biologics-related patents involved in BPCIA litigation invented?

Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national...more

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to ยง 560k of the Federal Food, Drug, and...more

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