By Mary An Merchant, Ph.D. / Intellectual Property and Life Sciences Groups – Morris, Manning & Martin, LLP

Do U.S. patent rights protect a patent owner from competitors that export key parts of inventions for reassembly in other countries? Competitive international activity is a common challenge for companies that only hold U.S. patents, especially when deciding whether, and where, to seek patent protection in other countries.  Diagnostic companies, medical device companies and others who hold patents on multicomponent inventions have followed this case closely.

The U.S. Supreme Court answered a part of the question recently, determining that exporting a staple article or commodity of a multicomponent

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The end of 2016 and start of 2017 found the FDA releasing guidance documents for biosimilar products that detail the conduct and analysis used for clinical pharmacology studies and how to name biosimilar products that are seeking FDA approval under the Biologics Price Competition and Innovation Act of 2009 (BCPIA).  The clinical pharmacology guidance (released in December 2016) provides recommendations for studies that assess the presence or absence of clinically meaningful differences between the proposed biosimilar product and the U.S.-licensed reference product.

In keeping with previous biosimilar guidance from the FDA, the December 2016 guidance document reaffirms the “totality of evidence”

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