How does the Antares Pharma case impact the original patent requirement?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The Antares Pharma Inc., v. Medac Pharma Inc. case significantly impacted the interpretation of the original patent requirement. According to MPEP 1412.01:

“To satisfy the original patent requirement where a new invention is sought by reissue, ‘… the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.’”

This means that claims to a new invention comprising a combination of features only disclosed as alternatives or part of the original invention, but not as a separate invention, would not satisfy the original patent requirement. The case emphasizes the need for explicit and unequivocal disclosure of the claimed invention in the original patent specification.