By Samuel Petuchowski, Ph.D.. A member of our Patent Practice Group
A patent application should be filed as soon as possible. Not only do patent rights go to the first inventor to file a patent application, but no invention may be patented if it has been publicly disclosed more than a year before an application is filed.
US law applicable to patent applications filed prior to March 15, 2013, that is, before the America Invents Act (AIA) took effect, specifically barred patenting anything more than one year after the first instance of its being sold or offered for sale.
In the case of The Medicines Company (“MedCo”) v. Hospira, Inc., MedCo ordered three batches of the anti-coagulant drug bivalirudin to be made by a manufacturing contractor, Ben Venue Laboratories, using a process that Medco later patented. While the market value of a commercial batch would have been about $10 million, no one could have sold the drug to consumers because FDA approval was still pending at the time.
When MedCo later sued Hospira for patent infringement, one of Hospira’s defenses was that MedCo’s patent application came too late, since it was filed more than a year after MedCo paid Ben Venue to make the preliminary batches for validation purposes.
The policy underlying the “on-sale” bar as it existed in Section 102(b) of the pre-AIA Patent Act was to preclude an inventor from profiting from the commercial use of an invention for a prolonged period before sharing it with the public by filing a patent application. However, the statute sought to give the inventor a “reasonable” time to discern the potential value of an invention before undertaking the patenting process. In 1998, the Supreme Court, in its decision in Pfaff v. Wells Electronics Inc., established a two-part test to determine whether an offer for sale occurred that would bar patenting more than a year later: The invention had to be the subject of a “commercial offer for sale” and had to be “ready for patenting.” More...
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