Doing the Patent Dance Without Knowing the Steps

Posted by Michael Francisco | Categories: ,

Amgen has been involved in several cases involving biosimilars of its blockbuster drugs.

The first day of BIO 2016’s Intellectual Property track featured three sessions that eventually dovetailed into what’s increasingly becoming a thorn in the side of drugmakers: the challenging of drug and biologics patents on multiple fronts and, in theory, without end. In addition to regular patent litigation under the Hatch-Waxman Act, the Patent Trial and Appeal Board (PTAB) formed in late 2012 as part of the America Invents Act gave rise to inter-partes reviews (IPRs) seeking to invalidate patent claims and entire patents. In just over three years, the number of IPRs have increased to the point that the process has come to be seen as a road block for patents.  Read more

A role reversal in biotech patenting

Posted by Michael Francisco | Categories: ,

A role reversal in biotech patenting

The difference in the patenting landscape between the United States and Europe used to be characterized as freewheeling versus cautionary; expansive versus patchwork. Think of Diamond v. Chakrabarty‘s “anything under the sun that is made by man” versus the long battle to finally allow the patenting of stem cells in Europe.  Read more