Biosimilars litigation

While a generic drug applicant needs to provide declaration of any IP pertaining to their filing, the 351k submitter is not required any regulatory submission; in return, the 351k submitter provides full disclosure of filing to the originator to examine if any IP is infringed--a complex patent dance starts leading to a binding agreement on which patents to litigate that includes process patents. However, the courts have recently ruled and many biosimilar developers have decided not to share the regulatory dossier with the originator, leaving a wide door open to originator to litigate any time. A good example is found when Abbvie sued Boehringer-Ingelheim and Amgen.

Given that biosimilars challenge multibillion franchises, it is clearly understood why the originators have created high firewalls around their products. These firewalls include claims for indication, dosage formulation, drug concentration, upstream and downstream specific process conditions, packaging and drug delivery devices, all creating a wide net for the originators to keep biosimilars out of the market as long as possible.


what's the fto for biosimilars

A freedom-to-operate dossier is routinely developed by all applicants for generic and biosimilar drugs; however, the biosimilar landscape creates a complex and often difficult choice, what to  include in the consideration of selection of the IP. For generic chemical drugs, the choice is simpler but when process patents are also included, the biosimilar FTO requires he following is placeholder text known as “lorem ipsum,” which is scrambled Latin used by designers to mimic real copy. Mauris egestas at nibh nec finibus. Aliquam bibendum, turpis eu mattis iaculis, ex lorem mollis sem, ut sollicitudin risus orci quis tellus. Donec eu est non lacus lacinia semper. Nulla lectus ante, consequat et ex eget, feugiat tincidunt metus.

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the pharmsci® difference

What differentiates us from many choices available include:

  • We are licensed practitioner of patent law with a long history of prosecuting bioprocessing, biotechnology, drug discovery, dosage delivery and many other fields.
  • We wrote the book on bioprocessing and also on biosimilars. We are able to advise you what would constitute an infringement and how you can go around a potential infringement--a rare combination of expertise.
  • We own more bioprocessing patents than any other solo inventor in the world; where needed, we can offer you alternate technologies that will allow you to obviate infringements.
  • We have established partnership with IP firms, qualified scientists and medical professionals to validate our FTOs; we provide to assure that your submission of the dossier to the originator, if you choose to do so, is robust and not challengeable. 
  • We are fast developing the core FTOs for potential biosimilar products--chances are we already have your FTO.