We all live in an Orange

Submarine

Graeser Associates International

What you don’t know can hurt you in the world of patents and biosimilars

With apologies to the Beatles, the “orange submarine” of the title refers to submarine patents and the Orange Book for generic drugs. Of course, biosimilars lack such an Orange Book – would be biosimilar sellers have to go through a lengthy and cumbersome patent process with the originator for a biological drug instead. But the principle remains the same; patents act as a gatekeeper for determining whether a biosimilar can be manufactured and sold in the US.

Submarine patents add a degree of extreme uncertainty and risk for biosimilar manufacturers. The term “submarine” refers to the fact that these patents remain secret until they issue as a granted patent, after which they have 17 years of life from their issue date. By their very nature, submarine patents cannot be planned for, as they appear without warning and effectively block biosimilars of a particular biological drug from being manufactured.

• Up until 1995, all patents were effectively submarines, as they were secret until they issued and they had 17 years of life from their issue date. After 1995, the life of such applications (and their granted patents) was 20 years from the date of filing of the application – not 17 years from the date of issuance of the patent. This change meant that no new applications filed after that date could truly be submarines.

• Of course, older patent applications – filed before that date and still pending – could be considered submarine patents once they actually issue. For a period of time, such submarine patents would regularly appear, disrupting various industries and otherwise suddenly injecting a previously unknown risk factor for companies. As time went on, these submarine patents dwindled in number – until everyone thought that they were gone.

• Think again - an important submarine patent covering the biosimilar drug Enbrel issued as late as November 2011 – meaning that it will be in force, unless abandoned or invalidated, until November 2028! No one predicted that such a patent could still exist, and certainly no one was prepared for this particular patent. Thus, submarine patents could still theoretically appear, disrupting plans for a particular biosimilar and generally injecting an unquantifiable risk to the business of biosimilars in the US.

• In our next blog posts, Graeser Associates International will be exploring these different challenges and uncertainties of biosimilars in the US, especially with regard to intellectual property.

• We will also be providing powerpoint presentations, written reports, and short audio and video presentations through this Slideshare channel. We will also be selling more detailed reports and longer audio and video presentations – please see our biosimilars product page for a list of products

• D'vorah Graeser, PhD is the founder and chief executive officer of Graeser Associates International (GAI), an international health care intellectual property firm. Dr. Graeser has been a U.S. patent agent for over 15 years and has extensive experience in the biomedical field. Follow Dr. Graeser on Twitter: @DGraeser. Follow our biosimilar communications on Twitter: @GAI-biosimilars. Email us at biosimilars@gai-ip.com.