Industry Expert Q&A with Robin M. Silva

An intellectual property attorney-Robin M. Silva, partner at Morgan, Lewis, and Bockius-discusses method and process patents for biopharmaceuticals. 

PharmTech: Will process and/or method patents prevail over molecule patents, once biosimilars products begin launching in the United States?

Silva: One issue that’s true in biosimilars is that [they] are coming up against what are the first generation product[s]. And while manufacturers of biologics have been moving forward, [and] as it gets close to the end of the lifecycle of the first generation, they’ve been developing second-generation products, sometimes referred to as biobetters. A great example of this was Epogen (epoetin alfa) and Neupogen (filgrastim). Epogen actually went off patent a number of years ago, but there wasn’t a biosimilar that came through [the regulatory process] because of the fact that Neupogen was on the market. One of the things we have to realize in this discussion is that biosimilars are not only competing with the first generation products, but will also be competing with the ‘biobetter.’

[Whether process or method patents will prevail] is a complicated issue. One thing that is true in the United States, and throughout the world, is that the methods [described in] the process patents for producing antibodies are pretty well known, and many of those techniques are actually going off patent now. The best example of this would be the Cabilly patents that came out of Genentech; these were the patents that defined expression of antibody chains in cells, and many companies took a license-or were using those techniques-to produce antibodies. Those patents are going to expire in the next few years, and as a result, anybody could be using those ‘older techniques.’ There is standard technology [currently in use] that is perfectly sufficient to produce any kind of antibody or biologic (I will use the term antibody interchangeably with ‘biologic’ for this discussion).

Process and method patents [will be explored over molecule patents based on] how novel or innovative these methods are, as standard techniques will be available. One of the issues will be, ‘if I produce an antibody using old techniques, I won’t be infringing anybody’s new, fancier methods moving forward.’ This plays out the most in second-generation molecules, like bispecifics or antibody-drug conjugates; those types of methods are different and much more cutting edge than the traditional expression of a [standard] monoclonal antibody. One of the things that is going to be true about molecule patents is that the Federal Circuit in the antibody and biologic area (protein engineering) has taken the view that it can be very difficult to describe a whole genus and they are generally looking down on broad, functional language, which is how many of the molecule patents are issuing now. There’s a question as to whether or not you can get a patent through the patent office, but then can you enforce it in the court system? The second part of that question looks like it will be the bigger, long-term issue.

Article DetailsPharmaceutical Technology
Vol. 39, No. 9
Pages: 66

Citation: When referring to this article, please cite it as “Industry Expert Q&A with Robin M. Silva,” Pharmaceutical Technology39 (9) 2015.