Opportunities at the door
One might be tempted to liken this situation to what happened after the Hatch–Waxman legislation passed 25 years ago, but
such an analogy does not reflect the complexity of manufacturing biologics or the quantum leaps in knowledge that have occurred
over the past quarter-century. We now know exponentially more about molecules and how to study them. We also have better and
faster tools with which to develop new products. If a follow-on biologics regulatory pathway is approved, companies that want
to come out on top will quickly need to stake out a patent position in one or more of the following technology spaces.
Improved methods and apparatuses to fully depict the composition and structure of a biologic as well as its performance are
urgently needed. This need includes new and better assays for identifying clinically meaningful differences between two products
and establishing bioequivalence or "similarity." As these technologies become more sensitive, FDA and the public would be
remiss for not requiring companies that want to produce follow-on biologic compositions to employ them.
There will be an incentive to develop new and better manufacturing methods that ensure more effective products. The inventors
of new manufacturing methods are not necessarily the same individuals who discover that a composition may be useful. For example,
a biologic company may obtain a patent for its biologic compound but then license in another party's method of manufacture
to make a consistent product. To the extent that the method is useful for more than one product, the owner of the patented
method could generate licensing revenues from multiple parties. Moreover, even if the maker of the follow-on biologic could
avoid infringing the pioneer patent holder's rights and wait out the data exclusivity period, it may still need a license
from a third party to manufacture its follow-on product.
Renewed focus will be placed on delivery systems. Delivery of therapeutics is challenging regardless of whether the active
material is a small molecule or a biologic. The efficacy of a biologic is tied to its delivery to a target tissue. Unlike
the delivery of small molecules, however, there is a much shorter history of developing effective systems, and subtle changes
in manufacturing may have a substantial effect on delivery. Thus, the companies that patent new delivery systems may be able
to profit as much as, if not more than, the innovator biologic and follow-on biologic players.
New and more effective methods for screening and diagnosing conditions that can be treated by biologics are likely to develop.
One might expect many of the inventors who develop these techniques to be the same as those who develop the techniques for
conditions currently treated by small-molecule drugs.
The bioinformatics industry will have the opportunity to grow. The patent landscape of this industry is the most difficult
to foresee because the way these inventions are patented is rapidly changing. The opportunity to capitalize on the wealth
of biodata is undisputable. But as pioneering and follow-on players feel the pressure and opportunity to grow, companies will
need to monitor data pertaining to therapeutic processes and reactions. In addition, industry players will need to consider
applications tailored to individual genomes and histories.
Each of these five areas could develop into a highly lucrative industry and, as with any shift in business rules, an official
regulatory framework for follow-on biologics could change the competitive landscape. That said, biotechnology will always
be shaped, in part, by patent positions. Thus, with a host of opportunities in the technologies that supplement the development
of new therapeutics, and the ability to obtain strong patent positions on these areas, biotechnology may be the industry to
lead America out of the recession.
Frances Weber, Esq., is executive vice-president of Article One Partners, a patent prior art research provider, tel. 347.838.0618, FWeber@articleonepartners.com
, and Scott D. Locke, Esq., is a partner at Kalow & Springut and an adjunct law professor at Seton Hall University, tel. 212.813.1600, firstname.lastname@example.org