by Dennis Crouch
We recently highlighted a WaPo editorial by Prof. Robin Feldman. Feldman has also just published a short article in Nature Biotechnology titled Negative Innovation: When Patents are Bad for Patients. (Co-authored with Profs. Nicholson Price (Michigan Law), David Hyman (Georgetown Law), and Mark Ratain (Chicago Med)). The article’s thesis:
[Sometimes] patents create incentives to bring a product to market in a way that is relatively harmful to consumers, and the existence of a patent (and the associated rents) discourages the patentee from taking steps to improve the product so as to prevent the adverse health outcomes.
The article uses the cancer drug ibrutinib as a negative innovation case study. Basically, the patentee (Pharmacyclics – AbbVie) discovered that ibrutinib was a useful cancer treatment at a wide range of doses. However, the patentee erred by publicly disclosing the low dosage idea prior to patenting and thus was only able to obtain patent claims covering the high dosage. They then pursued FDA approval of only the high dosage approach — even though this cancer drug is known to be somewhat toxic at higher doses. The FDA suggested that AbbVie pursue further research and an application on the lower dosage. But that suggestion has fallen on deaf ears — presumably because the lack of patent coverage eliminates the incentive to pay the $$$$ required to obtain FDA approval. Since the low dosage approach is in the public domain, no private company has sufficient incentive to seek and obtain FDA approval.
If you go back to the thesis statement, note that the argument is that ibrutinib is “relatively harmful to consumers.” If it were “absolutely harmful” then the drug presumably should not have been approved and no doctor should prescribe the treatment. (These are perhaps big presumptions given the current state of our system.) Relative harm is different — and focuses on whether the patent’s existence inhibits the development of a potentially better alternative. This is essentially a story of lock-in and private rent seeking. It is akin to the apocryphal story that major car manufacturers long shelved and impeded automotive battery power technology because they were so invested in the combustion engine. Perhaps they rightly recognized that battery driven cars would be so radically different as to allow upstart entry into an otherwise closed market. See Tesla.
Although the ibrutinib case study was based upon a misstep (pre-filing disclosure at a conference), there are plenty of examples of non-patentable treatments that are not made available because our current system relies upon exclusive patent rights to provide the monetary incentive to seek FDA approval and work out the kinks of manufacturing and supply. Generally the patent system has treated this is a FDA regulatory problem. But Feldman notes that there are also solutions within the patent system that begins with revitalization of the utility doctrine — evaluating whether the innovation is actually an improvement:
One avenue for reform might be to enforce a more rigorous utility requirement for pharmaceutical patents, demanding that they actually improve social welfare relative to the prior art.
If sufficient evidence is not available because of early filing incentives, an element of this may be a post-patenting requirement showing utility, similar to the working requirement of some countries or the proof of use requirement in trademark law.
I mentioned that part of the problem is that the FDA is relying upon the patent incentive, and that doesn’t work in certain instances. Feldman suggests that the Patent Office could do more to coordinate with the FDA in developing an understanding of patent coverage and how that is impacting FDA submissions.
Finally, the article suggests further development in linking and coordinating patent coverage in the pharmaceutical area. “The current jumbled system of compound patents, method of treatment patents, formulation patents, new chemical entity exclusivity, pediatric exclusivity, orphan drug exclusivity and other incentives creates limitless opportunities for gaming the system.” Of course we have a system of coordinating these involving patent families and the various obviousness doctrines (including obviousness type double patenting). What we have not tried is any sort of product-level coordination.