My beat on SLAW.ca is typically, if not all too predictably, the copyright trials and tribulations of scholarly communication. I’d be the first to admit that matters of access to this body of knowledge are relatively straightforward compared to what takes place next door with patent licensing, especially when pharmaceuticals are involved. Still, such patents disputes, which often involve government, university, and industry, can shed light on my interests in legal reforms that restore some part of intellectual property law’s original intent to promote the progress of science and encourage learning for the benefit of all.
This has led me to the report that on February 7th of this year, two tuberculosis survivors, Nandita Venkatesan and Phumeza Tisile, filed a challenge in the Mumbai Patent Office against the evergreening strategy of Johnson and Johnson. The company is seeking to extend their patent of the tuberculosis drug bedaquiline for another four years beyond the current expiry date of 2023. The story of Nandita and Phumeza, both rendered deaf by the only affordable, if toxic, treatment available for their multiple-drug-resistant form of TB, is heart rending. Bedaquiline’s pricing, which can run to over $264 a month and is needed for an extended period, places it out of reach for most of the close to 500,000 patients who acquire drug resistant tuberculosis each year.
Part of the troubling story here is how bedaquiline has emerged as the only medication to be approved for commercial distribution out of the hundreds of molecules related to TB that have been patented over the last six decades. Even then, bedaquiline access continues to be restricted. Although some patients receive free treatment through India’s Revised National Tuberculosis Control Programme, the medication can be found in only six centers across the country.
While researchers question why the TB patent pipeline is so constricted, the costs involved in the stalled patents, as well as the successful drug’s own development, may seem to warrant Johnson and Johnson’s pricing. This is, after all, the argument that intellectual property law must provide a sufficient incentive-to-invent, in the form of a limited-term monopoly, for the public to benefit. Yet, it turns out that the case of bedaquiline dramatizes how we need a new political arithmetic that gives more credit to public-private collaboration, as itself an incentive in bringing safe and effective treatments to market. This is where parallels begin to surface with scholarly communication, as many of us seek to increase public access to research by pointing to the public investment that such it represents.
The extent of such investment in bedaquiline has been helpfully set out in the open letter of September 14, 2018, that Els Torreele, executive director of the indispensable Médecins Sans Frontières, addresses to Johnson and Johnson. In asking the company to drop its bedaquiline prices to $32 a month, Dr. Torreele points to the extent of public support in the drug’s development, as well noting that it can “be manufactured and sold profitably for prices between $8 and $16 per month,” according to one study.
That public investment, in this case began with the U.S. National Institute of Allergy and Infectious Diseases and the TB Alliance funding a number of the drug’s necessary phase I and II trials, which were carried out by university researchers. The more extensive phase III trials have involved the International Union Against Tuberculosis and Lung Disease, as well as Médecins Sans Frontières, with USAID and UNITAID funding. Even if we set aside the tax breaks afforded Johnson and Johnson, as well other incentives – including a “priority review voucher” misapplied to a blockbuster drug – it seems reasonable to expect that Johnson and Johnson demonstrate how it has taken this public investment into account in arriving at its global pricing strategy for bedaquiline.
The U.S. government could assist in this process by expanding its tracking of public and private participation in drug approval through its Clinicaltrials.gov registry to provide a more thorough record of investment collaboration and its pricing benefits. On the enforcement side, it could extend its ability, within the Bayh-Dole Act of 1980, to forcibly license patents resulting from federal funding to additional parties, in order “to alleviate health or safety needs.” (The Act currently applies to patents held by universities and small businesses, but the bedaquiline case suggests reasons for its expansion.)
Yet rather than depend on the spectre of “march-in rights,” l would prefer to hold out the incentive of cooperation to pharmaceuticals. Publicly funded researchers are already absorbing the risks of failed patents in their efforts to promote the progress of science. In return, they need to now ask big pharma, when such collaborations do succeed (as they have with bedaquiline), for an account of how their efforts translate into greater global access to the successful medications.
Here the lessons for scholarly publishing fully emerge for me. For I continue to pursue models of public-private cooperation, as well as of legal reform, that seek to recognize and utilize what is distinctive about the research economy to increase public benefit. There is a common cause here among a great host of organizations involved in pharmaceutical patenting which might be directed toward finding a place within the law for encouraging greater cooperation, with a corresponding accountability, when it comes to advancing the benefits of science.