This Friday I attended a workshop at Yale Law School Global Health Justice Partnership to discuss the end product of a clinical project exploring human rights strategies to promote access to medicine. (This is a long term interest of mine. PIJIP held a conference and workshop on IP and Human Rights in February, I teach classes on the subject at WCL and the University of Pretoria,and helped with a symposium issue of the WCL Health Law Brief).
The paper from the Yale project is not ready for pubic release. One of my recommendations to the students was that they publish it because it contains a lot of great information, especially on some relatively recent cases that have used the right to heath to interpret or trump various maximalist versions of intellectual property laws affecting access to pharmaceuticals. Here is a quick overview of some of those key cases.
Tribunal Constitutional [T.C.] [Constitutional Court], 25 enero 2013, Rol de la causa: 2.411-13-CPT, p. 50 (Chile)
This case was brought by generic firms against local implementation of a “linkage” system, like that put in place by Hatch Waxman in the US, that allows a patent holder to get an injunction against a potential generic entrant through an expedited procedure. The generics claimed that it was a violation of an equal protection mandate because only pharmaceutical companies received this procedure. In interpreting the issue, the court looked toward the right to health as an interpretive principle and found the linkage legislation unconstitutional.
The Central Intellectual Property and International Trade Court, Oct. 1, 2002, Aids Access Foundation, Mrs Wanida C, & Mr Hurn R. v. Bristol-Myers Squibb company and the Department of Intellectual Property, BC Tor Por 34/2544, RC Tor Por 93/2545
Court used the right to health as a factor in the decision to grant patients standing to challenge a patent. The Court described access to medicine as “fundamental” to life and health, holding that “the injured parties from the grant of Patent are not limited to the manufacturers or the sellers of [the] medicine protected by the Patent.”
Sankalp Rehabilitation Trust v. F. Hoffmann-LA Roche AG, OA/8/2009/PT/CH (2009) (India)
Gave standing in patent challenge to NGOs with an interest to “bring the drug within the reach of the community for whom [the NGO] works, not only because of reduction in cost, but also because of increase in supply.” The court noted that “public interest is a persistent presence in intellectual property law.”
F. Hoffmann-LA Roche AG v. Cipla Ltd., I.A 642/2008 IN CS (OS) 89/2008 (2008) (India)
Court used the right to health to construct the proper balance of interests that should be considered in evaluating a request for a preliminary injunction involving a medicine patent. The court held that “unlike in cases involving infringement of other products, the Courts have to tread with care [when] pharmaceutical products and more specifically life saving drugs are involved. In such cases, the balancing would have to factor in unknowns such as the likelihood of injury to non- parties and the potentialities of risk of denial of remedies.” It continued: “the Court cannot be unmindful of the right of the general public to access life saving drugs which are available and for which such access would be denied if the injunction were granted. The degree of harm in such eventuality is absolute; the chances of improvement of life expectancy; even chances of recovery in some cases would be snuffed out altogether, if injunction were granted. Such injuries to third parties are un-[compensable]. Another way of viewing it is that if the injunction in the case of a life saving drug were to be granted, the Court would in effect be stifling Article 21 [which protects the right to life] so far as those [who] would have or could have access to [the medicine].”
Cipla Medpro v. Aventis Pharma 2012 (139/12) (S. Afr.)
Held that the “broader public interest, and not only the interests of the litigating parties” must be considered in evaluating a requested injunction by a patent holder to halt marketing of a generic competitor.
Patricia Asero Ochieng, Maurine Atieno, Joseph Munyi, & AIDS Law Project v. Attorney General, (2009) Petition No. 409 (Kenya) at 28-29 para. 52
Struck down an “anti-counterfeiting law” that the court held would negatively impact the marketing of legitimate generic medications. The Court held that the law “would have the effect of limiting access, . . . would ipso facto threaten the lives and health of the petitioners and others infected with HIV and [AIDS], and would be in violation of their rights under the Constitution.” Although recognizing the legitimate interests of the government in passing legislation to regulate counterfeiting, it scrutinized the means used under a standard resembling heightened scrutiny: “Had the primary intention been to safeguard consumers from counterfeit medicine, then the Act should have laid greater emphasis on standards and quality.”
Cámara Federal de Apelaciones [CFed.] [Federal Appeals Court], 1/2/2011, “Novartis Pharma AG c. Monte Verde SA / propiedad industrial e intellectual,” Causa No. 5.619/05 (Arg.)
Court rejected an argument that TRIPS Art. 39(3) requiring protection against unfair uses of commercial data required implementation of a data exclusivity regime barring generics from relying on originator clinical data to approve biosimilar products. The court used the right to health in its balancing of factors, holding: “[t]he reasonability of an impugned legal regime is better understood when one reads it in light of international human rights obligations.”
Tribunal Administrativo de Cundinamarca [Administrative Court of Cundinamarca], Sala, Lab. Febrero 29, 2012, Carlos Enrique Moreno Rubio, Expediente No. 2009-00269-01, (p. 53) (Colom.)
Court rejected a request for a compulsory license on Kaletra, an AIDS medication, but held that the drug’ price must be controlled by government to ensure broad access to it. The case held that “the right to health requires that budgetary and procedural aspects” to promote access to affordable medications, and those mechanisms must “be made viable and balanced.”
Conclusions
Some of the these cases (e.g. Colombia) were brought by access to medicines campaigns. Many others were not, but rather ended up addressing right to health arguments within litigation between private parties. Taken as a whole they show a lot of promise for the potential of right to health arguments to play a key role in judicial decision making that can have real impacts on access to medicines in particular countries. There is no current campaign by advocates to use these potential channels more deliberately. Whether there should be such a campaign was a point of discussion at the meeting with no firm conclusion. To succeed there would need to be a better coordination between human rights lawyers and access to medicines advocates than now exist. A prime consideration is whether forming such an alliance would be at the expense of existing resources or would grow the existing (dwindling) support for civil society advocacy in this area.
