This article compares national approaches towards secondary pharmaceutical patents. Because secondary patents can extend periods of exclusivity and delay generic competition, they can raise prices and reduce access to medicines. Little is known about what measures and policies countries have enacted to address applications for secondary pharmaceutical patents, how they function, and whether, in practice, these measures limit secondary patents. We analyse the cases of India and Brazil. We assemble data on pharmaceutical patent applications filed in the two countries, code each application to identify which constitute secondary applications and examine outcomes for each application in both countries. The data indicate that Brazil is less likely to grant applications than India, but in both countries, the measures designed to limit secondary patents are having little direct effect. This suggests, on the one hand, that critics of these policies, such as the transnational pharmaceutical sector and foreign governments, may be more worried than they should be. On the other hand, champions of the policies, such as NGOs and international organizations, may have cause for concern that laws on the books are not having the expected impact on patent outcomes in practice. Our findings also suggest that, at the drug level, the effects of countries’ approaches towards secondary patents need to be understood in the context of their broader approaches towards Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) implementation, including when and how they introduced pharmaceutical patents in the 1990s and 2000s.
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This page includes links to the Special 301 Reports and PhRMA’s submissions. http://www.keionline.org/ustr/special301
Six countries (the USA, Japan, Germany, France, UK, and Switzerland) account for 77 % of pharmaceutical patent applications filed worldwide during the 1995–2006 period (WIPO 2011).
Alternative forms of the same molecules may perform differently in the human body. In addition, once stable and effective molecular forms are found, pharmaceutical innovation also consists of establishing ways to deliver them. Consider that medications are typically consumed in tiny dosages, sometimes as little as 5 or 10 mg of the active pharmaceutical ingredient (API). Delivering such miniscule amounts would be exceedingly difficult, if not impossible, were they not combined with a range of additional inert ingredients (excipients). Yet, while excipients’ role may ultimately be simply to consume space and to facilitate handling, they must be selected and included in the manufacturing process in such a way as to make for a deliverable and consumable medication that retains the desired biological effects of the API. And, separate formulations must be undertaken for each dosage and different systems of delivery (e.g. capsules, pills, ointments and syrups). Finally, often the same molecules affect multiple parts of the body differently; when molecules intended for one therapeutic use turn out to be effective in ways other than intended, additional work is entailed to develop the drug for the “new uses”. Each of these steps can generate additional patent applications. As a result, for any given medication, it is common to see tens of patents covering the base compound as well as diverse molecular forms, formulations and uses (Howard 2007; Amin and Kesselheim 2012).
This process is widely referred to as “evergreening”. Pharmaceutical industry representatives tend to object to the use of this term (GSK 2007; IFPMA 2013), but no one denies that obtaining secondary patents constitutes a component of “life cycle management”. Of course, not all secondary patents have equal blocking effects. Analysing the conditions under which secondary patents deter competition is beyond the scope of this article. For present purposes, the simple point is that secondary patents are used as part of firms’ strategies to extend periods of market exclusivity.
By contrast, Farrell and Merges (2004) question the appropriateness of ex post re-evaluation via litigation.
Our objective here is not to survey the array of responses to the challenges of secondary patents, but rather to use the USA as an illustration of an ex post, litigation-based approach. Our sense is that the US system is unique in offering this bounty, although further research on the variety of ex post mechanisms would serve as a useful complement to our analysis.
This would be true even if developing countries had bounties for ex post challenges, which (to our knowledge) none do.
Drahos (2008) makes a similar point, distinguishing between prevention and cure. According to Drahos, once patents are issued, they are hard to remove, even if dubious, so countries may have an interest in adopting more restrictive granting practices.
The 2005 amendments to the patent act also included a provision that allows any firm that was producing a drug prior to 2005 to continue to do so, even if a patent is later granted, after 2005 when patent examination began. This provision, essentially an automatic compulsory license with a small royalty payment, assured that there would be no retroactivity in India.
Consider the case of a drug where the a patent is applied for in 1990. In 1990, the patent could not be obtained in Brazil because pharmaceuticals were ineligible, but by 1997, when pharmaceuticals became patentable in Brazil, no patent would be available because by then the invention was no longer new. If in 1997, however, this drug was not yet on the market, but rather was still in development and undergoing clinical trials, i.e. it was in the “pipeline”, it could be patented in Brazil for the remainder of the period of the original patent.
The international priority date refers to the date a patent application was first filed in any country. According to the Paris Convention, applicants have 1 year after an initial filing to make subsequent filings in other countries where protection is sought without losing “priority” (that is, inventions that become known over that year cannot be asserted as “prior art” to reject claims in the application).
Applying Section 3d thus entails two steps. First, a decision has to be made as to whether the claimed invention is subject to this rule (i.e. if it is derived from a known substance), and, if so, a second decision has to be made as to the efficacy of the claimed invention relative to the known substance.
Novartis also charged that Section 3d violated TRIPS, but the High Court ruled that it lacked the jurisdiction to make such a ruling. Novartis would have to get the Swiss government to pursue that claim in the WTO, something that has not happened
To be precise, this change was announced in 1999, as part of a provisional measure (presidential decree), but in reality, the examination system did not change until 2001, after the patent law was reformed.
Note that even when ANVISA consents, it may do so only after narrowing some of the patent’s claims.
The Prior Consent regulations were revised in 2012, with a new workflow introduced in 2013, such that now ANVISA evaluates pharmaceutical patent applications first, prior to INPI.
The precise language is said to have originated with the local pharmaceutical sector: According to Sengupta (2013, 45), “The language for Section 3d was provided by the Indian Drug Manufacturers Association (IDMA).” Gopakumar (2013, 57, note 2) provides an alternative account of the origins of the language, from within the judiciary.
The Indian Supreme Court ruling in the recent Novartis case goes into detail on the legislative intent. Likewise, the Madras High Court, in its 2009 ruling that 3d was constitutional, also goes into the history and legislative intent.
Stretching back to the 1980s, we can consider the Indian position towards pharmaceutical patents in three successive stages. Initially, in the TRIPS negotiations, India sought to prevent the inclusion of an obligation to grant pharmaceutical patents. Then, with TRIPS concluded and pharmaceutical patenting unavoidable, India used the full transition period available and did not allow retroactivity. Lastly, once the transition period expired and India was to begin granting pharmaceutical patents, the policy aims to minimize secondary patents.
Prior Consent formed part of a larger set of initiatives by the then-Minister of Health to deal with the escalating price of drugs. ANVISA itself was created at the same time.
ANVISA is based in the capital city of Brasilia, but its IP division is in Rio de Janeiro, which is where the INPI is located.
It is notable that Brazil’s pre-emptive mechanism has not received nearly as much attention from NGOs, health activists and international organizations. Based on this, and the press they receive, Section 3d appears to be viewed as more a boon for those who seek to limit secondary patents than Prior Consent. The differences in attention could reflect many things—including that India is a large supplier of generic drugs for many developing countries and that the Indian policy was the focus of a major Supreme Court decision in 2013 that captured international headlines. It may also reflect their different origins: that Prior Consent was not explicitly designed for secondary patents, and many observers are not aware of the fact that these two provisions are functionally similar.
See Hemphill and Sampat (2011) for a description of this dataset. The Orange Book lists most (though not all) of the pertinent patents for drugs marketed in the USA.
Pipeline patents in Brazil were not examined, but rather “revalidated”. If the patent was granted elsewhere, provided that no product was already being marketed, the patent was issued in Brazil too (with the same claims as granted abroad). Thus, to the extent that pipeline patents are assessed, they are not assessed with regard to novelty and inventiveness but simply to assure that (1) the patent had been issued abroad, and (2) the drug was not on the market (i.e. it was still “in the pipeline”). Of the Brazilian applications in our dataset, 94 (25 %) of these are pipeline patents.
Some of the patents coded as rejected are under appeal and may, ultimately, be granted, but the number of these is small.
In ongoing work on set of applications for which more detailed data are available, we examine applications that are rejected on the merits separately from applications that are abandoned and withdrawn.
INPI usually (though not always) reports if an application has been sent to ANVISA, but even then, it does not record data on what the health agency does with the application, hence the need to consult both sources.
Recall that the applications in our dataset constitute only a small portion of the total number of pharmaceutical applications received.
To repeat, not all of these are formally rejected by the patent offices, as we count abandoned and withdrawn applications in the category of “reject”.
If we include the “frozen” applications, 6 % of the applications were not granted on account of ANVISA’s intervention.
We address the question of indirect effects below.
Two applications had post-grant oppositions, which we do not classify as “pre-emptive,” and as a result we do not consider these two in the subsequent analyses.
Furthermore, even among those applications that received ANVISA’s consent and were granted, in some cases, ANVISA insisted on narrowing the claims.
An additional difficulty was presented by the quantity of “divisional” applications in India, where specific priority applications are broken into pieces yielding many Indian applications for a given Brazilian one.
Our coding of whether primary or secondary matched in over 95 % of the cases.
Another drug has no patents granted but has an application that has been frozen following an ANVISA denial.
ANVISA rejections are nearly two times as likely for drugs with pipeline patents, a point we return to in the “Discussion and Conclusions” section.
Although the Supreme Court’s ruling of April 2013 (in the Novartis case) went some way towards clarifying this issue, determining that efficacy is to be judged strictly and narrowly in terms of therapeutic efficacy (in contrast to other, perhaps physical, properties of a drug), it is too early to see effects of this ruling on patent prosecution more generally.
Shadlen (2011) also discusses the ambivalent position of the domestic pharmaceutical sector in Brazil.
Given that our database is based on drugs authorized by the FDA prior to 2004, any application attached to one of these drugs filed in 2006 or beyond would by certainty be for a secondary application.
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We are grateful to the Economic and Social Research Council (ES/K010999/1) and the joint LSE-Columbia University Research Committee for funding, and to Meriem Bekka, Kim Grauer and Jennifer Reid for research assistance. The article benefited from discussion at the authors’ workshop organized by the Watson Institute (Brown University) in January 2014, and we thank the participants at the workshop, along with the journal’s reviewers, for their helpful feedback. We are also received helpful feedback from participants at LSE’s Comparative Politics/Comparative Political Economy workshop and from Shamnad Basheer. We thank Tahir Amin for his assistance in coding the applications and his suggestions on previous drafts.
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Sampat, B.N., Shadlen, K.C. TRIPS Implementation and Secondary Pharmaceutical Patenting in Brazil and India. St Comp Int Dev 50, 228–257 (2015). https://doi.org/10.1007/s12116-015-9181-7
- Secondary patents
- Section 3d
- Prior Consent