Thailand Law Journal 2012 Fall Issue 1 Volume 15

In the year 2005, countries in Africa and Asia had stated that owing to the prices of the drug Tamiflu, they were unable to build stockpiles in their own countries for the purpose of countering the disease . The identified ‘Tamiflu Production Shortage’ has caused pressure groups to require Roche to give up its patent monopoly . The countries who qualify for the Tamiflu Reserves Programme are those countries who are members of the Global Allicance for Vaccines and Immunization (GAVI).

However, Jennifer Lazo has argued that minus financial incentive even the most altruistic corporation will not be mindful of its obligations to cater to international pandemic situations. With all due deference to fixing the ‘right to access of essential medicines’ as an international human right, United States being mindful of its duty as a developed country had enacted the Life-Saving Medicines Export Act in order to allow for compulsorily licensing of generic versions of patented drugs so as to facilitate access to impoverished countries . Apart from sublicensing agreements with India and China, Roche has also granted a knowledge transfer to a South African manufacturer (Aspen Pharmaceuticals) for the provision of generic Tamiflu for pandemic use on the African sub-continent .

Virology and Pharmaceutical Intervention
While dealing with Virology, Roche, defines Influenza as a “... [F]lu, is a highly contagious viral illness that occurs mainly in the autumn and winter months in temperate climates and year-round in tropical areas”. Pandemic, or global epidemics, occur every 10 to 40 years. The HIV virus is a simple virus consisting of nine segments in its genome. The Human genome in contrast has as much as 25,000 segments. The Influenza virus has eight segments and is further classified into types A, B and C. Subtype A can occur in both humans and animals. Some viruses might be zoonotic strains which can be transmitted cross species. The pig has been identified as an ideal mixing vessel in which such mixed transmission had occurred .

Antiretroviral therapy though not a cure, has reduced and alleviated the viral load thereby bringing down the damage to the immune system .In her introduction Eileen Kane outlines the possible scope of Pharmaceutical Intervention in the wake of a Pandemic as including both the generation of an immune response to a viral infection which is to be supplanted by the case of vaccines and secondly to prevent the replication of the virus gene which is done through antiviral therapy. She further traces the success of these measures as being dependent on the development of the appropriate drug, the facilitation of access to the drug and understanding the capacity of production . With respect to understanding the issue of ‘information’ she states that in order to counter the chances of an impending influenza crisis the first necessary action to be taken would include tracing the necessary virus, and for the purpose of a vaccine identifying the ingredient adjuvant .

In the case of United States v. Glaxo Group Limited the District Court had refused the Government’s request to order mandatory, non-discriminatory sales of the bulk form of the drug, however, it had allowed that bulk-sales restrictions were violations of Section 1 of the Sherman Act. The case dealt with the pooling agreement between Imperial Chemical Industries and Glaxo Group Ltd. to practice the bulk and dosage form patents in the manufacture and sale of a fungicide griseofulvin. Following the pooling agreement, a few firms in the United States had been sublicensed to practice the patent. In the consideration of the case, it was essential that there was no substitute for the griseofulvin in combating certain infections. Further impugned in the court of law, was a clause in the sublicense agreement which entered a covenant on part of the licensees to restrict bulk sales without the consent of Glaxo, in writing.  The United States, observed that his was an unreasonable restraint on trade. The court however, refused to order for compulsory sales stating that it might not essentially better the conditions for competition considering Glaxo could opt to cease producing the drug.

Stockpiling: The issue of compulsory licensing specifically with an interest to increase and augment the government stockpiles had come up in the anthrax issue, and Secretary Thompson, had identified the same as not being an option for the stockpiling need, but had contemplated ‘breaking the patent’ nevertheless . With respect to stockpiling, the three specific classes identified and supported by Roche are (i) children (ii) use as a ‘fire-blanket’ to contain or slow a pandemic at the site of its outbreak (iii) regional stockpiles in developing countries. 

Conclusion

The WHO has identified those flexibilities in the TRIPS agreement which could justify interference with the rights of a patent-holder. An identified pre-grant flexibility is in being able to define the criteria for patentability in such a manner so as to be able to preclude the patentability of essential medicines.  As embodied in Article 27.1, it is possible to enforce higher standards on the three conditions for patentability. The Indian Patent Act, through Section 3(d) has further defined ‘inventive step’ and used the same to deny a patent to Glivec, for which a compulsory license was granted in Thailand. Third parties are granted the right to oppose a patent, post the grant during a specific observation procedure. Exceptions to patent rights under Article 30 of the TRIPS Agreement, permit certain actions such as research and regulatory review exception. Article 8.2 of the TRIPS Agreement further authorizes Members to adopt appropriate measures to prevent the abuse of intellectual property rights by right holders, the resort to practices which unreasonably restrain trade and which affect the international transfer of technology. Article 40.2 of the TRIPS Agreement accords to Member countries the right to take action against licensing practices or conditions which might interfere with competition and licensing practices .

Sui Generis Protection for Pharmaceuticals: When does any system require sui generis protection?

A specific ‘field of technology’, if warranting a challenge under Article 27.1 of the TRIPS agreement, might be required to be addressed under a sui generis mode of intellectual property in order to ensure there is incentive for engaging in such innovation, yet, balance public interests against the prospective monopolization of the same innovation. When Patents had been identified historically, pharmaceutical patents and repercussions on the public health framework had not even been in the contemplation of the legislators. Pharmaceuticals are mismatched to be fit into the patent system forcefully. It might be easy to illustrate the same using the system of the mode in which a drug functions in a health-care system. Often other modes of incentivisation have been suggested as a mode of handling pharmaceutical innovation. There have been thinkers who propound that a certain drug must be given extended patent term so as to ensure the drug is not immediately commercially exploited in the market in order to break-even. This is in absolute incongruence from those other thinkers who require patents to constantly remain in public domain. Pharmaceutical companies tend to invest a lot in innovation. The statistical chances of a particular drug experiment attaining fruition are very few. Hence, there are required to immediately attempt to break-even. This is not the best course to be undertaken in case of medicines handling the situation of an anti-retroviral.

Pharmaceutical companies are not always the patent holder. Sometimes, they hold the licenses from the patent-holder. Hence, the motive of providing incentive to the innovator, might sometimes be displaced.The health system is so far advanced in western countries that once a pharmaceutical company has identified a particular drug which could be seminal in treating an infection, the patenting authority allows a ‘wildcard’ extension thereby permitting it to ‘reap the benefits’ on its other lucrative drugs by extending the period of exclusive marketing granted to it . Indeed as per Eric Kades, the idea of allowing for an extended term of patent use for an antibiotic might better serve the interests of the problem to be addressed at hand. It might insulate the parent company from the need of having to urgently oversell the antibiotic with a view to recover the return on investment and make profits .