Data Exclusivity Innovation Patent

The Draft Intellectual Property Policy of South Africa


The South African government released its much awaited ‘Draft National Policy on Intellectual Property, 2013’ (“Draft Policy”) for public Medicinesconsultation. According to the news report, the pro-reform civil society collective cautiously welcomed the release of the Draft Policy. The civil society collective inter alia advocated for reforming the South Africa’s IP laws such as a) adoption and implementation of an examination system for all pharmaceutical patent applications; b) strengthening patentability criteria to prevent evergreening; and c) promoting high standards for medical innovation. It is hoped that the new policy will enhance competition in the pharmaceutical sector, lower the price of medicines and promote a market free of patent manipulation.

Presently, the South African law provides for “a registration system that is not per se able to scientifically critique “newness”, “obviousness”, “novelty” and “usefulness in trade or agriculture”.(page 10) The Draft Policy proposed for a Substantive Search and Examination System which included pre-grant and post-grant opposition mechanisms. The Draft Policy considered the success of pre-grant and post-grant opposition proceedings in India in precluding the grant of weak patents. (page 9) However, I would like to caution that the Indian mechanism is not without criticisms and drawbacks. For instance, there is an argument that writ petitions challenging pre-grant opposition decisions wither alternative remedies and lead to unnecessary delays [see here]. Therefore, I always advise against blind adoption of any provision. It is, however, heartening to note that the draft policy of a foreign state is taking cue from the mechanisms set out by our Patents Act, 1970. It is a matter of pride that the Indian Patents Act has used the TRIPS flexibilities to a great extent and incorporated viable and pragmatic mechanisms such as pre-grant and post-grant mechanisms (in spite of some valid criticisms against it) for precluding the grant of weak patents.

If the intention of the Draft Policy was, however, to knock-out weak patents, then the Draft Policy could have suggested subjecting existing patents to post-grant opposition as well. Further, the Draft Policy could have broached upon incorporating a provision akin to Section 3(d) of Indian Patents Act, 1970 – a provision which has a proven track record in precluding the grant of weak patents. As Prof. Shamnad Basheer pointed out on Section 3(d) [here]: “If the patent office/courts interpret it very restrictively to exclude all kinds of incremental pharmaceutical inventions, then this will certainly contravene TRIPS. However, if interpreted sensibly, it will help weed out worthless patent applications that are filed to merely extend patent terms.”

The Draft Policy voiced against entering into BTAs which will negate TRIPS flexibilities. It also advocated for an activist role in the international arena so as to support developing countries against entering into such BTAs. On a pragmatic perspective, it was noted that South Africa may not be able to defend the gains alone in international arena. (page 9) This pragmatic realization inter alia reflects its desire to play a more active role in international arena and multilateral forums such as UN and BRICS. I hope that this will draw the attention of Government of India and inspire it to take a more activist role – especially for a genuine cause such as the instant cause. [I have earlier posted on ‘Principles for Intellectual Property provisions in Bilateral and Regional agreements’.]

As on data exclusivity, the Draft Policy could have taken an unequivocal stand. On the other hand, it put forward an ambiguous suggestion: “South Africa should remain committed to the protection of data in terms of Article 39, but not to the extent that multinationals are demanding as per their Governments as this could compromise access to health.” A clear and cogent intention could not be discerned from the aforesaid recommendation. For the uninitiated, Article 39.3 of TRIPS states as follows: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.” As Prof. Shamnad Basheer pointed out, this doesn’t mean that that the regulatory data submitted by an innovator cannot be relied upon by the government to approve a generic. As he stated here, “It could mean (as I have argued) that the government may use it to approve a generic version, but the generic manufacturer in question has to pay a certain sum of money to the innovator (a “compulsory licensing” scheme of sorts). It could also mean, as others have argued, that the data ought to be only protected against disclosure and fraudulent procurement by another third party.”

 

 

 

 

 

Mathews P. George

Mathews P. George

Mathews is a graduate of National University of Juridical Sciences, Kolkata. His interest in intellectual property was kindled when he bagged the second position in his second year of Law School (in the prestigious Nani Palkhiwala Essay Competition on Intellectual Property). His stint as a student of Prof. Shamnad Basheer further accentuated his interest in intellectual property. Winner of almost a dozen essay competitions in his Law School days, he was involved in various research and policy initiatives relating to intellectual property. Mathews is, currently, based out of Munich, Germany. He had earlier done his LLM in 'IP and Competition Law' from Munich Intellectual Property Law Centre (jointly run by Max Plank Institute for Innovation and Competition, University of Augsburg, Technical University of Munich and George Washington University, Washington).

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