In a surprising move,DIPP has taken a decision to refuse grant of CL for anticancer biologic Trastuzumab/Herceptin as reported by Sidhartha of Times of India.
Earlier in Nov 2012 and again in March 2013 campaign for affordable trastuzumab (an association of patients and NGO’s) had urged the Govt to take appropriate measures to ensure affordability of Herceptin. Subsequently Trastuzumab was recommended for CL by the health ministry. Read our previous posts (here and here).
However after several months of deliberation and debates, the DIPP has refused a plea for CL for Trastuzumab. India, in the recent past has attracted strong criticism from several quarters for taking a pro-patient stand in its patent disputes involving Pharma MNC’s. International scrutiny on India’s IP policies, heightened when India granted its first ever CL against Bayer’s anti-cancer drug Nexavar (read Shamnad’s post here). Ergo, I believe the DIPP must have decided to take it easy with grant of compulsory license.
Prashant makes a very interesting point here; does the DIPP have the right to turn down the recommendations of the health ministry? If the DIPP and health ministry disagree on the grant of CL for Herceptin, the matter should ideally have been directed to the Prime Minister’s office or Cabinet.
|Image from here|
Herceptin patent status:
Apart from platform technology patents, Herceptin is protected by three patents in the US viz. US6339142, US6407213 and US7074404, all of which expire in 2019. In India however, I am aware of only one granted patent relevant to Herceptin IN205534. This patent broadly covers a method of purification where a product molecule must be separated from a very closely related contaminant molecule (acidic variant). I have covered this in detail in this post here.
Now after refusal of plea for CL, the health ministry has suggested that the government use powers vested with it under section 66 of the Indian Patents Act to revoke the patent in public interest.
Revocation of patent in public interest: Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.
History of Section 66 shows that it has been used only a couple of times to revoke patents. The first instance was when a process patent was granted to Agracetus, a U.S. company, for genetically engineered cotton cell lines. Around the year 1997, this patent was revoked in public interest because it was viewed as being prejudicial to farmers’ rights. The Govt was of the view that Cotton is an important crop essential to national economy and should not be the subject matter of patents.
The other instance was when Indian patent 252093 was granted to Avesthagen for “synergistic ayurvedic/functional food bioactive composition”. The patent covered the composition consisting of jamun, lavangpatti and chandan to be used for treatment of diabetes, which is in effect traditional knowledge (section 3(p) of Indian patent act precludes patenting of traditional knowledge). Thus the patent was revoked as it was deemed to be generally prejudicial to public. Prashant has covered this development extensively in his blog posts here, here and here.
In both instances the patents were revoked either because their working was detrimental to public interest or because they contravened provisions of the Indian patent act. As I see it, Section 66 is a safeguard against patents (detrimental to public interest), which have been inadvertently granted by the patent office. However in this case, the fact that Trastuzumab/Herceptin is exorbitantly priced; can it be construed as being generally prejudicial to public?
CL u/s 92 versus Patent revocation in public interest
Provisions relating to grant of CL u/s 92 require that an interested person should make an application after weighing the benefits conferred by the CL against other costs like payment of reasonable royalties to the patentee, manufacturing costs etc. However these factors need not be considered by a potential biosimilar manufacturer if a patent is revoked u/s 66.
I believe that high price of Herceptin alone is not reason enough for the Govt. to invoke Section 66. It would be unfair to the patentee. Compulsory license would have been a better option in my opinion. Also if DIPP has refused a plea for CL; we wonder whether it will accept a plea for revocation of patent in public interest. It remains to be seen, what stance will be adopted by DIPP regarding this. Interesting times ahead!