- It appears Goodlatte has not read the order as it very clearly and logically lays out its reasoning for the compulsory license. (A) Reasonable requirements of the public were not being met, (B) the drug was not ‘reasonably affordable’ to the public, and (C) was not ‘manufactured to a reasonable extent in India’. As Shamnad mentioned in his post on the order, this third reason would probably be the most controversial, and expectedly, Goodlatte has only focused on this, ignoring the other two. To be clear: More than fussing about whether it was manufactured in India or not, it was vitally important in this case that the drug was neither affordable nor accessible by a majority of the patients who needed it.
- Goodlatte also refers to compulsory licenses as though they are evil. I wonder if he was around when the US govt was ‘threatening’ Bayer back in 2001 with a compulsory license on Anthrax pills, before Bayer agreed to US’ demands to supply 100 million pills at $0.95 instead of $1.75 when it had affected a few dozen people. For comparison’s sake, the treatment of Nexavar costs Rs. 280000 / month (~ $5100) and a little less than 9000 people were prescribed the drug per year. After the license, it will cost Rs 8800 (~ $160). ]
- Regarding the effects that compulsory licenses have on innovation, it turns out there is very little evidence to support this. In fact, Colleen Chien has written a good paper on how compulsory licenses have little to no negative impact on innovation.
- The rest of her speech here all comes across as very patronizing. I offer my sympathies to her for her dismay at the ‘lack of international standard’ of the order. And would like to also thank her for her for the USPTO’s ‘educational efforts’ and hope they continue to be as unsuccessful. I also don’t quite understand the significance of mentioning Kurian’s last day here.
- While they are discussing the compulsory license in India and talking about respecting the rights of US innovators, I’d also ask them to respect India’s IP regime, the TRIPS flexibilities and rights of Indian consumers. ]
- I don’t know if it’s through ignorance or veiled threats, but again, Rae comes across as being very patronising of India – stating that India wants to be a ‘good’ player in the international community – and thus would be willing to listen to America’s efforts to ‘educate’ them. If this is a veiled threat, then of course, the message is that India will be seen as a ‘good’ player internationally only if they listen to the USPTO.]
- Talking about foreign governments trying to help their domestic industries…. As opposed to America’s efforts to unabashedly support their (local) big pharma without considering public health concerns?]
- This moves the conversation into dangerous territory. Patent harmonization, especially substantive harmonization is a very very complicated and risky scenario – seeing as no country seems to have figured out an optimal patent regime for even themselves. Throw in issues of local contextualisation and region specific domestic industries and we have ourselves a nice big mess.
- Allowing compulsory licenses to be used as bargaining chips against the countries that need it, to further push a TRIPS plus IP regime which has no real basis in the first place is extremely dangerous for all countries involved, yet this is exactly what he is suggesting.
- Also, he does not seem to fully understand why compulsory licenses exist, as shown when he makes it seem like they only make sense when a drug is not available at all in a country.]
- This is probably in reference to the third reason for the compulsory license, that is the local manufacturing clause. For this, I reference another of Shamnad’s previous posts on this issue: “For one, Article 31 of TRIPS does not stipulate any “grounds” for invoking compulsory licenses—thereby suggesting that almost any ground would pass muster. Some argue that a local working provision contravenes the mandate under Article 27 to not “discriminate” between locally produced and imported patented products. Given the fact that in the WTO Canada case, the panel stated that discrimination meant “unjustified differentiation”, one could argue that “local working” is a “justified” differentiation. For one, the Paris Convention clearly stated that “importation” would not amount to working of a patent, and that if a patent wasn’t worked, this could be treated as an “abuse”. Secondly, TRIPS is premised on the promise of technology transfer to developing countries. And a local working provision is geared towards encouraging such technology transfer. By forcing patentees to “work” their patents in India, the regime encourages local use/transfer of the said technology.”
- Aside from this, according to KEIonline, “U.S. has also kept and added provisions to its own domestic laws that require patented inventions developed with federal research subsidies to be manfactured in the United States. A U.S. court even recently granted a compulsory license on a patent on a heart disease device, in order to prevent the manufacture of an infringing device from relocating manufacturing process in Mexico.”
Unclean hands, perhaps?]
Edit: Rae has now retracted and ‘clarified’ parts of her statement. As per the USPTO’s director’s blog where the clarification was made:
“I was also asked some questions during my testimony and want to take this opportunity to clarify my responses relative to data protection for biologics and compulsory licensing under TRIPS and wanted to take this opportunity to clarify my responses. Although compulsory licensing can be permissible under the TRIPS Agreement, we encourage our trading partners to consider ways to address their public health challenges while maintaining intellectual property rights systems that promote investment, research, and innovation. The broad interpretation of Indian law in a recent decision by the Controller General of Patents of India regarding compulsory licensing of patents, in my view, may undermine those goals.”