The continual news out of India about legal rulings breaking or invalidating pharmaceutical patents has become too much for the cleantech industry to ignore.
I’m not equating or conflating green technologies and pharmaceuticals (though some do, disingenously in my view), I’m just being realistic. The legal and policy rationales put forth and the precedents being set in connection with pharma patents could someday soon be applied to green patents.
In March, India for the first time ordered a compulsory license, allowing an Indian company to produce and sell a generic version of Bayer’s cancer drug Nexavar without Bayer’s permission (see article here).
In a ruling this spring, India’s Supreme Court held that Swiss drugmaker Novartis could not get a patent on the beta crystalline form of imatinib mesylate, the cancer drug Gleevec. The beta crystalline form of the drug has 30% increased bioavailability compared to the free base form, but the court was not persuaded by physical efficacy and instead focused on therapeutic efficacy.
This summer India’s Intellectual Property Appellate Board (IPAB) revoked a patent owned by GlaxoSmithKline for the breast cancer drug Tykerb. In particular, the lapatinib ditosylate salt was found to be unpatentable for lack of innovation. The IPAB did uphold the patent directed to the original compound.
The IPAB also revoked patents covering Allergan’s glaucoma drugs Ganfort and Combigan earlier this month.
And that is only this year. Significant patent revocations in India last year included Pfizer’s cancer drug Sutent, Roche’s hepatitis C drug Pegasys, and a Merck asthma treatment.
For most of these, the legal issue is that the variation of the original drug compound is deemed an unpatentable incremental innovation. It’s true that attempts at evergreening – extending patent protection by making minor changes in a product – are common among pharmaceutical companies.
Policy arguments also play a big role in most of these cases; advocates and supporters of the decisions contend that they are necessary to ensure affordable medicines. This Star Tribune article quotes an Indian lawyer saying this is “not an anti-patent movement” but instead is “about access to drugs for poor people.”
But I don’t really want to weigh on in this debate. Rather, as alluded to above, I want to point out why this movement (whether framed as “anti-patent” or pro-”access”) could render green technology patents vulnerable.
First, who’s to say the legal proscription against patenting incremental improvements in India won’t apply to green patents? A substantial proportion of patents on green technologies are directed to incremental improvements.
A prime example, and a close cousin to pharma, is advanced biofuels. There are a number of patents in this area directed to recombinant organisms with genetic modifications that could be deemed “incremental” but have a major impact on biofuel production capacity.
In solar, particularly thin films, where a 1% boost in efficiency can be significant, many advances are incremental. Would the technical improvements in wind turbines that differentiate zero voltage ride through capability from low voltage ride through be deemed unpatentable?
On the policy side, a number of countries over a number of years have been making the argument that patents act as a barrier to transfer and deployment of green technologies in developing countries and emerging markets.
Both the contentions – that patents make implementation of green technologies cost prohibitive – and the proposed solutions such as compulsory licensing would be very familiar to the Indian judges and other officials involved in the recent pharmaceutical patent decisions.
There is some recognition in cleantech that green technologies could be affected. The Solar Energy Industries Association was among the numerous diverse groups that asked Vice President Joe Biden to raise concerns about trade and IP policies on his recent trip to India (see article here).
Amid some some recent signs of US-India cooperation on climate change (during Biden’s India trip), green patents should be a ripe area of discussion. Let’s hope that pharma patent loathing won’t creep into green patents.
Eric Lane is a patent attorney at McKenna Long & Aldridge LLP in San Diego and the author of Green Patent Blog. Mr. Lane can be reached at elane@mckennalong.com
