As brought to light by blogger B2fxxx there was a story in the Economist about a recent study published in Science magazine concerning the viability of gene patents in general. See here.

Jordan Paradise and her colleagues at the Illinois Institute of Technology, published a study stating that more than a third of the patents they examined had claims that did not meet the requirements for patentability, that is, useful, novel and non-obvious, as well as meeting the requirements for description and enablement under section 112.

The group looked at gene patents including include not just human gene sequences, but patents that cover any human genetic material, such as mutations in a gene, or diagnostic methods that utilize human genetic material that would effectively preclude the use of that material by others. They chose genetic diseases that were subject to “public attention” and for which problems in gene patents could potentially have an impact on research and health care. Collectively, they examined 1,167 claims in 74 patents on genes related to nine diseases. If a claim failed to meet one of the legal requirements for a patent, it was deemed “problematic.”

In the judgment of the authors, 38% of the specific claims were problematic and 73% of the patents contained at least one such problematic claim. As for the causes of the problems, slightly more than 40% were due to concerns about utility – that is, whether the invention could yield correct results. Slightly less than 40% raised concerns because their descriptions were inadequate. The remainder failed the novelty and non-obvious requirements, or lacked “definiteness.”

Without seeing the actual specifications and claims in question, it is difficult to assess their results and conclusions. They cite some problems that seem straight forward, such as patents claiming more than what the inventor actually discovered, for example, claiming the sequence of a protein within a patent and then also asserting rights over all of the DNA sequences that encode for that protein without describing those DNA sequences. That would seem to be a clear cut problematic claim. However, they noted written description problems by stating that “One patent covers not only the particular polymorphism the inventor discovered but all other polymorphisms discovered in the future by anyone else in a region encompassing over 12 mega-base pairs (Mbp).” If true, then this would seem to be also problematic.

There are some inherent problems with any study where patent claims are deemed problematic by the authors, rather than the courts, so it’s difficult to say if what the authors deem problematic would ultimately be determined invalid by a court. While problematic claims can act as a drag on commercialization, there isn’t any indication it is a worse problem in biotech versus other, high-tech specialties.

I don’t think it’s really new to point out that biotechnology patents are difficult to prosecute and often have less than optimal claim language. It feels a little like complaining about the weather. I agree with the authors that one potential remedy may be more training or special selection of patent examiners. Not to mention better pay so that better Examiners are attracted from the beginning and have more incentive to stay on board longer. I feel the little hairs on the back of my neck bristling, though, at some of their ideas such as having biotech applications reviewed by the USPTO with different levels of scrutiny. I think this will meet considerable resistance, if you agree that Anything Under the Sun is patentable. Besides, what specialized patents couldn’t be improved with higher levels of scrutiny? I always have trouble with making any particular area more “special” than another.

I do like the author’s suggestion that the USPTO could also change its financial incentives to promote quality over quantity. Currently, patent examiners are encouraged with monetary bonuses to grant patent applications since patent examiners receive a salary bonus based on the number of final allowances or rejections of a patent authorized. Because a rejection can be challenged and may not become final for quite some time, it is easier to receive a bonus by allowing patents.

Let’s hope the changes announced by Commissioner Duddas will improve everyone’s circumstances.

See more on the Town Hall meeting here.

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