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« Genetic Heterogeneity in Tumor Samples May Explain Difficulties in Developing Personalized Medicine | Main | "Public Interest" Groups Call for Synthetic Biology Regulation »

March 12, 2012


Depending on country, the correct spelling of the brand name is Gleevec/Glivec, not Gleevac.

"(compared with the first patented compound, which "might not be absorbed into the bloodstream well enough, or it might be chemically unstable, or unsafe")."

I still struggle with the thought of a patent being granted on an item for which the use is so unproven.

My apologies, hit the post button too soon.

"that "[i]t would be impractical for drug companies to seek patents only after they have conducted years of clinical trials that could provide definitive proof that updated drugs work better than their older version."

Why is it "impractical" to have the claimed utility? If such an important aspect as the safety of human life is a critical component of the patent, then the stakes should be higher and such "impractical" concerns are an acceptable trade-off.

However, I am also skeptical of a blind acceptance of the statement "the Indian government has a legitimate interest in protecting its generic drug industry." Only if that industry respects established patent rights is there any legitimacy. Would we except a pirate nation's claim that it has a legitimate interest in protecting its bootleg software (or even worse) movie industries?

Yes, the last comment was a bit tongue in cheek.

Dear Kevin:

S.3(d) has nothing to do with drugs invented before or after 1995. The article and now you point an incorrect statement of law:
"As described in the article, the dispute concerns a provision of the law that precludes patent protection for drugs known or developed before 1995 unless it is in a new form that "significantly improves the medicine's 'efficacy,' or effectiveness."

The text of S(d) is without limitation or linking to any year of invention. The Section is to prevent minor 'inventions' moving to create ever greening by virtue of bringing in an enhanced efficacy threshhold to such minor invention applications.

So with the statute in your article, lets look at the actual invention being sought to be patented - the claim is for the beta polymorph of imatinib mesylate and not imatinib mesylate itself - its for the polymorph! The Indian Patent Office rejected it (amongst other grounds) since Novartis did NOT show 'enhanced efficacy' for this polymorph versus the prior art form of imatinib mesylate.

Dear Skeptical:

The PTO has a tough enough time applying patentability standards, much less regulatory standards. But I understand your point.

The last comment was informed by the principle that a government will do what's good for its country. That isn't a moral statement, it is a political one. And it is tragic that the drafters of the GATT/TRIPS treaties thought they could ignore that fact.

Thanks for the comment.

Dear S:

Thanks for your perspective. Question: IF Novartis had shown a different result (e.g., the prior compound had some deleterious effect that the polymorph did not have), would a different result have been possible or likely?

Thanks for the comment.

Dear William:

Thanks for the correction.

Dear Kevin:
I cannot give a clear answer to your question, but it logically does play out - since based on your hypo- the 'new' polymorph does show 'enhanced' efficacy over the current drug.
Remember, as per decisions, enhanced bio-availability or better shelf life are NOT enough for this criteria.
The efficacy enhancement aspect has to be justified from a medical perspective and if I recall correctly, the initial decision on this was based on definitions from Dorland's Dictionary.

For those who are interested in this, keep an eye out for Kaushik Sunder Rajan's forthcoming book, Lively Capital: Biotechnologies, Ethics and Governance in Global Markets. He has followed this story for years, done many careful interview and documentary studies, and has a balanced treatment of the issues. Not sure when it is coming out, but he gave a presentation here at Duke about a month ago.

Dear all,

As we all know that "3d" stands on the term "ëfficacy", so lets research about that first. As a pharmacologist i think the term efficacy is more related to the the pharmacodynamic property ie pharmacological effect(curing/treating)of the drug on the body.
Indian patent law prevent the minor invention under 3d unless there is efficacy shown. Now this efficacy could be shown in terms of its potency to treat the particular disease when compared with original drug. Simply any data (In vitro/in vivo etc)that shows that the present compound has superior activity as compared to original to treat or kill that particular cells with lower dose and less side effects would be sufficient to overcome the objection of 3d.
As rightly said in earlier post by one of friend that only bioavailability and better shelf life is not suficient to overcome the objection so combine this data with pharmacodynamic data as said above.

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