Update on the Novartis case before IPAB – 17 November 2008

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Update on the Novartis case before IPAB – 17 November 2008

Chennai, 17 November 2008

The Intellectual Property Appellate Board (IPAB) today commenced

hearing the appeals filed by Novartis AG (Novartis) challenging the

Indian Patent Office's decision to reject its patent application for

the beta-crystalline form of imatinib mesylate (Gleevec).

A special bench of the IPAB comprising Mr. Negi (Judicial Member) and

Mr. P. C. Chakraborti (Special Technical Member) is hearing these

appeals.

At the commencement of the hearing, Mr. Anand Grover, counsel for

Cancer Patients Aid Association (CPAA), informed the IPAB that he

would be objecting to new expert evidence that Novartis has sought to

introduce in the appeal. He argued that because Novartis did not

introduce this expert evidence before the Indian Patent Office while

the Patent Office was examining the patent application and the

pre-grant oppositions, it could not do so now. He added that if

Novartis wanted to bring this additional evidence on record, it would

have to file an application to do so. Mr. Grover also informed the

IPAB that CPAA has filed an application to introduce certain prior art

documents as additional evidence. Distinguishing these documents from

Novartis' additional evidence, he pointed out that the documents CPAA

sought to introduce are articles published in journals as opposed to

expert evidence that Novartis sought to introduce. Mr. Shanthi

Bhushan, counsel for Novartis, replied that he would oppose the

introduction of any new evidence by CPAA or any other party. This

issue will be argued before the IPAB later.

Commencing his arguments, Mr. Bhushan traced the history of the

Novartis litigation and summarised that the grounds for oppositions

that were filed by the five parties—novelty, non-obviousness, section

3(d) and wrong claiming of priority date. He then read out the

relevant provisions of the Indian patent law. Mr. Bhushan read out

the definition of " inventive step " under the Indian law and said that

the law requires a showing of technical advance or economic

significance and non-obviousness. He argued that when a person

expends a huge amount of time, money and effort in research and

development resulting in a new product, there is an inventive step and

the person ought to be compensated to enable him to recoup his

investment. The absence of such incentive, he argued, would kill all

research. Mr. Bhushan also read out section 3(d) of the Indian patent

law, which does not permit patenting of new forms of known substances

unless there is an enhancement in efficacy of the new form over the

known substance. He argued that section 3(d) only applied to " mere "

discovery of a new form of a known substance, i.e. a discovery without

expending time and effort in research. However, if the discovery was

the result of painstaking research involving huge amount of time,

money and effort resulting in a particular selection from numerous

possible permutations and combinations, the discovery was patentable

on a showing of increased efficacy.

Mr. Bhushan then referred the IPAB to an article on selection patents

authored by n Jeffs [n Jeffs, " Selection Patents " , 1988

European Intellectual Property Review 10(10), 291–296]. Quoting from

the article, he said that a selection patent involves the selection

for a useful and special property of a particular compound or class of

compounds. Relating this to section 3(d), he argued that section 3(d)

allows selection patents by allowing patenting of new forms of a known

substance on a showing of increased efficacy.

Outlining the development path of the beta-crystalline form of

imatinib mesylate, he argued that the main issue at hand was selection

patents and that Novartis had engaged in painstaking research and had

invested a lot of time, money and effort in discovering the properties

of imatinib mesylate, its crystal form and then the beta-crystal form

from the various possible permutations and combinations. Mr. Bhushan

said that US5521184, the 1993 patent issued by the United States

Patents and Trademark Office, disclosed the free base of imatinib. He

said that despite the fact that the 1993 US patent disclosed that salt

forms could be obtained in a customary manner, Novartis has been

granted patents on corresponding patent applications in over 35

counties. He argued that as the patent law was similar in almost all

countries, a patent ought to be granted in India too. Perusing the

list of countries in which corresponding patent applications have been

granted patents, Mr. Negi observed that it appears that Poland has not

granted a patent to Novartis on its application. Mr. Bhushan assured

the IPAB that he would update the patent status in Poland.

Pointing out that the beta-crystalline form of imatinib mesylate was

30% more bioavailable, thermo-stable at room temperature and less

hygroscopic than other forms of imatinib and imatinib mesylate, he

said that these advantageous properties made the beta-crystalline form

more efficacious. He added that for cancer drugs, which are attendant

with serious side-effects, such increase in bioavailability was

crucial as it meant that a greater quantity of the drug could reach

the target site with the same or lesser dosage. Mr. Chakraborti

queried if the 30% increase in bioavailability of the beta-crystalline

form of imatinib mesylate was an increase as compared to the imatinib

free base or imatinib mesylate. Mr. Bhushan clarified that the 30%

increase in bioavailability of the beta-crystalline form was over the

free base of imatinib. Mr. Chakraborti also asked Mr. Bhushan whether

he was arguing that an increase in bioavailability amounted to

increase in efficacy and asked him to explain his understanding of

efficacy. Mr. Bhushan replied that the increase in bioavailability

and the improved stability at room temperature and lesser

hygroscopicity all amounted increase in efficacy. Mr. Chakraborti

observed that the term " efficacy " has a fixed understanding in the

pharmaceutical field and asked Mr. Bhushan to provide documents to

support his explanation of efficacy. Mr. Bhushan replied that he

would do so when he specifically dealt with the argument on section

3(d).

Mr. Bhushan then read out relevant portions from the order of the

Patent Controller, Novartis' patent application and the pre-grant

opposition filed by Natco Pharma Limited.

The hearing was adjourned to 18 November 2008. The hearings are

expected to continue on a day-to-day basis and come to a close by the

end of next week.

Updates are also available on a daily basis on our website at

www.lawyerscollective.org.

In solidarity,

Lawyers Collective HIV/AIDS Unit