8 NEWS Pfizer criticises Indian pharma patent policy DELHI, INDIA
Pfizer’s associate general counsel, Justin McCarthy, has sent a letter to India’s ambassador to the US, Subrahmanyam Jaishankar, urging the Indian government to “shiſt from using destructive IP policy as an access strategy”, according to reports.
It is not the first time Pfizer has commented on India’s IP practices. In March 2013, Pfizer’s chief IP counsel Roy Waldron told the US House Committee on Ways and Means’ subcommittee on trade that India’s business environment for innovative industries had “deteriorated significantly”.
He added: “India has systematically failed to interpret and apply its IP laws in a manner consistent with recognised global standards.”
Te testimony refers to the Indian Patent Office’s decision to deny patent protection to cancer therapy Glivec (imatinib). Te drug was not deemed to show “enhanced efficacy”, which Waldron said limits the ability to obtain
a patent, adding that the requirement was against the WTO’s Trade-Related Aspects of IP Rights (TRIPS) Agreement.
Ranjan Narula, managing partner at Ranjan Narula Associates, said it is not fair to say the Indian patent system is not working, although he added: “Tere are certain provisions in the Indian Patents Act, within the larger framework of the TRIPS Agreement, that allowed India to develop an IP regime which restricted the grant of patents and required stricter criteria for inventions to be patentable and enforceable in India.”
Te US pharmaceutical industry has been “disturbed” by the Glivec decision, he said. “Te revocation of certain patents for not being inventive and the grant of a voluntary licence for not meeting the reasonable requirements of the public in India is leading to a conclusion that Indian courts are tilted towards protecting local industry.”
A spokesperson for Pfizer told LSIPR: “Te issuance of unwarranted compulsory licences,
LSIPR Newsletter 04:14
India’s patent system targeted
unfair revocation of valid patents, and denial of patentability of inventions in India are critical areas of concern in our industry.”
She added: “We look forward to collaborating and engaging with the Indian government to develop sustainable solutions that will enable us to continue to provide access to innovative medicines.” n
AstraZeneca ‘has value’ says former Pfizer lawyer LONDON, UK
AstraZeneca’s portfolio does not appear to offer a long pipeline of marketed products with long periods of exclusivity, says Jason Rutt, head of the patents group at Rouse in London and former head of Pfizer’s UK patent department.
Speaking to LSIPR on April 28 aſter Pfizer confirmed its interest in merging with the UK-based pharmaceutical company, he said: “AstraZeneca has a reasonable number of products that are off-patent, or that will go off-patent fairly shortly, and I can see that there’s value there for Pfizer.”
AstraZeneca appears to have boosted its research and development portfolio, and has a good oncology pipeline, he said.
“Something that seems understated is that AstraZeneca has some fairly good Alzheimer’s medicines in development, and Alzheimer’s was seen as a very attractive target within Pfizer.
“Pfizer’s real strength is as a late-stage development and marketing company,” Rutt
AstraZeneca: products in the pipeline
said, adding that if the deal were to go ahead, it would get “some good late-stage candidates”.
Concluding a month of big pharma mergers, and a week aſter the news was reported by Te Sunday Times, Pfizer confirmed it had submitted an indication of interest to
AstraZeneca’s board of directors regarding a possible merger transaction in January.
It added that aſter “limited high-level discussions” AstraZeneca declined to pursue negotiations, and discussions between the companies were stopped.
Pfizer contacted AstraZeneca again on April 26 seeking to renew discussions, although AstraZeneca again “declined to engage”, Pfizer said.
“Pfizer believes the possible combination would create a highly complementary mapping of products, pipeline and operating assets to Pfizer’s new operating structure,” the company said on April 28, including boosting its oncology portfolio in areas including lung cancer and breast cancer.
Pfizer said that it was currently considering its options.
Rutt told LSIPR that Pfizer’s bid was “intriguing”, and unusual for the company, which tends to close transactions that are more like “takeovers than mergers”.
“Pfizer has always bought big companies that had products it really wanted,” he said. n
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