API and IP Newsletter
Contents
Exports to China by Indian companies
We analysed exports by Indian companies to China.
We applied certain filters. We focussed on pharma and agrochemicals companies. We have analysed their major exports and not all exports to China; price of exported items analysed was above $ 10/Kg. In short, there are filters related to value and volume. There are few other filters too, which we have not mentioned here.
The glimpse of our analysis is as follows.
General information
SANTO Plans to Expand Its R&D Hub in Shymkent, Become Leader in Central Asia
The SANTO company, a leader in Kazakhstan’s pharmaceutical market, revealed plans for its research & development (R&D) hub, the company’s scientific laboratory and the plant, which manufactures a diverse range of medicines up to par with European standards of quality, the company’s press service reported on Nov. 2
News here.
What can Rishi Sunak do for the UK’s pharma industry
In June, the Association of the British Pharmaceutical Industry (ABPI) sent an open letter to the Conservative leadership, including Truss and Sunak, which warned that the UK is slipping behind its global competitors in the race to become a Life Sciences superpower. The letter reported that the UK fell from fifth place in 2017 to seventh in 2020 for the number of Phase III clinical trials initiated across the world. Furthermore, reportedly, only 68% of medicines approved by the EMA were made available in England between 2017 and 2020. In a more recent report, the ABPI found that the number of Phase III industry trials fell by 48% between 2017 and 2021.
In his first speech as the PM, Sunak indicated a return to the original 2019 Conservative manifesto. At the time of its publication, the document prioritised the finalisation of Brexit above all else. For the life sciences and pharmaceutical sector, the Conservative government promised £34 billion ($38.98 billion) per year
News here.
Intellectual Property
DS Biopharma Limited vs The Controller of Patents and Designs
Patent office issued the hearing notice to DS Biopharma stating “Subject matter is not Patentable” under section 3(d).
DS Biopharma attended the hearing, amended claims to further restrict them. However, the Patent Office rejected the patent application on 13 January 2021.
DS Pharma challenged the order on the ground that the objection raised in the hearing notice did not specify proper reasons for raising an objection under Section 3 (d).
In IPAB judgement of Fresenius Kabi v. Glaxo it was established that for an objection under Section 3(d), the Patent Office
to identify the `known substance’
to provide reasons to show how and why the claimed substance is a ‘derivative’ or a ‘new form’ vis-a-vis the ‘known substance’ and
to provide valid basis for asserting that the alleged ‘known’ substance and the claimed molecule or substance have the same ‘known’ efficacy.
As per DS Biopharma, the hearing notice has failed to identify any of the above three factors. They argued that the compound which constitutes the `known substance’ was not identified in the hearing notice.
Ms. Mani, Counsel appearing for DS Pharma submitted that all the initial objections which were raised in the FER were satisfied and the only new objection which was raised in the hearing notice was in respect of Section 3(d) of the Act.
She further submitted that there is no clarity as to whether claims 1 and 4 have been rejected or claims 1 to 4 have been rejected. In fact, there is contradiction between the hearing notice which states claim 1,4 and the final impugned order where claims 1,3 are stated to be not meeting the requirement.
DS Pharma counsel further argued that in the absence of identification of the 'known' compound in the hearing notice, she did not get a reasonable opportunity to defend the patent application, thus violating the principles of natural justice.
Hence the Court stated, in the absence of the proper identification of the “known substance” in the hearing notice and a lack of proper opportunity being afforded to respond to the objection under Section 3(d), the impugned order is not sustainable and opined in favour of DS Biopharma.
Decision here
