API and IP Newsletter
Contents
Patent applications filed by Alkem Laboratories Limited
We follow patent applications filed by Indian companies and analyse their development strategies. This week we analysed patent portfolio of Alkem. We downloaded patent families filed by Alkem and mainly studied their PCT applications.
In last 5 years Alkem had filed over 12 PCT applications. Some of our observations are as below.
General information
Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design
As the drug development landscape becomes more complex, pharmaceutical and biotech companies understand their business strategies have to evolve. This need is putting a spotlight on how clinical trial sponsors are increasingly looking to fine-tune their trial programmes and related strategies as early as possible, to accelerate development efforts with efficiency, cost, and time in mind.
News here.
Top 5 pharma marketing trends in 2024
2023 was a year of many innovations and changes. The rise of artificial intelligence (AI), digitalisation, wider adoption of tools for marketing automation, and numerous other technologies have significantly reshaped the world of pharma for the better.
In 2024, the industry is expected to continue changing and adjusting to new technologies that are being created and improved as we speak. What trends will dominate the pharma marketing this year?
News here
Intellectual Property
Pharmacyclics Llc & Anr. vs Hetero Labs Limited & Ors- Ibrutinib case
This is a batch of six suits and one writ petition.
The writ petition, filed by Laurus Labs Ltd ("Laurus") challenged the judgment dated 29 September 2020 passed by the Intellectual Property Appellate Board ("the IPAB").
The suits alleged infringement, by the respective defendants ie generic companies, of Indian Patent 262968 (IN'968). This judgment by Delhi HC decided the applications for interim relief filed in the writ petition of Laurus and the six suits filed by Pharmacyclics LLC.
The Plaintiffs Pharmacyclics LLC and others were the licensees of Ibrutinib, which was also being manufactured and sold by the defendants generic companies under various brand names. Following a post-grant opposition, the patent IN'968 was revoked. However, this order was subsequently set aside by a judgement of the IPAB by Manmohan Singh, J., who had continued to function as Chairman of the IPAB on 29 September 2020.
When this suit had come up earlier for preliminary hearing on 19 December 2019, the generic companies submitted that they had already launched the infringing product in the market. In the circumstances, while issuing notice on the present application, this Court directed the defendants to disclose the date of commencement of marketing of Ibrutinib by them, and the quantum of sales of the said product effected till then.
The defendants generic companies were also directed to file, before the Court, the sales of the impugned product as effected by them on a quarterly basis.
This submission is contested by Mr. J. Sai Deepak, who led arguments on behalf of defendants ie generic companies, on the ground that the Chairman of the IPAB, who authored the judgment dated 29 September 2020, was not competent to hold office. He was, according to Mr. Sai Deepak, coram non judice.
Coram non judice is Latin for "not before a judge", is a legal term typically used to indicate a legal proceeding that is outside the presence of a judge, with improper venue, or without jurisdiction. Wikipedia
The tenure of the Chairman of the IPAB, Mr. J. Sai Deepak submitted, had expired on 21 September 2019 and he was continuing to hold office on the basis of certain interim orders passed by the Supreme Court.
The Supreme Court ultimately held, vide judgment dated 27 November 2020 read with clarification dated 12 February 2021, that the tenure of the Chairman of the IPAB in fact had ended on 21 September 2019.
Thus, Mr. Sai Deepak submitted, all orders passed by the learned Chairman after 21 September 2019 were non est.
What is non est?
Awards passed by unilaterally appointed arbitrator are non est in the eyes of law.
Mr. Dayan Krishnan, in response to this submission, invoked the de facto doctrine. Mr. Sai Deepak, submitted that the de facto doctrine is not applicable in the facts of this case.
The Supreme Court, in its judgment dated 12 February 2021, noted the fact that Manmohan Singh, J., had continued to function as Chairman of the IPAB under various interim orders passed from time to time in Madras Bar Association.
Specific reliance was placed upon the order dated 16th September 2020, which had extended the tenure of office of all incumbent members of all tribunals, to 31st December, 2020. The applicant also urged that it is essential that there is continuity and that taking into consideration the workload of the board, it is absolutely essential that it is headed by a properly qualified chairperson.
Mr. Sai Deepak contends that all the orders passed by Manmohan Singh, J., during the aforesaid twilight period perish. According to him, every judicial order passed by Manmohan Singh, J. after 21 September 2019 has been rendered null and void.
The Supreme Court having held, in its judgment dated 12 February 2021, that Manmohan Singh, J's term of office as Chairman of the IPAB had come to an end on 21 September 2019, and having not passed any orders protecting judicial acts done by Manmohan Singh, J., thereafter, all such acts stand nullified.
The overarching consideration of public interest has, therefore, to inform the interpretation and application of the de facto doctrine.
However, the Court disagreed to Mr. Sai Deepak, opined, the Supreme Court did not limit or restrict, in any way, the discharge of functions by the members of the various tribunals whose tenures were extended.
The orders passed by Manmohan Singh, J., in his capacity as the Chairman of the IPAB, between 21 September 2019 and 31 December 2020, were, therefore, passed under lawful colour of authority, as he continued to hold office in accordance with the directives of the Supreme Court. Applying earlier decisions by Supreme Court, therefore, the de facto doctrine clearly legitimizes them.
As regards to inventiveness, the Court noticed Ibrutinib is Btk inhibitor and prior art compounds are Lck inhibitors.
Characterizing a granted pharmaceutical patent as lacking in inventiveness on the basis of the disclosures contained in a prior art document which deals with a compound which does not react with the protein with which the subject matter of the granted patent reacts, but with a protein which is homologous thereto is, therefore, a serious exercise.
It involves extensive in vivo and in vitro studies. It cannot ordinarily be reckoned by a mere glance at structural similarities between the proteins with which the subject matter of the suit patent, and the prior art, react.
As the patentee correctly pointed out before the IPAB, in medical studies, the slightest difference in chemical structure could alter, altogether, the effect of the drug.
The Hon. Judge of Delhi HC said, “I am unable, given the degree of circumspection that is needed in such matters, to sustain the decision of the Joint Controller to treat prior art compounds which reacted not with Btk but with Lck inhibitors as relevant prior art so as to justify a finding of lack of inventive step in the suit patent. At the very least, the Joint Controller clearly erred in treating Btk and Lck proteins as homologous. The IPAB was, therefore, correct in the view it took”.
the Court held that there was no ground for stay of the operation of the IPAB judgement, and patent IN'968 is valid. The Court restrained the generic companies from manufacturing and marketing the drug, but given the importance of the drug in treating diseases such as cancer, allowed them to exhaust the stock available with them.
Decision here
