API and IP Newsletter
Content
DMFs filed in April 2021.
General information.
Delhi HC creates Intellectual Property Division to deal with IPR cases.
Merck scores a win in bellwether Zostavax case, but nearly 2,000 remain.
Intellectual Property.
T 1326/18 of 22.4.2021, Board of Appeals decision for Natco’s α2 crystalline form of Imatinib Mesylate.
DMFs filed in April 2021
In SIDVIM, we analyse DMF filings by Indian companies every quarter. This week we analysed DMFs filed in the month of April 2021. This newsletter will run into several pages if we write about all DMFs, hence only few representative cases are presented here
General information
Delhi HC creates Intellectual Property Division to deal with IPR cases
The Delhi High Court has created an Intellectual Property Division (IPD) to deal with all matters related to intellectual property rights (IPR) as the Tribunals Reforms (Rationalisation and Conditions of Service) Ordinance, 2021 has led to the abolition of various boards and appellate tribunals which existed under different laws governing IPR.
The decision to create IPD was based on the recommendations of a committee which was created by Delhi High Court Chief Justice D N Patel and the panel comprises of Justices Prathiba M Singh and Sanjeev Narula, which has submitted its report both in respect of IPR and non-IPR subject statutes. (Read more)
Merck scores a win in bellwether Zostavax case, but nearly 2,000 remain
Merck scored a significant win for the vaccine this week in U.S. District Court. In a multidistrict litigation (MDL) bellwether case, Judge Harvey Bartle III of the Eastern District of Pennsylvania ruled in Merck's favor, tossing a plaintiff's claim that the Zostavax shot he received in 2008 caused him to develop shingles eight years later. (Read more)
Intellectual Property
T 1326/18 of 22.4.2021, Board of Appeals decision for Natco’s α2 crystalline form of Imatinib Mesylate
Natco was issued EP1720853 related to α2 crystalline form of Imatinib Mesylate which has atypical XRPD pattern. Opponents were, Onsagers AS and Gizinska-Schohe, Malgorzata. Patent was upheld at first instance. Matter was under appeal.
In EP oppositions, first it is decided as to what is the ‘objective technical problem’, that is going to be solved by the invention. In this case, it was decided that the objective technical problem is not that of providing a further crystalline form of Imatinib Mesylate, but that of providing a pharmaceutical composition comprising a crystalline form of Imatinib Mesylate which has balanced properties in terms of high solubility and sufficient stability.
It was argued that prior art WO 99/03584 A1 (D1) teaches the alpha crystalline form. It is known that the alpha form is less thermodynamically stable than the beta crystalline form.
The opponent submitted, it is expected that, based on the teaching that the alpha crystalline form is less thermodynamically stable, said form is more soluble than the beta crystalline form. The skilled person knows that the most stable crystalline form would need more energy to dissolve and would be less soluble than a crystalline form which is less thermodynamically stable.
However, the board said,
1. D1 does not teach that the alpha crystalline form is sufficiently stable and suitable for the pharmaceutical composition.
2. On the contrary, it is stated in D1 that the alpha crystalline form of Imatinib Mesylate is hygroscopic.
3. In this form, the crystals are not particularly well-suited to pharmaceutical formulation as solid dosage forms, because their physical properties, for example their flow characteristics, are unfavourable.
4. Furthermore, D1 teaches that the beta-crystal form is less hygroscopic than the alpha-crystal form and thus also stores better and is easier to process.
5. Finally, D1 mentions that the alpha crystalline form of Imatinib Mesylate is metastable at room temperature.
6. Therefore, these passages in D1 provide teaching that leads away from considering the alpha crystalline form as a candidate for solving the problem posed.
Consequently, the Board opined the skilled person would not have investigated the production or the development of an alpha crystalline form of Imatinib Mesylate, for solving the objective technical problem. So, patent was upheld.
There are several other interesting arguments about other articles too. But we will cover those later. Decision is here.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
