API and IP Newsletter
Contents
Patent applications filed by Neuland Laboratories Limited
Last, we analysed the import export database and imports of Neuland. It gave us a fair idea about development activities of Neuland and at what stage those development activities could be. This week we tried to analyse their patent portfolio in the last one and half years. Some of the observations are in the table below.
This would provide us an idea of key development molecules in their portfolio.
Conclusions:
Neuland is filing patent applications on value added products.
Main target in the recent past seems to be complex antidiabetic products, this research must have been done 2-3 years ago considering lag time in publication of patent applications.
General information
Personalised medication: Why dosage is so important
We can take Utrogestan as an example. This is bioidentical progesterone in a licensed form, available on the NHS, however it is only available in one dose, 100mg and one form, capsules. This dose is often too high for many women to tolerate and may result in nausea or drowsiness, for example, causing them to cease taking the medication. A compounding pharmacy can use exactly the same raw material (bioidentical micronized progesterone) and compound it into capsules in lower strengths or into a more tolerable formulation if, for example, they are unable to swallow capsules.
Put simply, this is moving away from a ‘one size fits all’ approach to the treatment and care of patients with a particular condition, to one which utilises the knowledge of a prescriber and the expertise of a pharmacist to achieve the best outcome for the patient in the management of their condition, especially where licensed medicines are not able to achieve the desired outcome.
News here.
There Will Be New Covid-19 Drugs. Will We Use Them to Save the Most Lives?
Because of concerns about Omicron, the W.T.O. postponed a meeting scheduled for this week in Geneva, where the group planned to discuss a temporary waiver of patents and other intellectual property protections for all Covid-19 health tools so that manufacturers around the world can produce sufficient supplies of affordable vaccines, tests and treatments, and avoid having to negotiate complex agreements for every new health technology.
To best make use of the new antivirals, there needs to be a huge increase in the availability of, access to and use of rapid tests in countries worldwide so that it is possible to detect cases during the first few days of infection, when the drugs are likely to be most effective.
News here.
Intellectual Property
T 2453/18 (Risperidone / INDIVIOR) of 22.11.2021
EP 2152315 (hereinafter: the patent) was granted on the basis of seven claims and issued to Indivior UK Limited. This seems to be one of the major product for Indivior UK and contributes approximately 11% of their turnover. (Here)
Independent claim 1 as granted related to:
"A flowable composition consisting of:
(a) a biodegradable thermoplastic polymer that is at least substantially insoluble in body fluid, wherein the polymer is a poly(DL-lactide-co-glycolide)/(PLGA) with a carboxy terminal group in a weight ratio of lactide to glycolide of 75:25 or 85:15;
(b) N-methylpyrrolidone (NMP); and
(c) risperidone;
wherein the flowable composition is an injectible subcutaneous formulation."
Independent claim 5 as granted relates to:
"A method of forming a flowable composition for use as a solid controlled release implant, consisting of the step of mixing, in any order:
(a) a biodegradable thermoplastic polymer that is at least substantially insoluble in aqueous medium or body fluid, wherein the polymer is a PLGA with a carboxy terminal group in a weight ratio of lactide to glycolide of 75:25 or 85:15;
(b) NMP; and
(c) risperidone;
wherein the mixing is performed for a sufficient period of time effective to form the flowable composition for use as a solid controlled release implant."
This patent was upheld by the opposition division, and in this write-up we will consider how Appeal Board at EPO discussed Inventive step to upheld the patent.
In EP oppositions, first the closest prior art is identified. In some cases there are several equally valid starting points for the assessment of inventive step, e.g. if the skilled person has a choice of several workable solutions, i.e. solutions starting from different documents, which might lead to the invention. If a patent is to be granted, it may be necessary to apply the problem-solution approach to each of these starting points in turn, i.e. in respect of all these workable solutions.
After deciding upon the closest prior art, the Board then firms up technical problem solved by the invention. In this case the Board formulated the technical problem to be solved as the provision of a sustained release risperidone composition which allows for a beneficial release profile involving a low initial burst and a prolonged release of at least 1 month following subcutaneous injection.
Once both, the closest art and technical problem solved by the invention are identified then the Board would evaluate whether the technical problem solved would be have been obvious to the skilled person and opine on the inventive step.
In this case,
Document D1 (WO2007/041410 ) states that the solvent type used in the depot formulations can influence the release profile on the basis of the higher initial burst release found for formulations with the more water soluble triacetin in comparison to formulations with the less water soluble ethyl benzoate.
The documents D6 (Packhaeuser et al.) and D18 (Brodbeck et al.) indicate that the use of NMP in PLGA based depot formulations was actually known to be associated with a high drug burst release
Document D1 (WO2007/041410 ) itself does therefore not suggest the claimed solution.
Documents D2 (US6565874) describes flowable compositions for use as a controlled release implant for leuprolide on the basis of PLGA with NMP as solvent. Document D2 recommends 50/50 PLGA with a carboxy terminal group for a one month delivery system and 75/25 PGLA without a terminal carboxy group for a three month delivery system. However, document D2 US6565874 provides no suggestion that the defined 75/25 or 85/15 PGLA with terminal carboxy groups in combination with NMP as solvent would, in contrast to 50/50 PGLA, allow to avoid an initial burst release and to sustain the prolonged release of risperidone.
The patent describes the PLGA/NMP type delivery systems used in the examples as ATRIGEL**((R)) delivery systems.
Document D8 (WO2006/041942) specifically describes such ATRIGEL**((R))type delivery systems for ocular delivery, in particular systems based on 50/50 PLGA with a terminal carboxy group or 75/25 PLGA without a terminal carboxy group.
Document D5 (WO00/24374) further indicates that PLGA for sustained release of drugs may comprise 50-90% lactide with 50-10% glycolide.
However, according to the Board, this information does not provide the skilled person with any suggestion towards the claimed subject-matter as solution to the identified technical problem.
The Board therefore concluded that the subject-matter defined in the claims of the patent as granted would not have been obvious to the skilled person having regard to the state of the art and thus met the requirement of inventive step. Details 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.
