API and IP Newsletter

Contents

• Analysis of import and export of Maithri Drugs

• General information

• The TRIPS Waiver: What Does it Mean to Change the Rules of the Game?

• Anvisa ordered the withdrawal of the drug Losartan used to treat high blood pressure

• Intellectual Property

• T 0752/19 (Ticagrelor, acetylsalicylic acid and a computer program/INTELLECTUAL … of 4.4.2022

Analysis of import and export of Maithri Drugs

Maithri as per their website a company established in 2014 at Hyderabad. The company had filed 39 DMFs, in last two years, each year they filed more than 10 DMFs. They filed 14 CEPs, 30 patent applications. 

Not much information is available at their website about their R & D capabilities and production facilities. 

Very brief analysis of their import and export is presented below. The objective of this analysis is not to derive any commercial conclusions but to try and analyse molecules under development at Maithri Drugs and to assess stage of the development.

Imported intermediates	QTY in KG	API	SIDVIM comments
4-Methyl-3-(trifluoromethyl)aniline	2	Avacopan	This is avacopan intermediate. Avacopan approved in October 2021. Looking at the quantities ordered, there is high likelihood that Avacopan must be at least at kilo-lab scale in the development and Maithri might file DMF soon.
2-Fluoro-6-methylbenzoic acid	2	Avacopan
2-Cyanoethyl 3-oxobutanoate	2	Finerenone	Finerenone approved in June 2021. Maitri Drugs must be developing molecule at kilogram scale and could file DMF soon. All three intermediates are being imported from China and Maithri will be highly dependent on Chinese sources, unless Maithri invests resources in backward integration.
4-formyl-3-methoxybenzonitrile	2	Finerenone
4-amino-5-methylpyridin-2 1h-one	2	Finerenone
2-Chloronicotinic Acid Ethyl Ester	5	Soticlestat	Takeda's drug in Phase III for epilepsy. Not yet approved. Maithri starts working on the molecules much earlier than their approvals, this could be one of such example. So within a year of approval of soticlestat Maitri would be able to file DMF!
4'-Hydroxy-4-biphenylcarboxylic acid	7	Trifarotene	Trifarotene was approved as Cream in October 2019 and 7 kilograms intermediate ordered for API synthesis, it looks like Maithri will file DMF soon.

Observations:

1. Maitri targets all new small molecules irrespective of therapeutic category and  dosage forms. 

2. Maithri must be starting product development very early, much before FDA approval.

3. Maithri could be filing DMF within 24 to 30 months from start of development.

General information

The TRIPS Waiver: What Does it Mean to Change the Rules of the Game?

What happens now that the WTO has changed the rules of the game on them with this TRIPS waiver? No matter the practical applications of the waiver, the Administration’s and the WTO’s rhetoric alone during this entire process has been damning to the vaccine makers’ investment incentive to produce life-saving vaccines. 

News here.

Anvisa ordered the withdrawal of the drug Losartan used to treat high blood pressure

This Thursday, the National Health Surveillance Agency (Anvisa) determined the ban and recall of batches of some drugs with the active ingredient of Losartan. According to Anvisa, “the measure was taken due to the presence of the “azido” impurity in concentration above the acceptable safety limit”.

The decision raised doubts in patients who use the drug, indicated to treat high blood pressure or heart failure. Anvisa says that people who use the drug should not interrupt the treatment, “even if they are using one of the affected batches”. The agency points out that there is no immediate risk in relation to the use of this medication and that the preventive measure was adopted after the evolution of knowledge about the impurities.

News here.

Intellectual Property 

T 0752/19 (Ticagrelor, acetylsalicylic acid and a computer program/INTELLECTUAL … of 4.4.2022

This case is about patent application EP 2666113.

The appeal is against the examining division's decision to refuse the application. The examining division decided that claim 1 of the main request and of the first auxiliary request then on file did not involve an inventive step.

Claim 1 of the main request reads as follows:

"Ticagrelor for use in a treatment of Acute Coronary Syndrome or myocardial infarction, in combination with acetyl salicylic acid and a computer program product comprising instructions causing a computer to perform a method comprising the steps

- providing a patient with a set of questions according to a question schedule, wherein said set of questions is specific to ticagrelor;

- collecting answers to said questions from said patient;

- subjecting said answers to a set of functions specific for the set of questions and ticagrelor thereby generating patient-specific feedback information;

- providing said feedback information to the patient; and optionally extracting clinically relevant information from said answers and providing said clinically relevant information to a database adapted for collecting clinically relevant information during clinical use of ticagrelor,

wherein said computer program product is adapted to be installed on a handheld device."

Claim 1 of the first auxiliary request differs from claim 1 of the main request in that it has the following additional text at the end:

", and wherein said set of questions and said set of functions are related to patient compliance to a preferred or prescribed dosage and/or administration regimen of ticagrelor."

The appellant Scientificmed Sweden AB did not contest that the second medical use of ticagrelor and acetylsalicylic acid for the treatment of Acute Coronary Syndrome or myocardial infarction was already known at the priority date. 

The subject-matter of claim 1 of the main request differs from prior art in that it further includes an interactive computer program. 

Scientificmed Sweden AB argued that, according to the established case law of the boards of appeal, in order to answer the question as to whether an intrinsically non-technical distinguishing feature, such as the computer program, contributes to the technical character of the invention, the distinguishing feature was not to be considered in isolation. Instead, it was the overall technical effect brought about by the distinguishing feature which had to be assessed, i.e. if it contributes to the technical character of the claim by interacting with the technical features of the claim to solve a technical problem. 

To answer this question, the board asked Scientificmed Sweden AB, whether the computer program according to claim 1 interacted with any biological target, which Scientificmed Sweden AB answered in the negative. Thus, it is not disputed that the computer program according to claim 1 does not interact with the technical features of claim 1 at the level of a biological target. Instead, Scientificmed Sweden AB argued that the alleged interaction of the computer program with the combination of ticagrelor and acetylsalicylic acid lay in an enhanced likelihood of a patient complying with a prescribed treatment regimen

The board does not agree with Scientificmed Sweden AB’s theory. 

In general, in a pharmaceutical formulation exhibiting improved patient compliance

In the case at hand, the pharmaceutical composition is indeed not new. Since the computer program of claim 1 does not interact with the intrinsic properties of the pharmaceutical composition, it can be ruled out that it leads to an overall technical effect in terms of improved patient compliance.

While the board does not dispute that such techniques may have the effect of improved patient compliance, such an effect is conditional on the patient's mental activities and thus does not contribute to the technical character of the invention.

Therefore, the distinguishing features of claim 1 of the main request do not have any overall technical effect, thus do not solve any objective technical problem and do not involve an inventive step. 

Decision here.