API and IP Newsletter
Contents
With just 16 new drugs approved in H1 2022, FDA poised for slew of approvals in H2
Aurigene partners with EQRx and announces drug discovery, development and commercialisation
Analysis of patent applications 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.
Last two weeks we analysed DMFs filed by Maithri Drugs and imports of Maithri Drugs. We estimated products under development and probable stages of their development.
This week, we analysed patent applications filed by Maithri drugs and tried to evaluate strengths of their IP. Glimpses of our analysis is published below.
General Observations:
Maithri Drugs targets all new small molecules irrespective of therapeutic category and dosage forms and starts development of API very early in lifecycle of the molecule.
Maithri has developed skills of polymorph screening.
Portfolio selection seems to be a reasonably good mix of old and new products.
General information
With just 16 new drugs approved in H1 2022, FDA poised for slew of approvals in H2
Although the second quarter and first half of 2022 were tough for many companies in the biopharma space, many investors are looking for a turnaround in the second half of the year.
A total of 16 new therapies were approved in the first half of the year. Based on recent annual trends, that's a bit paltry given the U.S. FDA approved 50 new treatments in 2021 and 53 in 2020.
Several companies are poised for a boost thanks to FDA action (PDUFA) dates that are upcoming.
Here are five candidates that the FDA is scheduled to make a decision on in H2 that are the most anticipated -- and could influence the company's stock price.
1. Bristol-Myers Squibb and deucravacitinib.
2. bluebird bio and beti-cel and eli-cel.
3. Novartis/BeiGene and tislelizumab.
4. Amylyx Pharmaceuticals and AMX0035.
5. Amicus Therapeutics and cipaglucosidase alfa and miglustat.
News here.
Aurigene partners with EQRx and announces drug discovery, development and commercialisation
Aurigene Discovery Technologies Limited, a research, and product development firm, announced on Monday that it is collaborating with EQRx for discovering, developing, and commercialisation of drugs. According to the company’s press statement, the collaboration combines Aurigene’s small molecule drug discovery platform and EQRx’s pioneering business model to accelerate the development of drug candidates in oncology and immune-inflammatory diseases and improve global access to innovative medicines.
News here.
Intellectual Property
T 2423/19 (OXIDATION OF ORGANIC COMPOUNDS/PeroxyChem) of 25.4.2022
EP 1720802 was issued to PeroxyChem LLC
PeroxyChem is now Evonik Active Oxygens. Evonik Active Oxygens is a leading global supplier of oxidative solutions based on hydrogen peroxide, peracetic acid, and persulfates, complemented by adjacent technologies to the electronics, energy, environmental, food safety, and other industrial markets.
The claim which was prosecuted as follows:
A method for oxidising an organic compound comprising contacting the organic compound with a composition being either: sodium persulfate and sodium hydroxide pH modifier, or sodium persulfate and potassium hydroxide pH modifier, wherein the pH modifier is capable of maintaining a pH of at least 10 in the environment being treated, and wherein the organic compound is present in soil.
The appeal lies from the decision of the opposition division to revoke the patent.
The opposition division concluded, inter alia, that the subject-matter of the then main request was not inventive when taking the following document as the closest prior art:
D5 P.A. Block et al., Novel Activation Technologies
The Patentee and opponent (United Initiators GmbH) agreed, D5 as a suitable starting point for an inventive-step objection. It discloses methods for the chemical oxidation of organic compounds in soil.
The patent is directed to the chemical oxidation of organic compounds.
The opponent argued that the entire D5 related only to sodium persulfate, as was apparent from the title. The treatment of soil was disclosed in D5. The in situ treatment of soil according to the claimed invention was thus obvious.
The patent proprietor indicated the problem is to maintain the pH in soil in situ.
The patent proprietor argued that "capable of maintaining" meant the same as "maintains". The subject-matter of claim 1 related to alkaline activation. D5 did not say anything about the new chemistry with new chemical mechanisms. For an in situ application, a proper site evaluation was necessary. D5 did not disclose a single way to implement an in situ process.
This is not persuasive, the appeal board said. The subject-matter of claim 1 did not require that a pH of at least 10 be maintained during the whole treatment. It merely requires the use of a pH modifier which could maintain the pH at a level of at least 10. It is not possible to reframe the significance of clear technical features to a different significance just because doing so is more convenient for establishing an inventive step.
Moreover, in view of D5, the appeal board said, it appears that a high (initial) pH alone does not provide the purported effect.
The purported problem according to the appeal board was not solved by the claimed features and must be reformulated to a less ambitious problem, which is to provide an alternative chemical oxidation process.
The whole article D5 relates to novel activation technologies for sodium persulfate for in situ chemical oxidation of organic compounds. D5 teaches the amount of base needed to take into account any acidity in the soil. Thus, the treatment of soil is disclosed in D5.
Hence according to appeal board, in view of D5, the subject-matter of claim 1 is obvious for the skilled person.
Patent was revoked. (Here)
