API and IP Newsletter
Contents
Novo Nordisk's semaglutide set to tackle obesity with hot-anticipated FDA green light
Former Jharkhand DC proposes substantial changes in New Drugs Bill, 2022
DMF filed in June 2022
We analyse DMFs filed by Indian companies. In the month of June 2022, there were about 64 DMFs filed, out of which about 38 DMFs were filed by Indian companies.
Some of our observations/comments are as below.
General information
Novo Nordisk's semaglutide set to tackle obesity with hotly-anticipated FDA green light
The final piece of the puzzle will be access and reimbursement, Langa said. Novo is keeping launch specifics close to the vest for now, but it has "big promotional plans" for Wegovy.
With obesity widespread, undertreated and largely misunderstood, Novo Nordisk has been gunning to overhaul the field with semaglutide, a drug originally approved to treat diabetes. On Friday, it won its coveted FDA green light in obesity.
News here.
Former Jharkhand DC proposes substantial changes in New Drugs Bill, 2022
Dr B L Das, the former director of the DCA, has primarily commented on five things with complaints and suggestions, but made recommendations for modifications. He forwarded his recommendations to the under-secretary – drug regulations at the ministry of health and family welfare recently and wanted to consider these for inclusion in the bill.
Later while speaking to Pharmabiz from Ranchi, Dr Das said several terms, concepts and expressions used in the Draft Bill 2022 need to be well-defined to avoid confusions. Similarly, he opines that certain terms can be defined on the lines of internationally accepted means of expressions. According to him, regulations of medicines, medical devices and cosmetics have some common rules globally; accordingly there are some common jargons which can be accepted by all.
For example, he says that the term, label, has great significance in pharmaceutical packaging. It has been used in the Draft Bill in Section (26) (2) (n) to authorize the government to regulate the mode of labeling of drugs, medical devices and cosmetics. Further, the term has been used in sections (83) (2) (d) and (83) (2) (f). But it has not been defined under the definition of the proposed bill. He argues that non-definition of the term will hamper effective prosecution.
News here.
Intellectual Property
T 0277/19 (Stabiliser system for liquid nutritional compositions/NESTLÉ) of 24.5.2022
This is regarding EP 2046143 issued to Nestle.
The opposition division had earlier decided that the subject-matter of claim 1 of the patent as granted involved an inventive step in view of D3 ( US 3,950,547) as the closest prior art. The other prior art cited was D12: G. Eisenbrand, P. Schreier, "Römpp Lexikon
Fresenius Kabi lodged an appeal against the opposition division's decision rejecting the opposition.
With its notice of opposition, Fresenius Kabi had requested that the patent be revoked on the ground for lack of inventive step.
The contested claim: "A liquid nutritional composition comprising partially hydrolysed protein, fat and from 0.1 to 10 grams per litre of an emulsifier with a hydrophilic lipophilic balance value of less than 5, from 0.1 to 10 grams per litre of an emulsifier with a hydrophilic lipophilic balance value of more than 5 and from 0.01 to 20 grams per litre of a low amylose starch, having an amylose content of less than 50% by weight."
Example 6 of D3 (which is considered to be the closest prior art by both parties) relates to a specific emulsion in line with the teaching of D3, comprising, inter alia, a specific mixture of emulsifying agents, i.e. Span 60 and Tween 60, fulfilling the hydrophilic lipophilic balance values of the emulsifiers and its amounts as required in claim 1 of the main request.
The parties also agreed that the subject-matter of claim 1 differed from Example 6 of D3 on account of the feature "from 0.01 to 20 grams per litre of a low amylose starch, having an amylose content of less than 50% by weight".
However, the parties disagreed as to whether an effect resulting from the distinguishing feature over D3 was demonstrated and consequently the parties had different views on how to formulate the objective technical problem to be solved.
There is unambiguous teaching in D3 that other starches, such as potato starch, may be added to the composition of D3. Potato starch is a low amylose starch having an amylose content in the range required in claim 1.
This is supported the common general knowledge as represented in D12.
Therefore, the objective technical problem to be solved is that of providing an alternative liquid nutritional composition.
The Board said, even when assuming, for the sake of argument, that the objective technical problem should also include a reference to the stability of the emulsion, i.e. to provide an alternative liquid nutritional composition having excellent emulsion stability, as argued by the patentee, the claimed subject-matter does not involve an inventive step in view of D3.
The patentee argued that a skilled person, when faced with the problem of providing a liquid nutritional composition containing partially hydrolysed protein and fat with excellent emulsion stability, would turn to the examples in D3 and specifically to Table 1, which related to "stability against separation"; however, Table 1 clearly demonstrated that the compositions containing "normal starch" are unstable or less stable emulsions. Accordingly, the skilled person would not be motivated by Table 1 to add another starch to a composition containing high amylose starch.
The Board was not convinced by the patentee’s line of argument in this respect.
The Board said, in Table 1 of D3 a different emulsifier system is used compared with Example 6 of D3, which represents the closest prior art. Consequently, it cannot be derived from Table 1 that the specific emulsifier mixture of Span 60 and Tween 60 used in Example 6 of D3 leads to phase separation or unstable emulsions.
The inventive step was not acknowledged by the Boards of Appeal and the patent was revoked.
