API and IP Newsletter
Contents
DMFs filed in June 2024
FDA publishes list of DMF filings every quarter. Second quarter list was published recently and we are analysing DMFs filed by the Indian companies. Last week we had looked at DMFs filed in May 2024 and this week we are analysing DMFs filed in June 2024.
In the month of June 2024, there are about 114 DMFs filed. Indian companies had filed <20 DMFs and Chinese companies filed > 50 DMFs. Chinese companies are clearly overtaking Indian companies in the DMF filing race at USFDA in last couple of quarters. This might be a threat to Indian supremacy in API business in the long term.
Some of the other observations are as below.
General information
Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after Covid delays
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the Covid-19 pandemic upended factory inspections in the U.S. and across the world News here
Voyageur Introduces Five New Barium Contrast Formulations Setting New Standards in Medical Imaging Industry
Voyageur Pharmaceuticals Ltd announces that in an innovative endeavor, it has completed formulation work on its new product line of 5 Health Canada licensed products. Voyageur has engineered these advanced formulations to improve existing market standards, prioritizing enhanced value for stakeholders. By introducing distinct brands, Vision and Smooth barium contrast agents, Voyageur brings versatility and performance to medical diagnostics. Notably, these products will be classified as new drugs under the 505(b)(2) FDA drug pathway.
News here
Intellectual Property
Kyorin Pharmaceutical Co vs Assistant Controller of Patents (India)
This Appeal lies against the rejection of the Patent Application by the Controller of the patent. This is regarding Patent Application No.5360/CHENP/2010, filed by Kyorin Pharmaceutical in Chennai patent office.
The Patent Application pertains to a claim of an orally, rapidly disintegrating tablet having excellent photostability, thereby having the advantage of being easily administered to elderly people and children. The Application has been rejected on two grounds viz., lack of inventive step under Section 2(1)(ja) of the Indian Patents Act, 1970 and non-patentability under Section 3(e) of the Patents Act, 1970.
Patentee Kyorin Pharmaceutical appealed against the controller’s decision. The appeal was filed at Madras High court.
Following prior art documents were cited.
D1: WO0134147A1
D2: WO0047233A1
D3: JP2004339071 A
D4: WO2007031860A1
D5: WO2006080481A1
Kyorin Pharmaceutical argued that the respondent controller of patent failed to see that the prior arts D1 and D3 were teaching away from the claim and even a combination of D1 and D3 was different from the invention claimed.
Kyorin Pharmaceutical further stated that even prior art D5 pertained to a sustained release which was not the case insofar as Kyorin Pharmaceutical‘s product.
Kyorin Pharmaceutical ‘s Counsel also contend that the controller of the patent has not even analysed the response of Kyorin Pharmaceutical in respect of prior arts D1, D3 and D5 as well as the objections raised under Section 3.
The Deputy Controller of patent, Dr.Rohit Rathore submitted that the tablet is only a mixture of two substances and controlled with a polymer and both prior arts D1 and D5 were also nothing but compounds with a polymer added to it. He contended that even D5 was rapidly disintegrating dosage form and therefore the claim was not reflecting any inventive step. He submitted that Kyorin Pharmaceutical had not shown or proved the photostability claimed and the controller had therefore passed a reasoned order and there is no necessity to even remit the matter and prayed for dismissal of the appeal.
The judge said he carefully considered the rival submissions advanced by the learned counsel for the Appellant Kyorin and the Deputy Controller.
The product for which patent is claimed is a tablet which dissolves in the mouth without requiring water and thus making swallowing easier and thus safe for use by children as well as elderly people. The respondent patent controller had held that there is lack of inventive steps in the claim as prior arts D1 and D5 were both dissolvable and like the Appellant’s Kyorin claim, added with a polymer and similarly D5 prior art was also possessing rapidly disintegrating properties.
The Judge had noticed that a European Patent has been granted to Kyorin considering the prior arts D1, D3 as well as D5. The fulcrum of the invention claimed by Kyorin is that the tablet is orally, rapidly disintegrating within the oral cavity and yet photostable because of the employment of gastric juice-soluble polymer used as a coating agent.
The process in a co-pending Application in No.5364/CHENP/2010, has been granted to Kyorin on 28.07.2017 in Patent No.285816 issued. When the method for preparing an orally rapidly disintegrating tablet has been granted a patent, the Judge said he is unable to see how the patent controller could come to a conclusion that the tablet, which is only the result of such an inventive process for which a patent has already been granted, lacks inventive step.
The process for which Patent granted is definitely distinct and different from the resultant product arising from the employment of the process and therefore as rightly contended by the learned counsel for the Appellant Kyorin, once the Patent has been granted for the process involved itself, the controller ought not to have rejected the Patent Application on the ground o lack of inventive steps.
The Judge further said the respondent patent controller, was estopped from even examining ‘lack of inventive steps’ in the first place and having come to a conclusion that the invention claimed was well known to a person skilled in the art.
Product Patents and Process Patents are different and merely because Kyorin had successfully obtained a Patent for the process, the Application for Patent for the product cannot be refused.
No doubt, an owner of a Patent for a process cannot claim monopoly rights over the product of the process and such Patent holder also cannot stop a person from claiming a different process which may result in even the same product.
But, here, in this case, after having granted a Patent for the process to manufacture the tablet, the Patent Controller has non-suited Kyorin citing the process involved alone in coming to the conclusion that there is no inventive step and there is no teaching away from the prior arts D1, D3 & D5.
Such an approach is totally erroneous as once the process has got a green signal from the controller of the patent, he is estopped from even scrutinizing the process or steps and come to a conclusion that the process does not involve any inventive steps, thereby disentitling the Appellant from the grant.
In such view of the matter, the respondent patent controller had erred in citing the prior arts D1, D3 & D5 against the claim of the Appellant, especially discussing the process involved, having already granted a Patent for the said process.
In any event, while coming to the conclusion that ‘As obvious from the disclosure of said prior art documents coated tablets comprising granules or particles of imidafenacin coat are well known to a person skilled in the art that before the present invention’, the respondent patent controller does not even cite the relevant document before arriving at such a conclusion.
The Hon. Judge said he’s constrained to set aside the findings and conclusions of the controller of patent regarding ‘lack of inventive steps.’ In view of the process Patent already granted to Kyorin, the controller was estopped from even reopening the said process and picking holes therein to conclude that the process/steps involved were no different from the prior arts.
The Hon. Judge said the appellant Kyorin is entitled to get a Patent grant subject to other non-patentability criteria.
Details here
