API and IP Newsletter

 Contents

• FDA approvals in September 2022

• General information

• Approval of 3 bulk drug parks a big boost to domestic API industry

• Rubius weighs up RI plant sale as part of pipeline restructure

• Intellectual Property

FDA approvals in September 2022

We analyse FDA approvals of small molecules. Deucravacitinib (innovator BMS) was approved on 09 September 2022 to treat moderate-to-severe plaque psoriasis. There are not many FDA approved deuterated drugs. One can find review of FDA approved deuterated drugs here. 

Synthesis reported for Deucravacitinib is as below

Example 52 in WO2014074661A1 family discloses above synthesis. 

WO2018183656A1 discloses Deucravacitinib crystal form A.

For day-1 launch, assuming compound patent would be valid, generics have to circumvent BMS crystalline form patent family WO2018183656A1

Suzhou Pharma filed patent application WO2021143498A1 for crystalline form CSIII 

From reaction scheme one would notice 2-methoxy-3-(1-methyl-1H-1,2,4-triazol-3-yl)aniline/ Benzenamine, 2-methoxy-3-(1-methyl-1H-1,2,4-triazol-3-yl)- will be main raw material.

Cipla  and Aragen are importing this intermediates. One could note Cipla imported two shipments of less than one kilograms in recent past. They could be ahead of their Indian competitors. 

General information

Approval of 3 bulk drug parks a big boost to domestic API industry

Three Bulk Drug Parks, one each to Himachal Pradesh, Gujarat and Andhra Pradesh. The Scheme, with a financial outlay of Rs. 3,000 crore notified in 2020, provides for financial assistance to three states.

News here.

Rubius weighs up RI plant sale as part of pipeline restructure

Rubius is exploring the sale of its manufacturing facility in Smithfield, Rhode Island.

The site was acquired in 2018 from Alexion Pharmaceuticals for $8 million following Rubius’ initial public offering (IPO), which raised $241 million. According to then Rhode Island governor Gina Raimondo, Rubius had pledged to invest up to $155 million in the 135,000 square-foot manufacturing plant.

Previous owner Alexion – now part of AstraZeneca – had used the facility to make the active pharmaceutical ingredient (API) for its immunosuppressant Soliris (eculizumab) as well as the finished product.

News here.

Intellectual Property 

Boehringer Ingelheim (BI) GMBH  Vs Controller of Patents (Delhi)

The appeal was filed by Boehringer Ingelheim (BI) GMBH against controller of patents.

The present appeal arises out of the impugned order dated 25 March 2022 by which the Controller has rejected the request of BI for pursuing a divisional application no.20178031279 dated 04 September 2017, titled ‘A medicament of a DPP inhibitor’. 

First let us understand what is divisional patent application? 

A Divisional application allows an inventor to split an application into two (or more) applications for patent, usually because the original application was attempting to claim multiple inventions simultaneously.

It is Plurality of claims, inventions in the same category are alternative forms of an invention or interrelated inventions. This is nothing but the unity of invention. The claim or claims of a complete specification should relate to a single invention, or to a group of inventions linked to form a single inventive concept. 

In this case, the Controller, while rejecting the divisional application has stated that the divisional application had similar claims, as had already been proffered in the refused amendment applications and the divisional application does not fall within the scope of the parent application.

Summary is as blow: 

Claims of present application (201718031279)	Exactly similar Claims of parent application 9501/DELNP/2008	Remarks
Claims 1, 2	Claims 1, 2 Amended dt.25/03/2015	Exactly similar claims have been examined in Parent application
Claims 3, 4	Claims 3, 4	Exactly similar claims have been examined in Parent application
Claims 5,6,7,8	Claims 5,6,7,8	Exactly similar claims have been examined in Parent application
Claim 9, 10	Refer claims 5 to 8	Exactly similar claims have been examined in Parent application
Claim 11	Claim 7, 11	Exactly similar claims have been examined in Parent application
Claim 12, 13	Covered under claims 7-11	Exactly similar claims have been examined in Parent application
Claim 14,15	Covered under claims 5 & 2	Exactly similar claims have been examined in Parent application
Claim 16, 17	Covered under claims 14 of new claims in 2016 , and 12 claim in 201515	Exactly similar claims have been examined in Parent application
Claim 18 (Method claims)	Claim 18, examined in 2015 and 2016 of claims 7 to 13	Only wordings rearranged no changes in technical parameters
Claim 20	Claim 5 of 2015	Exactly similar claims, Page 8 of 38 been examined in Parent application
Claims 24 and 25		repetitions of the old parent application claims

As for the divisional application, Counsel for BI submitted that Claims 1 to 25 are clearly based out of the original specification and thus within the scope of the parent specification.

So, this case raises an important issue as to whether divisional applications can be filed for claims, when such claims were not part of the claims in the parent application. 

Section 16(3) of Patent Act makes it clear that there cannot be duplication of the claims in the two specifications i.e., parent specification and the divisional application. This leads to the question as to how to determine “plurality of inventions”. For this, guidance can be drawn from Section 10 of the Act which elaborates on the meaning of complete specification and scope of claims.

Using this understanding of how an invention is ascertained in a patent application, it is clear that under Section 16 of the Act, the “plurality of inventions” should clearly exist in the claims of the original parent application and within the scope of the specification of the parent application. 

Therefore, under Section 16, the question of whether the claims of the complete specification relate to more than one invention i.e., a “plurality of inventions” has to be seen from the claims of the parent application.

Thus Court is clearly of the opinion that a divisional application in the present case cannot be filed since there was no “plurality of inventions” in the parent application. 

In the present case, the original ‘DPP IV inhibitor’ arising out of a Markush formula, in various permutations and combinations describing its use and method for treatment, which is only mentioned in the examples in the specification, cannot be permitted to be claimed as separate product Claims in a divisional application, as there were no product Claims in the parent application. 

Clearly, the Claims in the parent application only related to method or use claims whereas, the Claims in the divisional application concern “products” i.e., medicaments or their combinations. 

Once the product Claims were not sought in the original application and the said products were clearly disclosed in the content of the complete specification, the products ought to be treated as having been disclaimed. 

Thus, the parent application cannot be interpreted to have included a “plurality of inventions”, i.e., completely new product Claims, and hence they could patentable by way of a divisional application.

Hence the Court held that a divisional application shall not be maintainable if, it contains 

1. A claim which was not part of the claims of the parent application, or 

2. A claim which was examined and/or rejected during the prosecution of the parent application on any grounds other than the ‘unity of invention’. 

Decision  Here