API and IP Newsletter

 Contents

• Patent portfolio of Embio Limited

• General information

• Evonik and Laxxon to Produce More Effective 3D Printed Pills

• Medichem’s Stampa Takes Lead at Medicines for Europe

• Intellectual Property

• Canagliflozin composition patent revoked by Board of Appeals at European Patent Office

• Corrigendum

Patent portfolio of Embio Limited

In Sidvim, we analyse patent portfolio of many companies, last week we analysed patent portfolio of Embio Limited.

As per their website, Embio was incorporated in 1986, a leading global player in the domain of controlled substances and chiral molecules manufactured through bio-transformation. Here

Glimpse of their patent applications are as below. As one would notice, many patent applications are around control substances and chiral separations. 

Sr	Family number	Publication Date	Patent relates to	SIDVIM comments
1	WO2021176381A1	2021-09-10	1-(1-naphthyl)ethyl amine is an intermediate for many APIs such as Upadacitinib, cinacalcet.	Patent application relates to chiral separation.
2	WO2020099942A1	2022-01-13	Cannabidol derivatives	Allegedly claims with high stereo- specificity and reduction in  the unwanted isomeric impurities in cannabidol derivatives
3	IN202021020332A	2021-11-19	Cannabidol derivatives and process	Cannabidol process

General information

Evonik and Laxxon to Produce More Effective 3D Printed Pills

Evonik Venture Capital, which deals with all kinds of applications related to the use of 3D technologies, has announced its investment in the Nevada-based Laxxon Medical. 

News here.

Medichem’s Stampa Takes Lead At Medicines For Europe

Medichem CEO Elisabeth Stampa has been named as the new president of Medicines for Europe, setting out policy priorities that include bolstering the European API sector and supporting a “green transformation” for manufacturing.

News here.

Intellectual Property 

Canagliflozin composition patent revoked by Board of Appeals at European Patent Office 

1. EP 2568988 was claiming composition of Canagliflozin and was issued to Janssen. 

2. The patent was under appeal as opposition division upheld the patent in the amended form.  

 

3. The opponent, Lek,  filed an appeal requesting that the decision be set aside and the patent be revoked in its entirety.

 

4. In its reply to the statement of grounds of appeal, initially the Janssen requested that the appeal be dismissed.

 

5. The appeal board summoned the parties to oral proceedings and drafted its preliminary opinion. Here. 

 

6. In EP oppositions, it is first decided which is the closest prior art, later opposition division or appeal board decides what is the objective technical problem. Finally it is opposition division or the board opines whether such technical problem is solved by the invention.

 

7. Generally Patentee argues an invention claimed is an improvement to the science and opposants challenge this view by counterarguing there is no improvement to science but it is mere alternate way of solving the problem.

8. In this case, in written opinion, the Board construed that the problem solved is a mere  alternative than an improvement. Page 7 /9, second paragraph. Here.

 

9. In view of such a written opinion (and perhaps to avoid negative decision on inventive step by the Board), on 1 February 2022, Janssen stated that it no longer approved the text in which the patent had been granted. In addition, it withdrew all outstanding requests, including its claim requests and its request for oral proceedings.

  

10. By disapproving the granted text of the patent and withdrawing all pending requests, Janssen has withdrawn its approval of any text for maintenance of the patent. Hence, there is no approved text of the patent on the basis of which the board can decide on the appeal.

 

11. In these circumstances, it is established case law that the patent must be revoked without further substantive examination as to patentability.

 

The patent is revoked. Decision here.

Corrigendum

Contrary to what we referenced in our API and IP Newsletter dated 25 February 2022, Sai Life Sciences is a full service CDMO and has no intentions to develop the Daridorexant API process and file a DMF.