API and IP Newsletter

 

Contents

 

• Key Financials of select Pharma Companies: 

• General information. 

• Natco Pharma eyes launch of 8-10 new drugs in India yearly. 

• Granules India gets USFDA nod for potassium chloride tablets used to treat hypokalemia. 

• Intellectual Property. 

• Patent infringement: UK High Case. Merck vs Wyeth (October 2020) 

 

Key Financials of select Pharma Companies:

For more details check attached file.

https://drive.google.com/file/d/1WcbJREBrs0jYCM3WjAyFKB5nrKU7lAVO/view?usp=sharing

General information

Natco Pharma eyes launch of 8-10 new drugs in India yearly

Natco Pharma aims to launch around 10 new products every year in the Indian market. (Read more)

Granules India gets USFDA nod for potassium chloride tablets used to treat hypokalemia

Drug firm Granules India on Thursday said it has received marketing approval from the US health regulator for Potassium Chloride extended release tablets, used for treatment of patients with hypokalemia. (Read more) 

Intellectual Property 

Patent infringement: UK High Case. Merck vs Wyeth (October 2020)

UK High Court revoked Wyeth LLC’s pneumococcal vaccine patent, EP 2676679 (`679). The patent (`679) covered Wyeth’s Prevnar 13 product which vaccinates against pneumococcal bacteria. 

  

This product is covered by several patents, including`679. Merck Sharpe & Dohme Limited (MSD) challenged the patent at UK High Court. The patent was found to be invalid for lack of inventive step because several steps were thought to be within the common general knowledge of the skilled person.

MSD challenged the patent because of their clinical trial candidate V114.  MSD in June 2020 announced, V114, has met safety and immunogenicity goals in two initial phase 3 trials in adults, V114 is 15-valent pneumococcal conjugate vaccine candidate.

A brief about patent claim (`679):

A siliconized container means filled with a formulation which inhibits silicone induced aggregation of a polysaccharide-protein conjugate comprised in a siliconized container, the formulation comprising

(i)             a pH buffered saline solution, wherein the buffer has a pKa of about 3.5 to about 7.5,

(ii)            an aluminium salt and

(iii)          one or more polysaccharide-protein conjugates wherein the polysaccharide-protein conjugate comprises one or more pneumococcal polysaccharides.

High Court construed the claims bit differently, but that is not a part of this writeup. More details here. 

Prior art

This patent is also under opposition at EPO and following documents are being discussed at EPO.

UK High Court, for inventive step discussions, considered de la Pena (2004) document, D3a, which taught 13-valent pneumococcal vaccine. However, Pena is silent on the use of an aluminium salt adjuvant, a buffer or a siliconized container and does not suggest that a siliconized container could cause aggregation problems upon agitation. The feature lacking from Pena was to identify and solve the problem of aggregation using an aluminium salt adjuvant.

Although the problem of agitation-induced aggregation was not taught by the prior art (Pena), it was considered that this problem would be very trivial to a skilled formulator and that the solution offered by the inventors of `679 is nothing but the common general knowledge at the priority date of the patent.

It is interesting to note, though one needs to perform several steps to arrive at the invention of `679 from Pena (prior art), the patent was found to be invalid for lack of inventive step because those several steps were thought to be within the common general knowledge of the skilled person.

Detailed news here

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