API and IP Newsletter

 Contents

• FDA activities in last three quarters

• General information

• Merck's oral COVID-19 drug sees India's Everest Organics hit start on production

• University of Cincinnati researchers develop new treatment for common knee injury

• Intellectual Property

• Vasopressin:  CAFC affirmed the District of Delaware’s decision that Eagle’s vasopressin product does not infringe

Analysis of Imports of Natco 

We analyse imports of many companies to make an educated guess of their development pipeline. This week we studied imports of Natco. Part of our analysis is published below.

ITEM	QTY in Kg	Sidvim comments
Ethyl 7-Bromo-2,2-dimethylheptanoate	1.5	Bempedoic acid’s raw material. Six companies have already filed DMFs. Natco will file one soon.
3-trifluoromethyl acetophenone	2	Trifloxystrobin  is a widely used fungicide. It has lost patent protection recently and Natco must be developing it. Higher quantities import may indicate Natco would require intermediate for manufacturing TG for their field trial.  It seems Natco is not the first in India for Trifloxystrobin. In July last year Best Agrolife announced that the Central Insecticides Board & Registration Committee has granted Licence for indigenous manufacture of Trifloxystrobin Technical u/s 9(3)
6-Bromoquinoline	3	This is Capmatinib intermediate, NVS product approved in May 2020. There is high likelihood that Natco could be at advance stage of product development, noticing the order quantities of intermediates.
2,3-pyridene dicarboxylic acid	1.5	Imazapyr is a non-selective herbicide. This could be under development at Natco
(1R,2S,5S)-Methyl 6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate hydrochloride	0.75	Nirmatrelvir with Ritonavir is sold under the brand name Paxlovid. Natco could be developing paxlovid.

General information

Cambrex finishes first phase of expansion

North High Point pharmaceutical company Cambrex announced Thursday that it has completed the first phase of a $30 million expansion here.

Cambrex has added 30,000 square feet of lab space at its facility on Mendenhall Oaks Parkway in the Piedmont Centre business park, where it makes small molecule active pharmaceutical ingredients on a contract basis for drug companies that outsource their production.

News here.

Manufacturer Can't Claim Exclusivity Over trademark When It Is Derived From Principal Ingredient Of Drug: Delhi HC Dismisses Sun Pharma's Appeal

"The mark, 'LETROZ', is not similar to the trademark 'LETERO' merely because both the parties have adopted the initial letters (SUN adopted the first six and HETERO adopted the first three) of the INN 'LETROZOLE'. It is apparent that both SUN and HETERO are using their marks, which are derived from the INN 'LETROZOLE', which is descriptive of the active ingredient of the drug, that is, 'LETROZOLE'"

The High Court concurred with the view of the Commercial Court that prima facie, there is little possibility of confusion or deception in the drug's purchaser's mind. It applied the rationale in Panacea Biotec Ltd. v. Recon Ltd., where it was held that when the name is derived or coined from the word of the principal ingredient being used in the manufacture of the drug, no distinctiveness or exclusiveness can be claimed by the manufacturer.

The Court reiterated that in case of an action for passing off, the similarity between the competing marks is to be seen along with whether there is a likelihood of deception or confusion.

News here.

Intellectual Property 

T 1869/19 (Ocular implant obtained by double extrusion process/Allergan Inc.) of 7.6.2022

EP 2329811 assigned to Allergan Inc. The original patent was granted on the basis of ten claims. The Patent had been opposed by Generics [UK] Limited.  The opposition division revoked the patent. 

The appellant (patent proprietor) requested that the decision under appeal be set aside and the patent be maintained 

The main request comprised one single claim of EP 2329811 which read as follows:

"1. A bioerodible implant for treating a medical condition of the human eye, the implant comprising PLGA and from 40 to 80 wt% dexamethasone as active agent dispersed within a biodegradable PLGA matrix, wherein at least 75% of the particles of the active agent have a diameter of less than 10 mym, and the implant being made by a method comprising the steps of: (a) milling the PLGA; (b) blending the milled PLGA and the particles of the active agent, to thereby obtain a blended mixture of the milled PLGA and the particles of the active agent; (c) carrying out a first extrusion of the blended mixture, to thereby obtain a first extrusion product; (d) pelletizing the first extrusion product, and; (e) carrying out a second extrusion of the pelletized first extrusion product, thereby obtaining the bioerodible implant."

1. Basically, this invention relates to implants and methods for treating an ocular condition. In particular the present invention relates to implants and methods for treating an ocular condition by implanting into an ocular region or site a bioerodible implant comprising an active agent and a bioerodible polymer matrix, wherein the implant is made by a double extrusion process. 

2. There was lot of prior art, in patent specification it was mention about US 5,869,079. U.S. `079 discloses combinations of hydrophilic and hydrophobic entities in a biodegradable sustained release implant, and describes a polylactic acid polyglycolic acid (PLGA) copolymer implant comprising dexamethasone. 

3. The claimed bioerodible implant in EP 2329811 is characterized by "product-by-process features", comprising the essential following preparation steps:

• (a) milling the PLGA;

• (b) blending the milled PLGA and the particles of the active agent,

• (c) carrying out a first extrusion of the blended mixture

• (d) pelletizing the first extrusion product,

• (e) carrying out a second extrusion of the pelletized first extrusion product.

4. In the present case, the claimed subject-matter includes implants obtained by extrusion processes performed under extreme conditions, such as a cold extrusion at slow screw speed, as well as a melt extrusion at very high speed. 

5. Hence, no conclusion can be drawn from the patent on the effect of carrying out the double extrusion, for instance in much less stringent conditions. 

6. As a result, claim 1 covers embodiments in which the double extrusion steps is conducted in such mild conditions that the resulting implant cannot differ structurally from those reported in D1 (WO 02/43785 A2) . 

7. In this respect, the question is not whether the teaching of the prior art is sufficiently complete or can be modified so as to obtain the same properties as obtained in some examples of the patent or in the experiments of D7 (Experimental Test Report), but rather whether the claim is so broadly defined, in respect of the process conditions, as to cover implants that are necessarily undistinguishable from that of D1.

8. In declaration ie document D6, Mr Salameh an expert stated that in his opinion a double extrusion method could not be used to achieve a density value which is the same as, or similar to, the density observed in the single extruded sample of the experimental report D7. 

9. However, as explained above, in the absence of any limitation as the conditions in which the double extrusion is performed, claim 1 covers implants that could have very different densities.

10. Consequently, the Board concurs with the opposition division that a double extrusion as claimed in claim 1 of the main request does not inevitably cause the obtainable product to have distinctive properties and to be distinguishable from a bioerodible PLGA/dexamethasone ocular implant made by single extrusion as disclosed in D1.

 

11. Accordingly, the claimed subject-matter is not novel over D1.

12. In the absence of any limitation in claim 1 as to the conditions of the milling steps (a) and (b), and considering that the size of dexamethasone in D1 is identical to the claimed size, namely a diameter of less than 10 mym, and the size of PLGA in D1 is comprised between 9-12 mym in diameter while undefined in claim 1 of the main request, it must be concluded that the milling steps (a) and (b) cannot impart any identifiable differentiating feature to the implant. 

Hence Novelty was not acknowledged, and patent was revoked. Here