Swedish Meda Pharma, Cipla sue Apotex over Dymista patents

In June 2013, Cipla had granted global commercialisation rights for ‘Dymista’ nasal spray to Meda AB, except for certain geographies


Sweden-based drug maker Meda Pharmaceuticals Inc and Indian Cipla Ltd have sued Apotex Inc and Apotex Corp in US Federal District Court in Delaware to enforce patents of its allergy drug ‘Dymista’.


Cipla in a regulatory filing said, “We sued Apotex and Apotex Corp in Federal District Court in Delaware to enforce the Orange—Book listed patents covering ‘Dymista’ Nasal Spray.”


The company added that it has sued Apotex Inc and Apotex Corp “in response to Apotex’s submission to the US FDA of an abbreviated new drug application (ANDA), and accompanying Paragraph IV certification, seeking approval to market a generic version of Meda’s ‘Dymista’ prior to expiration of the ’Dymista’ patents.”


In June 2013, Cipla granted the global commercialisation rights for ‘Dymista’ to Meda AB except for certain geographies.


Commenting on the development, Meda CEO Dr J Thomas Dierks said: “Meda will vigorously enforce the ‘Dymista’ patent rights against Apotex and any other company who challenges these patents.


“The Complaint was filed within 45 days of receiving Apotex’s Paragraph IV certification notice, thus triggering an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months from receipt of the notice, unless ordered otherwise by a district court, the Cipla said.


“Meda has the exclusive licences to US Patent Nos. 8,163,723 and 8,168,620 covering the ‘Dymista’ composition and its approved uses, which does not expire until 2026,” it said.


Meda holds the new drug application (NDA) to manufacture and market Dymista in the US for the treatment of seasonal allergic rhinitis.


SEBI asks Moneyworld to immediately stop providing investment advice

SEBI said Moneyworld Research was offering trading tips to investors without obtaining requisite registration to act as an investment adviser


Market regulator Securities and Exchange Board of India (SEBI) has directed Moneyworld Research and Advisory Pvt Ltd to immediately stop providing investment advisory services with regard to the securities market and withdraw all the related advertisements.


SEBI said it prima facie found that Moneyworld Research was offering trading tips to investors without obtaining requisite registration to act as an investment adviser.


Accordingly, through an interim order dated 2nd December, the market regulator has asked Moneyworld Research and its two directors to "cease and desist from acting as investment advisers and cease to solicit or undertake such activities or any other unregistered activity in the securities market, directly or indirectly, in any manner whatsoever".


They are also required "to immediately withdraw and remove all advertisements, representations, literatures, brochures, materials, publications, documents, websites etc in relation to their investment advisory or any unregistered activity in the securities market".


SEBI had closed the application of registration of Moneyworld Research in March 2014, after it found several lapses on part of the entity.


However, it was noted that Moneyworld Research "solicited and induced" investors to deal in securities on the basis of their investment advices as well as guaranteeing returns even after the receipt of communication regarding the closure of their application for registration by SEBI on 27 March 2014.


The order observed that "subjecting the investment advisers to the statutory requirement of registration with SEBI is imperative for the protection of interests of investors and to safeguard the integrity of securities market".


Unrestricted imports from China will affect Indian industries

Protection of domestic industry is vital to India’s survival; and this is possible, when strong steps are taken to eliminate avoidable imports from China, in particular


According to the press reports available, the Indian Met Coke Manufacturers Association (IMCOM), the industry is facing a serious threat to its very existence due to the increased and continuing imports of met coke from China.


At present, met coke from China is subject to an import duty of only 2.5%, which is nominal. In the past, suppliers from China had to pay 40% export duty, till December 2012, when it was withdrawn completely, making it attractive for importers to buy from China. Even after paying the 2.5% import duty, imported met coke from China works out to be about $40 (Rs2,400) cheaper than the domestic supply.


The Indian steel industry needs about 35 million tonnes of coke per year, out of which about 20 to 25 million tonnes are met from captive capacities leaving a balance of 10 mt.


The installed capacity of merchant met coke is said to be 10 mtpa but the actual plant utilisation is said to be only 30%-35%, due mostly to cheaper imports from China.


This information was made available, when Gujarat NRE Coke Ltd held a two-day event, called "Global Steel 2014" with the theme "Steeling Recovery". Arun Kumar Jagatramka, Secretary of IMCOM as well as CMD of Gujarat NRE Coke Ltd, while attending the meet, made a pointed reference to the plight and precarious financial implication of the under-utilisation of installed Indian capacity due to this unrestricted imports. He further, pointed out that this is likely to cause tremendous financial strain and is a potential threat to the domestic coke industry, as it has large bank exposure to the tune of over Rs15,000 crore. In fact, he claimed, that many units are in the process of debt restructuring as a result.



Should the government accede to this request, they may also seek IMCOM's assistance that domestic met coke manufacturers should also be persuaded to reduce their margins to be in the market and actively resist the Chinese supplies, provided there are no quality issues.


We may continue to look at the state of affairs of the steel industry, due to this Chinese aggressive selling. In a publicity campaign carried, recently, by the All-India Steel Rerollers Association, they have given detailed methodology used by the Chinese manufacturers in "wrongly classifying the imported reinforcement bars in the Alloy Steel Category to gain benefit of the subsidy and thereby marketing at a discounted price in India". It may be noted that Government of China offers a 13% subsidy on export of Alloy Steel Bars and levies an export tax of 15% on reinforcement bars exported by Chinese manufacturers. This collusion of efforts by vested interest parties is detrimental to steel manufacturing industry in India.


This has been done by circumventing the standards and current imports do not conform to Bureau of Indian Standards (BIS) thereby having an adverse impact on the Indian industry. It is not, therefore, in our interest to continue the import of reinforcement bars from China.


In the case of power equipment, for instance, the Heavy Industry Ministry has taken up the issue with the Finance Ministry and are mostly likely to raise the subject again in the Inter-ministerial meeting on the Budget and request that import duty on power generation equipment should be raised to 10% from current 5% and that the countervailing duty be brought to nil. Such a move, if approved by the government, would directly benefit domestic manufacturers like BHEL, Larsen & Toubro and Bharat Forge. They may go even one step further that those who wish to import power generating equipment need to obtain a "no objection" certificate from domestic manufacturers.


The only good news, at the moment, comes from NMDC, a state owned successfully operating mining enterprise, that it is planning to open new iron ore mines both in Chhattisgarh and Karnataka, next year, and these will enable it to increase the production to 50 million tonnes, from the current level of 30 mt, in the next 5 years.


The other development concerns the acquiring of coking coal assets in Mozambique, according to Narendra Kothari, CMD of NMDC.


Protection of domestic industry is vital to our survival; and this is possible, when strong steps are taken to eliminate avoidable imports from anywhere, particularly from China, where our balance of trade is against us in billions of dollars!


(AK Ramdas has worked with the Engineering Export Promotion Council of the ministry of commerce. He was also associated with various committees of the Council. His international career took him to places like Beirut, Kuwait and Dubai at a time when these were small trading outposts; and later to the US.)



Dr Anantha K Ramdas

2 years ago

Thanks for the comments. I think the Finance Ministry, in cooperation with the Commerce Ministry must determine the list of those items that are being imported from China on a large scale, which can easily made in the country. In fact, lot of these goods were made in India before but our small scale and medium scale are shutting down because of these cheap imports.

After listing out these, the Ministry must also direct the banks not to open Letters of credit for such banned items, under a notification from the government.

Unless we stop this wholesale import of items that can be made in India and gainfully employ our own countrymen/women we are heading for serious trouble.

China not only wants to sell expensive high speed trains but also cheap toys, marbles and the like! One day somebusybody will wake up and say, let's import "chinese noodles", as these are their signature products! It is very much like saying "idly, dosa and samosa" are very Indian (of course they are), we will be eating chinese noodles, soon, if something is not done!

Madhusudan I. Mistry

2 years ago

Countries like Australia, does an exercise on continuous basis to allow immigrants either temporary or permanent in view of the shortage of certain category or based on the actual requirement basis. Similar way,we need to scrutinise the necessity of our imports judicially to ascertain the actual need. The plethora of chinese toys and other articles enter our country and draining the much sought after foreign exchange. I fee small unnecessary leaks should be mended on war footing basis. Also our imports are far more xceeding our exports to china and one way is to increase our exports to china is called for but at the same time unnecessary exports need to be strictly curbed. Imports need to be checked at different levels and they should be properly vetted to eradicate unnecessary and useless imports. Or here the bribe & corruption are also making the way to justify the unrequired & undesirable imports? This also need to be looked into seriously.


2 years ago

Should we pay for inefficiency of our industries and industrialists who enjoy public finance and indulge in asset stripping there by unduly enriching themselves at the expense of honest tax payers. Don't we see our people illegally mined huge iron ore deposits and even exported because or check posts, customs etc are highly compromised. More than 30% of food grains are allowed to perish for want of proper storage. So if our resources are not enough we should allow FDI in power, infrastructure etc

Narendra Doshi

2 years ago

Our own people's voice of industrialists should be duly considered before blind Chinese imports only on economic aspects.
Ramdasji, once again a timely perspective from you, only if it gets acted upon by all the concerned stakeholders.

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