Patent infringement : Delhi High Court restrains sale of generic drug Indacetrol by Indian pharma major Cipla till a decision on its compulsory licence application is taken

Delhi High Court, vide a judgment last week has upheld the patent infringement claim filed by Swiss drugmaker Novartis against Cipla, and granted an order of interim injunction restraining it from using Novartis' patent on respiratory drug Indacetrol (used for chronic obstructive pulmonary disease)

The Background: Novartis holds the patent for manufacture of the Indacaterol maleate salt as well as the manufacturing process for the drug, which is sold in India as an inhalation powder and inhaler under the trademark name of “Onbrez’ through Lupin since 2010.

In October last year, Cipla, India's fourth-largest drugmaker by revenue started manufacture and sale of Indacaterol powder and sale under the name “Unibrez”, citing urgent unmet need for the drug in India.

Novartis thereafter approached the Delhi High court to permanently restrain Cipla from manufacturing Indacaterol in any form and selling it in India. Novartis has also sought damages and payment for infringing the patented pharmaceutical product.

Cipla in its reply filed before the court had argued that the medicine sold by Novartis is too expensive and is sold only to government hospitals and is therefore not easily available to the public. Cipla also filed a representation before the ministry of commerce department of industrial policy and Promotion, to revoke the exclusive patent rights granted to Novartis, claiming that Novartis was not working the patent in India. Novartis argued that there was no obligation on the firm to manufacture the drug in India.

Judgment was reserved in the case by Justice Manmohan Desai on December 16, 2014.

The Judgment : In a 143-page long order, the Delhi High Court restrained Cipla from “using, manufacturing, importing, selling, offering for sale, exporting, directly or indirectly dealing in active pharmaceutical ingredient (API), pharmaceutical products, compund or formulation containing Indacaterol, specifically its Maleate set, namely Indacaterol maleate alone or in combination with any other compound or API or in any other form”, which may amount to an infringement of Novartis’ patent.

The Court said that statutory & monopoly rights of Novartis can’t be nullified until patent is held to be invalid, and that 'Public interest doctrine’ is an important consideration in patent cases, and Cipla should approach the appropriate forum while applying for compulsory licence application. Justice Desai also repelled the argument put forth by Cipla based on Article 21 of the Constitution, saying Article 21 cannot be pressed into service by an infringer seeking to justify the infringement of a valid patent.

The interim injunction has been granted till Cipla’s application for compulsory licensing of the drug is decided. The company has been allowed to sell its remaining stock. The Court further said that if such an application has indeed been filed by Cipla, the controller or the competent authority to decide the plea within six months from the filing of the application. 

 

Delhi High Court issues notice to Union Coal Ministry on Jindal Steel & Power Ltd.'s petition challenging change of end-use of coal blocks under Coal Ordinance and Ministry's Dec 18 order

The Delhi High Court on Monday sought to know the Centre’s response on a writ petition filed by Jindal Steel & Power Ltd. challenging a Coal Ministry order of December 18 and provisions of the Coal Mines (Special Provisions) Ordinance, 2014 "which allow change of end-use" of coal blocks in Chattisgarh and Odisha from sponge iron and steel to power.

Logo of Jindal Steel Power Ltd.

 Under the Coal Mines (Special Provisions) Ordinance, 2014, promulgated after the Supreme Court cancelled the coal block allocations, the end-use was changed with the provision for auction of blocks.

Senior advocates Kapil Sibal, Rajiv Nayar and Abhishek Manu Singhvi, appearing for JSPL, submitted that pursuant to the Coal Ordinance, the Coal Mines Rules were notified and under the same the ministry passed an order on December 18 changing end-use of their coal blocks from sponge iron and steel to power.

They contended that the December 18 order was passed arbitrarily and is in violation of the Ordinance as well as the Constitution.

JSPL contended that change of end-use has also resulted in making the company ineligible for participating in the ongoing auction process which is expected to culminate on February 14.

The company also alleged that while changing the end-use, captive power plants were also excluded from the power sector, hence, they are unable to bid for the blocks even for that.

Senior Counsels appearing for JSPL in the case said that the company has set up steel and sponge iron units in Odisha and Chhattisgarh for over Rs 24,000 crore and the entire investment would be "rendered fruitless" if they are unable to bid for the blocks which were earlier allocated to them and based on which the units were set up after obtaining all necessary environment and forest clearance.

During the proceedings, the ASG said that JSPL can purchase the tender document and submit it any day before February 14, 2015.

He also said there are other coal blocks available for JSPL, including those which have been put up for non-regulated end-use like steel and sponge iron.

Senior Advocate Mr. Kapil Sibal, however, was not in agreement with the ASG’s contention, saying that very few blocks have been put up for non-regulated end-use.

He also said that bidding for a far away block would not help them as they set up their units based on the Utkal and Gare Palma blocks in Odisha and Chhattisgarh respectively.

A Division Bench of the Delhi High Court comprising of Justice Badar Durrez Ahmed and Justice Sanjeev Sachdeva thereafter issued notice to the Coal Ministry seeking its response as to why and where end-use was changed, and posted the matter for hearing on Thursday, January 15, 2015. 

(Sonika Nair contributed in the reporting of this news story)

Judiciary neither “too ambitious” nor interested in taking over governance, but would act in public interest if “there is complete deficit in governance” : Justice T.S. Thakur, next in line to be the Chief Justice of India

Justice T S Thakur, next in line to take charge as the Chief Justice of India following the retirement of the present CJI, H L Dattu in December this year, on Sunday said that the judiciary was not “too ambitious” nor did it want to take over governance but it would be expected to act in public interest if “there is complete deficit in governance… when the darkness is all around”.

File Picture : Justice T.S. Thakur

Justice Thakur made these remarks while delivering a lecture in New Delhi, which was organised in memory of senior advocate Kapila Hingorani, whom Justice Thakur described as the “mother of public interest jurisdiction” in India. It was a Public Interest Litigation by Kapila Hingorani and her husband N K Hingorani, moved exactly 36 years ago in 1979, that became the first PIL filed in the Supreme Court. The PIL was filed for the release of 17 inmates from jails in Muzaffarpur and Patna, Bihar. They had been incarcerated for a period longer than what they had to serve even after conviction. This PIL led the Supreme Court to issue path-breaking verdicts and expand the scope of Article 21 (right to life) to include right to speedy trial and also right to free legal aid.

Speaking on the topic, ‘Evolving standards for a humane criminal justice system’, Justice Thakur pointed out that the judiciary has always been forthright in issuing directives to protect the rights of the people but the implementation has to be done by those in bureaucracy and government. “Is it a case of failure of the judiciary or the government when despite several judgments and orders by the courts, nothing changes on ground? I would say that judiciary has done its duty if the law is clear on the point and appropriate directions have been issued,” he said. Justice Thakur who was critical of the inefficiency and lack of will by the political executive to act said the judiciary’s commitment to reforms in the country was unquestionable and it would not look the other way when citizens knock on its door in hope of justice.

“If there is a complete failure of the system and there is no hope for the citizens, if there is complete deficit in the governance, where else should citizens go? If such is the situation, should the courts show fidelity to various strict principles when the people are suffering, when most of them cannot even afford to come to the Supreme Court? When the darkness is all around, don’t you think we will be asked to take over so many dimensions of governance?”

On the subject of Public Interest Litigations he said, “Our attention towards public interest jurisdiction is not because we want to take over governance, or because the judiciary is too ambitious and also not because we have a grudge against people who have the power and authority. It is only because of the necessity of the situation.” 

Referring to the Ganga clean-up — a PIL that has been pending for more than 15 years — he said while hearing this case, he realised that Ganga remained as dirty and polluted as it was when the matter started despite the court issuing several directions. He said the executive’s will had been lacking and those who were supposed to act must now be made responsible for their actions.

 Justice Thakur said that those in administration and governance, who were duty-bound to act to correct wrongs and improve the state of affairs, must be made to act since all stakeholders will require to work in tandem to bring about positive changes in society.

Supreme Court gives the go-ahead to the Centre to act on the Election Commission’s recommendation to extend voting rights to NRIs through postal ballots

 The Central Government on Monday submitted before the Supreme Court that the Election Commission’s proposal to extend voting rights to NRIs through postal ballots have been accepted by it in letter and spirit. 

ASG P.L.Narasimha representing the Centre, said certain amendments are required to be carried out and the Ministry of Law is working on them, taking into consideration the recommendations of the Election Commission.

In view of the Centre’s submissions, a Bench of the Apex Court comprising of Chief Justice H.L. Dattu and A.K. Sikri asked the Centre to inform it about “further steps taken to implement the suggestions.”

 

The Bench posted the matter after eight weeks, asking the Centre to do the needful at the earliest. 

“Since the views and recommendation have been accepted let them go ahead with the follow-up. They will have to carry out the follow-up process at the earliest,” the Court said. 

On November 14 last year, considering a batch of Public Interest Litigations (PILs) the Supreme Court had asked the Centre to make its stand clear on the EC’s proposal for allowing NRIs to cast their votes through proxy voting and e-ballots in polls in India. The court had earlier asked the Election Commission to place before it the report of the committee set up by it to “study various available options for the purpose of NRI voting“. 

A 12-member committee led by Vinod Zutshi, Deputy Election Commissioner, had prepared a report on 'Exploring Feasibility of Alternative Options for Voting by Overseas Electors’ wherein it opined that “the option of voting through proxy appointed by overseas electors…” as well as e-postal ballot, where blank postal ballot is transferred electronically to NRIs and returned by post, can be employed after validation of the process and pilot implementation in one or two constituencies. 

The report submitted by the Election Commission further claimed that the system can be initially tried in “one or two constituencies in elections to the legislative Assemblies and can then be “scaled up to more Assembly elections and finally Parliamentary elections if found feasible, practicable and meeting the objectives of free and fair elections”.

The committee also comprised of officials from the Election Commission, Law Ministry and the Ministry of External Affairs and it had elicited the opinion from people of all sections of society before submitting a report to the Supreme Court last year.

The poll panel had contended that the move to allow NRIs to use proxy voting on the lines of defence personnel and e-ballot facility will require changes in the law and a legislative framework. 

The report is the result of a batch of public interest litigations filed in the Supreme Court against the "inherent inequality" created by Section 20(A) of the Representation of the People (RP) Act which insists on the physical presence of an NRI in his local constituency at the time of voting. 

Although the proxy system was opposed by the major political parties of India, the Election Commission said that the proxy voting facility would be operationally the most simple and viable option. 

The petitioners had also submitted that 114 countries have adopted external voting and among them are 20 Asian countries. They said the external voting could be held by setting up polling booths at the diplomatic mission, or by postal, proxy or electronic voting.

The stand taken by the Central Government to accept the Election Commission’s proposal of allowing NRI’s to cast their votes in elections through postal ballots which has been given the go-ahead by the Apex Court comes as a huge relief to over one crore NRI’s who will soon be permitted to take part in the country’s democratic process, once the Government finalises the steps to make it a reality. 

 

CJI H.L. Dattu's remarks in praise of Prime Minister Modi, "inappropriate and ill advised": Fali S. Nariman

CJI H.L. Dattu's personal remarks in praise of Prime Minister Narendra Modi during an informal interaction with media has become the subject matter of a raging controversy which has engulfed the legal fraternity.  

    Mr. H.L. Dattu on Friday was quoted by some sections of the  media as having said  : “I had met the Prime Minister four times and I would rate him as a good leader, a good human being, a man with foresight who would strive for good governance.”

Reacting to the development, Senior Advocate Fali S. Nariman, eminent jurist and one of the foremost legal luminaries in the Country, in an e-mail response to a query from "The Hindu", labelled Chief Justice of India H.L. Dattu’s remarks as “inappropriate and ill-advised.”

   Mr. Nariman said, “My initial response to the reported comments of the CJI in the press is that what was said at an “informal interaction” [as you call it] is not to be publicised. But since the remarks have now been reported, I would describe them as “inappropriate and ill-advised”: because they send the wrong signals – especially to people looking for wrong signals!”