DHC maintains the injunction on Cipla for Onbrez

The Delhi High Court (DHC) by its decision dated 9th March 2017 continues to bar Cipla Ltd from selling copies of Novartis AG’s drug Onbrez in India.

The entire controversy is respect of Indacaterol, which Novartis holds a patent for. Novartis markets Indacaterol under the name Onbrez. Indacaterol is a bronchodilator and provides symptomatic relief to persons suffering from chronic obstructive pulmonary disease (COPD). Cipla launched its generic version of the drug, Unibrez, in October, 2004. Cipla changed the name from Unibrez to Indaflo due to an undertaking which Cipla gave in a trademark infringement action filed by Novartis.

An order was passed by Justice Manmohan Singh in January 2015 which restrained Cipla from selling copies of Onbrez (Indacaterol).

An appeal was thereafter filed by Cipla against the order of January 2015. Cipla argued that, Novartis does not manufacture Indacaterol in India. The drug is manufactured by the Novartis in Switzerland and only small quantities are imported catering to a negligible number of patients. Thus, according to the appellant, the respondents are not working the patent in India and consequently, they are not entitled to an injunction.

It was also argued that right under section 48 would be subject to the fact that the patent is worked in India on a commercial scale; that the patent is not used by a patentee merely to enjoy a monopoly for the importation of the article

It was submitted that the non-availability was further aggravated by the fact that the price of the respondents Indacaterol was exorbitant as compared to Indacaterol manufactured, supplied and sold by the appellant. The price of the respondents product was five times that of the price of the appellant‘s product

The Respondent argued that, while public interest considerations may be a relevant factor in certain circumstances such as in the case of life saving drugs, it cannot by itself outweigh the rights of a patentee in the case of infringement of the patent as provided under the said Act.

It was also submitted on behalf of the respondents that the statistics said to have been provided by the appellant with regard to the extent of COPD patients in India is not reliable. References were made to certain articles to suggest that COPD does not include an asthma-like respiratory symptom or chronic bronchitis and, therefore, the number of patients suffering from asthma or chronic bronchitis cannot be considered as part of COPD patients. It was also stated that manufacturing in India is not necessary for the working of a patent. The respondents have patents in several countries and this does not mean that they have to manufacture in each country. All that is required is that the manufacturing facilities must be capable of supplying worldwide depending on the demand.

The Division bench, after considering the arguments of both he parties, held that the injunction granted by the learned single Judge ought not to be disturbed.

The various reasons for the same stated by the bench are as follows: –

  • There is no credible challenge to the respondent‘s patent No.222346. Therefore, prima facie, the respondent is straightaway entitled to an injunction in view of the rights available to it as a patentee under Section 48 of the said Act;
  • The provisions of Section 83 (working and CL ) do not curtail or circumscribe the rights of the patentees under Section 48, except in the backdrop of compulsory licences and ancillary issue;
  • It is not at all necessary that for a patent to be worked in India, the product in question must be manufactured in India. A patent can be worked in India even through imports. All that is to be seen is that the imports are of a sufficient quantity so as to meet the demands for the product. Whether the extent of imports is not sufficient for meeting the demands of COPD patients in India, would be a matter of evidence which can only be thrashed out in the course of a trial.
  • Even though the question of public interest may be a factor in considering the grant of an injunction, it is only one of the factors which needs to be kept in mind.
Advertisements

Export within ambit of Bolar exemption

Justice Endlaw, today, pronounced the Judgment (Bayer v UOI & Bayer v Alembic order) in the Bayer Intellectual Property GmbH Vs. Alembic Pharmaceuticals Ltd. and Bayer Intellectual Property GmbH Vs. UOI (Natco Pharma Ltd.) cases relating to Section 107A of the Indian Patents Act (Bolar Exemption). The question for adjudication in both the proceedings was, whether the language of Section 107A of the Patents Act, 1970 permits export from India of a patented invention, even if solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.

As per the Court, export, of the patented drug, for research and development  is exempted under Section 107A of the Indian Patents Act.  Natco Pharma Ltd. and Alembic Pharmaceuticals Ltd., can therefore export small quantities of sorafenib and rivaroxaban respectively for research purposes.

S.107A of the Indian Patent Act, known as India’s Bolar Exemption, is a defence for patent infringement, when the invention is used or sold by a third party for purposes related to research and development.  The provision allows generics to conduct research on the product while the patent is still valid.

The first proceeding, a writ, was filed seeking a mandamus to the Customs Authorities to seize the consignments for export containing products covered by Compulsory Licence including Sorafenat manufactured by Natco Pharma Limited (Natco) and further seeking a direction to all the Customs Ports to not allow exports thereof.

 It was argued by Bayer that a person is permitted/ exempted under Section 107 A to make a drug or buy a drug for research purposes so long as the making and selling is all within India and is for the purpose of generating data also within India. It was also the contention of the Petitioner that  Natco was manufacturing the product covered by the Compulsory Licence for export outside India and the export by Natco was contrary to the terms of Compulsory Licence and amounted to infringement of the patent within the meaning of Section 48 of the Patents Act.

Natco contended that a grantee of Compulsory Licence cannot be deprived of his rights under Section 107A of the Act. The condition of Compulsory Licence to which attention is drawn is for making, using, and selling the drug covered by the patent  within the territory of India. However the purpose of sale under Section 107A is different and is only for obtaining the regulatory approvals under the laws of India or in a country other than India. Thus, the grant of Compulsory Licence would not come in the way of Natco exercising its rights under Section 107A as a non-patentee.

It was also argued by the petitioner that Section 107A of the Act uses the word “import” and absence of the word export therefrom, the only logical conclusion is of exports of patented invention being outside the ambit of Section 107A of the Act and also that the patented invention can be used only in India for conducting trials and the information generated from the said trials can be furnished to the concerned authorities in a country other than India. It was on the other hand contended by  Natco that Section 107A, during the validity of patent also, permits generation of data required by the laws of other countries for obtaining approval for manufacture, use and sale of products; if the laws of any other country require making and use of the patented invention in that country, for the purpose of granting the requisite approvals. It was also contended  to hold that Section 107A prohibits export of API to that country would amount to restricting the scope of Section 107A.

 The second proceeding is a suit filed by Bayer Intellectual Property GmbH and Bayer Pharmaceuticals Ltd to injunct Alembic Pharmaceuticals Ltd. (Alembic) from making, selling, distributing, advertising, exporting, offering for sale and in any manner directly or indirectly dealing in Rivaroxaban and any product that infringes Bayer‘s patent IN 211300. Alembic stated that the exports being effected by Alembic were within the meaning of Section 107A only.

The Court made the following observations:-

  • Sale by a non-patentee ( even if the non-Patentee is a compulsory Licensee ) of a pharmaceutical product solely for the purposes prescribed in Section 107A would also not be infringement;
  • Use of the word selling in section 107A refers to selling within India, and also exports;
  • Merely because no provisions are stated to exist in laws relating to export of pharmaceutical products, for ensuring that API exported is used in the destination country for the purposes for which it has been exported, does not allow Court to interpret Section 107A as not permitting export;
  • Natco and Alembic can export the patented invention for purposes specified in Section 107A of the Patents Act, and for no other purposes.

Trastuzumab “can” be sold as a bio similar to Roche’s Trastuzumab

The division bench of the Delhi High Court, of Badar Durrez Ahmed and Sanjiv Sachdeva, has permitted Biocon and Mylan to use Roche’s product data for Trastuzumab. Roche had challenged the approval mechanism adopted by the central drug standards controller (CDSCO) in giving Biocon and Mylan approval for its biosimilar drug and their product inserts containing product data before the single judge.

 Earlier, the Delhi High Court, in a single bench order, had allowed Biocon and Mylan to market their product without any reference to Roche’s product or biosimilarity.

 Stay tuned for a fuller report!

Writ for Enzalutamide admitted by the DHC

The Regents of University of California, has filed a writ against the order of the Controller refusing the grant of an application filed by them in India, covering the drug product Enzalutamide (Xtandi). On 2nd March 2017 the matter was listed before Hon’ble Mr Justice Sanjeev Sachdeva of the Delhi High Court (DHC) and Mr Chidambaram made the following arguments on behalf of the Petitioner:-

  1. That the present Writ Petition has been filed against the common order dated 8th November 2016 allowing the five pre-grant oppositions, rejecting the Petitioner’s Patent and the said order has been passed in gross violation of the principles of Natural Justice;
  2. That the Patent Application which is the subject matter of the Writ Petition has been granted Patent in around 50 countries;
  3. Further, the marketing approval has been granted in around 75 countries;
  4. That the patent applicant had filed evidence affidavits of three witnesses including the two inventors. However, the impugned order grossly erred in not considering or even referring to the evidence filed by the patent applicant.

In view of the above, the Hon’ble Judge has issued notice in the Writ Petition, returnable on 2nd May 2017.

Business Standard and http://www.india.com reported as to what transpired in Court on 2nd March 201, and the same can be accessed here:

http://wap.business-standard.com/article/pti-stories/hc-seeks-reason-for-denial-of-prostrate-cancer-drug-patent-117030500251_1.html

http://www.india.com/news/agencies/hc-seeks-reason-for-denial-of-prostrate-cancer-drug-patent-1894207/

Stay tuned for more updates!

 

 

Generation of foreign exchange is not in public interest

The plaintiff, Bayer sued BDR Pharmaceuticals for injunction restraining infringement of Product Patent no.IN225529 and Process Patent no. IN188419 and for other reliefs. Bayer asserted that the patents cover vardenafil, a drug used to treat erectile dysfunction.

Previously, Bayer sued Ajanta for injunction restraining infringement of the same patents. Justice Gauba of the Delhi High Court in the Ajanta Suit held that Bayer did not merit injunctive relief as the patent in question is a non-worked patent, and exports by Ajanta generated employment and tax revenue for the state, and it was therefore in the public interest to allow them to continue.

In the BDR case, a hearing was held on 14 February, and BDR cited Justice Gauba’s order in Ajanta case to argue that an injunction was not merited in its case either. BDR also argued that its exports earn foreign exchange for India and encourage economic activity. Justice Endlaw rejected the Ajanta order’s precedential value being an ad-interim order and ordered the case to be listed in two days. The court also held that if such parameters are to be adopted, then in each case of a non-working of patent, infringement of the patent would be allowed. The court also noted that the drug is also not a life saving drug.

On 16 February, the BDR case was referred to mediation. It is set to be listed again on 8 March.

Evidence is only a proof of pleadings

Interim applications filed by Defendants, Natco and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy) in respective suits of Infringement filed against them by Hoffman La Roche, averring that a portion of the deposition of the expert affidavit filed on behalf of Hofmann by way of examination-in-chief was beyond the pleadings of Hoffmann has been found to be valid by the Delhi High Court.

Hoffmann’s expert affidavit was found to be beyond pleadings by the Court and the objection of the Defendants, Natco and Dr. Reddys on the same were found to be valid.

Hoffmann filed a suit to restrain Natco from infringing the drug patent of Hoffmann. Hoffmann thereafter filed another suit to restrain Dr. Reddy’s Laboratories Ltd. (Dr. Reddy) and Natco, from infringing the same patent. The need for impleading Natco in the second suit arose because Natco was supplying Dr. Reddy the active pharmaceutical ingredient.

Natco, as well as Dr. Reddy filed counterclaim in the suits. Separate issues were framed in the two suits and the counterclaims therein. Subsequently, the suits were consolidated and Hoffmann commenced leading its evidence. The first witness of Hoffmann was examined and cross-examined by Dr. Reddy as well as Natco. Hoffmann thereafter filed affidavit by way of examination-in-chief of Dr. Alexander James Bridges. Hoffmann, along with the said affidavit, filed about 14 documents which had not been filed by Hoffmann at any earlier stage.

IA No.10698/2016 and IA No.10685/2016 were filed by Natco in the respective suits averring that a portion of the deposition of Dr. Bridges in the affidavit by way of examination-in-chief was beyond the pleadings of Hoffmann and seeking striking off of the said paragraphs of the affidavit.

The objection taken by Natco were found to be tenable by the Court and the portions of deposition of Dr. Bridges which are beyond the pleadings of Hoffmann, dealing with “polarity” and “toxicity” were held by the court to be liable to be struck down. The court held that the opinion of the expert is only a proof of the pleading and no different. Just like only those facts which are pleaded can be proved in evidence, similarly expert opinion can be given only of a scientific fact pleaded. Without the scientific fact having been pleaded and if controverted, having issue framed thereon, no evidence thereof in the form of expert opinion in proof thereof can be adduced. If the expert transgresses the pleadings, certainly the opposite party would be entitled to object that part of the deposition of the expert.

However, the Court also accepted the fact that the present controversy is a result of there being no clarity on procedure, partly owing to absence of Rules and owing to the erroneous framing of issues without crystallizing the real controversy and owing to Dr. Bridges deposing as a witness on the validity of the patent on behalf of Hoffmann even before Natco, on whom the onus of the issue qua validity rests, leading its evidence. For this reason, the court held that it would not be appropriate to deprive Hoffmann of an opportunity to defend the patent in its favor on the grounds urged for the first time in the deposition of Dr. Bridges. Court has therefore also directed counsel for Natco to inform the counsel for Hoffmann whether Natco requires to cross-examine Dr. Bridges further and if it is so, Hoffmann shall at its own cost produce Dr. Bridges for further cross-examination by Natco.

Notifications under Section 26A of the Drugs and Cosmetics Act declared legally untenable

454 petitions were filed against the 344 Notifications dated 10th March, 2016 of the Government of India, all in exercise of power under Section 26A of the Drugs and Cosmetics Act, 1940 (Drugs Act) prohibiting the manufacture, distribution and sale in the territory of India of drugs 344 Fixed Dose Combination (FDC) Drugs. The petitions have been declared legally untenable.

Section 26A of the Drugs Act, in exercise of powers whereunder the Central Government has issued the impugned Notifications, is as under:-

 26A. Power of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest.— Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, [regulate, restrict or prohibit] the manufacture, sale or distribution of such drug or cosmetic.

The question raised in the petition was that, is the Central Government entitled to exercise the power under Section 26A without consulting or even involving the Drug Testing Advisory Board (DTAB) and the Drug Control Committee (DCC). Further question which arises is, whether the Central Government can exercise the said power in consultation with and on the advice and recommendation of, another Committee, though also of technical persons only, constituted by the Central Government.

The court held that, undoubtedly Section 26A does not require the satisfaction thereunder of the Central Government to be in consultation with or on the aid, advice or recommendation of DTAB and/or DCC or after having the requisite tests carried out from the Central Drugs Laboratory but a mere absence of the said words from Section 26A would not mean that Section 26A is to be read in isolation.

As per the decision, the functions to be performed by the Central and the State Governments under the Drugs Act are not administrative, but largely technical, and therefore the Drugs Act has devised the machinery for advising the Central and the State Governments on such technical matters arising out of the administration of the Act and to carry out the functions assigned to them under the Act. Merely because the powers vested in the Central Government vide some other Sections of the Act expressly provide for exercise thereof on advice of or in consultation with DTAB and/or DCC does not take away from the wide language used in Sections 5&7 while prescribing the purpose of constitution of DTAB & DCC, to advise the Central Government on technical matters arising out of  administration of the Act and to carry out other functions assigned to Central Government by the Act.

The provision in the Drugs Act for constitution of DTAB and DCC is to ensure institutional integrity and compliance of public law principles in discharge of functions and exercise of power thereunder. Though the legislature, in the Drugs Act, vested the Central Government with the powers to be exercised thereunder but at the same time constituted DTAB to advice the Central Government on technical matters arising out of administration of the Drugs Act and to carry out other functions assigned to the Central Government by the Act and the DCC, also to advice the Central Government and the DTAB on any matter tending to secure uniformity throughout India in administration of the Act.

The Court cited 6 judgments delivered by various High Courts in support of the proposition that the DTAB and DCC play a central role in the decision making process envisaged by Section 26A. On the basis of these judgments, it drew the inference that a decision made under Section 26A without consulting these bodies would be legally untenable.

The court also held that the Central Government, though acting in public interest, seems to have gone about it in a haphazard manner. It claims that the FDCs for manufacture of which licences were issued by SLAs between September, 1988 and 1st October, 2012 without the same having approval of the Drugs Controller were wrongly granted such licences. However instead of taking action for cancellation of said licences, the manufactures were asked to apply for licences to be Drugs Controller, while continuing to manufacture the drugs for which according to the Central Government licence was wrongly given. When such applications were received, instead of the same being considered by the Drugs Controller, who is vested with the power of approval, ten committees were constituted for considering the applications. After the said committees failed to examine all the applications, the Kokate Committee was constituted. The said Kolkata Committee, instead of considering the applications for approval, went into the aspects of risk to consumers and therapeutic value and therapeutic justification and on receiving report whereof impugned Notifications were issued.