Patent granted for Prevnar13

Two pre-grant oppositions filed by Panacea Biotech and Medecins Sans Frontieres (MSF)have been dismissed and a patent has been granted in favour of Wyeth for Prevnar 13.

Stay tuned for detailed analysis of the order!


Non-compliant defendants face permanent injunction

DSM Sinochem Pharmaceuticals has been granted permanent injunction against Sinopharma Weiqida pharmaceuticals as the defendants failed to timely submit the defense (written statement) and pay the costs imposed by the Court.

The Plaintiffs DSM Sinochem Pharmaceuticals sued Sinopharma Weiqida pharmaceuticals for permanent injunction to restrain them from using , manufacturing , distributing, selling, offering for sale or dealing directly or indirectly in API Amoxixillin Trihydrate produced by a process that amounts to infringement of Indian Patent number 247301, or a formulation thereof.

The defendants did not file the written statement inspite of three opportunities and did not pay the costs imposed by the court. During a hearing on 16th May 2017, the counsel of the Defendants said that the written statement is ready, an advanced copy of which would be handed over to the counsel of the Plaintiffs and the cost imposed would be remitted in the course of the day.  The matter was listed for the next day, provided an additional cost of 50,000 is paid.

During the hearing on the next day, the Court observed that no written statement has been filed nor the cost imposed on the Defendants has been paid. Considering the same, the Court closed the rights of the Defendants to file a written statement. The Plaintiff’s in the absence of any challenge to its patent was considered to be entitled to a decree of permanent injunction in its favour.

CCI orders Investigation against Roche

The Competition Commission of India (CCI), based on a prima facie determination on contravention of Section 4(2)(c) of the Competition Act, ordered investigation against Roche with respect to the cancer drug, Trastuzumab. The complaint was filed by Biocon and Mylan Pharmaceuticals.

Facts of the case: –

  • Genentech developed a monoclonal antibody, which is used in the targeted therapy to treat breast cancer that over expresses the HER-2 (human epidermal growth factor receptor 2) protein. The International Non-Proprietary Name (hereinafter ‘INN’) for this monoclonal antibody is Trastuzumab
  • Genentech signed an agreement with Roche in July, 1998, whereby Roche was given the exclusive marketing rights to sell Trastuzumab, under the brand name HERCEPTIN, outside the USA. HERCEPTIN was introduced in India in 2002 by Roche. The drug was imported and marketed in India initially through a distributor, Taksal Pharmaceuticals, under a marketing arrangement. This arrangement was subsequently terminated, and the marketing was thereafter done by Roche Produces, India.
  • Roche was granted following approvals:
11th October, 2002, import of HERCEPTIN for treatment of patients suffering from ‘metastatic breast cancer’. HERCEPTIN in 440 mg.
25th January, 2008, import and market HERCEPTIN in 150 mg vials
07th August, 2006 HERCEPTIN for treatment of patients suffering from HER-2 positive early breast cancer (adjuvant and neo adjuvant)
03rd April, 2010 HERCEPTIN for treatment of patients suffering from HER-2 positive metastatic gastric cancer
  • Glenmark Pharmaceuticals Limited Challenged the drugs patent in a post-grant opposition on 12th December, 2008. Before a decision could be reached on this opposition, the Roche Group stopped paying annuities in May, 2013 and consequently, the patent lapsed.
  • Roche withdrew HERCEPTIN from the Indian market and rather introduced a lower cost version of Trastuzumab, known as BICELTIS, which was distributed and marketed by Emcure Pharmaceuticals as per an agreement.
  • The Informants have claimed that BICELTIS, which was priced at USD 1270 (Rs.75,000) per 440 mg vial, was primarily introduced in India due to the threat of compulsory licensing and development of biosimilar Trastuzumab. The Roche Group also launched another low cost version of Trastuzumab under the brand name HERCLON in India at a price of USD 1270 (Rs. 75,000) per 440 mg vial
  • On 18th January, 2014, the launch of biosimilar Trastuzumab was announced by Boicon and Mulan under the brand names, CANMAb and HERTRAZ, respectively.
  • It has been stated that the drug was proposed to be launched in vials of 150 mg priced at Rs. 19,500/-per vial and 440 mg priced at Rs. 57,500/- per vial. The price of the 440 mg vial of Trastuzumab manufactured by the Informants is claimed to be 25% lower than HERCLON and BICELTIS and 50% lower than HERCEPTIN.

It was alleged by the Informants that Roche Group, with the intention of preventing the entry of new players in its market of ‘Trastuzumab’, started indulging into frivolous litigations against the Informants: –

  • Writing frivolous communications to various authorities thereby attempting to impede the entry of the Informants.
  • Roche Group has also resorted to vexatious litigation against the Informants and other competitors/potential entrants in the relevant markets, with the sole intention of preventing launch and/or market penetration of approved biosimilars of Trastuzumab.
  • Misinforming doctors and hospitals about the pending Civil Suit and warning them of severe consequences as a result of prescribing HERTRAZ while the suit is pending.

Findings in the order:-

Before analysing the aforesaid allegations within the realm of the Act, the order deals with the preliminary objection raised by the Roche Group on maintainability of the present case. During the hearing, Roche Group has argued that the issues raised in the present information are squarely covered by the Civil Suit pending before the Hon’ble Delhi High Court and thus, the Informants should not be permitted to raise similar issues before the Commission.

The Court agreed with Biocon and Mylan , that while the issues before the Hon’ble Delhi High Court pertain to the validity of approvals granted by DCGI to Informants, the primary issue before the Commission is whether the Roche Group’s conduct in the market is abusive or not. The two are therefore different, and CCI has jurisdiction to decide the present case.

The order also first defines the relevant product market of the drug in question. Biological drugs as well as its biosimilars form part of the same relevant product market. In the present case, the relevant product market, thus, would be the “market for biological drugs based on Trastuzumab, including its biosimilars”. The court held that drugs based on Trastuzumab,i.e., the reference biological drug as well as its bio-similars, would be considered part of the same relevant product market. A relevant product market, within the meaning of Section 2(t) of the Act, need not comprise of products which exhibit ‘identical’ properties; it may also include products which are ‘similar’ in terms of their intended use. In this regard, the Commission finds force in the submission made by the Informants that a biosimilar drug obtains an approval from the regulatory authority only after proving itself to be similar to the reference biological drug in terms of ‘safety’ ‘efficacy’ and ‘quality’. Despite not being identical to the reference biological product, a biosimilaris highly analogous to an already approved biological product and may not have any meaningful differences from the reference product

With regard to the relevant geographic market, the Commission held that the conditions of competition are homogenous across India for pharmaceutical products. Therefore, the relevant geographic market in the present case would be ‘India’.

The Commission observes that undoubtedly, after the introduction of biosimilars, the market share of Roche Group has gone down in the relevant market during 2014 and 2015. However, the allegations in the present case pertain to abusive conduct by Roche Group during the period starting from year 2013 till date. Till 2014, Roche Group had 100% market share. Although its market share fell in the year 2014; it still held a considerable market share in 2014 (83.9% in terms of value and 77% in terms of volume of sales) and 2015 (70.9% in terms of value and 61% in terms of volume of sales).

Considering the long drawn legal battle between the parties before the Hon’ble Delhi High Court, the Commission held that they are reluctant to hold that the litigations filed by Roche Group are baseless. Recourse to legal proceedings, being a right of every party, cannot be concluded to be tainted with ulterior motives as a general principle. Such determination has to come sparingly in exceptional circumstances and the Commission held that it is not convinced that any such circumstance has arisen in this case. Thus, for the foregoing reasons, the allegations of the Informants with regard to vexatious litigation were, prima facie, found to be without merit.

It was however held by the commission that Roche group has approached doctors, hospitals, tender authorities, etc., to influence their perception about the efficacy and safety of the Informants’ products. The Commission is conscious that competitors, in normal business parlance, indulge in tactics to belittle competitors’ products. However, the commission observed that there is difference between puffery aimed at promoting one’s own product and adopting practices which disparage or malign the image of competitors, thereby causing competitive disadvantages to them. This is even more harmful in the pharmaceutical sector, where such disparagement is made to the doctors who are treating the patients of cancer. The line of difference between these two business strategies is very thin, however, when crossed by a dominant enterprise to its own illegal advantage, it warrants intervention by the competition authority.

The Commission also held that creating any iota of doubt in the minds of doctors can adversely affect the market for biosimilars, which is prescription induced, beyond repair. Such disparagement may also have ripple effects within the medical community. In this scenario, those biosimilar manufacturers who do not have strong marketing channels amongst doctors may be forced out of the market because of abusive denigration by a dominant player.

Based on the foregoing analysis, the Commission held that prima facie, the contravention with regard to Section 4(2)(c) of the Act is made out against Roche Group, which warrants detailed investigation into the matter.

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.

DHC maintains the injuction on Cipla For Onbrez

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

An appeal was filed by Cipla against an order passed by Justice Manmohan Singh in January 2015 which restrained Cipla from selling copies of Onbrez (indacaterol). In the Appeal, the Court has maintained the decision on January 2015.

Stay tuned for a detailed report!

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!