Landmark Cases - Patent Act

1. F. Hoffmann-La Roche Ltd vs Cipla Ltd., Mumbai Central,

Two plaintiffs, namely, F. Hoffmann-La Roche Ltd. and OSI Pharmaceuticals Inc., have filed the suit for permanent injunction restraining infringement of patent, rendition of accounts, damages and delivery against Cipla Ltd. Mumbai. Indian Generic manufacturer Cipla has won the landmark Roche v. Cipla Patent Infringement case in the Delhi High Court over Cipla’s Generic version of Anti-cancer Drug Erlotinib. The case is the first Patent Litigation in India post India’s 2005 Product Patent Regime which included public interest and pricing issues in addition to India’s Section 3d that prevents evergreening. The case was followed by Pharma Giants worldwide.

Roche sued Cipla in 2008 before Delhi High Court claiming that Cipla’s generic product Erlocip violates former’s Indian ‘774 patent claiming “Erlotinib Hydrocloride”. The trial Judge rejected Roche’s appeal to grant interim injunction restraining Cipla from selling generic version of Tarceva on the grounds of public interest and the fact that there was an ongoing patent revocation proceedings against ‘774 patent. Cipla’s generic version costs about 1/3rd of Roche’s patented drug. Roche’s subsequent appeal to Division Bench also failed when not only did the bench uphold the findings of Trial Judge but also imposed costs on Roche for suppression of material patent information about Roche’s later filed application in India (IN/PCT/2002/00507/DEL). This was the Patent Application which was actually on Polymorph Form B of Erlotinib Hydrocloride but was rejected in 2008 following the opposition filed by Cipla primarily on Section 3d. Cipla argued that Tarceva corresponds to Polymorphic Form B (which is not a product of ‘774 patent but a ‘507 rejected application) and that it is Form B which is more stable and suitable for solid oral dosage form than the compound disclosed in ‘774 patent comprising a mixture of Forms A and B. Roche’s subsequent appeal before the Supreme Court (SC) challenging the order passed by the division bench got dismissed due to the ongoing trial at the Delhi High Court.

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2. Bajaj Auto Ltd. vs Tvs Motor Company Ltd

The case of Bajaj vs. TVS Motors involves the controversy regarding the unauthorized application of the patent of the DTSi. The case is very crucial regarding not only the financial stakes of the parties but also regarding the application of the doctrine of pith and marrow. The paper deals with the case study of the same, involving the facts, contentions, judgment and its analysis.

This is one of the few patent cases in India that have been decided keeping in view the Doctrine of Equivalents, which is also termed as the doctrine of pith and marrow. Above all, the principles involved in arriving at the decision are also crucial.

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3. NovartisAG vs Union of India

Swiss drug firm Novartis has lost its legal case against the Indian government, who it had accused of 'unconstitutional' patent law practices. The ruling sets an important precedent that will cheer the flourishing generics market in the country.

The case was launched earlier this year, after the Indian government refused to grant a patent to Novartis for its cancer drug, Glivec (see Chemistry World, March 2007, p18). Having established itself as a patent-free zone where generic drug-makers flourished, India finally joined the World Trade Organization in 1995, and had to agree to start granting patents. As a developing nation, the country was given ten years in which to bring its patent laws into line with other WTO member states.

But India introduced a provision within its patent law - section 3(d) - which excludes 'incremental innovations'. Since a patent had previously been granted for imatinib (the active ingredient of Glivec) in many countries - prior to the introduction of patent laws in India - this meant that Novartis could be refused a patent for what it claims to be an innovative and improved therapy.

Novartis challenged the constitutionality of section 3(d), but that case has now been dismissed by the High Court in Chennai.

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4. Strix Ltd v Maharaja Appliances Ltd

The Delhi High Court granted interim injunction restraining Maharaja Appliances from manufacturing and marketing Maharaja Whiteline electric kettle Model No EK 172 as it infringed Strix’s patent (IN 1,92,511, US 6,080,968). In granting injunction, the Court made two critical observations on why Maharaja failed to discharge its burden of raising a ‘creditable challenge’ to the validity of the Strix patent.

First, the court observed that the defendant failed to place on record some acceptable scientific material, supported or explained by the evidence of an expert, that the patent is prima facie vulnerable to revocation. Secondly, the court observed that the burden on the defendant to show that it has put forward a creditable challenge will be greater on account of the fact that there was n opposition filed to challenge Strix’s patent.

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5. Glochem Industries Ltd vs Cadila Healthcare Ltd

In a recent judgement, the Bombay High Court considered the validity of a pre-grant opposition and affirmed the petitioner's claims that a new form of an existing substance cannot be considered patentable unless its claims go beyond prior art to produce a different or altogether enhancing effect. Glochem Industries had petitioned the Court, after its pre-grant opposition to Cadila's drug patent application (No. 413/MUM/2003A) was dismissed by the assistant controller of patents. Glochem's chief objections were that the patent claims were neither novel nor capable of producing an enhancing therapeutic effect, under Section 25(1) and Section 3(d) of the Indian Patents Act, a view upheld by the Court. In its petition before the Bombay High Court, Glochem submitted that Cadila had failed to provide legal or admissible evidence before the authorities by way of supporting its claims; that Cadila had failed to show that the new form of known substance for the applied for patent actually enhances existing therapeutic efficacy, and that the assistant controller of patents in dismissing the opposition, did so upon misconstruction and misapplication of the provisions of Section 3(d) of the Act. The substance at issue here is clopidogrel besylate, a salt derived from clopidogrel (already patented in the US - Nos. 4529596 and 4847265 - by Sanofi SA).

The Bombay High Court after deliberating, opined that the alternative options suggested by Cadila in regard to the petitioner's actions is no basis to non suit the petition, especially if the latter's grievances were valid that the authorities had indeed committed manifest error. Therefore the court set aside the order granting the patent and directed the authorities to re-examine the matter.

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6. Bayer Corporation & Anr vs Union Of India & Ors

This is a very interesting case attempting to create controversial Drug-Patent Linkage mechanism as provided in the USA to the legal regime in India.

Bayer Corporation, instead of filing a suit for infringement, filed an inventive writ petition in the Delhi High Court desiring that since the applications of Cipla "SORANIB" allegedly infringe its patent, its (Cipla's) marketing approval application under the Drugs Act should not even be processed or entertained. It is for the first time that an attempt is made to link drug approval to patent infringement in India. However, the Delhi High Court, denying the injunction, imposed a substantial cost of Rs. 6.75 Lakh to deter any such future attempts. Bayer relied on the argument that a combined reading of Section 2 of the Drugs and Cosmetic Act along with Section 48 of the (Indian) Patent Act, 1970 establishes a Patent Linkage Mechanism under which no market approval for a drug can be granted if there a patent subsisting over that drug. It also claimed that CIPLA's "SORANIB" is a "Spurious Drug" as defined under the Drugs Act, for which market approval cannot be granted.

The Hon'ble High Court of Delhi held that there is no Drug- Patent Linkage mechanism in India as both the Acts have different objectives and the authority to determine patent standards, is within the exclusive domain of the Controller of Patents. Moreover, the patent linkage will have undesirable effect on the India's Policy of Public Health. It further held that the market approval of a drug does not amount to infringement of patent. Therefore, the patent infringement cannot be presumed, it has to be established in a court of law. Such adjudication is beyond the jurisdiction of Drug Authorities.

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