Life Sciences 250 - Editorial - The evolving interpretation of patent law in India

Patent law in India has evolved amid various legal amendments and litigation. Though expensive, litigation is strategic to the development of any legislative regime. Last year witnessed some critical patent decisions which have clarified existing law. This chapter describes recent trends in patent litigation arising from the statutory interpretation of Indian patent law by the judiciary.

Disclosure requirements are governed by Section 8 of the Patents Act. Under Section 8(1), a patent applicant must provide a statement disclosing the detailed particulars of any application filed outside India corresponding to its Indian patent application. Clause (b) of this section goes on to state that the applicant must keep the controller updated about the progress of any applications filed elsewhere in the world relating to the same or substantially the same invention. This obligation on the applicant is a continuing one.

In addition, Section 8(2) states that the applicant must furnish the controller with details of the processing of applications filed elsewhere in the world if and when the controller requests such updates. This might appear to be a one-off obligation.

In Chemtura Corporation v Union of India Justice Murlidhar held that the obligations established under Section 8 are mandatory and are not fulfilled if the applicant simply provides the Patent Office with the filing details and a one-off status report on its corresponding foreign applications. In this particular case the plaintiff had failed to advise the office of various developments in its corresponding US application and of an examination report issued for its European patent application.

The judge further held that disclosures regarding the processing of corresponding applications should be periodic and include full particulars, and should not hinge on the controller’s request. He rejected the idea that Section 8(2) establishes a one-off obligation, instead stating that the section merely suggests that the controller may also require the applicant to furnish details relating to the processing of the corresponding application.

In Nokia Corp v Asst Controller of Patents & Designs the Intellectual Property Board (IPAB) interpreted Section 8 of the Patents Act as holding that putting down the international filing date as the actual filing date does not amount to filing false and incorrect information, particularly in view of the fact that Article 11(3) of the Patent Cooperation Treaty, together with Sections 7 and 138(5) of the Indian Patents Act, clearly states that the international filing date shall be considered as the actual filing date of the national phase application in each designated state.

A patent grants the patentee the exclusive right to make, sell, use or import a patented product or process for a defined period of time. However, such rights are subject to certain limitations, as laid down in Section 47 of the Patents Act. This establishes that a patented product or process can be used by the government. Such government use was dealt with in detail by the Bombay High Court in Garware Wall Ropes Ltd v M/s A1 Chopra, Engineers and Contractors.

In this case the applicant held a patent on galvanized steel wire rope and a spiral lock system. A railway contractor supplied a product that was similar to the patented product to the railway authorities and also participated in a tender floated by Central Railways. Garware sought an interim injunction, which was denied by the trial court. Subsequently, Garware preferred an appeal before the Bombay High Court. The respondents set up a defence under Section 100 in view of the fact that a contract had been signed between the railways and the contractor on behalf of the president. The respondents further alleged that since Section 48 is subject to Section 47, their use of the patented product did not amount to infringement.

Justice AH Joshi has helped to clarify case law on government use by comparing Sections 47 and 100 of the Patents Act. Section 47 uses the phrase “merely for its own use”, which indicates that the patented product can be used by the government or any government department, employee or agent in the discharge of its duties. Thus, such use is restricted to direct use by the government to discharge the sovereign functions of the state; it does not contemplate any payment of royalties by the government.

In contrast, Section 99 refers to use of the patented invention “for the purposes” of the government, meaning that the invention can be utilised for purposes other than performing the sovereign functions of the state. Thus, a third party – such as the railway contractor in this instance – may use a patented invention for government purposes under an agreement or licence with the patentee on payment of royalties.

Further, Section 100 contemplates that written authority must be given by the central government before an invention can be used for government purposes. Accordingly, the agreement interposed the name of the president between the railways and the contractor; however, the court held that the respondents’ use of Garware’s patented invention did not amount to government use under Section 100.

The position regarding Section 47 was reiterated by the courts in Chemtura Corporation v Union of India. Section 156 establishes that the government is bound by patents, under certain conditions. In this case the court held that when read together, Sections 47 and 156 indicate that when the government uses a patented product for its own use, it shall be exempt from any kind of patent infringement. However, in the event that such use is made by the government without the patent holder’s consent, Section 156 holds that the patent may be enforced, even against the government.

The law on amendments to patent claims, as set out in Sections 57 to 59 of the Patents Act, was dealt with in great detail by the Delhi High Court in AGC Flat Glass Europa SA v Anand Mahajan. The plaintiff filed suit against the defendant for infringing its patent on a mirror with no copper layer and the process for preparing the same. In this case the plaintiff filed an amendment to the main claim under Section 58 during the infringement suit’s pendency with a view to overcoming prior art cited by the defendant. The issue which arose was whether this amendment fell within the scope of Section 59 of the act. Justice Manmohan Singh held that an amendment may be allowed, provided that it is clarificatory in nature. Further, the amendment should not alter the scope of the claim or introduce any new claim which was not present in the original invention. The judge further held that the scope of enquiry in relation to amendments is limited to amendments that introduce a new claim to extend the scope of the patentee’s monopoly rights and to amendments that narrow or limit the scope of the invention.

Similarly, in EI DuPont de Nemours v Jagdish Jain, an amendment of the claim during an infringement action’s pendency was again allowed.

A patent application can be challenged at the pre-grant stage under Section 25(1) of the Patents Act. A pre-grant opposition can be filed by any person after publication, but before the grant of the patent application on several grounds set out in the act. Such an opposition will result in one of the following consequences:

• The controller may accept the representation and refuse to grant the patent.

• The controller may require the applicant to amend the patent specification before granting the patent.

An order issued under Section 25(1) is held to be non-appealable, in view of the fact that it is not mentioned in the list of sections that are appealable under Section 117A of the act.

Invariably, the filing of a pre-grant opposition will run simultaneously to the application’s prosecution, as the controller can consider the pre-grant opposition filed only after an examination request has been lodged.

One such case was Abraxis BioScience LLC v Union of India. In this case NATCO filed a pregrant opposition to Abraxis’ patent application. It also requested a hearing under Section 14 of the act (an order passed under Section 14 or 15 is appealable), in addition to a hearing for pre-grant opposition. After hearing both parties, the controller passed an order under Section 25(1) refusing to grant the patent. Abraxis filed a writ petition before the Delhi High Court challenging the controller’s order. Justice Sanjeev Khanna granted Abraxis leave to challenge the controller’s order and file an appeal before the IPAB against that part of the order relating to the merits of the case.

Justice Muralidhar of the Delhi High Court dealt with a similar issue and passed a combined order in six writ petitions filed by several aggrieved applicants. The case involved the following issues:

• Whether a writ under Article 226 of the Constitution challenging an order of the controller under Section 25(1) of the act is maintainable.

• Whether an appeal can be made to the IPAB against the controller’s decision under Section 25(1) of the act.

The court held that a pre-grant opposition is “in aid of the examination” of the patent application by the controller. It further held that where a pre-grant opposition by an “interested person” is rejected and the patent is granted, the aggrieved party has several alternate remedies under the Patents Act, such as a post-grant opposition under Section 25(2) or revocation of the patent before the IPAB under Section 64. The court held that even if the post-grant opposition or application for revocation is rejected, the aggrieved party can file an appeal to the IPAB under Section 117A. Finally, such a party may seek judicial review against an IPAB decision by filing a petition with the High Court. Justice Muralidhar further held that where an efficacious alternative remedy is available, the courts should decline to exercise their power and jurisdiction under Article 226 of the Constitution so as not to interfere with the orders of any quasi-judicial statutory authority. The judge contrasted the pre-grant opposition filed by an interested person with that filed by an uninvolved third party and observed that the legislature has consciously denied a further statutory remedy of a postgrant opposition in the event of such a third party failing to prevent a patent from being granted in the pre-grant stage. In a situation where the pre-grant opposition is accepted and the grant of patent is refused, the applicant may appeal to the IPAB under Section 117A, as a refusal under Section 25(1) should be understood as an order by the controller under Section 15, which in any event is appealable to the IPAB.

Finally, the controversy over patent linkage seems to have been laid to rest. The Division Bench of the Delhi High Court dismissed an appeal by the Bayer Corporation seeking to introduce a patent linkage system in India. Bayer filed an appeal against the order passed by a single judge in August 2009 dismissing his writ and seeking directions, among other things, to restrain the drug controller of India from granting marketing approval to Cipla for the generic version of Nexavar (Sorafenib tosylate). The court held that the drug controller’s main function is to ensure the safety, quality and efficacy of drugs available to the public in India. Section 156 of the Patents Act does not prevent the controller from granting marketing approvals to non-patentees in respect of patented drugs and creates no duty or positive obligation on the government or any department thereof to protect a patent from infringement. Therefore, by granting marketing approval to a generic for a patented drug, the controller is by no means itself infringing or abetting the infringement of any patent. On patent linkage, the Division Bench endorsed the view of the single judge, who held: “This court cannot possibly read into the statute a provision that plainly does not exist. The scheme of both the Patents Act and the Drugs and Cosmetics Act are distinct and separate and the attempt by Bayer to establish a linkage cannot be countenanced. Whether patent linkage should be introduced is an issue that requires a policy decision to be taken by the government. It is not for the court to determine if the government should bring in a system of patent linkage.”

The court further held that the drugs controller is under no obligation, and is not equipped, to deal with issues concerning the validity of patents. It is entirely up to the patent holder to seek whatever remedies are available to enforce and protect its patent from infringement.

The third issue related to spurious drugs; the High Court held that the issue of spurious drugs cannot be determined when marketing approval is sought, but must be dealt with during the manufacturing and marketing stages.

Looking at these trends, it appears that patentees and patent applicants have a growing confidence and expectation that the judiciary will have a clear understanding of the intent of the legislature when it comes to enforcing patent rights.

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The evolving interpretation of patent law in India