India: Patent Newsletter January 2015

Last Updated: 3 February 2015
Article by Lall & Sethi Advocates

The story continues......... those who have been reading our past newsletters will understand that in the patent landscape our focus has been pharmaceuticals. This is not intentional and we do try very hard to veer away from it and focus on other technology areas as well, but since so much activity is always happening in this area, we are compelled to write and focus about this technology area. Here we are again! Back with another edition with some more news in the pharmaceutical landscape. This time however it is notjust news, we have tried to collect, collate and analyze data on enforcement of pharma patents in India in recent years. Specifically we are bringing you the trend in the relief granted to plaintiffs in these disputes.

And it is that time of the year again! The deadline for filing working statements for granted patents is just round the corner. We bring you an updated article on the working of patents in India with the latest case law in this regard.

A few words patting the Patent Office on its back for bringing some muchneeded transparency and efficiency in its working will complete this edition.

We wish all our readers a wonderful 2015. We hope you find the information useful.

Right to Infringe?

This is the impression the world has of India in the pharmaceutical space. To the world India is a no-holdsbarred country where anyone (read the generic companies) can copy your invention and live-happily-everafter. However the reality may be quite different. With the Indian pharmaceutical market growing at double digit rates1 competition between the innovator companies and the generic companies is predictably fierce. As the innovators and the generics fight it out, we try and bring you a realistic picture from the Ground Zero!

Patentee's Rights and Protection

The rights of the patentee2 are enshrined in the Indian Patents Act, 1970 that gives the exclusive right to the patentee to prevent others, without his consent, from the act of making, using, offering for sale, selling or importing the patented product in India. In case of a process it is the exclusive right to prevent others, without his consent, from using that process and from using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India. The rights are however subject to conditions stated in section 473. Infringement per se is not defined in the Act but flouting of these rights by a third person amounts to infringement.

The patentee can file a suit for infringement against the infringer. The Court can grant relief4 to the patentee in the form of an injunction and either damages or an account of profits. The Court can also order seizure of infringing goods.

The injunction granted by the Court can be either temporary or permanent. For granting interim injunctions the Courts follow three criteria5 to determine its grant: availability of a prima facie case (that a patent is valid), the balance of convenience and irreparable injury. Traditionally Courts have not been very keen on granting injunctions, either interim or permanent, in patent cases, especially in pharmaceutical disputes. Recently, however this scenario seems to be shifting.

What follows below is the trend in grant of injunctions in the pharmaceutical space in recent years for the protection of various drug molecules. Sitagliptin Merck Sharp and Dohme (MSD) found infringement of its patent covering the molecule Sitagliptin, an antihyperglycemic drug of the DipeptidylPeptidase-4 (DRP-4) inhibitor class for which theyfiled infringement suits against several parties.

The Court granted interim ex-parte injunction against eight defendants, while refused injunction against Glenmark. In case of infringement suit against Glenmark6, the Court held that since the plaintiff (MSD) had failed to prove that Sitagliptin Phosphate was identical in its properties to Sitagliptin, hence the product (Sitagliptin Phosphate) of the defendant (Glenmark) would be outside the purview of the plaintiff's patent. The Court averred that the plaintiff had not submitted any pleadings with regards to the fact that that Sitagliptin Phosphate was merely a new form of Sitagliptin, and did not result in the enhancement of its efficacy and was a mere combination of other derivatives of Sitagliptin. The fact that the plaintiff had obtained patents on Sitagliptin Phosphate in the US and Europe by showing that it was a new product worked against them. The patent application for Sitagliptin Phosphate had been earlier rejected by the Indian Patent Office. The matter had been referred for mediation, however since attempts to settle disputes have failed, matter is into the trial phase.

Erlotinib:

Roche filed several infringement suits between 2008 and 2010 against a number of generic drug companies namely Cipla, NatcoPharma, Dr. Reddy's, Glenmark, Oncare Life Sciences, Aureate Healthcare, Innova Life Sciences, Mylan Laboratories Inc, Fresenius Kabi, Accura Care Pharmaceuticals and Intas Pharma for its patent on a drug molecule "Human Epidermal Growth Factor Type- I/Epidermal Growth Factor Receptor (HER/EGFR)" inhibitor which is known as 'Erlotinib' for treatment of cancer. However, in nine of the ten cases the Court decided only on jurisdiction part and main issue of injunctive relief remains open. Only in Cipla's case Court rendered its decision7, denying permanent injunction to Roche. In this case Roche was denied permanent injunction based on the Court view that Cipla did not infringe on the patent, though patent was held valid by the Court. Appeals were filed by both the parties against the Court decision.The defendant also filed revocation application for the same patent before Intellectual Property Appellate Board. Later in the case, the two parties agreed to work with the Court direction to provide mediation. The mediation also has however failed, and the both the parties are back in the Court.

Sorafenib:

The patent covering the famous drug of Bayer used for treating kidney, liver and radioactive iodine resistant advanced thyroid cancers was the subject of the first Compulsory License granted to NatcoPharma Ltd. In December 2014 Supreme Court rejected Bayer's Special Leave Petition (SLP application) that challenged a July, 2014 order of the Bombay High Court that upheld the grant of the Compulsory License to produce a cheaper version of its patented drug Sorafenib8.

Bayer had filed infringement suit against Cipla in 2010 for the infringement of its patented drug Sorafenib.The Delhi High Court did not grant interim injunction to Plaintiff in 2010 suit which is still pending with the Court.

Dasatinib:

Bristol-Myers Squibb's (BMS) patent covering the drug molecule Dasatinib survived the Compulsory License grant by the Patent Office in 2013. Dastanib is a multi-BCR/Abl and Src family tyrosine kinase inhibitor for first line use in patients with chronic myelogenous leukemia (CML) and Philadelphia chromosome – positive acute lymphoblastic leukemia (Ph+ ALL).

Earlier BMS had filed infringement suits against several parties for infringing its patent covering the drug molecule Dasatinib. It managed to get interim injunctions against Dr. BPS Reddy, Hetero Drugs, BDR Pharmaceuticals and Natco to restrain them from infringing its patent. Delhi High Court however refused granting an interim injunction against Shilpa Medicare for the same drug.

Vildagliptin:

Novartis filed several suits of infringement against parties infringing its drug molecule Vildagliptin, an antihyperglycemic agent of the Dipeptidyl Peptidase-4 (DPP-4) inhibitor class of drugs.

In seven separate suits for infringement filed by Novartis in the Delhi High Court in 2014 against the various Indian Generic companies like Ranbaxy Laboratories, Wockhardt Ltd, Biocon, Alembic Pharmaceuticals, Glenmark Generics, Cadila Healthcare and Bajaj Healthcare, quia timet ex-parte interim injunctions were granted to Novartis. The Court granted permanent injunction to Novartis against Bajaj Healthcare.

Atazanavir:

Bristol-Myers Squibb (BMS) was denied an interim injunction by Hyderabad Trial Court in a suit against generic manufacturer Matrix (owned by Mylan) regarding the export of HIV Drug Atazanavir to Venezuela. While BMS had no product patents in either India or Venezuela, they had brought the suit on the basis of two secondary process patents.

The plaintiff appealed in the Hyderabad High Court against the trial Court decision that was rejected and thereby denying the interim injunction application, noting that the applicants failed to demonstrate a prima facie case and balance of convenience in its favour.

Glatiramer Acetate:

Teva Pharmaceutical Industries Ltd (Teva) was denied interim injunction against Natco Pharma Ltd by the Delhi High Court in an infringement suit for infringement of two patents covering the process of making Glatiramer Acetate for want of appropriate jurisdiction. Glatiramer Acetate is an immunomodulator drug used to treat multiple sclerosis. Natco is manufacturing Glatiramer Acetate in India on behalf of Mylan for sale outside India. The Court refused the application on the basis of Delhi High Court not being the correct jurisdiction as the patents in question were process patents and not product patents.

Saxagliptin:

Astra Zeneca AB sued Glenmark Generics Ltd for infringing its patent on its anti-diabetic drug Saxagliptin monohydrate which is co-developed by Bristol Myers Squibb. The plaintiff alleged that Glenmark exported the Saxagliptin. The Delhi High Court has passed a status quo order that allows Glenmark to continue export of Saxagliptin Monohydrate only.

Linezolid:

Symed Laboratories Pvt. Ltd. (Symed) filed suits of infringement against several parties for infringement of its patents covering Linezolid intermediates and process for the perpetration of Linezolid and related compounds. Linezolid is a synthetic antibiotic.

The court granted ex-parte injunctions against Sharon Bio- Medicine and Optimus Pharma and permanent injunction against Alken Laboratories.

Imatinib Mesylate:

Novartis AG sued several generic manufacturers over the strength of its EMR (Exclusive Marketing Right) obtained for its drug, the beta crystalline form of Imatinib Mesylate in the Madras High Court. The Court issued an ex-parte injunction against six generic manufactures (which includes Cipla, Ranbaxy, SunPharma, Emcure, Hetero Drugs, Intas) preventing them from producing the drug. However, in another parallel litigation, the Bombay High Court refused to grant injunction against Meher Pharma, while ex-parte injunction granted in favour of plaintiff in Adarsh Pharma case.

Entecavir

Bristol - Myers Squibb filed a suit for infringement of its patent covering Entecavir, an antiviral drug used in the treatment of Hepatitis B virus (HBV) infection.The plaintiff prayed for permanent injunction to restrain Ranbaxy Laboratories from infringing its patent at Delhi High Court but injunction was not granted by the Court.

Sunitinib

Pfizer and Sugen were granted an injunction preventing Cipla from launching Sunitinib that flouted their patent for the drug molecule by the Delhi High Court. Sunitinib is a multi-targeted receptor tyrosine kinase (RTK) inhibitor for the treatment of Renal Cell Carcinoma (RCC) and Gastrointestinal Stromal Tumor (GIST). Injunction was also granted against Natco and two other defendants.

Indacaterol

Novartis filed a suit for permanent injunction against Cipla Ltd and got restraining orders against Cipla for infringing its patent covering its drug molecule Indacaterol, an ultra long-acting Beta 2- agonist approved for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

Others:

Vifor (International) AG obtained ex-parte interim injunction against Symed Laboratories for violation of its patent which is related to process for preparation of water soluble iron carbohydrate complex of a particular weight. In Cadila vs Instacare Laboratories related to patent for process for amoxicillin formulation, the Ahmedabad High Court vacated the Trial Court's order of rejecting ex-parte ad-interim injunction to Cadila.

In K Ramu vs. AdayarAnandaBhavan and Muthulakshmi Bhavanthe Madras High Court granted interlocutory injunction for its patent which is related to low glycemic sweets.

Footnotes

1 http://www.ibef.org/industry/indian-pharmaceuticals-industry-analysis-presentation

2 Rights of patentees.—Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent granted under this Act shall confer upon the patentee—

(a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India;

(b) where the subject matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India.

3 Grant of patents to be subject to certain conditions.—The grant of a patent under this Act shall be subject to the condition that—

(1) any machine, apparatus or other article in respect of which the patent is granted or any article made by using a process in respect of which the patent is granted, may be imported or made by or on behalf of the Government for the purpose merely of its own use;

(2) any process in respect of which the patent is granted may be used by or on behalf of the Government for the purpose merely of its own use;

(3) any machine, apparatus or other article in respect of which the patent is granted or any article made by the use of the process in respect of which the patent is granted, may be made or used, and any process in respect of which the patent is granted may be used, by any person, for the purpose merely of experiment or research including the imparting of instructions to pupils; and

(4) in the case of a patent in respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own use or for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the Government or any other dispensary, hospital or other medical institution which the Central Government may, having regard to the public service such dispensary, hospital or medical institution renders, specify in this behalf by notification in the Official Gazette.

4 Reliefs in suit for infringement.—(1) The reliefs which a court may grant in any suit for infringement include an injunction (subject to such terms, if any, as the court thinks fit) and, at the option of the plaintiff, either damages or an account of profits.

(2) The court may also order that the goods which are found to be infringing and materials and implements, the predominant use of which is in the creation of infringing goods shall be seized, forfeited or destroyed, as the court deems fit under the circumstances of the case without payment of any compensation.

5 The Supreme Court of India has provided precedential jurisprudence in SeemaArshadZaheer Case (SeemaArshadZaheer -vs- Municipal Corpn. of Greater Mumbai, (2006) 5 SCC 282) where the Court has laid down its guidelines for the grant of temporary injunction orders. The Court opined that "The discretion of the court is exercised to grant a temporary injunction only when the following requirements are made out by the plaintiff: (i) existence of a prima facie case as pleaded, necessitating protection of plaintiff's rights by issue of a temporary injunction; (ii) when the need for protection of plaintiff's rights is compared with or weighed against

the need for protection of defendant's rights or likely infringement of defendant's rights, the balance of convenience tilting in favour of plaintiff; and (iii) clear possibility of irreparable injury being caused to plaintiff if the temporary injunction is not granted. In addition, temporary injunction being an equitable relief, the discretion to grant such relief will be exercised only when the plaintiff's conduct is free from blame and he approaches the court with clean hands".

6 CS(OS) 586/2013, High Court of Delhi

7 CS(OS) No. 89/2008, CC 52/2008 & CM No.6436/2013 in RFA(OS) 92/2012 in High Court of Delhi

8 SC 30145/2014

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