1 Dinris

Case Study On Patent Law In India

Introduction

Traditional Knowledge (TK) is a living body of knowledge that is developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity1. Traditional Knowledge per se that is the knowledge that has ancient roots and is often informal and oral, is not protected by conventional intellectual property protection systems. This scenario has prompted many developing countries to develop their own specific and special systems for protecting traditional knowledge. India has played a very significant role in the documentation of traditional knowledge thereby bringing the protection of traditional knowledge at the centre stage of the International Intellectual Property System. Provision of Traditional Knowledge Digital Library (TKDL) Access (Non-Disclosure) Agreements with several international patent office's including USPTO, EPO, JPO etc. by Indian Government has led to many patent applications concerning India's traditional knowledge have either been cancelled or withdrawn or claims have been amended in several international patent offices2.

Traditional Knowledge Digital Library

TKDL is a pioneer initiative of the Indian Government, and came to the fore due to the

India's efforts on revocation of patent on wound healing properties of turmeric at the USPTO and the patent granted by the European Patent Office(EPO) on the antifungal properties of neem. India's traditional medicinal knowledge exists in local languages such as Sanskrit, Hindi, Arabic, Urdu, Tamil etc. is neither accessible nor comprehensible for patent examiners at the international patent offices. It was identified by the TKDL expert group in 2005 that annually around 2000 patents were granted around the world erroneously concerning Indian system of medicine by patent offices around the world. TKDL provides contents of the ancient texts on Indian Systems of Medicines i.e. Ayurveda, Siddha, Unani and Yoga, into five international languages, namely, English, Japanese, French, German and Spanish, with the help of information technology tools and an innovative classification system - Traditional Knowledge Resource Classification (TKRC) Bio-piracy and Misappropriation of TK.

The use of intellectual property systems to legitimize the exclusive ownership and control over biological resources and biological products and processes that have been used over centuries in non-industrialized culture can be defined as "bio-piracy". In other words bio-piracy means misappropriation of traditional knowledge with an intention to gain patent protection over that knowledge. Devolution, encroachment, the bio prospecting rush, lack of appropriate legal systems and a clash of systems all make traditional knowledge highly vulnerable to bio-piracy. Traditional knowledge is associated with biological resources which in turn is a component of biodiversity. The clues/ leads provided by TK can be utilized to develop best practices/processes/ system for mankind without the investment of huge amount of money for research and results validation through clinical trials in labs, above all such knowledge saves time. In the recent past, several cases of bio-piracy of TK from India have been reported. The following are the most prominent cases with regards to misappropriation of TK from India.

Turmeric Patent

Turmeric is a tropical herb grown in east India. Turmeric powder is widely used in India as a medicine, a food ingredient and a dye to name a few of its uses3. For instance, it is used as a blood purifier, in treating the common cold, and as an anti-parasitic for many skin infections. It is also used as an essential ingredient in cooking many Indian dishes. In 1995, the United States awarded patent on turmeric to University of Mississippi medical center for wound healing property. The claimed subject matter was the use of "turmeric powder and its administration", both oral as well as topical, for wound healing. An exclusive right has been granted to sell and distribute. The Indian Council for Scientific and Industrial Research (CSIR) had objected to the patent granted and provided documented evidences of the prior art to USPTO. Though it was a well known fact that the use of turmeric was known in every household since ages in India, it was a herculean task to find published information on the use of turmeric powder through oral as well as topical route for wound healing. Due to extensive researches, 32 references were located in different languages namely Sanskrit, Urdu and Hindi. Therefore, the

USPTO revoked the patent, stating that the claims made in the patent were obvious and anticipated, and agreeing that the use of turmeric was an old art of healing wounds. Therefore, the TK that belonged to India was safeguarded in Turmeric case.

Neem Patent

The patent for Neem was first filed by W.R. Grace and the Department of Agriculture, USA in European Patent Office. The said patent is a method of controlling fungi on plants comprising of contacting the fungi with a Neem oil formulation. A legal opposition has been filed by India against the grant of the patent. The legal opposition to this patent was lodged by the New Delhi-based Research Foundation for Science, Technology and Ecology (RFSTE), in co-operation with the International Federation of Organic Agriculture Movements (IFOAM) and Magda Aelvoet, former green Member of the European Parliament (MEP)4. A tree legendary to India, from its roots to its spreading crown, the Neem tree contains a number of potent compounds, notably a chemical found in its seeds named azadirachtin. It is used as an astringent in so many fields. The barks, leaves, flowers, seeds of neem tree are used to treat a variety of diseases ranging from leprosy to diabetes, skin disorders and ulcers. Neem twigs are used as antiseptic tooth brushes since time immemorial. The opponents' submitted evidence of ancient Indian ayurvedic texts that have described the hydrophobic extracts of neem seeds were known and used for centuries in India, both in curing dermatological diseases in humans and in

protecting agricultural plants form fungal infections. The EPO identified the lack of novelty, inventive step and possibly form a relevant prior art and revoked the patent. Apart from this, several US patents were recently taken out Neem-based emulsions and solutions.

Basmati patent

The US patent office granted a patent to 'RiceTec' for a strain of Basmati rice, an aromatic rice grown in India and Pakistan for centuries .Rice is the staple food of people in most parts of Asia, especially India and Pakistan. For centuries, the farmers in this region developed, nurtured and conserved over a hundred thousand distinct varieties of rice to suit different tastes and needs. In 1997, in its patent application Ricetec also acknowledged that "good quality Basmati rice traditionally come from northern India and Pakistan...Indeed in some countries the term can be applied to only the Basmati rice grown in India and Pakistan." However, the company then went on to claim that it had invented certain "novel" Basmati lines and grains "which make possible the production of high quality, higher yielding Basmati rice worldwide." The Indian Government had pursued to appeal only 3 claims out of 20 claims made in the original patent application of RiceTec Inc. What were being challenged were only claims regarding certain characteristics of basmati (specifically starch index, aroma, and grain dimensions)5. It is to be noted that WTO Agreement does not require countries to provide Patent protection to plant varieties. It only requires countries to legislate so that plant varieties are protected

in some manner (not necessarily through patents). However, US being a strong proponent of Patent protection of plant varieties allowed the patent application. Three strains development by RiceTec are allowed patent protection and they are eligible to label its strain as "Superior Basmati Rice". Therefore, in Basmati case, RiceTec altered the strain through crossing with the Western strain of grain and successfully claimed it as their invention and the case is an example of problems illustrated in TRIPS with regards to patenting biotechnological processes.

TKDL as Global IP watch systems

"Global IP watch monitoring systems have an important role to play in enabling the identification of published TK-related applications on which third parties � in accordance with the patent law of the country concerned � may file observations."6

Advantages-

  1. TKDL has enabled the submission of third party observations (TPOs) which has proven the only cost-effective way of misappropriation of TK at the pre-grant stage.
  2. TKDL has enabled successful opposition of hundreds of patent applications filed around the world.
  3. Enables immediate corrective action to be taken with zero cost so as to prevent bio-piracy.

Conclusion

It is to be noted that the IP world has acknowledged the importance of successful

documentation of indigenous TK like India's TKDL- play a role in defensive protection within the existing IP system. As suggested by World Intellectual Property Organization (WIPO) as a global measure to curb bio-piracy and misappropriation of TK the following strategies are discussed. Inventions based on or developed using genetic resources (associated with traditional knowledge or not) may be patentable or protected by plant breeders' rights. The other couple of measures considered, discussed and developed by WIPO7 are firstly, defensive protection of genetic resources which aims at preventing patents being granted over genetic resources (and associated traditional knowledge) which do not fulfill the existing requirements of novelty and inventiveness. The said measure further entails the possible disqualification of patent applications that do not comply with Convention on Biological Diversity (CBD) obligations on prior informed consent, mutually agreed terms, fair and equitable benefit-sharing, and disclosure of origin. Secondly, WIPO members want to make it mandatory for patent applications to show the source or origin of genetic resources, as well as evidence of prior informed consent and a benefit sharing agreement.

Footnotes

1 http://www.wipo.int/pressroom/en/briefs/tk_ip.html

2 http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_39_1_5-tk-guidelines.pdf

3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038276/

4 http://www.countercurrents.org/bhargava140709.htm

5 http://www.delhiscienceforum.net/intellectual-property-rights/87-victory-on-basmati-by-amit-sen-gupta-.html

6 http://www.wipo

7 http://www.wipo.int/pressroom/en/briefs/tk_ip.html

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Saipriya Balasubramanian

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Patent Litigation in India has steadily increased over last 2-3 years. Dramatic swift has been observed in the innovator’s perspective from the mere aspect of invention to gaining patent protection for their respective invention. Patent owners have adopted aggressive approach towards their patent protection and enforcing their proprietary rights as businesses, are now well-positioned in the realm of patent litigation.  The patent owners are not at all hesitant to challenge the validity of patent rights of their rivals. There has also been gradual increase in the understanding of the complex patent infringement and validity issues.

We will now deal with some of the recent and important patent litigation cases in India.

Merck vs. Glenmark over “Sitagliptin”

In an interesting note, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. Merck Sharp & Dohme filed an application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals from using its patented product Sitagliptin (Indian Patent No. 209816) at the Supreme Court. The Delhi high court conclusively held that all the three ingredients (Prima facie, Irreparable injury and balance of convenience) for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

Ericsson vs. Xiaomi

In December 2014, Ericsson had filed a suit against Xiaomi in India for the alleged infringement of the 8 standard-essential patents. The Delhi High Court granted an ex-parte injunction on the sale, manufacture, advertisement, and import of Xiaomi’s devices.

Xiaomi claimed that its latest devices in the Indian market (as of December 2014), the Mi3, Redmi1S and Redmi Note 4G, contained Qualcomm chipsets, which implemented technologies licensed by Ericsson. Xiaomi subsequently challenged the injunction before a Division Bench of the Delhi High Court, which issued temporary orders to allow Xiaomi to resume the sale, import, manufacture, and advertisement of its mobile devices subject to the following conditions:

  • Xiaomi would only sell devices having Qualcomm chips.
  • Xiaomi would deposit Rs. 100 towards royalty for every device it imported to India from the date of the launch of the device in India toJanuary 5, 2015. This amount was to be kept in a fixed deposit for three months during the proceeding of the case.

Novartis vs. Cipla

In another patent litigation case, Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction. Further, the court observed that Cipla did not provide any figures about the “inadequacy or shortfall in the supply of the drug.” Earlier Cipla lunched its generic version of Indacarterol in October claiming “urgent unmet need” for the drug in india.

Without going conventional way, Cipla, also approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol. Cipla argued on the basis of 3 main points i.e. “epidemic” or a “public health crisis” of COPD, unable to manufacture the same in India by Patentee and high cost of patented drug.

Vringo Vs. ZTE

In January 2014, Vringo and Vringo Infrastructure filed a patent infringement suit in the Delhi High Court against ZTE, over the alleged infringement of its patent IN200572.

In February 2014, the Delhi High court granted an ad-interim ex-parte injunction restraining ZTE from importing, selling, advertising, installing or operating devices that comprise the infringing components. The High court also appointed local commissioners to inspect ZTE’s premises and instructed customs authorities to detain ZTE’s shipments that may contain such devices and to notify Vringo. In March 2014, ZTE appealed against the injunction, which was vacated on August 5 the same year with ZTE being ordered to deposit Rs. 17.85 crore to the court.

The suit is sub judice now. As of August 2014, ZTE had filed for the revocation of IN200572 on grounds of it not being innovative as well as for violating some statutory provisions under Section 64 of the Indian Patents Act.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

Vringo vs. Asus

In April 2014, Vringo filed a patent infringement suit against AsusTek Computer Inc. in Delhi High Court. As per public updates issued by Vringo to its shareholders, Vringo has alleged the infringement of patent IN223183 entitled “Method and system for providing wireless communication using a context for message compression” by Asus in India.

Asus had claimed that in the context of IN 223183 it was using technology licensed to it by Google. In August 2014, Google filed a request to become a party to the proceedings.

Vringo had requested for an injunction on Asus’ use of the technology in India. The injunction has not been granted yet. No further information about the lawsuit is publicly available.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

SYMED Labs vs. Glenmark Pharmaceuticals

In another case of SYMED Labs vs. Glenmark Pharmaceuticals, Symed Labs Ltd. had sued Glenmark Pharmaceuticals Laboratories before the Delhi High Court for allegedly infringing two of its patents: IN213062 & 213063. First patent was granted for “Novel intermediates for Linezolid and related compounds” while the ‘063 patent was granted for “A novel process for the preparation of linezolid and related compounds. While declaring the judgment on 9th Jan 2015, the judge convinced that the Plaintiff has got good prima facie case in favour of SYMED. Further the judge decided that protection to the patent processes ought to be granted to the Plaintiff as damages will not be an efficacious remedy. Thus, there will be irreparable loss and injury because of the long uninterrupted use of patents, the balance of convenience also lies in favour of the Plaintiff. Thus the judge granted an ad interim injunction restraining Glenmark from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Plaintiff’s registered Patents.

Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips

In this litigation case, Sukesh Behl made a counter claim for revocation of the suit Patent No. 218255 under Section 64(1)(m) of the Patents Act, 1970 (for short “the Patents Act”) for non-compliance of the provisions of Section 8. Earlier in another suit Koninklijke Phillips sought for permanent injunction restraining Sukesh Behl from infringing its patent and for other incidental reliefs. While delivering the judgement, the judge answered the question of whether the failure to comply with the requirement of Section 8 of the Patents Act would invariably lead to the revocation of the suit patent under Section 64(1)(m) of the Patents Act, the word “may” employed in Section 64(1) indicates that the provision is directory and raises a presumption that the power of revocation of patents conferred under Section 64(1) is discretionary. Citing Chemtura case, the judge hold that the power to revoke a patent under Section 64(1) is discretionary and consequently it is necessary for the Court to consider the question as to whether the omission on the part of the plaintiff was intentional or whether it was a mere clerical and bonafide error. Finally, the judge dismiss the plea of Sukesh Behl for revocation of said patent under section 64 (1)(m).

Enercon vs. Dr. Aloys Wobben

In this land mark decision, Hon’ble Supreme Court of India addressed the multiplicity of patent proceeding cases with respect to Invalidation, opposition and revocation. Dr.Aloys Wobben has filed around 19 infringement suits before the High Court and Enercon India Limited have filed around 23 “revocation petitions” before the Appellate Board, praying for the revocation of the patents held in the name of the Dr. Wobben. The respondents had also filed “counter claims” to the “patent infringement suits” filed by the appellant.  Even though some revocation petitions have been settled by the IPAB, the same issues were being re-agitated by Enercon before the High Court. The Supreme Court of India following rules – firstly, if “any person interested” has filed proceedings under Section 25(2) of the Patents Act, the same would eclipse all similar rights available to the very same person under Section 64(1) of the Patents Act. This would include the right to file a “revocation petition” in the capacity of “any person interested” (under Section 64(1) of the Patents Act), as also, the right to seek the revocation of a patent in the capacity of a defendant through a “counter-claim” (also under Section 64(1) of the Patents Act). Secondly, if a “revocation petition” is filed by “any person interested” in exercise of the liberty vested in him under Section 64(1) of the Patents Act, prior to the institution of an “infringement suit” against him, he would be disentitled in law from seeking the revocation of the patent (on the basis whereof an “infringement suit” has been filed against him) through a “counter-claim”.  Clearly, this judgement laid a smooth road for complex patent litigation practices in India.

It would be interesting to note the developments that would take place in the Patent protection scenario in India and the gradual increase in the patent litigation cases in India.

About the Author: Mr Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:Sitanshu@khuranaandkhurana.com

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By IIPRD, on April 29, 2015 at 5:30 am, under India, IP Litigation, IP Practice in India, News & Updates, Patent Infringement, Patent Litigation, Patents. Tags: advertising, AsusTek Computer Inc., Chemtura, counter-claim, Department of Industrial Policy and Promotion (DIPP), Enercon India Limited, Enercon vs. Dr. Aloys Wobben, Ericsson vs. Xiaomi, Glenmark Pharmaceuticals, Indacarterol, infringement suit, Linezolid, Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips, manufacturing, Merck vs. Glenmark over “Sitagliptin”, Mi3, Novartis vs. Cipla, Novartis’s “Onbrez”, offering for sale, Qualcomm chips, Redmi Note 4G, Redmi1S, revocation petitions, selling, SYMED, SYMED Labs vs. Glenmark Pharmaceuticals, urgent unmet need, Vringo vs. Asus, Vringo Vs. ZTE, wireless communication using a context message compression, Zita and Zitamet. No Comments

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