India mourns the loss of its former President APJ Abdul Kalam

(October 15, 1931 – July 27, 2015)

The former President of India, Dr. Avul Pakir Jainulabdeen (A P J) Abdul Kalam died of a massive cardiac arrest on the evening of July 27, 2015. He collapsed while delivering a lecture on 'Livable Planet' at Indian Institute of Management, Shillong at around 6.30 p.m. and was rushed to the hospital in a critical condition where he was pronounced dead.

The 11^th President of India  (from 2002 to 2007) was born and raised in Rameswaram, Tamil Nadu. He studied physics and aerospace engineering and began his career in 1960 as a scientist in the Aeronautical Development Establishment of the Defence Research and Development Organization (DRDO).  

In 1969, he joined the Indian Space Research Organisation (ISRO) where he was the project director of India's first Satellite Launch Vehicle (SLV-III) which successfully deployed the satellite, ‘Rohini’, in July 1980. 

Dr. Kalam, during 1970-1990, made a successful effort to develop the Polar Satellite Launching Vehicle (PSLV) and SLV-III projects. He also played a major part in developing many missiles including ‘Agni’, an intermediate range ballistic missile and ‘Prithvi’, the tactical surface-to-surface missile. Thus, he was known as the Missile Man of India. He also played a pivotal role in India's Pokhran-II nuclear tests in 1998.  

In the year 1998, Dr. Kalam along with cardiologist Soma Raju developed a low cost coronary stent, named the "Kalam-Raju Stent". Again in 2012, they designed a rugged tablet computer for health care in rural areas, called "Kalam-Raju Tablet". 

As Chairman of Technology Information, Forecasting and Assessment Council (TIFAC), he led the country with the help of 500 experts to arrive at Technology Vision 2020 for transforming India into a developed nation. Dr. Kalam was responsible for evolving policies, strategies and missions for many development applications and piloted India Millennium Mission 2020. On October 04, 2000, Dr. Kalam, launched Mission REACH (Relevance and Excellence in Achieving new heights in educational institutions) aiming to develop human resources of international standards by imparting high quality education in chosen areas of high relevance to industry and society. 

He always used to encourage young innovators to develop new technologies to remove poverty from the nation. He said: 

“Excellence is not by accident. It is a process, where an individual or organization or nation continuously strives to better oneself” 

Further, an annual national competition, IGNITE is conducted by National Innovation Foundation (NIF)-India inviting students to send their original creative technological ideas and innovations. The results of the winners are announced on October 15, the birthday of Dr. A. P. J. Abdul Kalam and the awards were also distributed by him.  

Dr. Kalam was elected as the President of India in 2002 and returned to his civilian life after serving a term of five years.  

He received several prestigious awards, including the Bharat Ratna (India's highest civilian honor), Von Braun Award, Padma Vibhushan, Padma Bhushan etc. He has also received honorary doctorates from 30 universities.

Maharashtra Government issues Trade Circular Levying Vat on Transfer of Right to Use Trademark

The Commissioner of Sales Tax, Maharashtra on July 13 has issued a trade circular under Section 10(10) of the Maharashtra Value Added Tax Act, 2002 (MVAT Act), according to which Value Added Tax (VAT) can be levied on transfer of right to use goods of intangible nature like trademarks, copyrights and technical know-how, even if such right is transferred to multiple companies.

The said circular has been issued pursuant to the decision of Bombay High Court in the case of Tata Sons Limited and Another v. State of Maharashtra (Writ Petition No. 2818 of 2012) wherein the Court delved into the issue whether the agreement executed by Tata Sons with the Tata Companies providing detailed guidelines for use of the Tata name and trademark will attract tax under Transfer of Right to Use Goods for Any Purposes Act, 1985 (hereinafter referred to as the ‘Act of 1985’).

Brief Facts of the Case and Court’s Judgement in the Case

Facts:

• The Petitioner (Tata Sons) in the year 1998 entered into agreements with multiple companies with a view to systematically develop and enhance the brand equity in the word TATA. By the Agreement, the companies were granted the right to obtain a non-exclusive and non-assignable license to use TATA marks;
• The impugned Agreements entered into by the Petitioner were examined by the Sales Tax Department which concluded that the transaction embodied in the Agreements fell under the purview of the Maharashtra Sales Tax on the Act of 1985 and thereby issued Assessment Notices for levy of sales tax and passed Assessment Order;
• Aggrieved by the aforesaid, the Petitioner filed appeals against the assessment order. However, the appeals were dismissed by the Deputy Commissioner of Sales Tax (Appeals) and the Maharashtra Sales Tax Tribunal;
• Thereafter, the Petitioner filed a writ petition with the Bombay High Court claiming that such an agreement would not attract the law as enumerated under the Act of 1985;

Petitioner’s Contention:

• While advancing its arguments, the Petition heavily relied on the Apex Court’s decision in the case of Bharat Sanchar Nigam Limited v. Union of India & Ors. (2006) STC Vol. 195. and contented that in the said case the Supreme Court considered somewhat identical issues and the Tribunal should have considered the Court’s opinion in the case instead of brushing them aside;
• That the facility and concession given to the use of trademark and the name will not necessarily mean that there is any transfer within the meaning of Act of 1985;
• That the impugned agreement (Brand Equity and Business Promotion Agreement) is an incident of right to use the trademark and is not an agreement for the transfer of trademark;

 Respondent’s Contentions:

• That the Act of 1985 dealt with the right to use any goods and the words “exclusive” and “unconditional” which are being read into this Act by the Petitioner are totally absent therein;
• That if the right to use trademark is transferred then the Act applies and it does not necessarily mean that the trademark is itself transferred or assigned;
• That there could be multiple transfer of right to use and in such circumstances when the Act does not contemplate cession of user by transfer, then levy could not be avoided;

High Court’s Decision and Observations in the case:

• That in case of intangible goods the right to use them is capable of being transferred and if transferred it may be subjected to tax. The Act does not give an indication that right to use the incorporeal right goods should be exclusive transfer in favour of the transferee;
• That the deal or transaction between the Petitioners and the subscribers envisage that a transfer of right to use the goods and which could be said to be the marks as well;
• That upon a conjoint reading of the provisions of the Act, the Court was of the opinion that in case of intangible goods the right to use them is capable of being transferred and if transferred it may be subjected to tax;
• That it is clear from the clauses of the Agreement that proprietor continues to control even the limited right conferred by the clauses in favour of the subscribers;
• That we are of the opinion that so long as the agreement transfers the right to use intangible goods which are the trademark in this case, then there is no question of the petitioners escaping the consequences of the enactment;

Conclusion

In view of the decision of the Bombay High Court the Commissioner of Sales Tax (Maharashtra) has issued the circular clarifying tax imposition on transfer of right to use intangible goods including trademarks, copyrights and technical-know how even when transferred to multiple users.

Supreme Court of India decides on Jurisdiction for filing Trademark and Copyright Cases

On July 01, 2015, the Hon’ble Supreme Court of India gave an authoritative Judgement on the issue territorial jurisdiction for filing of Trademark and Copyright cases. The Supreme Court primarily dealt with the question that in case when the cause of action arises at a place where the Plaintiff has an office (head or subordinate), can they sue in another jurisdiction?

It held that these suits could be instituted only in the District Court that exercised jurisdiction over the place where the cause of action (in whole or in part) arose, if the Plaintiffs instituting the suit had an office in that jurisdiction.

Relevant Law

Under the Code of Civil Procedure (Section 20), a suit can be instituted in a Court within whose territorial jurisdiction the Defendant resides or carries on business or personally works for gain or where the cause of action arose. However, an exception to the normal rule is provided under the Trade Marks Act, 1999 (Section 134) and the Copyright Act, 1957 (Section 62). It provides that ‘District court having jurisdiction’ shall notwithstanding anything contained in the Code of Civil Procedure, 1908 or any other law for time being in force, include a district court within the local limits of whose jurisdiction, at the time of the institution of the suit or other proceeding, the person instituting the suit or proceeding (i.e the Plaintiff) actually and voluntary resides or carries on business or personally works for gain.

The issue of how Plaintiffs have been using (misusing) the provisions under Section 62 and Section 134 of the Copyright Act and the Trade Mark Act respectively has been considered by the Hon’ble Supreme Court.

Brief Facts leading to the present Appeal  

• The Indian Performing Rights Society Ltd. filed a suit for copyright infringement in the Hon’ble Delhi High Court invoking territorial jurisdiction under Section 62 of the Copyright Act, 1957 (“Copyright Act”).
• The Advance Magazine Publishers Inc. filed a suit for trademark infringement under Section134 of the Trade Marks Act, 1999 (“Trade Marks Act”) at the Hon’ble Delhi High Court.
• The objection was raised by the Defendants with regard to the territorial jurisdiction of the Court at Delhi. The Plaintiffs have their principle office at Mumbai and alleged infringement and cause of action also arose in Mumbai, however the suits for infringement were filed in the High Court of Delhi where the Plaintiff companies have their branch office.
• The Learned Single Judge and the Division Bench of the Hon’ble Delhi High Court upheld the objections and held that the suit should have been filed at Mumbai.
• Aggrieved by the decision of the Hon’ble High Court, the present appeal was filed before the Hon’ble Supreme Court of India.

Contention of the Plaintiff

The Plaintiffs contended that under Section 62 of the Copyright Act and Section 134 of the Trade Marks Act , the party instituting the suit has the right to file a suit for infringement of a Copyright or a registered trade mark in any court within whose territorial jurisdiction the filing party (owner of the copyright/registered proprietor/registered user) carries on its business and keeping in mind the fact that the Plaintiffs/Appellants have their regional/branch offices in Delhi, the Hon’ble High Court of Delhi would have the territorial jurisdiction to hear, try and adjudicate the suits.

Contention of the Defendant

The Defendants objected the Plaintiffs’ contention stating that this would be an abuse of the provisions under the aforementioned sections of the two Acts and same cannot be permitted at the hands of the multi-national corporations to harass the Defendants. The Defendants/Respondents relied on Haydon’s rule of mischief.

The said rule directs that the courts must adopt the construction which “shall suppress the mischief and the advance remedy”. In other words, while interpreting a statue, the problem or mischief that the statue was designed to remedy should first be identified and then a construction that suppresses the problem and advances the remedy should be adopted.

Decision of the Supreme Court

The Hon’ble Supreme Court held that:

 “If the interpretation as suggested by the Plaintiffs is accepted, several mischiefs may result, intention is that the Plaintiff should not go to far flung places than that of residence or where he carries on business or works for gain in order to deprive Defendant a remedy and harass him by dragging to a distant place

If such an interpretation is permitted, as rightly submitted on behalf of the Defendants/Respondents, the abuse of the provision will take place. Corporations and big conglomerates etc. might be having several subordinate offices throughout the country.

The avoidance of the counter mischief of the Defendant is also necessary while giving remedy to the Plaintiff under the provisions in question. After discussing the Parliamentary Debate with respect to the provisions in question. The Hon’ble Supreme Court held that the right to remedy given is not unbridled and is subject to the prevention of abuse of the aforesaid provisions, as discusses above. Parliament never intended that the subject provisions to be abused by the Plaintiff by instituting suits in wholly unconnected jurisdiction.”

The Hon’ble Supreme Court also held that there is no doubt that a suit can be filed by the Plaintiff at a place where he is residing or carrying on business or personally works for gain. He need not travel to file a suit to a place where the Defendant is residing or cause of action wholly/partly arises. However, if the Plaintiff carries on business or has his principle place of business or works for gain at a place where cause of action also arose, the Plaintiff has to file the suit at that place and not at its branch office in a different location.

Conclusion

Multi-nationals and Indian Conglomerates alike will have to take into consideration the present Judgement before filing an infringement suit under Sections 62 of the Copyright Act and Section 134 of the Trade Marks Act. The branch office will not give companies territorial jurisdiction and needs to be distinguished from their principle office.

This will put an end to forum shopping where only a few High Court or lower Courts were burdened with IP matters. Further it will speed up and take IP awareness to different areas/cities in India as other courts will also have the benefit of IP litigation and in the long run would result in better understanding of IP laws by the Judges as well as lawyers, thus raising the bar.

Karnataka High Court Gives Safe Landing To Mark “Vistara” For Tata Sia Airlines

In a recent trademark tussle between Vistara Voyages and TATA SIA Airlines concerning the trademark VISTARA, the Karnataka High Court granted relief to TATA SIA Airlines based on jurisdictional issue of filing suit under Section 134 of the Trademark Act in Bengaluru.

Facts of the case:

1.  Vistara Voyages (India) Pvt. Ltd. (hereinafter referred to as the Respondent/ Plaintiff) having its head office in Karnataka, Bengaluru is a travel management company, delivering travelling solutions to its clients.
2. In January 2015, a joint venture of TATA Sons and Singapore Airlines namely M/S TATA SIA Airlines Limited (hereinafter referred to as the Petitioner/ Defendant) launched its airlines in India under the brand name VISTARA;
3. Aggrieved by the adoption of an identical trademark, the Respondent initially filed a suit before the District Judge, Bengaluru for issue of an injunction restraining the Petitioner from using the mark “VISTARA” and claimed damages of Rupees 1 Crore from the Petitioner;

Brief Facts and Findings of the Trial Court

In response to the aforesaid suit filed by the Respondent (Plaintiff), the Petitioner (Defendant) filed an application for rejection of the plaint or return of the plaint for being presented before the Jurisdictional Court on the following grounds:

• That the suit is liable to be dismissed for lack of jurisdiction as the Petitioner (Defendant) was not carrying any business in India;
• That Section 134 of the Trademark Act, 1999 (the Act) does not apply to unregistered trademarks;

Finding of the Trial Court

The Court dismissed the application filed by the Petitioner (Defendant) for rejection of the plaint on the following grounds:

1. That the certificate issued by the Joint Director, District Industrial Centre, Bengaluru indicates that Respondent (Plaintiff) has been permitted to do the activity of travel and forex in Bengaluru and Plaintiff (Respondent) is having an office at Bengaluru;
2. That there is no record placed by the Petitioner (Defendant) to indicate that the Government of India has permitted it to carryout business only in Delhi;
3. That the permission to provide Airport and allied services to domestic passengers includes the entire territory of India;

Aggrieved by the aforesaid order to the Trial Court, the Petitioner (Defendant) filed a writ petition before the Karnataka High Court for quashing of the impugned order.

Contentions forwarded by the Petitioner (Defendant):

1. That no cause of action has arisen within the jurisdiction of this Hon’ble Court and as such the suit was not maintainable before The Civil Court, Bengaluru;
2. That Section 134(1) (4) of Trade Marks Act, 1999 requires that in a suit for passing off the Petitioner (Defendant)  shall be carrying on business at the place of suing and when no cause of action had arisen within the jurisdiction of Civil Court, Bengaluru, suit under the said provision was not maintainable; 
3. That the right flowing from Section 134 (1) (a) & (b) of the Act would be available only to a registered proprietor or registered user and in the present case Respondent’s (Plaintiff) mark Vistara is still pending at the Registry;

Contentions forwarded by the Respondent (Plaintiff):

1. That even if a small part of cause of action accrues the Court will have jurisdiction and cause of action being a bundle of facts would entitle the party to maintain a suit;
2. That in this age of advanced technology people would read newspapers and magazines via internet and the Petitioner’s (Defendant) website which is accessible across the globe entitles the Respondent (Plaintiff) to maintain a suit at Bengaluru;
3. That it is the prior user of the mark VISTARA, as it has been in the business of travel and travel related services since 2008 and has been trading under the mark “Vistara Voyages” and “Vistara”;
4. That on account of being widely publicized, its mark Vistara has acquired a distinctive feature;

That the Petitioner’s (Defendant) use of an identical and similar mark Vistara is bound to create confusion and deception among public who are looking to avail similar set of services;

Observation and Decision of the Hon’ble Court:

In view of the facts and circumstances the Court made its observations and findings on the following issue:

Whether in the present case, the Respondent would be entitled to maintain suit despite the bar prescribed under clauses (a) to (c) of Section 134(1) of the Act?

1. That a plain reading of Section 134 indicates that in an action for infringement of a registered trademark or relating to any right in a registered trademark as the place for suing would be a District Court having jurisdiction and includes the jurisdiction of the Court where the person instituting the suit or proceeding actually and voluntarily resides or carries on business or personally works for gain;
2. The Court also referred to the decision of the Apex Court in the case of K. Narayanan & Ors. v. S. Murali (AIR 2008 SC 3216), wherein the Court held that in order to maintain a suit for infringement of a registered trademark, it would be the District Court where Respondent (Plaintiff) resides or carries on business as indicated under Section 134(2) of the Act. Hence, as on the date of filing of the suit if there is no infringement of a registered trademark it cannot be said that cause of action would be available to file a suit in the District Court where Respondent (Plaintiff) carries on business and such suit would be maintainable;
3. That the Respondent’s (Plaintiff) case would not even fall under Section 134 (1)(c) of the Act to enable the Respondent (Plaintiff) to institute the suit at Civil Court, Bengaluru. Further, the Petitioner (Defendant) is undisputedly having its office at Delhi and has not yet commenced its business operations at Bengaluru and as such the suit in question instituted at Bengaluru ought to be held as premature;
4. That the Petitioner (Defendant) does not reside at Bengaluru, no business is carried at Bengaluru, and no branch of Petitioner (Defendant) is located at Bengaluru. Since, Defendant has not commenced its operations at Bengaluru it cannot be said by Respondent (Plaintiff) that there would be confusion in the mind of public or travelers about the services of the Plaintiff and Defendant being deceptively similar;

In view of the aforesaid, the Court set aside the impugned order of the Trial Court.

The Judgement can be accessed by clicking here

Conclusion:

Jurisdiction constitutes an essential ingredient to claim relief and if the correct forum is not chosen then however reasonable is the claim of the Party it would not be heard adequately as he has not approached the correct forum.

Another point to take home from this judgement is that a registered trade mark gives certain advantages to the proprietor which cannot be claimed when an application is pending, this means that prior use though taken into consideration, the advantages of a registered trade mark are far beyond.

Source of news can be accessed by clicking here

Indian Patent Office refuses to grant Abraxis’ patent on anti-cancer drug ‘Abraxane’ after pre-grant opposition by Natco

                                                

Image source: http://www.pharmafile.com/news/181988/cancer-treatment-abraxane-gets-eu-nod

Date of decision- June 01, 2015

Applicant- M/s Abraxis Bioscience, LLC, USA

Opponent- Natco Pharma Limited, Hyderabad

IN THIS ISSUE

The Assistant Controller of Patents & Designs, on June 01, 2015, refused to grant patent application pertaining to a new composition for Paclitaxel, an anti-cancer drug marketed under the trade name Abraxane by Abraxis, citing lack of novelty and inventive step, in response to a Pre-grant opposition filed by Natco.

The application for Abraxane formulation was refused since it lacks inventive step, and violates Section 3 (d) of the Indian Patents Act -- a provision under which Novartis lost the patent on its blockbuster cancer drug, Glivec in 2013. Section 3(d) - an important safeguard in the patent law specifically applicable for pharma and chemical industries, prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance. 

FACTS

The Applicant had filed Indian Application No.4572/CHENP/2006 on December 14, 2006 entitled ‘Treatment methods utilizing albumin-binding proteins as targets’. The patent application pertains to Abraxane, a composition of paclitaxel coupled to an anti-SPARC antibody with a pharmaceutically acceptable carrier.

The Opponent filed a Pre-grant opposition on September 8, 2008 under section 25(1) of the Indian Patents Act and presented the following arguments: 

OPPONENT’S CONTENTIONS

Obviousness/Lack of Inventive Step (section 25 (1) (e))

     The Opponent submitted that the following features of the present invention are already known in the art and hence the invention lacks inventive step, based on the cited documents:

1. Composition free of cremophor
2. Use of paclitaxel- antibody therapy for targeted, selective delivery and better cytotoxicity;
3. SPARC is a potential marker for such targeted delivery;
4. Affinity of SPARC to bind with albumin;

Section 3(d) and Section 3(e)

The Opponent contented that the present composition is a combination of known substances, namely paclitaxel and anti-SPARC antibody. There is no demonstration of efficacy and thus it fails to qualify as a patentable invention under Section 3(d). Such composition claimed in the impugned application is a mere admixture and not patentable under Section 3(e) of the Act.

APPLICANT’S CONTENTIONS

The Applicant contended that an anti-SPARC antibody is not taught in the prior art. The Applicant argued that Section 3(d) objection is irrelevant for the claims of the instant invention.

CONTROLLER’S DECISION

In light of the above findings, the Assistant Controller, agreeing with the Opponent’s contentions, concluded that the claimed composition is obvious to a person skilled in the art in view of the disclosures cited by the Opponent. The present composition is a combination of known substances, namely paclitaxel and anti-SPARC antibody. The Applicant failed to demonstrate efficacy and thus it fails to qualify as a patentable invention under Section 3(d), hence the application for grant of a patent was refused under section 15 of the Patents Act, 1970.

The Controller’s decision can be accessed on the below link: 

http://ipindiaservices.gov.in/decision/4572-CHENP-2006-10560/4572-chenp-2006%20order-Final.pdf

The European Parliament maintain ‘Status Quo’ of Freedom of Panorama

According to the European Union Parliament Press Release dated June 16, 2015, a Draft Report was to be tabled to discuss whether permission should be obtained from the copyright holder to commercially use images or videos of monuments and sculptures in Europe. Our previous newsletter, titled “New EU Law, A Midsummer Nightmare?” (available here) discussed the issue of Freedom of Panorama in Europe.

Latest Development

On July 9, 2015, European parliament by a non-legislative resolution conclusively rejected the suggestion to limit the right to freely photograph public space. The non-binding resolutions, which assesses the implementation of the key aspects of EU copyright law ahead of upcoming Commission proposal to modernize it, was passed by 445 votes to 65, with 32 abstentions.

The EU parliament decisively removed the controversial proposal to restrict the so-called Freedom of Panorama, the right to use pictures of public buildings and sculptures without restriction, which had previously been inserted by the Legal Affairs Committee.

The EU Parliament Press Release titled “Copyright reform: promote cultural diversity and ensure access to it, say MEPs” was issued soon after the voting on July 9, 2015. The news reads “Concerning the right to create and publish images and photographs of public buildings and art works, MEPs prefer to retain the current situation by rejecting the proposal in the draft resolution that commercial use of such images should require authorisation from the right-holders. Under current EU copyright law, it is possible for member states to insert or not to insert a so-called freedom of panorama clause in their copyright legislation.”

The Next Move

The Parliament is believed to table a proposal by the end of 2015 to modernize EU copyright law to make it fit for the digital age.

Parliament wishes to bring a single European copyright title that would cover the whole of the territory of the EU; review the existing exceptions to copyright laws to better adapt them to the digital environment and examine the application of minimum standards and ensure fair and appropriate remuneration for all categories of right-holders, including with regard to digital distribution of their works, and improve the contractual position of authors and performers in relation to other right-holders and intermediaries.

References

1. http://www.europarl.europa.eu/news/en/news-room/content/20150703IPR73903/html/Copyright-reform-promote-cultural-diversity-and-ensure-access-to-it-say-MEPs
2. http://www.greens-efa.eu/copyright-14332.html
3. https://juliareda.eu/2015/07/eu-parliament-defends-freedom-of-panorama-calls-for-copyright-reform/

'CREATIO' TM, The Fourth Annual Design Competition- Announcement of Winners

As announced earlier, Vidya Darshan Charitable Trust in collaboration with S.S. Rana & Co. organized 'CREATIO' TM (the fourth annual design competition) on the occasion of World Industrial Design Day on June 29, 2015.  Several entries were received from young creators from all over India who took the initiative to create new designs and exhibit their talent through this platform.

Out of the various entries received for the Competition, the two most innovative designs as per our Judge’s panel were as follows:

Winner- 3D Table Clock designed by Mr. Vivek

First Runner Up- Mobile-cum-Pen Stand designed by Mr. Aquiv Hasan   

Our hearty congratulations to the winners and participants of the Competition…!!!

The Prize money and participation certificates are being forwarded to them.

Compulsory License Application filed against AstraZeneca’s "SAXAGLIPTIN"

On June 25, 2015, Lee Pharma Limited has filed an application for the grant of Compulsory License (CL) with Indian Patent Office, Mumbai for manufacturing and selling of the product (compound) called "SAXAGLIPTIN" in India. The product is marketed and sold in India by AstraZeneca AB. It is a dipeptidyl peptidase-4 (DPP4) inhibitor prescribed for the treatment of Type-II diabetes mellitus. 

Lee Pharma Limited is a Hyderabad based company, incorporated in the year 1997 and is involved in research and development, production, distribution, sales, marketing and export of pharmaceutical products, pharmaceutical formulations, intermediates and APIs.

Saxagliptin is protected by Indian Patent No. 206543 titled "A CYCLOPROPYL-FUSED PYRROLIDINE-BASED COMPOUND" which was granted on April 30, 2007 to M/S Bristol-Mayers Squibb Company. It was then transferred/assigned to AstraZeneca AB.

Currently, Saxagliptin is being sold in tablet dosage form as a single active agent under the brand name "ONGLYZA" (strengths 2.5 mg and 5 mg) and also in combination with Metformin under the brand name "KOMBIGLYZE XR" (strengths 5/500 mg and 5/1000 mg). Their current price in India are as shown in below table-

S. No	Brand	Cost per strip	Cost per tablet	Monthly cost
1	ONGLYZA (2.5 mg)	Rs. 605 (14 tablets)	Rs. 43.211	Rs. 1296.42
2	ONGLYZA (5 mg)	Rs. 581 (14 tablets)	Rs. 41.5	Rs. 1245
3	KOMBIGLYZE XR (5/500 and 5/1000 mg)	Rs. 343 (7 tablets)	Rs. 49	Rs. 1470

In its CL application, Lee Pharma stated that it has made sincere efforts to obtain a license and received no response in regard to the same from the patentee. Now Lee Pharma has filed a CL application against AstraZeneca on the following grounds of Section 84 of the Indian Patents Act, namely:-

1. That the reasonable requirements of the public with respect to the patented invention have not been satisfied;
2. That the patented invention is not available to the public at a reasonably affordable price; and    
3. That the patented invention is not worked in the territory of India.

Lee Pharma alleged that: 

1. Even after eight years of grant of patent, Saxagliptin is not been manufactured by the  Bristol-Mayers Squibb or AstraZeneca within the territory of India
2. Saxagliptin and Saxagliptin + Metformin combination is imported in India at a cost as low as less than one Rupee per tablet;
3. However, the same tablet is sold to Indian patients at a price as high as Rs. 41-45 per tablet;
4. Quantity of the imported tablets is too less to meet the requirements of Indian Patients suffering from Type-II Diabetes Mellitus;
5. Whereas, the import of the tablets in India itself is too less to meet the Indian requirements, a majority of the imported medicine is again being exported back to foreign countries making this medicine virtually unavailable to Indian patients.

Further, Lee Pharma proposed the following cost for the said product if CL is granted:

S. No	Product	Strength	Cost per strip (14 tablets)	Cost per tablet
1	Saxagliptin	2.5 mg	Rs. 378	Rs. 27
2	Saxagliptin	5 mg	Rs. 406	Rs. 29
3	Saxagliptin + Metformin XR	5/500 mg	Rs. 210	Rs. 30
4	Saxagliptin + Metformin XR	5/ 1000 mg	Rs. 220.50	Rs. 31.50

To access the CL application, please click here:

http://ssrana.in/News/News%20header/Images/2015-06-25-Application-for-CL-Lee-Pharma-Limited.pdf