Tag Archives: Pharma

Pharmaceutical Patents a Threat to India’s Drug Industry?

The Indian Pharmaceutical industry is one of the largest, ranked fourth in the world in respect to the production volume. Over the last three decades, the industry’s growth has resulted from no existence to a world leader in terms of production of high quality generic drugs.

 Prior to 2005, no patent was granted on medicines in India, which resulted in the growth of the generic drugs manufacturing industry that helped treatment diseases like HIV/AIDS, tuberculosis, cancer, etc. around the world. This made India the prey of the larger pharmaceutical companies like the U.S. and Europe who believed that the patent protection for such drugs is necessary for further innovation.

 As according to Medicines Sans Frontieres (MSF) report, “Sick people around the world depend on Indian producers to manufacture affordable generic versions of new medicines.” This has changed since after India became a signatory to WTO (World Trade Organisation).

Now, a large number of generic drugs are being patented in India including vaccines making it difficult for the industry to produce life-saving medicines. Various patient groups note that India’s ‘strict’ patent regime was one of the reasons why drugs are available at affordable prices in India. Cancer Patients Aid Association (CPAA) Chairman and Chief Executive, Y.K. Sapru quoted, “interventions and patent challenges by patient groups have helped to reduce the prices of many drugs. Still, cancer drugs like Herceptin are available in India only at a very high cost,” he says.

Whole game changed after the judgment was passed in the case of Pfizer Products granting the patent to produce such vaccine until 2026 damaging the country’s drug industry. It gave the company exclusive rights to distribute vaccines in India and blocked the manufacturing of such drug.

Also in the case of Novartis, after losing a 6-year legal battle where the Supreme Court concluded that small changes to its Leukaemia drug, Glivec did not deserve a new patent for the same as it would lead to “ever-greening” of such patents.

 Matthew Rimmer, a professor of Intellectual Property and Innovation at the Queensland University of Technology believes that the Trump Administration is pressuring India about generic drug manufacturing as they have strong views about Intellectual Property and trade.

 The U.S. market is pushing India to play by its rules but India does not want to yield ground to U.S. negotiators. CEO’s like Ian Read and other U.S. – based Pharma majors are worried that India allows the domestic companies to launch cheaper medicines under the clause of “compulsory licensing” under the Patents Act. It is pertinent to note that the U.S. companies call this practice, a patent violation while the Indian government calls it a legitimate right. Before the arrival of the patent regime in 2005, it was easier for Indian pharmaceutical companies to imitate the drugs discovered by MNC’s at a much cheaper price but since the new regime, the Indian companies have to rethink and invest more on Research & Development.

 The question that persists is whether India should change its Patent Policy for Pharma practices in the world market or it should continue with the same approach that is beneficial to a larger section of people who can have access to life saving drugs as well as drugs of huge importance, at much affordable price, which in my opinion is a much larger issue.

Author: Ms. Tushita Dogra, intern at Khurana & Khurana, Advocates and IP Attorneys. Can be reached at swapnils@khuranaandkhurana.com

 References:

[1]http://www.abc.net.au/news/2017-09-28/what-india-pfizer-patent-decision-means-for-region-health/8981206
[2]https://www.usitc.gov/publications/332/EC200705A.pdf
[3]http://www.journals.uchicago.edu/doi/abs/10.1086/596603?journalCode=edcc

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NATCO FILES INDIA’S FIRST COMPULSORY LICENSING APPLICATION

Natco Pharma has filed India’s first Compulsory Licensing (CL) Application (in accordance with Section 84(1) of the Indian Patents Act) against one of the Bayer’s patented drug Sorafenib, marketed by Bayer as Nexavar for treating Kidney and Liver Cancer. Patent on Sorafenib is granted in India on 03.03.2008 having number IN 215758. This will be a landmark development of such licensing in India and being a test case would set a precedent for the forthcoming similar cases. The CL Application is published in the Official Journal of the Indian Patent Office and can be seen here.

Section 84(1) of the Indian Patent’s Act allows any interested person to make an application to the Controller for grant of compulsory license after the expiry of three years from the date of grant of patent on any of the following grounds:

a. that the reasonable requirements of public with respect to the patented invention have not been satisfied

b. that the patented invention is not available to the public at reasonably affordable price,

c. that the patented invention is not worked in India.

As documentary evidence, Natco has presented a number of facts in support of a prima facie case of reasonable requirements of public not being satisfied.

Natco has stated in its CL Application that Sorafenib is not manufactured in India but is being imported and sold by Bayer at an exorbitant price in India. The average price of the treatment with Sorafenib per month per patient is Rs. 2, 80, 428/- and almost out of reach of the public. Round Natco has stressed that they will be able to sell the drug for Rs. 8,880/- per month! Natco has showed that at least 30,000 patients are diagnosed of Liver or Kidney cancer every year in India and out of these 99% of patients are unable to afford the drug and die every year.

Further Natco stated that there is a limited availability of the drug and is available only in metros cities, for example, Delhi, Mumbai, Chennai and Kolkata with an exclusion of second tier and smaller cities. Also the distributors of Sorafenib are only in Delhi, UP, Punjab, Gujarat, West Bengal, Bihar, Kerala and Tamil Nadu. Natco points that it has the distribution network in all almost every city and district of India.

Natco earlier requested Bayer to receive Voluntary License to manufacture and sell the drug in India by writing to them on 06.12.2010. The letter which was submitted along with the Application as an annexure is not available for its analysis. However, it would interesting to note whom the letter was addressed to and by whom was the same replied as the concerned stakeholder to whom a request Voluntary License (VL) was sent could play a role in deciding the reasonable efforts taken by the Applicant to obtain the VL. We believe that the person being contacted should be a person having due authority to take decisions on such matters, be it in the business development team or the Sr. Management team. Contacting any person not having the necessary authority would not add value and would not be construed as making appropriate efforts to obtain a license from the patentee. This however is a general issue and not pertaining to the case in context. Also, as a practice, the request for VL should disclose the proposed terms and conditions by the party trying to obtain the CL, in absence of which, the offer would not be held explicit.

Further, Natco stated in its Application that Bayer refused on 27.12.2010 without any further discussion whatsoever. According to S. 84(6) (iv) which says that one of the factors which Controller will take into account while considering a CL Application is whether the applicant has made efforts to obtain a license from the patentee on reasonable terms and conditions and such efforts have not been successful within six months. Natco’s CL Application was filed on 28th July 2011.

Another important factor which the Controller will take into account while considering a CL Application is the ability and capability of Natco to manufacture and cater to the needs of the entire public. Nacto has stated in the Application that it can manufacture 20,00,000 tablets  a day when there is need of 4,80,000 tablets a month. Natco has asserted that it can manufacture the drug by employing existing facilities without requirement of any additional investment/plant etc. as Natco has been already manufacturing other anti-cancer products for the last 20 years.

Earlier this year, Natco has also sought for a voluntary license from Pfizer to manufacture and sell Pfizer’s HIV drug maraviroc (marketed as Celsentri), the application is still pending. It is much expected that Pfizer will decline to give such license owing to high R&D investments incurred and it is quite likely that another CL Application might be coming from Natco soon.

This application by Natco has already started motivating the pharma companies in India in preparing to file CL Applications against patented drugs by Foreign players in manufacturing and selling their generic versions in India. A few of these drugs might not yet even have been marketed and might be in the clinical phase, wherein  S. 84 (a) (iii) could be a ground of filing CL in those cases namely the non-working of the patent in India. However, how strong such an application would be on grounds of S. 84 (a) (iii) is debatable as the drug itself is in the clinical phase and cannot anyways be worked upon by any company till the time it is registered with the regulatory authority.

A key point being stressed here is that the first CL Application has not even been granted by the Controller as yet and there is a feeling of urgency that is being felt right away in the Indian Pharma community to file multiple CL’s as possible. I wonder how Natco’c victory in this case could motivate the Indian generic industry to go ahead with the compulsory licensing. However, it is foreseen that the outcome and the ultimate result of this CL will be long awaited owing to the expected court battle between the two as the losing party is likely to challenge the decision. One thing is for sure, grant of the CL to Natco will motivate a large number of Indian pharma players to apply for the same against costly patented drugs (being sold by big Foreign players) mainly on price affordability ground as the Government in many of Indian pharma patent battles has already seemed to be inclined in favor of the generic companies selling cheaper drugs in public interest.

About the Author: Ms. Meenakshi Khurana, Patent Specialist at Khurana & Khurana and can be reached at: meenakshi@khuranaandkhurana.com

 

Anti Cancer drug: Making it Patient-driven, not Disease-driven

Introduction:

French compatriots Ipsen and bioMérieux, have been few most potential companies, since 2007 in the development of companion assay to assess patient benefit from a compound useful for treating several severe forms of cancers.Partnership between two companies has focused on the two main broad areas of pharma research: Personalized medicine and Theronostics. Personalized medicine basically emphasizes the customization of healthcare, with all decisions and practices being tailored to individual patients in whatever ways possible. It involves the systematic use of genetic or other information about an individual patient to select or optimize that patient’s preventative and therapeutic care.

While theranostics involves the development of innovative therapeutic agents such as with diagnostic companion tests—may be the key to improve treatment efficacy and safety through the identification of potential responding patients. This method is looked upon as the possible end result of new advances made in Pharmacogenomics, Drug Discovery using Genetics, Molecular Biology and Microarray chips technology whereby it accelerates time-to-market of new compounds through an improved selection of patients enrolled in clinical trials. This in turn helps addressing the global challenge of R&D productivity, as stated by the companies.

Member’s Views:

Prof. Christian Bréchot, vice president of bioMérieux and a member of bioMérieux’s board have addressed: “Our goal is to reinforce personalized medicine and contribute through this partnership to the novel paradigm in medicine, which is increasingly ‘patient-driven,’ rather than ‘disease-driven,’”. The partners plan to achieve this paradigm shift in patient’s treatment by combining Ipsen’s compound portfolio and bioMérieux’s diagnostic tests. For the last three years, Ipsen and bioMÈrieux have been developing a companion assay to determine the patients best suited to benefit from BN83495 (Irosustat), Ipsen’s steroid sulfatase enzyme (STS) inhibitor compound, currently in Phase I clinical development for the treatment of breast and prostate cancers, and in Phase II for the treatment of advanced endometrial cancer.

“The STS mRNA NASBA assay has been successfully developed and is currently used ad-hoc in our oncology clinical trials, even though we now know that STS mRNA levels are not predictive of STS enzymatic inhibition, and hence cannot be developed as an efficacy biomarker,” says Didier Véron, Ipsen’s general manager.

Hence, for the purpose of this newly established collaboration, both companies will jointly identify programs and measures that would benefit from the co-development of a therapeutic and a companion diagnostic test, in the prevention and treatment of prostate and breast cancers, neuroendocrine tumors and pituitary tumors.

“At this stage,” Véron explains, “the agreement between our two companies is a framework contract that sets a common governance to analyze areas of cooperation. Specific agreements will be signed on a project-by-project basis, and those will focus on medical, scientific, financial and regulatory issues. Although the partnership agreement covers our overall pipeline, a particular focus was given to the areas that are more relevant for personalized medicine.”

As already extensive research work has been conducted for development of companion diagnostic tests and innovative compounds, it is believed that the partners (companies) might produce an early clinical proof of concept and also would be able to support the registration of Ipsen clinical drug candidates.

As per Veron, “There is strong scientific evidence that in many diseases, physiopathological processes, as well as response to treatments, are determined by genetics. This is particularly true in oncology, where the identification of relevant biomarkers is key in predicting patient response and monitoring their treatments,”

About the companies:

Ipsen, being a global biopharmaceutical group with a worldwide staff of more than 4,400 employees, is focused on the development of primary care drugs as well as specialty care drugs in oncology, endocrinology, neurology and hematology. Drug market analysis has shown that Ipsen’s sale exceeded $1.4 billion in 2009. On the same line of context, bioMérieux, a leading pharma company for more than 45 years in the field of in-vitro diagnostics, extends more than 150 countries through 39 subsidiaries and a large network of distributors. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. The company has stated that it is committed to making personalized medicine a reality by building partnerships to develop theranostics for infectious diseases, cancer and cardiovascular diseases. bioMérieux revenues reached $1.9 billion in 2010.

Conclusion:

Looking into the current scenario of various cancers, its chemical, biological/genetical cause and therapeutic measures, it is observed that companies are extensively involved in research in developing both personalized medicines and theranostics. This concept in therapeutic step has proved to be a more efficient measure in treating cancers like prostate cancer, breast cancer, endometrial cancer etc which involves basically a combinational or companion assay wherein the patient receives the therapeutic effect of two potential drugs with minimal side effects, and capable of fighting against the disease/cancer more effectively in less time. Hence, the joint collaboration of such two potential companies for adapting this kind of cancer therapy has proved to be a successful approach in the fields of pharmacogenetics.

About the Author:- Ms. Minusmita Ray, a Patent Specialist in IIPRD and can be reached at minusmita@iiprd.com

Roche’s Struggle Over its Patents in India – Two suits, Two oppositions

The struggle between innovator pharmaceutical companies (mostly in the Western world) and developing world Generic companies has been lately played out in India and especially for the last 2-3 years in the form of litigations and oppositions. Here I would be discussing the specific case of Roche (a Swiss Pharma Company) showcasing its journey of wins and loses over its patents and the discussion over the emerging issues in India.

Roche and Wockhardt – Roche got its first product patent in India in 2006 (and in return India got its first pharma product patent since its amended patent regime came into being) for Hepatitis Drug Pegasys. (Pegylated interferon alfa-2a). Its first and forthcoming patents all were being attacked by Indian Generics (not to forget various NGOs) whether through series of oppositions filed or counter attacking to Roche’s suits of infringement. Its struggle over its patents started in 2007, when India’s first post grant opposition was filed by Wockhardt and a Mumbai based NGO for “IN198952” on Pegasys attacking its validity claiming it to be non-inventive and not satisfying Section 3d (the section which has become the most controversial sections of Indian Patent Act since Novartis attacked its constitutionality in the famous Novartis Gleevec Case, an appeal is still pending in the Supreme Court).  That was the time (and the only time) when Roche could taste success with its patent by defending it successfully. Interestingly, Assistant Controller T.V. Madhusudan (in March 2009) ruled against the recommendation of Opposition Board to revoke the patent and held the patent to be valid. Roche successfully cleared the “enhanced efficacy” test in the Section 3d of the Indian Patent Act (including the novelty and obviousness tests). Section 3d allows a novel derivative of a known compound only when such derivative shows enhancement in known efficacy of a known compound. The efficacy is defined as therapeutic efficacy as per Madras High Court decision in Novartis Gleevec Case. Well, Interferon is known compound and known efficacy is its antiviral and anti proliferative activity and the experimental results in the patent showed that there is indeed enhancement of therapeutic efficacy which resulted in Roche’s victory. The complete decision could be read here:

Roche and Cipla – After Roche’s successful stint at winning Pegasys’ patent in the opposition proceeding, it faced the first blow to its Patent Rights for Tarceva, an anti-cancer drug. Roche sued Cipla before Delhi High Court claiming that Cipla’s generic product Erlocip violates former’s Indian Patent IN196774 claiming “Erlotinib Hydrocloride”. The trial Judge held against Roche on the ground of “public interest”, rejecting Roche’s appeal to grant interim injunction restraining Cipla from selling generic version of Tarcev as Cipla’s drug costs about 1/3rd of Roche’s patented drug. Roche’s subsequent appeal to Division Bench also failed miserably 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) which was specifically on Polymorph B of Erlotinib Hydrocloride (‘507 application was rejected in 2008 following the opposition filed by Cipla primarily on Section 3d. Cipla argued that Tarceva corresponds to Polymorphic Form B of active ingredient Erlotinib Hydrocloride (claimed in ‘774 patent) 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. The interesting part was that the claims were not even construed during the trial even once. Roche’s subsequent appeal before the Supreme Court (SC) challenging the order passed by the division bench got dismissed on August 29, 2009. Key reason for the dismissal was the ongoing trial at the Delhi High Court and SC ordered the ongoing trial be expedited.

Roche and Natco – While Roche’s fight for Tarceva over Cipla’s Erlocip was still continuing at the Delhi High Court, Roche brought another suit of infringement against Natco Pharma for infringing the same Tarceva Patent (‘774 patent). The issues pertaining to:

– drug pricing and public interest (the price of Natco’s drug “Erlonat” is equally low),

– interim injunction rejection (in Roche v Cipla) as a precedent,

– Natco’s filing of Compulsory license for the same patent (Natco earlier filed for the pre grant opposition for the same patent attacking its validity and later seeking to get compulsory license to produce generic version of the drug and export to Nepal),

– the selection patent application ‘507 later filed in India specifically pertaining to Polymorph B and suppression of material patent information.

All these are core issues (some of them were being discussed in Cipla too) which are being argued in the ongoing trial. Natco argued and proved by showing X-ray diffraction data that Tarceva is actually Polymorph B form of the compound claimed in suit patent ‘774, and that the Form B is claimed in ‘507 and not in the patent of question thus there could be no question of infringement. The Court will be hearing the Roche v Natco matter on a daily basis from July 27, 2010 onwards.

Roche and Ranbaxy plus others Roche got another blow meanwhile (in April 2010) when it lost patent rights (IN207232) over its anti-viral drug Valcyte (Valgancyclovir Hydrochloride), following the post grant opposition filed by Ranbaxy, Cipla and four other parties including Pharma companies and Indian NGOs. Valcyte is L-valine ester prodrug of known anti-viral drug “Gancyclvoir”. The patent was rejected primarily on grounds of lack of inventive step over US patent US 4957924 which claims L- valine ester prodrug of structurally similar nucleoside analogue and an anti-viral drug “Acyclovir” with improved oral bioavailability and is marketed as a hydrochloride (HCl) salt of said L-valine ester as Valacyclvoir Hydrochloride. It was argued that a person skilled in the art would be motivated to follow the same route to improve the oral bioavailability of Gancyclovir by forming its L-Valine ester prodrug and forming HCl salt of said ester with reasonable expectation of success. As regarding Section 3d here, it was held that increase in oral bioavailability is not an increase in therapeutic efficacy as both prodrug and the original drug are same classes of anti viral drugs and achieve the same therapeutically. The complete decision could be read here.

Key issues emerged

  • Interpretation of the controversial Section 3d: The section 3d is under debate for quite some time now ever since the Novartis Gleevec case took off in India and its interpretation in the Madras High Court. The Court in the same case interpreted “efficacy” as “therapeutic efficacy” only and not in terms of enhancement in bioavailability or other pharmacological parameters. This ruling has been followed since then and the cases that follow and the cases we discussed above. The major issue revolving around is the lack of any quatifier for the term “efficacy” which makes the section open ended to be interpreted by courts at their own discretion.
  • There should be a detailed analysis on the claim construction in such cases. The claims were not construed in the Cipla Tarceva case. The Indian Judges seem to lack technical know-how in pharmaceutical sciences and the various complexities involved. Having more resources and training could go a long way!
  • Public Interest issue: In developing Countries like India, the issues like drug price and drug affordability make it unlikely that they will be able to resist pressure from their own citizens in favor of multinational drug companies like Roche. TRIPS intented to benefit both innovator and generic industries and both developed and developing nations , the balance seems to be little tilted towards the generic pharma world as pricing issue takes priority in most of the cases as discussed above
  • Setback for innovation and R &D: The developed (innovator) industry should formulate some strategy for designing around drug prices in developing countries so that rewards for millions of dollars spent on research and innovation do not get diluted.

It is to be seen now when Roche’s wait for the verdict of the ongoing trials would be over and how it would affect its future business and patenting scenario in India.

About the Author: Ms. Meenakshi Khurana, a Patent Specialist in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: meenakshi@iiprd.com.

EMERGING IP LANDSCAPE FOR GENERIC PHARMA COMPANIES: A CASE STUDY

IP Issues that concern generic pharma companies generally center on ANDA filing, Patent Litigation, Patent Outlicensing and Brand Acquisitions. It has been very rare for an Indian generic player to be involved into all the four aspects in a single case involving a common drug molecule. One such case with India headquartered Sun Pharma as the ANDA Filer and Key Litigator has been taken as the subject matter for the current study.

Sun Pharmaceuticals Ltd, a leading India-based global pharmaceutical company with interests in the cardiology, psychiatry, neurology, gastroenterology, diabetology and respiratory disease segments has been very active in building and enforcing an exhaustive patent portfolio. Sun has also been one of the early Indian players to take on with the Big Pharma on issues of ANDA Para IV and gaining exclusive marketing rights into US geographies.

Facts of the Case

As a part of its global business strategy Sun acquired US-based Caraco Pharmaceutical Laboratories in 1996. In March 2006, Caraco filed an Abbreviated New Drug Application (ANDA No. 78-219) with FDA seeking a generic approval for escitalopram oxalate in March 2006. Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is indicated for adults with major depressive disorder, generalized anxiety disorder, social anxiety disorder, or panic disorder and was developed by Danish pharmaceutical firm Lundbeck. Forest Laboratories, which also co-developed the molecule with Lundbeck, was assigned the exclusive license to manufacture and market the escitalopram oxalate based commercial brand, Lexapro.

Litigation

In reply to Caraco’s ANDA application, Lundbeck and Forest Labs jointly initiated a legal action against Caraco and on July 10, 2006 filed a patent infringement lawsuit at United States District Court Eastern District of Michigan alleging that Caraco’s ANDA products would infringe their patents covering escitalopram. The Orange Book lists three patents – US 6916941, US 7420069, and RE34712 – for escitalopram and Lundbeck’s and Forest’s assertion was that Caraco has to prove that its product would not infringe any of its 3 patents.

On February 20, 2007, Caraco filed a declaratory judgment action against Forest and Lundbeck seeking a declaration that Caraco’s ANDA Products will not infringe the ‘069 and the ‘941 patent.

Out-of-Court Settlement

Before the court could decide on the matter, the three companies reached a mutually agreed settlement in July 2009. The major provisions under this settlement were:

  • Sun Pharma would give a global license to Lundbeck for the former’s patent applications related to escitalopram in return to a one-time upfront payment and if the Sun’s technology is used in any marketed product by Lundbeck, a royalty on sales would also be paid to Sun.
  • Forest would provide licenses to Caraco for any patents related to Lexapro and with respect to the marketing of Caraco’s generic version of the product as of the date that any third party generic that has received final approval from the FDA enters the market other than an authorized generic or the first filer with Hatch-Waxman related exclusivity.
  • Caraco would take over the commercialization and sales of several products from Forest’s Inwood business. Caraco would pay Forest an undisclosed advance against royalties and royalties on net sales of these products.
  • Forest would reimburse Caraco for a portion of their costs related to this litigation.

Analysis

The terms and conditions for the settlement clearly indicate that the innovator companies could foresee the impact that the litigation could have on their revenues and goodwill. It also signifies the growing clout of mid level generic players who are now getting into a position to dictate their terms and conditions and getting an upper hand during such settlements. In the current case, Sun Pharma, through its US Subsidiary, Caraco Pharma Lab, was not only able to avoid a huge litigation cost but, through licensing and commercializing clauses, made the most out of the situation.

Conclusively, IP Litigation can not be taken to separate from other Business related Strategy. As is established from the current case, a sound strategy during following up an ANDA litigation can bring benefits for the Company that might not be exactly from the IP realm but goes much beyond it to cover Product and Brand Acquisition.

Latest Developments

  • In October 2009, Caraco closed an asset purchase agreement with Forest Laboratories to acquire several products from Forest’s Inwood line of business.
  • Sun Pharma received a one-time receipt of US $20mn from Forest Lab as a part of the Lexapro settlement.

About the Author: Mr. Abhishek Sahay, a Senior Patent Consultant in Institute of Intellectual Property Research & Development (IIPRD) and can be reached:  abhishek@iiprd.com.

Indian Pharmaceutical Industry Licensing Deals: Case Studies

  • Glenmark Pharmaceuticals

Glenmark, research-driven, global, integrated pharmaceutical company with Research Focus on Inflammatory Diseases, Metabolic Disorders and Pain has a presence in over 80 countries around the world.

The Company has a proven track record of entering into Licensing deals with Big Pharma and entered into Outlicensing deals in 2004 with Forest laboratories for Oglemilast, a drug that was potentially indicated for chronic obstructive pulmonary disorder (COPD) and asthma and was still in the Development Phase at the time of entering into the deal. The potential value of the deal was $ 190 million in US. Glenmark later entered into an agreement with Teijin Pharma Ltd in Japan for the same molecule where the deal value was $53 million. Till date, Glenmark has received $35 million from Forest and $6 million from Teijin.

In a case of In-licensing, Glenmark announced in 2005 a collaborative agreement with Napo Pharmaceuticals for Napo’s proprietary molecule Crofelemer, indicated for four distinct disease categories. Glenmark has Crofelemer rights for diarrhea Indications in 140 Countries. Currently the drug is into the Phase 3 trial and the product launch is expected to happen sometime in mid-2010.

Glenmark entered into an outlicensing agreement with Merck in 2006 for Melogliptin, an anti diabetes target. Glenmark received $ 31 million as upfront payment for the same. But, in an unfortunate development Merck decided to drop off the agreement due to a shift from the focus on anti diabetes segment (2008). Currently, Glenmark is developing the drug on its own and have completed the Phase IIb trials.

In 2007, Glenmark’s in-house developed molecule for a potential treatment of pain was outlicensed to Eli Lilly for an upfront payment of $ 45 million. Only a year after the deal, work on the clinical trial of the molecule was stalled. Both Glenmark & Eli Lilly are currently working on the way forward on the molecule.

Despite suffering setbacks from 2 out of 3 key licensing deals, spirits at Glenmark are high, courtesy the success it is enjoying in the Generics segment. Only last week, Glenmark Generics ltd, was able to ink 3 key agreements that has not only strengthened its position in the global generics market but also established Glenmark as an aggressive player that knows how to make maximum from an opportunity.

Following two patent law suits filed by Glenmark, Medicis Pharmaceutical came to an agreement with Glenmark to let the latter launch the former’s dermatological product Vanos in 2013, long before the patent is set to expire in 2023. In a separate arrangement, Glenmark and Medicis have agreed to jointly develop a product from the former’s pipeline to treat acne. Glenmark is to receive an upfront of $5 million from Medicis. Apart from this, Glenmark had entered into a licensing deal with Sanofi-Aventis for the development and commercialization of novel molecules to treat chronic pain. It has also announced a licensing deal with Par Pharmaceutical to market Ezetimibe tablets.

Very clearly, Glenmark’s business model involve a lot of in-licensing and out-licensing arrangements and the Company wish to ride upon the success of such deals to project itself as an innovation driven global pharmaceutical player. Add to it the rapidly rising of clout of Glenmark in Generics space and its deal-signing spree with pharma majors and it is not difficult to understand on why Glenmark is set to make its mark in the Global Pharmaceutical domain.

  • Dr Reddy’s Laboratories

Dr Reddy’s has been a frontrunner in many aspects of the Indian Pharmaceutical Industry Growth Story that has been witnessed by the globe. Licensing is one of such aspect. In fact, even during the times when India had just opened its gate to a global economy, Dr Reddy’s had inked its first Outlicensing deal.

In 1997, an in-house developed anti-diabetic molecule, DRF 2593 (Balaglitazone), was licensed to Novo Nordisk. In fact, with this deal Reddy’s became the first Indian pharmaceutical company to out-license an original molecule. But, late in 2004, after phase II studies, Novo Nordisk decided to terminate further clinical development of balaglitazone, as the phase II results did not suggest a sufficient competitive advantage for balaglitazone compared to existing products. Post this development, Dr Reddy’s entered into an agreement with Rheoscience for Balaglitazone (DRF 2593). As on January 2010, Blaglitazone (DRF 2593) Phase III clinical trials were announced.

A year later, Dr Reddy’s licensed another anti-diabetic molecule, DRF 2725 (Ragaglitazar), to Novo Nordisk. In 2003, Novo Nordisk, which had suspended trials on Ragaglitazar in 1999 on finding tumors in long-term animal studies, decided to terminate further trials on the molecule completely.

In 2001, Dr Reddy’s Out-licensed DRF 4158, a potential dual-acting insulin sensitizer, to Novartis for an upfront payment of US $55 million. Later in 2003, Novartis decided to discontinue working on DRF 4158, but continued collaborating with Reddy’s for additional development compound that is a dual-acting insulin sensitizer.

Despite a low success rate from its licensing deals, Dr Reddy’s went ahead with one of its molecule and despite criticism from its original licensing partner, Reddy’s now have successfully completed Phase III trials of the same molecule. This clearly depicts the conviction and faith in one’s abilities that Dr Reddy’s has demonstrated for its first in-house developed drug molecule. This in itself stands as a testimony to Dr Reddy’s capabilities to mark new beginnings for Indian Pharma Sector.

About the Author: Mr. Abhishek Sahay is a Senior Patent Consultant at Institute of Intellectual Property Research & Development (IIPRD). Currently, He is working on Patent Licensing Issues in the Life Sciences domain and some of his success stories can be found at http://iiprd.com. He can be reached at abhishek@iiprd.com.