Category Archives: Pharma- biotech- Patent Commercialisation

Blogs in this Category would include all Patent commercialisation’s in Pharmaceutical/Bio tech Domain with focus on IIPRD’s analysis and key take away strategies.

The Nagoya Protocol – Convention on Biological Diversity

A new international treaty named the “Nagoya Protocol” will be giving some relief to India and other developing countries. The Nagoya Protocol on Access to Genetic Resources with an objective of ensuring access of genetic resources to the signatory countries and ensuring fair and equitable sharing of benefit to the local community and signatory country that provides genetic resources is a supplementary agreement to the Convention of Biological Diversity. The protocol singed in Nagoya, Japan on 29th Oct 2010 having 50 signatory states (ratification by 50 countries being the threshold requirement) as on today is all set to come in force on 12 Oct 2014.

Let’s look at the different perspective of The Nagoya Protocol and how it would help the providers (country)/ local community, sourcing country and users in the coming days after its implementation.

BACKGROUND

It all started in June 1992, when Convention on Biological Diversity (CBD) was opened for signature. CBDs inspiration came from the world’s community growing commitment to sustainable development.

Genetic resources are the heritable characteristics of a plant or animal of real or potential benefit to people. The core idea of CBD is to allow its members to get easy access to genetic resources (GR) and provide an equitable share of derived profit to the sourcing country/ local community and to the people who have helped to grow and protect the genetic resources.  The Nagoya Protocol was adopted after nearly six years of negotiations to provide a legal framework which will create transparency for both the country (provider) and users of genetic resources by establishing a unified system for allowing access to genetic resources, stopping illegal international trade of GR and by creating a equitable sharing model wherein both the user and provider can acquire equal benefits.

The Protocol has three main objectives i.e. access, benefit- sharing and compliance which lets the users and provider to establish more predictable conditions about usage of genetic resources, and ensure that only legally acquired genetic resources are used.

Now for these above conditions to lay down in an appropriate manner a unified protocol system was required. The protocol should find a practical way in order to share these benefits since until now the lack of a coherent global standard has resulted in a high level of mistrust and obstacles to biodiversity research and its potentially valuable outcomes.

Parameters under which the Protocol gets Applied

The Protocol will be applied only when genetic resources pathogens are ‘accessed’ and ‘used’. Under the Protocol, the term ‘used’ also means to include research and development work on the genetic and/ or biochemical composition of genetic resources. In addition to genetic resources in its original form, the protocol also covers traditional knowledge (TK) associated with genetic resources. On the other hand the protocol does not apply to genetic resources covered by benefit-sharing agreements and specialised access such as the International Treaty on Plant Genetic Resources for Food and Agriculture, or the framework for pandemic preparedness of the World Health Organisation. Also it will not be applied to human genetic material, or to resources that were acquired before the Protocol comes into practise.

Ratification of Nagoya Protocol by India

India and other developing countries with biological diversity and natural resources will be benefited by commercial use of these resources. India lead group of nations for over two decades in UN negotiation to get the other developed countries signed the Nagoya Protocol in 2011 and the Union Cabinet ratified it in 2012. India is one of the mega diverse countries rich in biodiversity and traditional knowledge is expected to get maximum benefits as this protocol gets implemented this October.

It has also been seen that our country has been a regular victim of misappropriation of our genetic resources and associated traditional knowledge, which have been patented in other countries (well known examples include haldi and neem). It is expected that the Access Sharing and Benefit (ABS) Protocol which is a key missing pillar of the CBD, would rectify this problem.

Who will Be Affected

A myriad of industries globally are likely to get benefited due to easy access of genetic resources and associated traditional knowledge that was kept protected by the local community and was hard to procure in absence any established protocol. Because of the transparent, fair and equitable sharing of benefits derived from commercial/R&D use of genetic resources, the local community or provider country would be motivated to offer their natural/genetic resources, and tradition knowledge to industry. However companies in the pharmaceutical industry, agriculture space, and FMCG/CPG are likely to get impacted due to the profit sharing clause of the protocol and will have to carefully evaluate their long term sourcing strategies, new product launches, brand positioning etc since they would be expected to share their profits with local communities for not only using the original resource, but also for any derivative products developed from it.

Intellectual Property Rights (IPR’s)

As the genetic resources and traditional knowledge is transfers from provider country to the user (industry), property rights including intellectual property rights (IPR), are the most relevant critical factors in the access and benefit sharing of genetic resources (ABS) concept. There are two possibilities that exist for strengthening the property rights of resource managers. On the one hand, national governments can ensure that the local level participates in the property rights over biodiversity and the benefits that arise from their use. On the other hand, international and national patent law requires the disclosure of the origin of genetic resources when IPR’s are granted.

It is hoped that the Nagoya Protocol would address the imbalance arising from property rights distribution. The Protocol has strengthened the local level by asking the parties to take legislative, administrative or policy measures to ensure that benefits arising from the utilization of genetic resources that are held by indigenous and local communities are shared in a fair and equitable way with the communities concerned.

High Level observation

The industries that could get major impacted are Pharmaceutical Industries, Health Care Products and its various verticals, fast moving consumer foods (FMCG)/ Consumer Packaged Goods (CPG), Agriculture Products, Non-Commercial Research, and chemical industries etc.

It will also definitely provide the R&D sector with the certainty they need to invest in biodiversity-based research. Further the Indigenous and local communities may receive benefits through a strong legal system that respects the value of traditional knowledge associated with genetic resources.

Also the provider (country) of genetic resources is obliged to receive either monetary or non-monetary benefits which will include a portion of the total revenue generated from the sales of the final product by user from the source (within that country/ region) to the end used. Examples of the monetary and non-monetary benefits include Up-front payments; Payment of royalties; Joint ownership of relevant intellectual property rights; Transfer of technology and expertise etc.

The exploitation of natural resources and small-scale players (farmers) is expected to decrease, and key constituents within the supply chain are likely to obtain higher benefits with the implementation of the Nagoya Protocol.

On the other hand some of the drawbacks associated with this system will be with respect to ownership of patents since with the implementation of new rules and standards set up by various bodies including CBD, ownership of patents could become a serious threat. Also, problems associated with multiple patent ownership can erupt, because of a benefit-sharing scheme.

Companies might  have to look up for  alternative strategies of usage of genetic resources to ensure that it should not fall within the framework of the Nagoya Protocol and also assess the criteria on new product development costs and strategies surrounding it.

As the organizations are required to provide benefits to the provider country, the organizations may increase the market prizes of the products obtained from genetic resources in order to sustain higher profit percentage with shrinking operating margins. Further there will also be an increase in the timeline involved for product development because of various documentations and approvals required to source the products.

Though protocol in its essence has lot to offer, both to the provider and user, its enforceability and compliance may be a real challenge because of the complexity evolved in identifying the amount of profit to be shared, identification of beneficiaries, procedural requirements, technology transfer issues and overlapping property rights.  It is yet to be seen how the signatory countries establishes the procedures and comply with the articles of the protocol.

About the Author: Ms Sugandhika Mehta, Patent Associate at Khurana & Khurana and can be reached at:  sugandhika@khuranaandkhurana.com.

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Two-Days International Symposium on Strategies for Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios

We are happy to inform you all that IIPRD and Khurana & Khurana, in association with Cantor Colburn (US) and Fukami Patent Office (Japan) are holding an International Patent Symposium covering all major and relevant Pharmaceutical/Biotechnology Related Patent issues in the month of February, 2014 in India. The Two-Days International Symposium would be covering Strategies for Managing Pharma, Biotech & Chemical Patent Portfolios in US, Japan & India and is being held from 3′rd-4’th February 2014 at Hotel Hilton, Mumbai and 5’th-6’th February 2014 at The Gateway Hotel Ummed, Ahmedabad.

Symposium February 2014

About the Speakers: The speakers are a unique gathering of Patent Attorneys, Legal Counsels, who have extensive years of experience in their professional fields. These Speakers will put across to the delegates a real insight of Patent Laws & Practices, and Commercial perspectives as prevalent and practiced in Japan, United States, and India. The speakers include:

  • Mr. Michael Cantor, Co-Managing Partner at Cantor Colburn LLP, USA
  • Mr. Steven M. Coyle, Partner at Cantor Colburn LLP, USA
  • Mr. Jeffery Arnold, Partner at Cantor Colburn LLP, USA
  • Ms. Leslie-Anne Maxwell, Ph.D. , Counsel at Cantor Colburn LLP, USA
  • Mr. David E. Rodrigues, Ph.D., Partner at Cantor Colburn LLP, USA
  • Dr. Toshio Nakamura, Patent Attorney at Fukami Patent Office, Japan
  • Mr. Tarun Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys, India.

Please see the complete details including Program Schedule, Topics, Speakers Profiles etc. in a brochure available over here .

If you wish to attend the symposium, please send your nominations to iiprd@iiprd.com.

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

 

INVENTORS, ALL TECHNOLOGIES AREN’T WORTH BILLIONS

Working in the IP/Technology Commercialization and Out-Licensing domain makes you assess and evaluate commercial viability of numerous IP backed inventions across technology domains.  Apart from learning about and assessing new technologies, we also tend to learn quite of lot about Inventors mindset, specifically about their perspective of their own inventions. This article relates to our experiences in dealing with some of such Inventors and/or Applicants and making a humble submission to them to analyze their own work, not only from a technology point of view, but more important from a commercial viability and marketability perspective before initiating their research and investing in protecting IP relating thereto. It would be appreciated that the below comments are not being generalized in any manner and that these are only Author’s views based on his own interactions with Clients.

We understand from our Associates in Israel and some European Countries including Denmark, that there are hardly any patents filed in these countries without proper due-diligence on the future return on investment on the patent and without some of kind tie-up already having being done for commercialization or Out-Licensing of the technology. In India, a land where there exists a mandatory requirement for submission of details on working of the invention by the Patentee, where there are numerous agencies supporting technology transfer and commercialization, there exists no such practice, and in fact far from out, to my knowledge there wont be even .01% of patents being granted to Indian Applicants, that would ever see light of the day.

Although, a partial reason for such a low rate of successful commercialization and Out-Licensing could be the mentality of Indian Corporates not to invest in new technologies, not to consider innovation as an integral part of a company, not appreciating Intellectual Properties and enforceable rights given thereby, to have a practice of designing around technologies to avoid infringement, to have an impression of the Courts being slow in granting damages, among many other reasons.  In addition, sections such as Sec. 111 (1) of the Indian Patent Act, which state that “In suit for infringement of a patent, damages or account of profits shall not be granted against a defendant who proves that at the date of infringement he was not aware and had no reasonable grounds for believing that the patent existed.”, really boost up the confidence of Legal Entities not to In-license or buys strong IP’s as reports such as freedom to operate can come to rescue. Having personally seen literal infringers get away from any civil damages under the protection of this clause and the plaintiff’s merely getting injunction granted to them, reinforces this thought of how successful Licensing Efforts can be in India. Anyhow, this article does not even pertain to Licensees or hurdles present in the systems per se, but rather relates to Licensors and their approach towards commercialization.

Hundreds of patent applications across technology domains are filed every month, with a number of them being from Individual Inventors and Research Institutes. Having said so, as individual inventors and R&D entities, most of the times have limited resources for commercialization of their technologies, including but not limited to manufacturing and marketing capabilities, they look out to Out-License or sell the patent right either before or after the grant of the patent. Further, as even Licensing needs dedicated efforts, strong potential licensee analysis, marketing strengths, and convincing capabilities, a number of times Licensing firms are chosen to represent such patented technologies and approach appropriate licensees and understand their interest levels in the technology before proceeding for discussions on terms and conditions for licenses and valuing the technology for the same. As most of the times, such Licensing efforts are taken on success basis, it becomes crucial for the licensing firms to assess and evaluate commercial strength of the patent and the technology protected there through before committing to proceed with the Out-Licensing process.

The challenge however is to convince the patentees as to why this commercial evaluation is an important step in the Out-Licensing process and why it lays down the basis framework for all future efforts through an understanding of the market, the in-licensing behavior of the market, the major players involved, which of these players are approachable based on their background, the costing involved in substitute technologies, strength of patent, among many other parameters. Unfortunately, as we have experienced, its most of the times a one way thinking strategy, wherein the Patentees, believe their technology to be a superior one and that technology is all what counts. As if a sense of how the market and existing products behave would not matter. As if a sense of whether the patent, as granted, is strong enough to be enforceable does not matter. As if all potential licensees are eagerly waiting to consider such technologies for possible in-licensing opportunity. As if the geography in which the patent is granted and intended to be commercialized does not play a role. Most importantly, as if the need for the technology in the concerned domain can not be refuted and that the market is eagerly waiting for the technology.

I strongly believe that it is high time that technology commercialization, as a field of IP, be looked upon from a matured perspective, in which novelty and patentability of technology is only one parameter to be considered while assessing of the chances of successful commercialization. A host of other attributes play an even more important role during commercial evaluation, some of which have been very briefly discussed below with respect of certain examples. These examples are mere illustrations and no other interpretations should be drawn from the analysis:

The first technology relates to a method and system for administering life cycle of Health insurance policy holder, in particularly a web-based solution for managing complete life cycle of Health insurance policy holder. More specifically, the disclosure relates to a web based system that is capable of managing the entire life cycle of a health insurance policy holder, right from the time he/she subscribes to a policy till the final settlement of insurance claims. The system and method described in the said patent application particularly discloses various interfaces and modules to connect the policy holder to the different stakeholders in his treatment, specially, the Doctors, the Drug Store Attendant, the Lab Assistant, the Nurses, and the Surveyor at the Insurance Company etc.

The second technology relates to a topical formulation for treatment of Warts comprising of two carrier systems, with one being a soluble sulfide and the other being a mixture of two drugs in an oil in water emulsion.

Market Perspective: Under the assumption that the Patent has been granted, it is extremely important to understand the market of the concerned domain and whether the same is receptive to new technologies, especially royalty expecting products/technologies. For instance, in the warts application, the existing treatments available for warts include Chemical Destruction, Cryosurgery, Surgical removal method, and prescription medications using agents including Pondophyllin, Cantharidin, Bleomycin, Dinitrochlorobenzene, and Fluorouracil. The proposed formulation, on the other hand, is a topical formulation, based on sulphides alkali metals, which inherently have stability and toxicity issues. Further, sulphides based products, are typically not OTC products and hence have to be prescribed by Doctors, which is non-preferred route of curing the warts by the patients. The market scenario also tells us that companies such as GSK, Merck, Dr. Reddy’s, and Cipla are the major players in the domain, and being a skin disorder product, which is already heavily populated, most of the focus of these companies lies in other medical indications including cervical cancer etc. Further, with a flood of salicylic acid based and non salicylic acid based products in the market, there seems to be little scope for companies to invest in such products. This is more in cases where there is limited clinical data available to the Potential In-Licensees.

Existing Technology Perspective: As was discussed above, with respect to the warts technology, a snapshot of products being right now marketed was analyzed and over 45 products including Duofilm, Salicure-17, Shaloxy-FW, Salicylix-SF, and Dr. Scholl’s were found out in the same domain. Being a heavily populated domain, introduction of a new product, which combines an active ingredient with a pain reliever, which also is quite known, would have a hard time creating excitement.

Patent Strength/Enforceability Perspective: Being granted a patent is completely different from being granted a strong and enforceable patent. A number of times, we encounter patents which good and bypass the market and product level analyze, but are drafted and protected so narrowly that instead of in-licensing, there of more chances of the potential licensee designing around the technology. Taking for instance, the first independent claim of the web-based health insurance software, which claims a

“A web based method for managing complete life cycle of health insurance policy
holder, said method comprising acts of:

a.        registering subscriber to policy…;

b.        prescribing clinical tests for the insured person …;

c.        performing the prescribed tests and updating the test results …;

d.        commencing the treatment by admitting the patient based on the test results …;

e.        generating discharge summary upon completion of the treatment …;

f.         forwarding claim documents along with discharge summary to the surveyor…”

Even if we assume that the above subject matter is patentable under S. 3(k) of the Indian Patent Act and also overcomes the novelty and obviousness issues, with the above exemplary claim being so narrowly drafted, enforceability would always be questionable and significantly hamper efforts of Out-Licensing the patent rights.

Potential Licensees Perspective: There are often cases in which the technology has strong market application and that there does exist a need for such a technology to improve the manufacturing process. However, even under such circumstances, the out-licensing efforts might not go through because of the target potential licensees that might be involved. For instance, a wire mesh machine that allows a continuous strip being used for making a welded metal lattice is a product that would do very well in EP and US geographies but Indian companies, most of them being unorganized in this domain, would be reluctant to in-license or buy patent rights of such a machine due to parameters such as cost involved, ease of replication, among others.

Supporting Data/Prototype/Clinical Data Perspective: Another important parameter used for evaluating products/technologies, especially in the pharmaceutical domain, is the level to which the Clinical tests have been done. With most in-licensees, particularly in India, looking to evaluate in-licensing proposals based on prototypes being developed and the clinical data available, it becomes integral to provide as much supporting data as is possible along with the IP details being given in the commercialization proposal.

It would be appreciated that above mentioned parameters are only an exemplary set, and many other attributes such as patent validity, extent of estimated effort and time involved in the process of commercialization, expectations of upfront and royalty payments, research being carried out with other competing technology companies, other available in-licensing opportunities, among many others play an equally important role.

I therefore believe that the Patentees should appreciate that there is more to a successful technology transfer than merely having a patent in hand and a superior technology in mind. Many other considerations play a role in determining whether the patented product would be acceptable in the market and these are the considerations that need to be analyzed before even initializing the R&D process so that there is little resentment in case after the complete R&D and patent process, one realizes that the applicability and commercial viability of the concerned subject matter is limited.

About the Author: Mr. Tarun Khurana, Partner and Patent Attorney in Institute of Intellectual Property Research & Development (IIPRD) and can be reached: Tarun@iiprd.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

Food Market making Profit from Climatic Changes

Climatic changes being a source of making profit for food crop manufacturers.

Adverse changes in climate has triggered the ecosystems affecting crops, livestock, fisheries and forests and the billions of people whose livelihoods depend on them. Extreme climate events (especially hotter, drier conditions in semi-arid regions) are likely to slash yields for maize, wheat, rice and other such primary food crops.

Seed manufactures are now positioning themselves to take advantage of such changes with genetically engineered seed crops that can withstand such changes.  While good for the seed companies, this has some groups concerned.  ETC Group, dedicated to the conservation and sustainable advancement of cultural and ecological diversity and human rights, has issued a report showing the policy implications of patent on genes.

The group sites certain reasons / issues for producing genetically engineered crops:

  • A temperature increase of 3–4 degrees Celsius could cause crop yields to fall by 15–35 percent in Africa and west Asia and by 25–35 per cent in the Middle East according to an FAO report released in March 2008.
  • 65 countries in the South, most in Africa, risk losing 280 million tonnes of potential cereal production, valued at $56 billion, as a result of climate change.
  • Projected increases in temperature and changes in rainfall patterns will decrease growing periods by more than 20 percent in many parts of sub-Saharan Africa.
  • Farmers in dry land areas of sub-Saharan Africa will experience revenue losses of 25% per acre by 2060. The overall revenue losses of $26 billion per annum would exceed current levels of bilateral aid to the region.

Reports have shown that many of the world’s largest seed and agrochemical corporations are obtaining patents on genes in plants genetically engineered to withstand environmental stresses such as drought, heat, cold, floods, saline soils, and more. BASF, Monsanto, Bayer, Syngenta, Dupont and Biotech partners have filed 532 patent documents (a total of 55 patent families) on so-called “climate ready” genes at patent offices around the world.

Key areas of consideration:

There can be two ways: One, it is a way for companies to prepare to meet a foreseeable demand in the face of climatic change and a potential world food crisis. Or, it could be an opportunity for corporations to push genetically engineered crops using climate change as a scapegoat. The truth is probably somewhere in between but the concern is that proprietary technologies will ultimately concentrate corporate power, drive up costs, inhibit independent research, and further lessen the ability of farmers to save and exchange seeds.

Other than U.S. and Europe, patent offices in major food producing countries such as Argentina, Australia, Brazil, Canada, China, Mexico and South Africa are also seeing huge increases in patent application filings in GM seeds/crops. Monsanto and BASF have put together a $1.5 billion partnership to engineer stress tolerance in plants. Together, the two companies account for 27 of the 55 patent families (49%) of those identified by ETC Group.

The question now according to the ETC Group: “Will farming communities now be stampeded by climate change profiteering?”  Well “the patent grab on so-called climate-ready traits is consuming money and resources that could be spent on affordable, farmer-based strategies for climate change survival and adaptation,” there can be an issue when the top 10 seed companies control major part of the global seed market.

It must be seen how the small scale industries would cope up with such patents and how the respective government bodies try to protect farmers from these giant companies.

Reference: ETC Group Reports

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