BrainWave Wish You a Merry Christmas and Happy New Year to all our clients. BrainWave Biosolutions Limited provides Bio-IT and KPO services to the various industries across the globe. Our vision “To be a global life science informatics solution Provider for drug discovery process” and our mission “Improving the productivity of our customers by providing custom decision support”

Life science informatics is an emerging field today and has an important role in shaping modern bio-science concepts and methodologies. It is the science that deals with the study of various methods used for storing, analyzing and retrieving biologic data, pathways, and processes. To put it in simpler words, life science informatics or bioinformatics is the application of information technology to the management of biological information.

Interdisciplinary Contribution and Growth

The knowledge that the life science informatics or bioinformatics has generated is enormous. The growth of this field has opened with it a new vista of opportunities and channels that has paved the way for significant advances in the fields like medicine, genetic engineering, and pharmacology. The relevance of bioinformatics can be understood by the fact that the biological data that is procured should be managed and stored for a host of different purposes and applications. Also the information or data that is being stored should be updated constantly in tune with the times and latest findings. Thus life science informatics has provided an impetus to associated fields like software engineering, which in turn has helped this field grow. Many areas of scientific and mathematical methods are involved while dealing with data and analysis in bioinformatics. These include but are not limited to data mining, artificial intelligence, statistics, computation theory, image processing etc. Ultimately, the most accepted goal of life science informatics has been human welfare.

Recent Course and Significance

Life science informatics has been seeing a steady growth in terms of research, inventions, innovations, and demand for services ever since the turn of this century. More and more clinical trials are set up based on results of bioinformatics projects and the results thereof. Pharmaceutical companies not only base their drug discoveries but also constantly upgrade and regulate the mechanisms based on newer findings that might arise from updated bioinformatics studies. Life science informatics has everything to keep its practitioners interested and excited. It is always evolving and is a niche area that calls for aspiring specialists and biologists.

Outsourcing and the Indian Picture

Outsourcing to offshore locations in life science informatics has been a profitable option for many multinational companies. According to latest surveys and reports, outsourcing to India offers about 30-40% cost savings when compared to other developed countries. This can further go up when it comes to outsourcing core bioinformatics services. The favorable conditions like lower infrastructure costs, lower wage costs, and skilled manpower make this pleasing situation possible.

With both biotechnology and software technology being strong points in the Indian scenario, life science informatics outsourcing to India is one wise thing that entrepreneurs and big time investors can delve into quite confidently.

Knowledge process outsourcing (KPO) is one of the new dimensions of BPO that has given global outsourcing scenario a new meaning.  Over a decade KPO has had a tremendous growth in India.  Leading countries turn to India to get their job done when compared to other countries.  There are many reasons for this.  The main reason for outsourcing to India is the highly rated knowledge pool and low costs compared to other countries. Recently, the infrastructure and government policies too attract prospective entrepreneurs in this area.  Interestingly, our competitors are Philippines, Russia, China, Canada, Ireland and Mexico who are establishing themselves as our competitors.

India has well-developed varsities and institutions that have molded over 75,000 IT graduates and 20 lakhs of English speaking graduates.

Price wise India will be the right choice when compared to other countries like Philippines and China. Particularly the telecom industry cost is very high compared to India.  Our competitors have been facing issues like political risk, laborious license process, high taxes and government trade policies and their regulations are very complicated compared to India.

The Indian KPO industry was hit by the 2008 global crisis and ever since the industry has recovered step by step. Notwithstanding, India is still the “king” of KPO market with 70 percent global share.  According to Evalueserve Source Company, the global KPO is expected to grow to $17 billion in 2014 from $ 9 billion in 2011.  Indian KPO industry will grow to $ 10 billion with 205,000 professionals by the year 2014.  In the year 2011, the KPO market earned $ 5.95 Billion with 135,000 professionals, and is expected to grow annually approximately 20% for the next four years (2010-14).

NASSCOM reports on KPO Market

The Nasscom-Crisil study says that the Indian KPO market is expected to grow at a CAGR of 22.2% and touch $5.6 billion in 2015. In the year 2010, the KPO market value was $ 2 billion.  The KPO service business research would contribute a high value of share (39.4%) with the market rate of $2.2 billion.  Another branch of data analytics service is expected to be around 18.5% to 20.6% ($1.15 billion) over the same duration.  The legal process outsourcing is expected to grow $1.3 billion by FY15.  The largest contributor of financial services is expected to grow to 32% market share ($1.4 billion).  Likewise, healthcare at 19.5% and telecom hi-tech retail sector are having 13% share respectively.

ASSOCHAM reports on KPO Market

ASSOCHAM (Association of India Associated Chambers of Commerce and Industry of India) has given positive reviews on the Indian KPO industry. According to the ASSOCHAM data, the KPO firm market in India was $ 5.7 billion in 2010. In 2011, the market range was $ 8 billion and 10 billion in 2012 with an approximate growth rate of 25-27% in the last few years. From various sources, the countries like Philippines, China, Russia, Poland, and Hungary are the major outsourcing competitors to India.

Growth and stability in the KPO firm

The initial stage of Indian KPO firms has covered only few sectors, but now they are expanding and we have our market in multiple sectors  The Indian knowledge-based firm experts in Research & Development, Pharmaceuticals and Biotechnology, Intellectual Property (IP) Research, Network Management, Training & Consultancy, Writing & Content Development, Business and Technical Analysis, Animation & Design, Business & Market Research have their tasks cut out and have well laid paths in front of them.

India has highly talented domain experts in every field that provides holistic balance. So the Indian vendor has a vast amount of clients from around the globe.

Article by
S.Rajasekaran
Associate Scientist

The Indian patent office (IPO) made an unbelievable decision by granting compulsory license (CL) to Hyderabad based NATCO Pharma Limited. On Monday 9th March 2012, the Controller General of Patents P.H. Kurian found that all grounds prescribed in section 84 of the Indian Patents Act (amended) 1970 made an issue to grant compulsory license to Natco pharma Ltd to market a generic version of Bayer’s patented drug Nexavar.
The drug Nexavar (sorafenib tosylate) is used for treating liver and kidney cancer. The decision is worldwide appreciable because this is the first time in India being the developing country used the provision of compulsory license to safe guard the patient who suffer from liver/kidney cancer. The grant of compulsory license allows the local generic maker Natco pharma to make and sell the life-prolonging drug cheaper in India.

BACKGROUND
Bayer is a big pharma company well knows for invention and manufacturing innovative drug globally. In 1990, Bayer invented a new drug sorafenib (Carboxy Diphenyl Substituted Ureas) for treatment of kidney/liver cancer. On 13th January 1999, Bayer filled a patent application in USPTO and at the same time filled Patent Cooperation Treaty (PCT) application PCT/US00/000648 on 12th January 2000. In 2001 Bayer’s application entered the national phase of registration in India. Meantime in 2005-2006, Bayer started marketing the drug internationally under the market name Nexavar. On 1st August 2007 Bayer received a license to import and market the drug sorafenib in India.
The drug Nexavar well known as a sorafenib tosylate, the chemical name for the drug is Carboxy Diphenyl Substituted Ureas.

The structure for a novel compound of the drug Nexavar is -

On 3^rd March 2008, under the provision of Indian patent Act 1970 Bayer’s patent was granted in India, by the patent number as IN215758. In 2008 Bayer received regulatory approval for importing and marketing the drug in India. The Indian Patent Office (IPO) found that Bayer did not import the drug in 2008 and only a small quantity was imported in 2009 and 2010.

There was a huge demand on this drug in India due to minimum import of drug Nexavar by Bayer and the cost of drug cited at a huge price. The cost of the drug wasn’t affordable by poor patient because drug should be consumed by the cancer patient still they survive and its cost is INR2, 80,428 per month and INR33, 65,136 per year.

Finally, Indian generic drug manufacturer Natco Pharma Limited planned to go for a voluntary license with Bayer to manufacture and sell its generic version of drug Nexavar (sorafenib) in India. On 6^th December 2010, Bayer crop refused the request from Natco pharma for marketing the drug fully across India. The out come of result from Bayer, Natco pharma approached the controller to grant compulsory license for the drug.

According to Indian Patent (amended 2005) Act 1970 a person or legal person can apply compulsory license after three year from the date of grant of the patent. On 29^th July 2011 Natco pharma filled an application for compulsory license under section 84 of Indian patent Act 1970 for patent IN215758. On 12^th August 2011 Natco’s application was published in official journals.

ANALYSIS ON THE CASE ISSUES

The compulsory license fashioned a new birth place in Indian Patent act 1970 after 2005 under        TRIPS (Trade-Related aspects of Intellectual property rights). The patents (Amendment) Act, 2005 allowed product patents to be granted for drugs, which was not allowed under the 1970 Act. The provision was introduced to grant compulsory license for export of medicine to countries that have insufficient or no manufacturing capacity to meet emergent public health situations.

COMPULSORY LICENSE

Section 84(1) of the Indian patents act provides that an interested person may apply for a compulsory license to work the patented invention after expiration of 3 years from the grant of a patent on any of the following grounds:

a)      The reasonable requirements of the public with respect to the patented invention have not been satisfied;

b)      The patented invention is not available to the public at a reasonably affordable price;

c)      The patented invention has not been worked in the territory of India.

Reasonable requirements of the public

The drug has not met the requirement of public who suffer from liver/kidney cancer. From the above graph it shows very clearly that in 2008 Bayer has not imported drug in India and very least amount has been imported in 2009 and 2010. In 2008, India had 20,000 liver cancer patients and 8,900 kidney cancer patients, the patent controller reported that only around 200 bottles were imported in 2009, but the drug was launched massively around worldwide. The demand of the patented drug to public has increased and it was not notified.

Reasonably affordable price

The patented drug was sold at huge cost were the public were not able to afford such an amount. Germany based company Bayer sold the drug to India at INR 2, 80,482 per month where as Natco proposed the drug to afford at low cost of INR8, 800 per month.

Worked in the territory of India

The patented drug was not manufactured within the territory of India because the drug is being imported in India from Bayer.

The controller decided to grant compulsory license to Natco pharma against Germany based Bayer Company as it satisfied all the grounds of compulsory license in Indian patent Act 1970.

APPLICANT ARGUMENT

1. Natco pharma filed a compulsory license application u/s 84(1) based on the following claims:

v     Bayer has failed to work the invention in India.

v    It is not available to the public at a reasonable price.

v    The reasonable requirements of public have not been met.

1. Natco intends to exercise the license only in the territory of India. The generic version will not be exported.
2. The patentee has imported the drug in very little amount; it has not taken any steps to manufacture the drug in India.
3. The patent was granted on 2008 and from then till 2011 the patentee did not bother to fulfil the demand.
4. The cost of the drug is also too high and simply unaffordable by the common man. Bayer’s Nexavar is priced at Rs. 2.80 Lakhs (approx. US$5800) for a one month course, whereas Natco plans to sell its generic version, for just Rs. 8,800 (APPROX.US$181).

PATENTEE’S ARGUMENT

1. The patentee argued that the reasonable requirements of the public are being fulfilled by the company.
2. The generic version of the drug is already in the Indian market produced by Cipla Ltd (Bayer filed an infringement case against Cipla, the case is pending), so there is no need to give a license for the product.
3. The controller rejected that point argued by the patentee, because the case is still pending.

FINAL VERDICT

1. On March 9, 2012, the controller’s decision came in favours of Natco Pharma  – u/s 84.
2. Decision: The reasonable requirements of the public with respect to the patented invention have not been satisfied in this case and a compulsory license is issued to the applicant u/s 84 of the patent act.
3. Natco is now free to manufacture and sell a generic version of Nexavar (a kidney/liver cancer drug).
4. The final order by controller allowed Natco Pharma to manufacture and sell generic version of Bayer patent drug by paying a 6% royalty on the net sales (every quarter) and charge Rs 8800 for a monthly dose (120 tablets).
5. Natco Pharma committed to donate free supplies of the medicines to 600 needy patients every year.

FUTURE IMPLICATIONS

1. The India’s first patent compulsory licensing order will be the baby step for the future cases and who all are battling pharmaceutical patents and excessive prices for many years now.
2. The judgment by the controller general made awareness to multinational companies who afford huge cost for their patented drug.
3. Many MNC companies from Switzerland, UK & US may build different price structure for selling their drug in developing countries like India.
4. A few days after this judgment, Swiss healthcare major Roche Holding AG released the news of its collaboration with an Indian pharmaceutical company to repackage and sell its cancer drugs at a low and affordable cost. This may be a good revolutionize in many developing counties to build or adopt similar provision of act i.e compulsory license.

FILE WRAP FOR THE CASE STUDIES

Patents are an important form of Intellectual Property. Awareness on Intellectual Property and Patent filing in India has gradually increased towards the turn of the last century. The inventors and corporations have started realizing the importance of filing patents and protecting their technology locally and globally rather than losing their money or invention in the market. Filing a patent in Indian Patent Office (IPO) is an economical and an extensive process.

Once we have an idea or invention in our mind, immediately we should think how to protect the invention. So next what is the cost for going for filing a patent? After filing a patent, the patent is sustained by paying periodic maintenance fee i.e. renewal fees to IPO.

There are two types of costs involved in obtaining a patent. They are:-

(1)   Professional Fee

(2)   Official/Statutory Filing Fee

Professional fees are paid to the legal service providers who handle our invention in good shape. They charge to prepare application, file and to prosecute the patent application with the patent office. The professional fee may vary from one firm to other.

The official/statutory fee is paid to patent office to pursue patent application. The section 142 and in rule 7 of Indian Patent Act 1970 is endowed with the details of fee for natural persons and legal entity like companies. The official fee for legal entity is four times the fee for natural persons in India. The professional fees vary from attorney to attorney. Herein, only the statutory fee is disclosed.

Table-1 shows the normal procedure for filing and grant of patent in Indian patent office.

Points:
1. A fee of INR 1000 for natural person has to be paid while submitting the patent application in the IPO.
2. In order to accelerate the patent process in IPO, the applicant has to request for early publication, a request for early publication made in form 9 with prescribed fee of INR 2500 for a natural person. If this request is not made, then the IPO publishes your patent application after 18 months from priority date.
3. Once the patent application is published, the applicant immediately can apply requesting for examination process. A fee of INR 2500 has to be paid, requesting the IPO to examine your patent application. The IPO puts your application in queue for examination only after receiving this fee. Hence, if you want to accelerate the patent process, it is advisable to pay this fee at the earliest.
4. Apart from depositing the official fee for getting the patent, one has to deposit patent maintenance fee from time to time to keep patent active during its term of 20 years.

Data is a valuable resource upon which various aspects of a professional setup depend. Data management involves all the disciplines that help to manage data and treat it as a valuable resource. In today’s scenario, data management is a term that cannot be used alone, as it coexists with information management and knowledge management. Data management services are now offered by many organizations in a variety of packages that include many components. Notable among them are data conversion process, data entry, data extraction, validation, word processing and so on.

Outsourcing and Off-shoring

Outsourcing in this arena has witnesses a big leap from the past due to advances in internet and also availability of talent pool in countries like India. Multinational companies are keen on saving their valuable time and costs by getting these jobs done in off-shoring locations. This strategy gives them double-edged advantage. First, their data management needs gets taken care of. Second, it gives them scope for routing further work, finding more avenues and diversification of their business in these offshore countries. Thus they ultimately end up opening their own production and delivery centers in these places instead of keeping these places only as their “outsourcing stations”. Thus this global type of strategy helps to extract the best out of both worlds.

Trends in Outsourcing Demands

The new trends in outsourcing reveal new policies and expectations that go just beyond cost cutting and time saving. The business organizations world over have become more and more conscious of the fact that it is important to maintain their reputation and win over their customers amongst stiff competition. A single error is enough to tarnish the imaged created over the years. Thus the customer satisfaction must be maintained at the desired level at all times.

Recent trends indicate new outsourcing demands that lay emphasis on direct customer interaction meaning complete customer support and technical support. Thus the projects are expected to be more holistic in terms of their delivery. These demands are met by able personnel in various branches of data management services, which include both knowledge and technical domains. The various processes in data management like data conversion, document conversion, file conversion, data entry, OCR services, word processing, and survey processing are providing favorable and profitable business in the outsourcing locations, especially India.

With advancing technology and fast internet connections, knowledge based services and data management services in particular offer excellent opportunities leading to mutual benefit to both organizations and outsourcing firms.

Key Opinion Leaders, KOL as they are widely known, are personalities who influence the behavior or decision-making of peers in the domains such as pharmaceutical research and development, healthcare etc. The Key Opinion Leader naturally is held in high esteem by those who follow or accept his or her opinions. Interestingly enough, KOLs are seen to have more influence than the media. Many reasons are attributed to this. One among them is that these KOLs are deemed trustworthy and non-purposive. The feeling of thought manipulation that creeps up in media related domains does not arise in the case of KOLs. While the media can be forcing an idea or concept on the public, the KOLs are seen as experts in their respective fields with no commercial motives. So the media are less influential and KOLs stand out in their reach and spread in defining and establishing new patterns of process or decision-making in their respective domains.

Role in Various Domains

The concept of KOL greatly benefits the progress in the drug development process and the stepwise growth can be gauged and enhanced through these KOLs. Healthcare and pharmaceutical industry are industries, where KOL activity is aplenty. Key Opinion Leaders offer valuable viewpoints, which would extremely useful in determining the usage and efficiency of the prospective drug. Various stages in the drug development are ably guided by Key Opinion Leaders. Pharmaceutical and research companies greatly benefit from their repertoire and vast experience, which ultimately sets the drug discovery process on the right track.

KOL and Clinical Research

Key Opinion Leaders play an increasingly important role in clinical research. The roles they perform range from enlightening the pharmaceutical company on the research and development trends, conducting clinical trials, and creating and building up product awareness at both the pre and post launch phases. The KOL’s inputs are vital in decision-making relating to product acceptance. All the regulatory guidelines and reimbursement policies are ably covered and guided by this.

From the consumer or patients’ point of view, Key Opinion Leaders find more acceptability than any other agent, namely media or other marketing personnel. It is the Key Opinion Leader who handles and ably executes the task of informing and educating the patients so that they are left convinced and reassured regarding the drug in question.

Recent Trends

Many companies are now outsourcing the tasks of KOL to countries due to rich resource availability, favorable costs and work conditions, and huge scope for continuity and improvisation of existing projects. The major tasks that an organization does is the identification of the right KOL, detailed profiling, continuous monitoring of ongoing activities, and building long-term relationships that would bring about mutual benefit.

Thus, in recent times outsourcing has found, in KOL, another area that is justifying expectations and continuing to grow and provide handsome returns to those investing in it.

A hot debate indeed!

The future of outsourcing is a hotly discussed topic ever since it started and the debate is still on. The recent slowdown in the US and Europe has brought into focus the outsourcing debate with respect to unemployment and economic compulsions in these countries. American president Obama’s recent speech has added fuel to fire notwithstanding his intentions being dismissed as election oriented. With specific reference to India, in addition to already existing apprehensions, the addition of competitors like Philippines, Vietnam, and even China have made the subject more intriguing.

Indian strength

Still, India remains a favored destination due to its strategic time location and over half of the Fortune 500 companies use Indian software services. The internal scenario remains competitive as ever. The cost factor is propelling more outsourcing firms towards India. In turn, to offset any negatives on the cost front posed by emerging BPO competitors like the Philippines, delivery centers have now started blooming among smaller cities and towns in contrast to a few metros a few years ago. Also, diversification and new areas of business are being witnessed in the form of account outsourcing, legal process outsourcing, and banking management outsourcing. Even companies that are averse to outsourcing their work to India expect BPO concerns here to take up more expansive domains and contribute more towards decision making processes, in a way redefining the outsourcing principle and making it look more comprehensive and efficient.

The changing “looks” of Indian BPO

In any case, the outsourcing scenario looks only brighter for the Indian BPO players and young techies in particular. Entering and diversifying into unexplored regions in Europe and China are spelling exciting prospects for zealous entrepreneurs here. Also the latest trend is the unique “Swadeshi” or Gandhian innovation that young professionals are willing to adapt, i.e. transitioning from manning the back offices for Western clients to owning front offices, which are 100% Indian. These will cater to Indian needs and offer creative and feasible solutions to Indian problems and needs of the Indian markets. This has brought alive and kicking the meaningful implementation of IT in much needed sectors like agriculture, scientific research, and infrastructure. Thus, including more business and decision oriented processes to fall under the ambit of outsourcing agenda has transformed “outsourcing” into more of a burden sharing and mutually beneficial exercise. From the way things look, Indian BPOs are poised to go even higher on the growth chart in the coming years.

Note: The article is based on market news and views and does not reflect the author’s opinion.

Article by
K. Muthukumaran
Senior Technical Writer

Bioinformatics Services:

At Informatics Outsourcing we offer Bioinformatics services that focus on computational biology and clinical trial informatics.

Our Bioinformatics services are tailor-made mainly for multinational organizations and institutions in the life science industry where R&D is involved. Informatics Outsourcing uses it to build solutions to biological and data analysis problems.

Value of Outsourcing Bio informatics Services:

Our Bionformatics Services would definitely add measurable value to the business process. It also accelerates drug development, protein study, structural analysis and structural prediction.

Benefits of Bioinformatics Outsourcing:

There are many potential benefits that can be derived from bioinformatics outsourcing.

Informatics Outsourcing offers the following benefits that prove to be a driving force behind the outsourcing phenomena,

* Cost saving and access to quality resources (PhD and Masters in life sciences)
* Database Creation: Our bioinformaticians use computer software tools for database creation.
* Software Development: Development of new software tools for genomics, proteomics, sequence alignment, gene prediction & related applications and development of teaching and e-learning modules in bioinformatics.
* Our Strength: Our team of well experienced scientists, software engineers and bioinformaticians are involved in offering the best bioinformatics services to our clients.

Advantages of Outsourcing bio informatics Services to Informatics Outsourcing:

* Focus on core capabilities
* Improve operational efficiency and improve competitiveness
* Minimize on total cost of ownership
* Improve service delivery to customers
* Manage cost and time
* To comply with the market trends

Like to know about Outsourcing Bioinformatics Services Contact Us

Article by

A. Vijay Babu,
Associate Scientist