A BUSINESS MODEL TO AVOID PATENT INFRINGEMENT:

Few days before when I was going through some patent litigation informations, I came across a futuristic business model for MNCs. Generally MNCs have some non-practicing entities (NPEs) and use these for licensing and earn royalty. Companies which are not aware of these NPEs, generally land up in patent litigation cases because of lack of databases regarding the patents of these NPEs.
PatentFreedom LLC is an on-line community of companies which share information about non-practicing entities (NPEs) that own and enforce patents primarily to collect license fees. Membership is restricted to companies that have more than $100 million in sales per year, exclusive of any income they themselves earn from patent licensing. It has 20 member companies till now and was founded in May 2008, chairman is Dan McCurdy. Earlier he was the CEO of ThinkFire, Inc., the leading intellectual property strategy and transactions firm, resigned to become Chairman of Patent Freedom LLC. Patent Freedom is a membership organization where members pay an annual dues and have access to information provided by other members about non-practicing entities who are asserting patents. It is hoped that the sharing of information will help the member companies reduce their exposure to patent infringement lawsuits.
The information includes who the entities are, who is funding them, and who they have asserted their patents against. As of December 2008, Patent Freedom database has following information:

• A database of over 220 distinct NPEs and over 800 subsidiaries, with detailed profiles and comprehensive links to important news articles on those of greatest threat.
• Information and insight on more than 16,000 patent families and applications held and enforceable by NPEs, including the product categories that an NPE might allege they infringe.
• Information and insight on over 2,200 lawsuits involving these NPEs.
• An Internet-enabled platform and email alerts for accessing this information and proactively monitoring NPEs of greatest concern.
• Access to best practices and broad-based IP expertise from a community of experts.
  

Common deficiencies found by USFDA in DMFs

Earlier Global API market was mainly dominated by Italy & Spain but now situation has been changed because of the emergence of Indian & Chinese generic companies. These companies are giving very tough competition to regularly increase their market share from the share of Italy & Spain. In the fast growing generic market the companies dealing in API have also geared up themselves to tap the huge opportunity of generic API market by developing & filing DMF for no. of APIs, off those patents are to going to expire. Market reports suggests us with in few years India will be at second position in API market.
Due to current FDA regulation DMF filing is not a regulation to sell an API however It becomes a basic requirement of a supply agreement between an API manufacturer and ANDA applicant due to following reasons.
1)As per the import procedure of US and few other countries DMF is required to supply bulk material (API) to the US & other markets.
2)API manufacturers who have large number of DMFs tend to be more dependable in terms of quality, regulatory requirement, and ability to meet cGMP guidelines.
So all the manufacturers are filing DMFs to register their API but only few manufactures are able to utilize their DMFs efficiently because most of the time they got stuck in DMF deficiencies, customer queries, and failed to manage a number of obligations due to these deficiencies. This may also lead to pending and inactive status of their DMF.
I had found most of manufactures were not able to manage the following functions properly, those are very important for the DMF filing and their maintenance.
1)Quality DMF Submission
2)Management of DMF deficiencies & Customer queries
3)Management of DMF Holder’s obligation and other function
In this way at last I found that DMF management system is a good concept
by which a manufacturer can improve a lot in managing their all these important functions which were critical for the success of DMF filing.

IN-LICENSING AS A POTENTIAL RESORT TO BUILD PRODUCT PORTFOLIO

In the last five years, health scene in India has shown marked improvements in all the vital indicators of health development. This improvement is a result of changing paradigm of Indian Pharmaceutical companies from In-house R&D to more rational routes for bringing new products to the market. However, much remains to be done with a substantially unfulfilled agenda for poverty and poor health in the country. The health problems in India different from those of that of developed countries.
Oncology is a growing area of interest in the Indian Pharmaceutical industry, in which late stage products have doubled in the past ten years. Oncology represents about 10% of the current Pharmaceutical market. The number of drugs in clinical development has increased 2.4 times in ten years and it is currently the latest hub of novel drug research (Bionest Partners report).
In today’s competitive environment, limited resources and unlimited opportunities is a brute reality. Pharmaceutical companies are finding it difficult to strengthen their product portfolio according to the market needs. Changing dynamics of competition has resulted in companies opting for adjunct routes in addition to the in-house research to enhance their product & service portfolio.
In India, new drug discovery is still in nascent stage hence, the Pharmaceutical companies are finding it difficult to introduce new drugs in order to cope with current demand. Moreover, due to the cost factor in India multinational companies are not finding it feasible to launch new drugs at the same time as they launch elsewhere. This change in dynamics of demand & supply has resulted in the Pharmaceutical companies opting for ‘Alternative Routes’ to build their product portfolio. These routes are - Product acquisition, Strategic alliances, Co-development, Outsourcing, In-Licensing etc, is a result of the strategic reaction by the companies to cope competition. Companies are now adopting these alternative routes as the part of their ‘Core Strategies of Growth’ to get their desired product within stipulated time, cost and quality. The reason for escalation of these routes is comparatively low risk with lesser Lead Time for Return on Investment.
So in this changing market dynamics ‘To be the first and the foremost’ is one management principle that still is invincible. ‘To be the first and the foremost’ is one management principle that still is invincible.. But reality is different from perception and hence adopting adjunct routes can be the most important means of soothing product flow to manage commercial operations especially in India where new drug discovery is still in nascent stage.