GENERIC AIDS DRUGS

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http://www.aidsmap.com/The-generic-generation/page/2541038/





DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

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http://newdrugapprovals.org/

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO

Putting patients before patents as affordable drugs approved

Leap forward: The Research and Development Centre of Natco Pharma Ltd, in Hyderabad, has been given the licence to produce anti cancer drug

Read more: http://www.dailymail.co.uk/indiahome/indianews/article-2289214/Affordable-drugs-approved-Putting-patients-patents.html#ixzz3LrARDddL





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Are drug patents impeding access to affordable medicine?

At a NATCO lab in Hyderabad. Bayer is contesting the first ever compulsory license given to NATCO to produce Nexavar, an anti-cancer drug, at 3% the cost.

READ AT

http://www.thealternative.in/society/are-drug-patents-impeding-access-to-affordable-medicine/





DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

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Should Patents on Pharmaceuticals Be Extended to Encourage Innovation?

'Without extended patent protection for new discoveries,' there will be 'decreased innovation, fewer new drugs and more job losses.' -- JOSH BLOOMAmerican Council on Science and Health

READ AT
http://www.wsj.com/news/articles/SB10001424052970204542404577156993191655000?mg=reno64-wsj

CLAIMS® .......Classic Databases

Classic US Patent Database with Legal Status

The most extensive online, text-searchable collection of U.S. patents.

The CLAIMS U.S. Patents Database contains references to more than 3 million patents granted in the United States since 1950. Known for our broad coverage, in-depth indexing of chemical patents and extensive standardization of company names, the database represents the largest collection of clean and reliable, text-searchable U.S. patent references available in an online database.

The CLAIMS U.S. Patents Database includes:

• All chemical patents since 1950
• All utility patents since 1963
• Complete collection from 1971-74, including 96,000 patents not found in USPTO online records or other files for that time period
• All design patents since December 1976
• All plant patents since December 1976

Each record in the database provides:

• Patent title, patent number, issue date
• Assignee names(s)
• Inventor name(s)
• Bibliographic data including the U.S. Patent Office Classifications and International Patent Classifications
• Main claim from the USPTO Official Gazette (O.G.)

For patents issued since 1971, database records also include all data from the front page of the patent (application data, priority application data, addresses of inventors, etc.) plus abstract from the front page of the patent and all patent claims.

The CLAIMS US Patents Database is available from the following online vendors using these file names:

Dialog — 340

STN — IFIPAT

Questel — IFIPAT

Classic Comprehensive US Patent Database with Chemical Indexing

The premier source for U.S. chemical patent information. CLAIMS Chemical Indexing Databases (Uniterm Database and Comprehensive Database) include all of the information contained in the CLAIMS U.S. Patents Database as well as in-depth subject indexing for chemical and biological patents.

This indexing, which uses standardized terminology to describe chemical concepts, novelty, and utility of the invention, provides for more comprehensive retrieval of chemical and biological patents. Some key features of the CLAIMS Chemical Indexing Databases include:

• Effective and versatile polymer search system
• Coverage of all chemical and biological technologies back to 1950
• Indexing based on the complete patent document, emphasizing what is novel and useful about the invention
• In-depth fragmentation system used to describe Markush structures, generic chemical structures and specific structures not found inIFI's compound registry
• Standardized linear notations for chemical structures which can be searched and displayed online
• Indexing performed by experienced IFI chemists
• Well-defined indexing guidelines and a comprehensive proprietary thesaurus which ensure consistency
• Monthly updates.

The CLAIMS Comprehensive Database is available only to IFIsubscribers. The database contains all of the patent information that is in the CLAIMS U.S. Patent and CLAIMS Uniterm databases. In addition, this file contains special subject indexing with enhanced retrieval capabilities for chemical and chemically related patents. This indexing, which includes general terms, compound terms, and fragment terms, provides for much more comprehensive retrieval of chemical patents.

Some of the important features of the CLAIMS Comprehensive Database include:

• Enhanced polymer retrieval system
• Comprehensive substructure fragmentation system
• Ability to search roles to define chemical functions
• Usage time not restricted

Roles are two digit numbers used to tell whether a substance is present, a reactant, or a product in a particular patent, and are used extensively in the IFI polymer indexing system.

Chemical Structure Images

Chemicals in patents are often described as images, which cannot be retrieved in a text search. IFI indexers interpret and annotate patents with standard chemical terminology that can be easily searched by a chemist.

In this example, an IFI chemical indexer recognized and indexed the drug tadalafil from the following Markush structure claimed in a patent, even though that drug’s common name does not appear in the patent (US7550479):

Searching Polymer Chemistry

The IFI Polymer system breaks complex polymer structures into easily searched prescribed monomers, and special 2 digit role indicators further identify polymer class, and whether the monomer is part of a homo- or copolymer.

For example, when a patent describes a polysiloxane polymer using a representation like the one here, IFI identifies the component monomeric units, and indexes a standard silanediol compound for each type of repeating unit. The repeating units are tagged with appropriate role indicators, and IFI standard terms are indexed for Polysiloxanes and Copolymers.

With this information, a searcher can find this patent when searching for the exact copolymer described here, or whenever the search requires any one or more components included in this polymer, e.g., any polysiloxane copolymer containing diphenylsiloxane units.


IFI indexed each unit in copolymer roles:

• Diphenylsilanediol 77 (2 digit copolysiloxane role indicator)
• Silanediol, methyl/3,3,3-trifluoropropyl/- 77
• Dimethylsilanediol 77

IFI also indexed the class term: Polysiloxanes

The CLAIMS Comprehensive Database is available from the following online vendors using these file names:

Dialog — 942

STN — IFICDB

Questel — IFICDB

CLAIMS® is a registered trademark of IFI CLAIMS Patent Services.

About IFI CLAIMS Patent Services/Fairview Research
IFI CLAIMS Patent Services, a division of Fairview Research, is the preeminent producer of value-added patent databases, the innovative CLAIMS DIRECT web service, and provider of the KMX Patent Analytics solution. From the most rigorous U.S. assignee name standardization process in the industry, to continual class code updates, and comprehensive indexing for chemical patents — IFI has built a solid reputation as a leader in patent databases. Fairview Research (Madison, Conn., and Barcelona, Spain) is a provider of data-enrichment technology and services for information retrieval and analysis. Founded in 2006, the company is skilled at making large-scale scientific and technical databases more searchable and helping to lower the cost of specialized research. For more information, visit www.ificlaims.com.

HOW TO PREPARE A BUSINESS PLAN

1. What is the purpose of a business plan?
   There are various reasons for preparing a business plan, including ordering your ideas about starting a new business into a logical plan, documenting an action plan on how to go about starting a new business or improving on or changing the direction of an existing one, and marketing your business to others, usually potential funders. The style and content of your business plan will depend on the objective you are trying to achieve, but most business plans have the same broad headings.
2. How do I write a business plan?
   Below is a list of the main headings that should be included in a business plan.
   1. Table of Contents
   2. Executive Summary
      1. Concept Description
      2. Problem/Opportunity
      3. Solution
      4. Value Proposition
      5. Process
      6. Management
      7. Financials
   3. Company Overview
      1. Introduction
      2. Mission Statement
      3. History and Current Status
      4. Objectives
   4. Products and Services
      1. Introduction
      2. Description
      3. Market Comparison
      4. Proprietary Rights
      5. Stage of Development
   5. Industry and Market Analysis
      1. Introduction
      2. Industry Analysis
      3. Marketplace Analysis
      4. Customer Analysis
      5. Competitor Analysis
   6. Marketing Plan
      1. Introduction
      2. Target Market Strategy
      3. Product/Service Strategy
      4. Pricing Strategy
      5. Distribution Strategy
      6. Advertising and Promotion Strategy
      7. Sales Strategy
      8. Marketing and Sales Forecasts
   7. Operations Plan
      1. Introduction
      2. Operations Strategy
      3. Scope of Operations
      4. Ongoing Operations
      5. Operations Costs
   8. Development Plan
      1. Development Strategy
      2. Development Timeline
      3. Development Expenses
   9. Management Plan
      1. Company Organization
      2. Management Team
      3. Administrative Expenses
   10. Financial Plan
       1. Financial Statements
       2. Financial Comparables
       3. Financial Summary
       4. Financial Assumptions
       5. Funding Requirements
       6. Sources and Uses of Funds
       7. Business Risks
   11. Offering (Funding Request)
       1. Investment Requirements
       2. Valuation of Business
       3. Offer
       4. Exit Strategies
   12. Appendices
       1. Required items (e.g. Financial Statements, CVs etc.)
       2. Optional items (e.g. Surveys, Development timeline, Operations layout etc.)

The IC is able to assist you with writing your business plan.

SECTION G: HOW TO PREPARE A MARKETING PLAN

1. What is the purpose of a marketing plan?
   The marketing plan is an important component of the business plan. It should provide you with a clear plan of how you will introduce your product into the market, including the commercialization route to be taken. Developing a good marketing plan requires a thorough investigation of the market, in particular to determine whether there is a need for your product in the market, whether customers will buy your product, how to let customers know about your product, how best to get the product to them, and how to compete with existing businesses in your proposed industry.
2. How do I write a marketing plan? 
   A marketing plan can be presented as part of your business plan or as a separate document. If it is presented on its own, it must include a Title Page, Table of Contents, Executive Summary, and Industry and Market Analysis. See How do I write a business plan for a list of the main headings that should be included in an Industry and Market Analysis.
   
   The Industry and Market Analysis must describe the broader industry environment in which your business operates, the characteristics of the specific market(s) for your product, who your potential customers are, who your competitors are, and how you will compete against them. Some of the questions that must be addressed in the Industry and Market Analysis include:
   • What is the state of the economy and how does this impact on your business?
   • What industry is your business in?
   • Are there any industry trends that could affect your business or product?
   • What are the current political, cultural and social trends and how do they affect your business?
   • What current or pending provincial, national and international legislation may affect your business?
   • Are there any threats or opportunities in the environment that could affect your business?
   • What is the target market, i.e. who are your customers?
   • Is there a need for your product in the market?
   • How big is the market?
   • Is it shrinking or growing?
   • What trends are visible in the market?
   • Is the industry mature or relatively young?
   • Who are your major competitors in the industry and what are their annual sales, market share, and growth profile?
   • What strategies have competitors in the industry been using?
   • What are the relative strengths and weaknesses of the competitors in the industry?
   • Is there a threat of new competitors coming into the industry and what are the major entry barriers?
   • What is your competitive advantage, i.e. why will people buy your product or service, as opposed to that of a competitor?

The Marketing Plan, on the other hand, focuses on how you will introduce your product to the market, through the 5 P's, i.e. Product, Price, Promotion, Place and Personnel, otherwise known as the marketing mix. Some of the questions that must be addressed in the Marketing Plan include:

• What features or benefits does your product have?
• Who are your customers?
• What are the personality traits of your customers?
• Do they have a high disposable income?
• Are they price sensitive?
• What influences their buying decisions?
• What pricing strategy will ensure that the target market is reached?
• How should you let customers know about your product?
• What is the best way to get your product to the customers?
• Where should your business operate from?
• Where should you sell your product?
• Who should sell your product?
• What are the expected marketing costs?
• What are the expected revenues from selling your product?

The Marketing Plan should also include a SWOT analysis of your business. A SWOT analysis involves determining the strengths and weaknesses within your company, as well as the opportunities and threats outside of the company.

3. How do I do market research? 
   There are two main sources of market research data, i.e. primary data and secondary data. Primary data refers to data gathered from the customers, suppliers and competitors themselves through direct observation, interviews, email or telephone surveys etc. Secondary data, on the other hand refers to information that already exists. The most common sources of secondary data are publications, databases, company reports, the internet etc. Market research is not difficult to do but takes time and requires some knowledge of data gathering and analysis. The IC is able to provide advice on or assist you with market research and with the development of your marketing plan.

SECTION H: FUNDING FOR COMMERCIALIZATION OF RESEARCH

1. What funding channels apply to the commercialization process? 
   Funding sources for the commercialization of research include specific and generic and public (government-backed) and private sources. Public funds can be structured as grants, loans, rebates, tax incentives, co-investments, or venture capital (VC), while private funding includes seed/incubation funding, angel investments, venture capital and private equity, and private donations, trusts or foundations. The relevant funding channels that apply to different stages of the development and commercialization process are illustrated in the figure

There are a number of different sources of funding for fundamental and applied research. Some of them are listed in the figure. Once it has been recognized that the research has commercial potential, the invention enters into the commercialization process. This may involve proof of concept, further development of the idea, preliminary market analysis etc. Funding for this stage is usually in the form of angel investment or seed funding, though other sources include the NRF's THRIP and Innovation Fund schemes and the Biotechnology Regional Innovation Centres (BRICs). Angel investments are high risk, early-stage investments usually made by wealthy individuals or groups of individuals.

Angel investors are often family members or close friends and are usually experienced and successful entrepreneurs looking for new challenges and investment opportunities. They will probably get heavily involved as mentors to new start-ups in which they invest. Seed funding is also for new ventures in the initial phases of commercialization. This funding instrument is not directed towards R&D, and is also high risk capital.

The next funding stage, which forms the natural exit opportunity for angel investors or self-funded entrepreneurs, should be venture capital or private equity investment. These investors will normally only invest after proof of concept or prototype development. They invest either in potentially sustainable and competitive companies or in the final development, marketing and licensing or sale of inventions to existing industry players. Venture capitalrepresents later stage funding that is usually invested by specialized VC firms who manage funds on behalf of investors. Investments are usually made into medium to low risk ventures for a significant equity stake in the business. More than one venture capital firm may invest in a company, even at an early stage in its development. Venture capital firms, apart from providing funds for development, usually provide assistance with business development and management and access to their extensive business networks. Venture capital firms take a risk when investing in new ventures, and therefore require high returns on their investments. The firms usually exit the investment and make their money by selling their shares in the companies. Typically this happens when a company makes a public offering, or when it is acquired by another company. Private equity is late stage funding typically reserved for existing businesses with established track records of profitability that wish to expand operations. This instrument is also utilized in the funding of management buy-outs and similar deals.

2. What public funding is available for commercialization of research?
   There are a number of public funding mechanisms available for the commercialization of research in South Africa. These include:

• Biotechnology Regional Innovation Centres (BRICs) located in the Western Cape (Cape Biotech Trust;www.capebiotech.co.za), Gauteng (Biopad) and Kwazulu Natal (LIFElab; www.lifelab.org.za). Funds available from the BRICs are directed at the development of biotechnology in South Africa, and therefore are limited to biotechnology projects that are aimed at application in industry. Please visit the respective websites for more information on the procedures and criteria for applying for funding.
• The biotechnology-focused seda-funded incubator, eGoli BIO Life Sciences Incubator (www.egolibio.co.za) in Gauteng. The incubator provides business support to projects at various stages of commercialization. Please visit the eGoli BIO website for more information on the procedures and criteria for assistance.
• Innovation Fund (www.innovationfund.ac.za), administered by the National Research Foundation (NRF). The Innovation Fund supports projects in various focus areas that are aimed at commercialization. Funding is usually for a period of 3 years. The NRF has also established a seed fund to bridge the gap between the Innovation Fund and venture capital funding. More details can be found on Innovation Fund website.
• Patent Support Fund, administered by the Innovation Fund. The fund provides assistance to public research institutions by covering a portion of all patenting costs.
• Department of Trade and Industry (DTI) (www.dti.gov.za) incentive schemes, which are not specifically aimed at the commercialization of research but which may apply to some aspects of it. Examples include the Technology and Human Resources for Industry Programme (THRIP) and the Support Programme for Industrial Innovation (SPII). Details of these schemes are available on the DTI website.

3. What private funding is available for commercialization of research?
   Private funding includes funding from private companies, incubation funding, angel funding, venture capital and private equity, and private donations, trusts or foundations. Examples of such funders can be found on the SA Venture Capital Association Website (www.savca.co.za).

THE COMMERCIALIZATION PROCESS

1. What is involved in commercializing research?
   The commercialization process is generally long and expensive. It involves a number of different stages, which will differ according to the product or process under development. Example commercialization processes are illustrated in the diagram below for a new medical device and a novel drug. Each stage in the process requires specific skills and resources.

2. What are the possible commercialization routes that I can take? 
   There are various options available for commercializing research. The specific commercialization route to be used will be dictated by the following factors:

• Financial investment required for each commercialization route
• Potential return on investment for each commercialization route
• The nature of the technology/product/process itself
• The target market and how it can best be reached

Each of these factors must be examined before deciding on how to commercialize an invention. Some of the available routes are discussed in more detail below.

I.1. LICENSING

1. What is a license?
   A license is a legal document that allows an individual or company (the licensee) to use the intellectual property (proprietary materials or know-how) of another individual or company (the licensor) in return for remuneration. This remuneration is usually in the form of royalty payments, but may also involve an upfront lump sum payment. Unlike an outright sale or assignment, a license allows the licensor to retain ownership rights of the IP. The major advantage of licensing is that the responsibility for manufacturing, selling, distribution and even further development of the technology/product/process can be transferred to the licensee, thus reducing the investment required by the MRC or the inventor in commercialization.
   
   The license agreement has terms defining the length of time the license is valid, the markets (territory) in which the licensee can use or sell the product, whether or not sublicenses are permitted, the nature and amount of upfront fees and royalties, and whether or not the licensor has rights to any improvements developed by the licensee.
   
   MRC researchers may want to license in technologies for use in their research, or they may have a technology that they would like to license out to industry. The IC, together with the relevant legal experts, will assist MRC researchers in both of these scenarios.
2. What issues must be addressed in terms of license agreements? 
   License agreements are very complex and need to be as comprehensive as possible in order to ensure that the rights of both the licensor and the licensee are covered for all eventualities. It is highly recommended that the negotiating and drafting of license agreements are carried out with the assistance of a legal specialist with expertise in the licensing of technologies.
   
   Below are listed some of the key issues that must be addressed when negotiating a license agreement.
   • Obligation for the licensee to share plans for commercial development
   • Time limits on the development and release of the product onto the market by the licensee
   • Clear definitions of the intellectual property related to the license agreement
   • Clear definitions of the types of products the licensee is permitted to develop using the intellectual property
   • The term of the license agreement (In the case of patents this is often the lifetime of the patents)
   • The payment amounts, structure, and terms
   • The exclusivity and geographical scope of the license
   • Guarantees or warranties on the technology
   • Rights of the licensor to any improvements developed by the licensee
3. What types of technology licenses do you get?
   The majority of technology licenses are for patents, copyright (especially in software) and know-how, and one license may relate to more than one patent and/or other type of intellectual property. The following types of technology licenses can be granted by licensors:

• Patent commercialization licenses provide licensees with rights to patented technology or technology covered in patent applications that have been filed in anticipation of receiving a patent. These licenses can be exclusive or non-exclusive.
• Exclusive licenses are those in which one licensee receives exclusive rights to develop products using the IP. This means that both the licensor and other potential licensees are prevented from exploiting the IP. This often provides the licensee with a significant competitive advantage and the potential for a large financial return, therefore, the royalty obligations and financial terms in such licenses are often quite substantial.
• Non-exclusive licenses give several licensees as well as the licensor the right to develop products using the IP. Such licenses are often given when the technology has the potential to significantly benefit the wider public, and when providing multiple licenses may accelerate its entry into the marketplace. Some non-exclusive licenses allow the licensee to use the IP internally only, e.g. where the technology is useful as a tool or process but is not itself a marketable product.
• Commercial evaluation licenses (also known as options) grant a potential licensee the option (for a fee) to negotiate a license within a specific time, while the company assesses the commercial potential or appropriateness of the technology. This allows the licensee to explore the value of a new technology for a limited time before making the financial and resource commitment of a full license. Commercial evaluation licenses have smaller financial terms and are of a short duration. If the licensee finds the technology meets their needs, then the parties can negotiate a new agreement for an exclusive or non-exclusive patent commercialization license.
• Biological materials licenses provide licensees with access to non-patented materials or biological constructs that were prepared at great effort and expense and may only be available from the laboratories that made them. These licenses can be non-exclusive and for internal use only, or for commercial sale to promote the wider use of unique materials or biological constructs.

4. What are royalties and upfront payments in licensing and how are they decided?
   A license is a transfer of value, and royalties and up-front fees are the agreed price of that value. Since licenses are not traded in open markets, where the price can be set through supply and demand, each negotiation is unique and has to reflect the intense evaluations of each party. A licensor will want, at a minimum, to recover the costs, or some reasonable portion of the costs, already invested in the product, and to generate a steady flow of income. Up-front payments should be high enough, if possible, to meet the licensor's need for short-term income and to assure that the licensee is according an appropriate level of seriousness to the product, but should not be so high as to limit the ability of the licensee to invest in the product and make it a success. Other factors to consider are the life of the product and the life-time of the intellectual property rights being granted. The shorter the life of a product (because other better products are expected to emerge quickly), the less the licensor can ask for up-front fees and, to a lesser extent, royalty.
   
   Royalty rates differ considerably and depend on the following main factors:
   • The stage of development of the product when licensed out
   • The type of product
   • The industry in which it is applied
   • The price at which the product can be sold
   • The maturity of the market
   • The geographical scope of the license
   • The term and exclusivity of the license

Royalties can vary from 0% for technologies or products that are licensed out at the idea stage to 10% for a product with a captured market and distribution channel.

If the license is based on a patent, the level of royalties may decrease, or the license may even expire at the end of the patent life. The issue of license term is more complicated when the license is for know-how. A reasonable approach toward a know-how license is for the royalty to diminish with time and eventually reach zero when both parties agree the know-how would be no longer of value. However, if know-how is essential for the successful manufacture and sale of the product throughout its lifetime, there is no reason for the royalty to change. Also, a licensor may make continual changes in the know-how and pass those to the licensee. Again in this situation, royalties may be collected for a very long time.