PATENT

HISTORY :

The later part of the nineteenth century saw an increase in inventions in the field of art, process, method of manufacture, machinery, apparatuses and other substances by manufacturers who became very much interested that the inventions done by them should not be infringed by anyone else by copying them or by adopting the methods used by them.

In order to save the inventors the then British rulers enacted the Indian Patents and Design Act, 1911 . Since then due to substantial changes in the political and economic conditions of the Country , it was found desirable to enact a comprehensive law on the subject which would protect interests of both the inventor as well as consumer.

The Patents Act, 1970

The Patent Act, 1970 was therefore passed to amend and consolidate the existing law relating to patents. The Act extends to the whole of India. 

What is a Patent?

The term patent usually refers to a right granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof.

 In general the term of a new Patent is 20 years. From the date of filing.

INVENTION

The term invention according to the Patent Act has been defined as “a new product or process involving inventive step and capable of industrial application” where “inventive step” means a feature that makes the invention not obvious to person skilled in the art.

Inventions Not Patentable :

     I.        An invention which claims anything obviously contrary to well established natural laws.

   II.        The mere discovery of a scientific principle or the formulation of an abstract theory.

  III.        The mere discovery of any new property or new use of a known substance.

 IV.        A substance obtained by admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance.

  V.        A method of agriculture or horticulture.

Types of Patents :

     I.        An ordinary patent.

   II.        A  patent or addition for improvement in or modification of an invention for which a patent has already been applied for or granted.

  III.        A patent granted in respect of a convention application filled under section 135 of the Act.

A product patent for a medicine or drug as provided by the Patents(Amendment)Act, 1999

Procedure for getting a Patent

•      An application for an ordinary patent including for a product may be made by the person claiming to be the first or true inventor , his legal representative , or his assignee , either alone or jointly with any other person.

•      An application for the patent of addition may be made only by the applicant for original patent to which it is an addition, if the application for original patent is pending , or by the registered proprietor of such original patent if the patent has already been granted.

•      A convention application may be made by any person who has made the application for patent in respect of that invention in convention country , or by this assignee or his legal representative.

•      Every application for a patent should be for one invention only and should be made in the prescribed form and filled in the Patent office (Head office of Calcutta and Branch Offices at Chennai , Mumbai and Delhi ).

•      If the application is made by virtue of an assingnment, then the proof of the right to make an application should be furnished.

•      It must be stated in the application that the applicant is in posesion of the invention and the name of the owner claiming to be the true and first inventor must also be stated.

•      Every application must be accompanied by a provisional or a complete specification .

A complete specification is a document drawn in a prescribed form and contains the following :

     i.        A  full description of the invention and its operation or use and the method of performance.

    ii.        Disclosure of the best method of performing  the invention known to the applicant and for which he is entitled to claim protection.

3. A statement of claim or claims defining the scope of the invention for which protection is sought.

Intellectual property rights in India

As was the case with China, India too showed signs of resistance to quick enforcement of international intellectual property right (IPR) protection laws as demanded by the developed countries, particularly the US. China could get away on grounds that it is not a member of the World Trade Organisation (WTO), but India was required to comply. Under the terms of the WTO, India is required to implement WTO-standard IPR protection laws by 2005. It must be acknowledged that there has been remarkable progress in IPR protection the field of software and cinema products. India's general argument was that it does acknowledge in principle the case for strict IPR protection, but this can be done only in phases suited by its own ground reality. The reality is that absence of international IPR protection for some decades  has spawned employment for millions, so an overnight clampdown on IPR violators would foment social unrest. However, under pressure from its own domestic industry and the United States, India strengthened its copyright law in May 1994, placing it at par with international practice. The new law, which entered into force in May, 1995, fully reflects the provisions of the Berne Convention on copyrights, to which India is a party. Based on its improved copyright protection, India's designation as a "priority foreign country" under the United States' Special 301 list was revoked and India was placed on the "priority watch list." Copyright enforcement is also rapidly improving. Classification of copyright infringements as "cognisable offenses" expands police search and seizure authority. While the formation of appellate boards under the new legislation should speed prosecution, local attorneys indicate that some technical flaws in the laws, which require administrative approval prior to police action, need to be corrected. Trademark protection is considered good by the US authorities, and could be raised to international standards with the passage of a new trademark bill that codifies existing court decisions on the use and protection of foreign trademarks, including service marks. The bill was first introduced in 1995 but failed to win parliamentary approval. Passage of the trademark bill is expected in 1998. Enforcement of trademark owner rights had been weak in the past, but is steadily improving as the courts and police respond to domestic concerns about the high cost of piracy to Indian rights' holders. India's patent protection is weak and has especially adverse effects on international pharmaceutical and chemical firms. Estimated annual losses to the US pharmaceutical industry due to piracy are $450 million, but Indian authorities have a different point of view. India's patent act prohibits product patents for any invention intended for use or capable of being used as a food, medicine, or drug or relating to substances prepared or produced by chemical processes. Consequently, many drugs invented by foreign companies are widely reproduced. Processes for making drugs are patentable, but the patent term is limited to the shorter of five years from the grant of patent or seven years from the filing date of the patent application. Product patents in other areas are granted for 14 years from the date of filing. However, as a signatory to the Uruguay Round of GATT, including its provisions on Trade Related Intellectual Property Rights (TRIPS), India must introduce a comprehensive system of product patents no later than 2005. The Indian government has formed an advisory committee to recommend changes in the 1970 Indian Patents Act. A temporary ordinance for patent protection implementing the "mailbox" provisions of the WTO TRIPS agreement and providing for exclusive marketing rights was issued in December 1994. However, the ordinance lapsed and the parliament has yet to pass a new patent bill implementing the provisions of the ordinance. In July 1996, the U.S. initiated WTO dispute settlement procedures over India's failure to implement its TRIPS obligations. The final panel report on this case was issued in August 1997, and ruled that India had failed to meet its obligations under the TRIPS agreement. Indian officials have pledged to introduce another bill in parliament which, if passed, will put India in compliance with its TRIPS obligations. The bottomline is that India considers itself a responsible member of the WTO which suggests that international class IPR protection should be in place by 2005. Besides, given India's determination to emerge as a power in the global software industry, it is most likely that all IPR protection laws will be instituted and enforced by 2005. Note that Bill Gates, the chief executive officer of Microsoft Corporation, has distinguished India as a most promising base for software development. If such an IPR-conscious business leader like Gates is of this opinion, one can only conclude that India's IPR scene is no deterrent to foreign companies.

Quality Assurance of Pharmacy Education

Background

As the practice of pharmacy has become more complex and more accessible and as medical therapies have been used in more and diverse patients, patient safety and accountability for outcomes of therapy have become a greater focus of attention. Consumers and governments are demanding higher standards and seeking assurances of quality. Likewise, greater attention is being paid to the quantity and quality of pharmacist and pharmaceutical human resources, including the systems in place to assure the quality of education and training and the ongoing competence of practitioners. Consequently, many countries are introducing, expanding or undertaking major reform of pharmacy education. Such developments must be accompanied by robust systems to assure the quality of the educational structures, processes and outcomes; the latter primarily being graduates who are competent and capable of performing safely and effectively in their practice setting and contributing to the delivery of healthcare.

Introduction 

To promote and facilitate international dialogue and collaboration in the area of quality assurance of pharmacy education, the International Forum for Quality Assurance of Pharmacy Education was established in 2001. It operates under the auspices of the Academic Section of the International Pharmaceutical Federation (FIP), primarily as an informal network of individuals interested in the quality assurance and quality advancement of pharmacy education. The Forum has identified that countries seeking to establish or improve their quality system would benefit from an internationally‐developed and adopted QA framework. The Quality Assurance Project Team of the Pharmacy Education Taskforce was convened to continue the development of this “global framework”. The framework incorporates core principles and elements considered essential for an effective approach to quality assurance.

The objectives of the Quality Assurance Project Team are to: 1. Validate and further develop the Global Framework for Quality Assurance of Pharmacy Education. 2. Examine accreditation and quality assurance models and systems in country case studies 3. Provide guidance for the development of national and regional quality assurance systems

What makes a good Regulatory Affairs professional?

Most regulatory professionals are graduates in a scientific discipline – commonly life sciences or pharmacy – although increasingly biotechnology-based degrees are valuable. Some choose to have an additional legal qualification, and TOPRA offers an MSc in Regulatory Affairs for those who wish to gain a formal professional qualification in the discipline.The ability to tackle data in a wide range of scientific areas and to quickly grasp new concepts and complex technical information is vital.

Communication skills are very important.Analysing issues and presenting both written and oral evidence before a panel of experts such as scientists, pharmacists, doctors and lawyers who run the government agencies require considerable understanding of both legal and scientific matters. An attention to detail is a pre-requisite.

How do Regulatory Affairs professionals relate to other professionals?

The very nature of the task to be done brings regulatory personnel into contact with almost every discipline within the industry. This may include scientists such as pharmacologists, toxicologists, analytical chemists, pharmacists, medical doctors, veterinarians, engineers, physical chemists and statisticians.

That being said, the work is by no means confined to science but extends to the interface with and appreciation of advertising,marketing,legal,patent and manufacturing skills.

An ability to liaise closely with every kind of specialist is a crucial part of the job. Not only must there be the ability to use and assimilate information provided by such specialists, but also to present that information to regulatory authorities and feed-back their opinions to the rest of the company and appraise staff about the current thinking of the regulatory bodies.

In short, the regulatory specialist is central to the business and has the opportunity to interact with a wide range of specialities and extend his or her knowledge while doing so.

Why is Regulatory Affairs important?

In today’s competitive environment the reduction of the time taken to reach the market is critical to a product’s and hence the company’s success.The proper conduct of its Regulatory Affairs activities is therefore of considerable economic importance for the company.

Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost many millions of pounds, Euros or dollars to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data, or the release of product bearing incorrect labelling, may easily result in the need for a product recall. Either occurrence may lead to the loss of several millions of units of sales, not to mention the resulting reduction in confidence of the investors, health professionals and patients.

A good Regulatory Affairs professional will have a ‘right first time’ approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximise the cost-effective use of the company’s resources.
The Regulatory Affairs department is very often the first point of contact between the government authorities and the company.The attitudes and actions of the Regulatory Affairs professionals will condition the perceptions of the government officials to the company -for better, or for worse! Officials respond much better to a company whose representatives are scientifically accurate and knowledgeable than to one in which these qualities are absent.

The importance of the Regulatory Affairs function is such that senior Regulatory Affairs professionals are increasingly being appointed to boardroom positions, where they can advise upon and further influence the strategic decisions of their companies.

What is Regulatory Affairs?

Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals – and those who don’t, rely on the expert advice of independent regulatory consultants to meet their obligations.

The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products.They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.

They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned.

They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.

It may take anything up to 15 years to develop and launch a new pharmaceutical product and many problems may arise in the process of scientific development and because of a changing regulatory environment. Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.

WHAT IS QUALITY?

THERE ARE A 4 WAY TO SAY “WHAT IS QUALITY”:

A.   "Quality itself has been defined as fundamentally relational:  'Quality is the ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs"

B.     The quality of something can be determined by comparing   a set of inherent characteristics with a set of requirements. If those inherent characteristics meet all requirements, high   or excellent quality is achieved. If those characteristics do  not meet all requirements, a low or poor level of quality is achieved.

C.   According to Iso 9000: "Degree to which a set of inherent characteristics fulfills requirements." The standard defines requirement as need or expectation.

D.   The totality of features & characteristics of a particular product( or service) which bear on its ability to satisfy stated & implied needs.

WHAT IS QUALITY ASSURANCE?

• Quality Assurance is a vital part of drug development in the small pharmaceutical environment. It is the department which is responsible for ensuring that all the appropriate procedures have been followed and documented so that clinical progress can be made.
• It reffers to planned & systematic production process that provides confidence in product suitability for its intented purpose.
•  A system in which the delivery of aservice (or product) is assessed & compare with that standards
• conforming the degrere of excellence of a product ( or service) which is measured against its defined purpose
• A progrrame that is intented by its actionto guarantee a standard level of quality.
• In develoipingt product ( or service ) QA is a systemic process of checking to see wheather product( or service) being developed is meeting specified requirements.

WHAT IS PURPOSE OF QUALITY ASSURANCE?

"The primary purpose of the quality assurance review shall be to advance error prevention by analyzing, individually and collectively, investigative and other pertinent data collected in response to a medication error to assess the cause and any contributing factors such as system or process failures."