IPR Yatra reiterates rationale use of medicines through govt intervention

Aimed at creating awareness about the proper functioning of pharmacies in private and public sector and the need for rational use of medicines, India Pharma Revolution (IPR), a Delhi-based Group of Pharmacists reached Goa and met state government health officials on November 18 after touring 25 states.

In order to sensitise patients towards health safety, pharmacists through the IPR yatra advocated the need of common man to access knowledge on Adverse Drug Reactions (ADR), rationale use of medicines, drug interactions, side effects and toxicity through the establishment of drug information centres and pharmacovigilance centre in the Goa state.

Among the other demands IPR yatra pursued were setting up of warehouses for stocking all lifesaving drugs and creation of medical supply depot for storage of generic drugs. "State government should take the initiative on this front as central government will readily support such a system. Besides this, quacks should also not be allowed to practice medicine and the state government should take this aspect seriously," members of the yatra said. Other demands included creation of separate directorate of pharmacy in the state and also restructuring of pharmacists cadre.

Reiterating the fact that pharmacy sector at the government level needs a revamp to provide better services to the public, Yatra convenor Amitav Joyprakash Choudhury pointed that modernization of drug testing labs in the state, appointment of drug analysts and technical manpower need to be met urgently by the concerned authorities for better patient safety.

As per the agenda of IPR, the pharmacists from across the country have also demanded that the government should recognise professionals with Doctor of Pharmacy (Pharm. D) as primary healthcare providers in the state. Professionals holding Pharm D degrees are not recognised as primary healthcare providers, while they have all the knowledge about the drug information and can treat basic illness.

Among other demands, the pharmacists have proposed the state government to create a separate Directorate of Pharmacy in the medical and health department and designate Pharmacists as Director Pharmacy, Deputy Director (Admin), Deputy Director (purchase), officer in charge pharmacy and chief pharmacists in each hospital in every district.

Source: PharmaBiz

UTILITY MODEL PATENTS

India’s commerce ministry is reported to be considering a proposal to introduce a Utility Model for patents in the country as a new tool for granting intellectual property rights. The Utility Model is a framework for providing limited protection to those innovations which may not meet the standards of the Patents Act but are still commercially exploitable and socially relevant. The Department of Industrial Policy & Promotion under the commerce ministry floated a discussion paper on the utility model of IP protection in India a few weeks ago. The requirements for obtaining a utility model protection for a product are less stringent than what is required for a patent with the test of inventive step being absent. And the applications for the utility model of patents need not necessarily be accompanied with substantive examination. It seems that the MNC lobby is behind this new initiative by the government so as to dilute the effectiveness of the revised Patent Act. The Section 3(d) of the Indian Patent Act, amended six years ago, has already prohibited patenting of insignificant or minor improvements of known compounds. The Section has also given opportunity to anyone to object a patent before and after it is granted. It is this crucial section of the amended Patent Act that has prevented pharmaceutical companies from obtaining patents in India for pharmaceutical substances that are not actual inventions such as combinations or minor modifications of formulations of known compounds.

Frivolous patent filings are done by the companies to prevent and delay generic competition that could lead to lower prices and thus greater access to essential medicines. There is no doubt that granting patent protection for pharmaceutical substances involving only incremental innovation is against the public interest as such research does not involve any huge expenditure or time line unlike in the case of a new molecule. A 20 years market exclusivity for any incremental innovation cannot be justified as powerful pharma companies charge any price for such products by strongly promoting them at the cost of patients. Currently, there is no price control on patented products world over. Take the case of Glivec, the high priced anti cancer drug of Novartis. Dispute on its patentability is on for the last more than five years. Although it is a clear case of incremental innovation, Novartis is not willing to give up its claim for patent and now it has approached Supreme Court. Since the amended Patent Act was notified in 2005, there are several where patent applications are being opposed by generic companies on patentability. Considering these facts, any move by the MNC lobby to influence the commerce ministry to circumvent the Section 3(d) has to be resisted. Doha declaration on TRIPS agreement and public health had confirmed the flexibilities allowed to WTO members to define patentability in the national laws.

6 MONTH PART-TIME DIPLOMA IN PHARMA REGULATORY AFFAIRS

AIPS is introducing this training course for all those seeking a career in the field of Drug Regulatory Affairs in the pharmaceutical industry. The course has been specially designed keeping in the mind the needs of the Indian Pharmaceutical industry, and the course contents include.

Introduction to Regulatory Affairs

Good Manufacturing Practices, QA and Regulation

ICH

Dossier preparation and CTD Compilation

Pharma Regulatory Regime in the U.S., EU, Japan, India and Rest of the World

Clinical Investigational Studies

Pharma Patents, IPR and Regulation

Electronic Submissions

To register, please e-mail info@aips.ac.in

One day Seminar on PATENT STRATEGIES FOR PROTECTING INVENTIONS IN U.S., EUROPE & INDIA

Academy of Intellectual Property Studies, Intellectual Property Management - Mumbai, India organizes a one day seminar that will look at the challenges and pitfalls faced while prosecuting patents in the U.S., Europe and India, and suggest strategies that can be adopted to protect biotech and pharmaceutical inventions. IP challenges for biosimilars will also be studied, including freedom -to - operate issues, the regulatory pathway for approval of biosimilars, and the related IP strategies for innovator and generics companies. A combination of US and EP perspectives in a single event, supplemented by some specific aspects of national Indian law, will add value to the event.

Dates January 18, 2011

For further information, send in youre-mails to info@aips.ac.in

Two day Seminar on the Indian Patent Act

Academy of Intellectual Property Studies, Intellectual Property Management - Mumbai, India organizes a two day training course providing an in-depth analysis of the Indian Patent Act. This course will be suitable for practicing professionals working in attorney firms or IPR Patent Cells, as well as those taking the Indian Patent Office patent agent examination to qualify as Registered Patent Agents. The methodology will be interactive, and the expert faculty will provide a Chapter / Section wise analysis of the Patent Act. Case studies and on-going Q&A sessions will give participants the opportunity to pose queries and become fully conversant with the nuances of the Act.

Dates: January 8 & 9, 2011
Faculty Dr. H. Subramaniam, Managing Partner, Subramaniam Natraj & Associates, New Delhi

6 MONTH PART-TIME DIPLOMA IN PHARMA REGULATORY AFFAIRS

Academy of Intellectual Property Studies is introducing this training course for all those seeking a career in the field of Drug Regulatory Affairs in the pharmaceutical industry. The course has been specially designed keeping in the mind the needs of the Indian Pharmaceutical industry, and the course contents include.

Introduction to Regulatory Affairs
Good Manufacturing Practices, QA and Regulation
ICH
Dossier preparation and CTD Compilation
Pharma Regulatory Regime in the U.S., EU, Japan, India and Rest of the World
Clinical Investigational Studies
Pharma Patents, IPR and Regulation
Electronic Submissions

To register, please e-mail info@aips.ac.in

Short term courses at NIPER

In an effort to generate revenues with the help of private partners to run the newly established NIPERs, the Department of Pharmaceuticals (DoP) is planning to launch some short term courses in the new NIPERs as per the detailed project report submitted by the consultant firm, Deloitte Touche Tohmatsu Pvt Ltd. Courses like those on intellectual property rights concerning the pharma industry, short term courses for the employees of the pharma companies, course on emerging sectors like biopharma are being planned in these institutes.

Two-day clinic on “Meeting the Inventor”

The Academy of Intellectual Property Studies (AIPS) will be organizing a two- day clinic on “Meeting the Inventor” on February 12 and 13.

The clinic will be an in-depth analysis of the interaction between the inventor and the IP cell in an organization. In an effort to maximize the IP value of the R&D efforts of the organization, especially that of the patents it files, the patent has to stand in the court of law and also have the best achievable commercial value. To ensure this, the patent manager / attorney and the actual inventor have to work in tandem, such that the groundwork laid is dependable and foolproof. The clinic is devised to develop related expertise, and looks at how the IP cell and the R& D team in an organization should interact such that potential IP is recognized and its full value extracted.

The clinic will adopt a highly interactive methodology .Under the mentorship of experienced professionals, a real-life scenario will be simulated wherein the participants will work on suitable cases.The AIPS clinic will train participants with the support of leading faculty H. Subramaniam of Subramaniam, Natraj & Associates, New Delhi and Dr B N Roy of Lupin Ltd.

For more details e-mail info@aips.ac.in or gita@aips.ac.in

NGOs ask govt to reject Mashelkar Committee recommendations on patent

NGOs working on patent issues in the country have asked the government to reject the recommendations of the Mashelkar Committee on the twin issues of 'evergreening of patents' and 'excluding micro-organism from patentability'. Instead, the NGOs have asked the government to accept the recommendations of Department Related Parliamentary Standing Committee which has recommended that the patentable pharmaceutical product should be restricted only to 'new drug molecules'.

"Apparently, the recommendations of the Parliamentary Committee should take precedence over those of the Mashelkar Committee on the two issues under consideration, and, therefore, the recommendations of the Mashelkar Committee should be disregarded and appropriate amendments introduced in the amended Patents Act 1970," National Working Group on Patent Law (NWGPL), an NGO of decades of standing, said in its letter to Union commerce minister Anand Sharma.

Pharma patents: Mashelkar report gets Centre approval

Two years after he was accused of acting against country’s national interest by producing a report that apparently favoured multinational drug companies — to the detriment of generic manufacturers with India — eminent scientist R A Mashelkar has been redeemed by the government which has now accepted all recommendations contained in that report.

Mashelkar, as head of a Technical Expert Group that had four other members, had been asked by the government in 2005 to examine whether the grant of patents for pharmaceutical substances could be limited only to ‘new chemical entities’ and ‘new medical entities’ involving one or more inventive steps, or they could be granted to ‘incremental innovations’ on existing drugs as well.

The Mashelkar Committee, in its report in February 2007, had concluded that under the TRIPS (Trade Related Intellectual Property Rights) Agreement, to which India is a signatory, ‘incremental innovations’ would have to be granted patents. The committee also found that patents could be obtained on micro-organisms as well, another sensitive issue for Indian pharmaceutical companies.

The report had been severely criticised by many generic drug manufacturers and industry associations but a major controversy began only after it was discovered that one of the paragraphs in that report, backing the findings, was an exact reproduction from a submission made to the committee by a UK-based lawyer, who had represented multinational drug companies in the past, but without any attribution. Mashelkar, who served as the Director General of Council of Scientific and Industrial Research (CSIR) for 11 years, was accused of plagiarism and this charge was used to trash the entire report by many organisations and political parties.

Owning responsibility for the ‘technical’ error, Mashelkar — who has won famous international battles for the country on patents of neem, basmati and turmeric — had resigned from the committee but stood by the findings of his report. His resignation, however, had not been accepted by the government which persuaded him earlier this year to submit a fresh report on the same matter.

The fresh report, submitted in March this year, came to the same conclusion, backed by some additional technical and legal arguments, and has now been accepted by the government.
“TEG (Technical Expert Group) has come to the conclusion that it would not be TRIPS compliant to limit the grant of patent for pharmaceutical substance to a new chemical entity or to a new medical entity involving one or more inventive steps. It would also not be TRIPS compliant to exclude micro-organisms from patenting. This view has been accepted by the government,” said Secretary, Department of Industrial Policy and Promotion, Ministry of Commerce, in a letter signed on August 5.

Mashelkar told The Sunday Express that he was happy that truth had finally prevailed. “I appreciate the fact that the government has reposed faith in me despite attempts to question my integrity by certain groups. As I have said earlier, an inadvertent technical error in the drafting of the report cannot be used to trash the solid scientific and legal arguments on which it is based,” he said.

The fresh report has the signatures of three of the four other members of the committee — Prof Goverdhan Mehta, Prof N R Madhava Menon and Moolchand Sharma. The fourth, Prof Asis Dutta, had ceased to be a member following his resignation after the controversy broke out in 2007.

IIPS to start 4-month certificate course in intellectual property

Mumbai-based Shri Vile Parle Kelavani Mandal's Institute of Intellectual Property Studies (IIPS), a pioneer in IP education, is starting a 4-month certificate course in intellectual property (CCIP) on August 8, 2009.

CCIP - trains you in the mechanisms of management of IP. The course is ideal for the legal and technical students those are working with corporate IPR cell. It is designed for all professionals from the knowledge industry wanting to leverage and capitalize their intellectual property.

The programme provides a sound insight into the Intellectual Property Rights regime, the different forms of IPRs such as Copyright, Patents, Trademarks, Trade Secrets, Industrial Designs, GIs etc., their role and significance; and methods of obtaining and protecting them.

The 4-month certificate course on intellectual property is held twice a year and is intended to cater to working professionals as well as students seeking to make a career involving IP issues. The course will help to complement professional skills in a niche area, and will be useful for careers in a wide cross section of industry.