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.

Seminar on European patent prosecution on April 15

Academy of intellectual Property Studies (AIPS) will be organising a one-day seminar on 'European patent prosecution' on April 15 at AIPS, Mumbai. The seminar will focus on the patent claims vis-à-vis Article 19 and 34 amendments. It will focus on the amendments to Articles 19 and 34, and comment on how they influence the patent prosecution process.

Filing of patent applications at the European Patent Office (EPO) had to take into consideration a variety of amendments in the recent past. The seminar will discuss issues that are often raised while patenting certain specific types of subject matter in the pharmaceutical, chemical field, such as polymorphs and formulations, patenting of biotech inventions, etc. Strategic tips and techniques that can be employed to successfully prosecute patent applications at the EPO will also be provided at the event.

The speakers of this event are Mike Snodin, from the US & European Patent Attorney, Partner, Potter Clarkson LLP and Dr John Miles, Fellow of CIPA, European Patent Attorney, Partner, Potter Clarkson LLP.

AIPS is an institute that has been set up, in affiliation with the Indian Drug Manufacturers Association (IDMA), It aspires to be a leader in the field of IP studies, offering a mix of training and learning programmes that will enable the participants to become IPSmart.

For further details, contact: Gita Chandrashekhar on 2874 6123/6522 1097, or e-mail:gita@aips.ac.in

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

Suspension of licence to Manufacture/Sale/Distribution of Rosiglitazone

Drugs Controller General of India has requested All State Drug Controllers to suspend the Manufacture/Sale/Distribution of Rosiglitazone and rosiglitazone FDCs following the recommendation from an expert committee that was constituted to examine the safety issue of Rosiglitazone.

European Medicine Agency (EMEA) and U.S. FDA recently suspended the marketing authorisation of rosiglitazone and rosiglitazone FDCs due to the cardiovascular events and adverse effects on lipid profile.

One Day Seminar on How the Indian Patent Office Decided in 2009

Year 2009 was an active year for the Indian Patent office, with more than 150 decisions involving patent applications being rendered. The choices the Patent Office makes in coming to these decisions gives an insight into the decision-making process at the Patent Office. More than the Patent Manual, it is these decisions that provide real-life situations of how applications are decided at the Patent Office. The orders of the Patent Office cover a wide array of matter ranging from application refusals under section 15 to pre-grant opposition . Your interest may lie in seeing your patents granted or in opposing others patents before their grant. Either way, you need to know the mind of the Patent Office this Seminar will tell you how the Patent Office decided in 2009.

The Agenda will include:
- Brief survey on the adjudicatory functions of the Patent Office with specific focus on section 15 and section 25 orders.
- Survey of all the cases decided by the Patent Office in 2009
- Analysing general trends on how the patent office decides in particular situations involving:
* Request for examination of applications
* Refusal of applications
* Divisional applications
* Abandonment of applications
* Pre-grant opposition of the application

Specific case studies to understand why and how patent applications get rejected

Venue: Academy of Intellectual Property Studies, Mumbai'

Date: Saturday, June 26, 2010-06-04

For more details :call 91 22 2874 6123 / 6522 1097 or e-mail info@aips.ac.in

One Day Seminar on Pre Grant Opposition

The Patent Office offers a level-playing field for challenging patents before their grant. This mechanism of a Pre-grant Opposition is a legal and cost-effective option, allowing companies to avoid expensive and time consuming infringement suits being brought against them. It also provides a good way to expand business opportunities, and companies have used pre-grant opposition to effectively challenge some of the biggest drugs in history such as Glivec, Forteo, Cialis, Diovan, Iressa, Viread, Caduet, Prezista, Nexium, Hepsera, Tamiflu, etc. The Seminar will study pre-grant opposition as an option, and the Agenda for the day includes:

1. General introduction on pre-grant opposition
2. The mechanics of drafting, filing and contesting a pre-grant opposition
3. Pre-grant opposition and the aftermath: What to do when the matter goes beyond the Patent Office
4. Survey of pre-grant opposition cases decided by the Patent Office since 2005 to 2010
5. Specific case studies to study the trends in pre-grant opposition

Venue: Academy of Intellectual Property Studies, Mumbai

Date: Friday, June 25, 2010

5 Day Workshop on Patent Fundamentals and Practice.

This training programme, designed for executives whose scope of work calls for a broad working knowledge of patents, will provide an insight into the related legal & practical issues. Eminent faculty will take the participants through sessions on Patent Basics, Prior Art Search, Data Mining, Search Strategies, Specification Drafting, Filing and Prosecution of Patent Applications including PCT applications, Opposition Procedures at the Indian Patent Office, Claim Interpretation and Analysis, Freedom to Operate guidelines, the Trade Secrets vis-a-vis Patents debate, etc.

Venue: AIPS, Mumbai
Date: May 14 - May 18, 2010
For more details : info@aips.ac.in

Patent office begins data compilation on 'working patents' in India

For the first time in the history of patents in the country, the government has started the gargantuan process of compilation of data regarding the status of the valid patents granted during the last over 20 years in the country. Aiming to codify a data to make it available to the public, the Controller General of Patents, Designs and Trademarks has asked the patentees and licensees to furnish information 'on working of patents' before March 31, 2010. The Controller General of Patents has also warned that any failure to comply with the order will attract punishment.In a notification dated 24 December, 2009, the Controller General of Patents said, “All patentees and licensees are required to furnish information in Form No 27 on working of patents as prescribed under section 146 of the Patents Act (as amended) read with Rule 131 of the Patents Rule 2003 (as amended). Attention of the patentees/licensees are also invited to provisions of section 122 of the Patents Act, 1970 (as amended) wherein penalty is prescribed for non-submission of such information.”

This is for the first time that the patent office is codifying the patents granted by the patent office in India. “My aim is to make available to public the complete information about the valid patents granted in India. We will publish the complete information about the Indian patented products, whether they are working or not working etc, by June or July this year,” said P H Kurian, controller general of Patents, Designs and Trademarks.

It is the fundamental duty of the Patent Office to make it public the information regarding the patents which are working or which are not working so that others can apply for compulsory licensing, Kurian said and added that those who do not comply will be prosecuted as per the law. All these data will be combined and will be published in the patent journal, by June-July this year and now onwards it will be published every year, Kurian added.

Pharmexcil's 2nd Patent Facilitation Centre to be set up at NIPER, Mohali

The Pharmaceuticals Export Promotion Council will launch its second Patent Facilitation Centre (PFC) at National Institute of Pharmaceutical Education and Research (NIPER), Mohali, by the end of the month to provide patent related information for the exporters in Northern Region.Pharmexcil, which had launched its first PFC at Hyderabad in July, 2008, will launch the second centre on November 26, 2009. The centre will also provide a platform to students at NIPER to engage in patent related services to pharmaceuticals industry through various projects and research activities.

The council has altered its earlier plans to set up a centre at New Delhi to support the exporters in Northern Region and has finalised the location at Mohali considering the suggestion of the Department of Pharmaceuticals. Launching of PFC at Mohali will also help the exporters around the area, with pharma manufacturing hubs like Himachal Pradesh, Uttranchal are at proximity, said Dr P V Appaji, executive director, Pharmexcil.

"There are a lot of resources and data available at NIPER, Mohali. Further, the location is also near to so many pharma manufacturing hubs including Baddi. For the timebeing, our centre at Mohali will act as the support centre for pharma exporters in Northern Region," informs Dr Appaji.

The centre is being set up with funding support from Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Pharmexcil is hiring the small facility at NIPER, Mohali.

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.

Free online courses on Intellectual Property Rights

WIPO Worldwide Academy provides the following free online courses on Intellectual Property Rights

DL-001 Primer on Intellectual Property
Summary: Covers briefly the fundamental aspects of intellectual property
Tutored: No
Duration: 3
Cost: Free of
Next Session: Open
Exam:
Certificate: No

DL-101 General Course on Intellectual Property
Summary: This course covers the main areas of intellectual property, namely copyright, related rights, patents, trademarks, geographical indications, industrial design, plant breeders' rights, unfair competition and international registration systems.
Tutored: No
Duration: 50 hours
Cost: Free of
Next Session: October 1 to November 15 (Exam: November 16-18)
Enrollment: July 1 to September 20,
Course Administrator: DL101e.academy@wipo.int

101PCT General Primers - Introduction to the Patent Cooperation Treaty
Summary: This course provides an introduction and general overview of the Patent Cooperation Treaty (PCT), an international system for seeking patents on a global scale.
Tutored: No Duration: 4
Cost: Free of
Next Session: Open
Exam:
Certificate: No
Course Administrator: pct.our@wipo.int

Click here for more details and to enroll

Certificate Course in PATENT FUNDAMENTALS

Academy of Intellectual Property Studies is providing a certificate course in PATENT FUNDAMENTALS

The course will provide an in-depth understanding of the theory underlying patents. It will guide participants on the role of patents, patentability requirements and the major concepts of Patent Law. The Indian Patent Act, International and Comparative Patent Law, Filing and Prosecution of patents in India, PCT filing etc. will also be studied. Hands-on training will be provided on Prior-art Search and Specification Drafting, and these technical sessions will ensure that the participant has gained sufficient expertise to contribute effectively at the work-place. The faculty includes practicing professionals who are experts in the field, dealing with patenting issues on a daily basis.

Duration 5 months . (Part time)

Commencement June 27, 2009 .

For details, please mail info@aips.ac.in

Award for Companies who secure Patents in 2008-09

In order to encourage Patent Knowledge utilization by Pharma Exporters, it is proposed to present awards to the PHARMEXCIL members securing the patents from any Patent Granting Authority in the year 2008-09. These awards are sponsored with support from Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India.

Patents under the following 7 product groups under LSM / SME categories will be considered for awards separately:

Ø Bulk Drugs / APIs
Ø Formulations
Ø Biotech Products
Ø Herbal / ASU / Nutraceuticals
Ø Medical Devices/ Surgicals / Diagnostics
Ø Clinical Research/Trails
Ø NCEs / Drug Discovery

Members who have been granted patent awards are advised to send the details of their patents received in 2008-09 to Pharmexcil as per enclosed proforma.

The awards will be declared based on the recommendations of the expert panel to be constituted for this purpose.

Patent Awareness Seminar

With the support of Dept. Pharmaceuticals, Govt. of India, Pharmexcil has started a Patent Facilitation Centre in July 2008 and has been extending services on IPR matters to its members regularly.

Pharmexcil has so far serviced to about 30 small and big pharma exporters by providing information on Patent status of various drugs and formulations in different countries. The objectives of the council are to educate/help Pharma companies particularly SMEs category, to be aware and utilize the benefits of IPR regime and to ensure hassle (IPR issues) free shipment of their goods to various destinations globally.

In continuation of series of awareness programmes, Pharmexcil is organizing a Programme on 26th May 2009 at Chandigarh, where eminent speakers in the Pharma Patents field viz., Dr. Gopakumar G Nair, Advisor, Pharmexcil, Mr. Feroz Ali, Advocate, Chennai, Miss. Andreya Fernandes, Gopakumar Nair Associates would be making presentations on the Indian and International Patent Scenario in Pharmaceutical sector.

Members can register their names immediately through email at
patents@pharmexcil.com
info@pharmexcil.com

before 22nd May 2009.

For More information please contact:
Patents Analyst, Pharmexcil, 040-23735462/66