JANUARY 2012

One day Seminar on Drafting and Prosecuting Pharmaceutical Patent Applications in the EU and U.S.

The seminar comprised a series of presentations,covering both general material and an interesting ‘real life’ case by working through the preparation and prosecution of US Patent No. 7,537,774 for "Therapeutic Formulation," issued in May 26 2009.

The speakers were well experienced and expert patent attorneys from leading U.K. and U.S. based law firms, and the sessions covered practically relevant issues such that tips leading to successful prosecution emerged.

The Agenda for the day included topics such as drafting of a Markush formula for a new chemical entity, drafting patent applications for enantiomers and polymorphs, added subject matter at the European Patent Office, Medical use claims at the European Patent Office, Claiming methods of medical treatment at the USPTO, patent term extensions, etc.

SEPTEMBER 2011

Half day Seminar on European Patent Prosecution - Some Key Issues

There have been varilous developments in European laws in the recent past, especially in relation to the law on Supplementary Protection Certificates (SPCs). The objective of this seminar was to make the participants familiar with these developments, get an insight into the areas of uncertainties, and gain an understanding of the threats and opportunities such uncertainties can pose.

Other issues that were discussed included Patentability of Dosage regimes and diagnostic methods, Indirect patent infringement and knowledge requirement, Regulatory data protection and orphan marketing exclusivity, etc.

The speakers, from the reputed and highly experienced firm of Potter Clarkson LLP, U.K., also took queries on general maters of European Law,non-patent IP for pharmaceuticals, etc.

JULY 2011

AIPS One Day Seminar on SECTION 3(d): PROOF OF EFFICACY

Patent applicants are often faced with the unenviable task of proving efficacy vis-?-vis section 3(d) of the Indian Patents Act, 1970. The Seminar was designed to provide an opportunity to discuss and analyze recent important decisions at the Patent Office in this regard, and learn from the practice of the patent office as to what needs to be done to prove enhanced efficacy of a known drug such that the patent applicantion process could be made more efficient. The focus was on understanding the requirements of section 3(d), to know how efficacy is understood, what needs to be shown to prove or disprove enhanced efficacy, and on how to get over the common pitfalls that result in the failure to prove efficacy.

APRIL 2011

SEMINAR ON EUROPEAN PATENT PROSECUTION, WITH FOCUS ON

Patent Claims vis-à-vis Article 19 and 34 amendments

Special areas of pharmaceutical/chemical patenting, including Polymorphs and Formulations

Filing of patent applications at the European Patent Office (EPO) has had to take into consideration a variety of amendments in the recent past. This seminar focused on the amendments to Articles 19 and 34, and commented on how they influence the patent prosecution process at the EPO.
The Seminar went on to 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. Expert faculty, registered with both the CIPA and as European Patent Attorneys, provided strategic tips and techniques that can be employed to successfully prosecute patent applications at the EPO.

March 2011

5 Day workshop on Patent Fundamentals & Practice

This annual training programme for executives whose scope of work calls for a broad working knowledge of patents provided an introduction to the legal & practice issues relating to patents. Expert faculty addressed 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

January 2011

Two day Seminar on the Indian Patent Act

This two day training course provided an in-depth analysis of the Indian Patent Act, and addressed issues facing practicing professionals working in attorney firms / IPR – Patent Cells, as well as those taking the Indian Patent Office patent agent examination to qualify as Registered Patent Agents.

Expert faculty Mr. H. Subramaniam of SNA, New Delhi employed a highly interactive methodology, and provided a Chapter / Section wise analysis of the Patent Act. Case studies and on-going Q&A sessions gave participants the opportunity to pose queries and become fully conversant with the nuances of the Act.

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

The Seminar looked at the challenges and pitfalls faced while prosecuting patents in the U.S., Europe and India, and studied strategies that can be adopted to protect biotech and pharmaceutical inventions. IP challenges for biosimilars, freedom -to - operate issues, the regulatory pathway for approval of biosimilars, and the related IP strategies for innovator and generics companies were studied in the second session. A combination of US and EP perspectives in a single event, supplemented by some specific aspects of national Indian law, added significant value to the event.

December 2010

One day Seminar on Bioequivalence

Bioequivalence Studies, a commonly accepted method to demonstrate the therapeutic equivalence between two competing drugs, form an essential part of the drug registration dossier. Bioequivalence as a tool to introduce a new generic drug into the market can lead to significant reductions in both the time and costs involved, and the design, performance and evaluation of the related bioequivalence studies have become critical in the drug development process in the pharmaceutical industry. The one day interactive Seminar on Bioequivalence offered by AIPS gave an excellent understanding of the planning, conducting, analyzing and reporting of BE Studies, and was attended by professionals in the drug development R&D, regulatory, clinical, medical, business development etc functions.

October 2010

Lecture Series on Patent Specification Drafting including Pharmaceutical Drafting.

The programme helped in improving patent specification writing and claim drafting skills. Expert faculty took the participants through both mechanical and chemical cases, and group and individual exercises provided hands-on practice to sharpen patent specification writing skills.

September 2010

One Day Seminar on "PRECEDENTIAL PATENT CASES".

The decisions of the Intellectual Property Appellate Board, the High Courts and the Supreme Court of India have precedential effect on the Patent Offices. Since 2005, the IPAB and the higher courts in India have rendered significant decisions that contribute to the body of patent law, and also impact the conduct of patent litigation in India.

The AIPS seminar reviewed some of the important cases that have been decided by the IPAB, High Court and the Supreme Court since the Patent (Amendment) Act, 2005, and analyzed trends on how the Courts decided in particular situations. A critical analysis of the powers of the IPAB vis-a-vis the power of the High Court in revocation proceedings was also made.

August 2010

Lecture Series-cum-Practise Sessions on Patent Prior Art Search.

The course comprised six full day sessions covering the basics of patent documentation, search tools and techniques, study of the search results and preparation of the search report. Using both web based free databases and paid sites, participants were taught to initiate search proceedings in the most appropriate manner, retrieve relevant documents and thereafter prepare the search reports.

June 2010

One Day Seminar on Pre Grant Opposition: A Business Opportunity at the Patent Office

The Seminar focus was on Pre-grant Opposition as a legal and cost effective tool enabling companies to avoid expensive and lengthy infringement suits being brought against them. The mechanics of drafting, filing and contesting a pre-grant opposition were considered, and with the aid of multiple case studies the faculty took the participants through issues such as pre-grant opposition and its aftermath, suggestions as to what can be done once the matter goes beyond the Patent Office, recent trends in pre-grant opposition, etc.

June 2010

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. More than the Patent Manual, it is these decisions that provide real-life situations of how applications are decided at the Patent Office. The Seminar discussed in detail how the Patent Office decided in 2009, and the agenda included issues such as the adjudicatory functions of the Patent Office with specific focus on section 15 and section 25 orders, analysis of 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, etc. Specific case studies were also used to understand why and how patent applications get rejected at the Patent Office, thus providing very useful learning for executives dealing with the Indian Patent Office.

May 2010

One Day Seminar on Challenges in Decentralized Procedure (DCP) Filings in Europe

AIPS organized this one day seminar on Decentralized Procedure Filings in Europe for drug regulatory professionals, to offer an understanding of DCP Deficiency handling vis-a-vis multiple European Authorities. After providing an overview of the European Filing procedures, the seminar focused on DCP Filing deficiencies, their impact on the DCP review, the current trend of deficiencies, ways to address these deficiencies, the turn around time for addressing deficiencies etc. Expert faculty conducted interactive sessions in which queries relating to day to day functioning were answered.

5 Day Workshop on Patent Fundamentals and Practice

This annual training programme, designed for executives whose scope of work calls for a broad working knowledge of patents, provided an insight into the related legal & practical issues. Eminent faculty took 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.

The second half of the Seminar highlighted the various options available to pharmaceutical organizations to improve or extend the patent protection for their products by way of SPCs, and non-patent protection for pharmaceuticals by way of regulatory data exclusivity, orphan medicinal product marketing exclusivity, etc.

March 2010

1/ 2 Day Lecture Series on EUROPEAN PATENT PROTECTION.

Significant changes that influence the grant procedure before the European Patent Office have been made recently - the AIPS Lecture Series provided an overview of the developments in this regard. Speaker Dr. Mike Snodin, a U.K. and European registered Patent Attorney focused on both the rule changes and the impact on the patent litigation system in Europe in the first half of the programme, incorporating also a study of the recent important case law in Europe in his presentation.

The second half of the Seminar highlighted the various options available to pharmaceutical organizations to improve or extend the patent protection for their products by way of SPCs, and non-patent protection for pharmaceuticals by way of regulatory data exclusivity, orphan medicinal product marketing exclusivity, etc.

February 2010

A 2 day Clinic on “Meeting the Inventor” was organized to offer 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. 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 was devised to develop related expertise, and to look 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.

November 2009

AIPS organized a 2 day workshop for Drug Regulatory professionals on

Drug Master Files – Compilation and Compliance, and Drug Marketing Authorization Procedures in Europe

The event was well attended, with training being provided on how to prepare reliable and efficient DMFs that are compliant with official guidelines and requirements. Participants gained an understanding of how to compile a DMF in different jurisdictions including what to include/ not include, maintenance of the DMF, strategy to avoid unfavourable reviews, etc Day 2 of the workshop focused on the EU compliant Application process required to secure marketing approval. Topics covered included authority (HMA) responsibilities, different MA procedures and their scope, documentation required, post Authorization activities etc.

September 2009

Full day lecture cum practice session on Patent Prior Art Search were conducted to cover the basics of patent documentation, search tools and techniques, study of the search results and preparation of the search report. Participants were taught to initiate search proceedings in the most appropriate manner, retrieve relevant documents and thereafter prepare the search reports. The Faculty covered both the web based free databases and a few paid sites.

August 2009

AIPS organized a Lecture Series on Patent Specification Drafting designed for IP / Patent professionals wanting to improve specification writing and claim drafting skills. Expert faculty took the participants through both mechanical and chemical cases, and group and individual exercises provided hands-on practice. One session was devoted especially to Pharmaceutical Drafting.

April 2009

5 Day workshop on Patent Fundamentals and Practice

This annually held workshop, designed to provide an appreciation of the various legal & practical issues relating to patents, took the participants through sessions on Patent Fundamentals, Filing and Prosecution of Patents in India and abroad, Prior art Search, Drafting of the Patent Specification, Claim Interpretation, Patent Licensing etc. The interactive sessions and class assignments assisted in providing an understanding of the patent scenario worldwide and in demystifying the elements of patentability, and extensive use of case studies by the expert faculty gave the participants an easy understanding of situations as they could arise in the workplace.

February 2009

1 day Workshop on Challenging Patents: Developing an In-house Strategy on Pre-grant Opposition

This interactive workshop provided a useful guide on how organizations can develop an efficient and cost effective in-house strategy for challenging patents before their grant, in an effort to protect their rights and commercial interests. Numerous examples were provided to illustrate key issues vis-a-vis the Indian context. In addition, pointers were also given on what could be done if one’s own patents were opposed in the Patent office.

January, 2009

3 Day Workshop on Drug Registration (Regulatory) Dossier Compilation

The workshop catered to Regulatory and QA executives involved in the challenging process of introducing a high investment drug into the commercial environment. Highly interactive sessions took the participants through the hows and whys of the entire Dossier Compilation process – identification of the various sources of required information, collation of the data collected, role of the different departments, the CTD / e-CTD document, ICH Guidelines, the registration procedure etc were all addressed in detail, and a practical insight into the actual preparation such that there is regulatory compliance was provided by the expert faculty members.

August 2008

5 day workshop on International Drug Regulatory Affairs

This interactive programme provided a practical insight into the international regulatory framework while learning and assimilating from the experts. Compliance Managers, Documentation Managers, Product Registration Personnel, Product Managers in Regulatory Affairs, Marketing Managers, Quality Control Personnel etc. benefited from participating in this course, and obtained training on a variety of issues including how regulations affect product development strategies, writing of a DMF in the new format, keeping the DMF up to date, effective submission procedures, streamlining of the application process, how to handle inspections and compliance, impact on pricing etc


July 2008

Lecture series on Patent Specification Drafting

The programme comprising five lectures catered to IP professionals seeking to improve their general specification writing and claim drafting skills. Expert faculty guided the participants through both mechanical and chemical cases, and group and individual exercises provided hands-on practice to sharpen patent specification writing skills. One full day session was also devoted to Pharmaceutical Drafting.


April 2008

Workshop on Drafting Responses to Office Actions (US, EP and PCT International Examinations) 

In addition to skills in patent drafting, it is extremely important for patent agents / attorneys to know how to respond to office actions while prosecuting a patent application.  Office actions are at the core of the examination process in patent offices, and the expert faculty from Schwegman, Lundberg & Woessner , U.S.A. shared their considerable expertise on drafting replies to Office actions, keeping in mind the objections raised by U.S., EP and PCT International Examiners. Both substantive and procedural objections raised by the Examiners were dealt with. The primary focus was on presenting material alterations in the claims and/or defending claims over cited prior art. In addition, tips on stylistic presentation of statements, with some emphasis on procedural aspects, were also provided. The faculty used real-life examples from US, PCT and EP patent applications with Office Actions and other communications from patent offices as a basis for the workshop.

5 Day Workshop on Patent Fundamentals and Practice

This training programme, specifically designed for executives whose scope of work calls for a broad working knowledge of patents, provided an insight into the related legal & practical issues. Eminent faculty took 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, Claim Interpretation and Analysis, Patent Licensing, the Trade Secrets vis-à-vis Patents debate, etc.

Two day Advanced Level Workshop on Patent Opposition

The workshop was structured to provide experience in preparing oppositions and appeals in the opposition procedure followed at the Indian Patent Office. Participants were divided into teams representing the Applicant and Opponent, and under the mentorship of Mr. H. Subramaniam of SNA, New Delhi and Mr. S. Majumdar of S.Majumdar & Co., Kolkata, received practical lessons in both patent strategy and preparation of memorials. A mock hearing was held in which the participants gained a good understanding of the procedures as well as the important issues underlying such proceedings at the Patent Office.
 

February 2008

2 Day workshop on Patent Licensing and Alternative Dispute Resolution

AIPS, in association with the Arbitration and Mediation Centre of WIPO, offered a 2 day workshop on Patent Licensing and Alternative Dispute Resolution. With more and more Indian companies considering the takeover of foreign generic companies, the issue of patents and licensing has gained significance, and with the development of ANDAs and other process patents, licensing of the technology / patent is expected to increase. However, Organizations often have to deal with a variety of controversial issues, many of them with important legal implications. Their options should, therefore, include a cost effective, efficient and ideally a non adversarial alternative to litigation

The WIPO-AIPS workshop examined the basic elements of a patent licensing transaction, and provided the background needed to structure, draft and negotiate a patent license. Participants were put through a series of licensing issues involving different levels of complexity, and issues such as Initial payments, Royalty rates, R&D collaboration agreements, tech transfer agreements etc were addressed.

The Faculty, Dr. Heinz Goddar, past president of LES International, and Mr. Ignacio De Castro of the Arbitration and Mediation Centre of WIPO, engaged highly interactive sessions. Time was spent on learning how to analyze a patent license agreement through a case study, and Group work formed part of the methodology.



February 2008

A One Day Lecture Series on Pharmaceutical Patents was held on February 4, 2008. The faculty from the reputed firm of Schwegman Lundberg Woesnner, U.S.A. spoke on key technical, commercial and legal issues being faced by patenting professionals in both the generic and branded pharma companies. The topics ranged from Patent Searching, Patent Certifications (Para 1 –IV), Non infringement and invalidity opinions to support ANDA certifications to IP Licensing and Agreements, IP Valuation, Technology Transfer etc. The recent USPTO Rules changes, Legal Opinions on Freedom to Operate was also covered in one of the sessions


October 2007

2 day workshop on Designing around Chemical and Pharmaceutical Patents

In a competitive market, the value of a patent to its inventor often increases when the difficulty in designing around the patent increases. However, patents as techno-legal documents provide a public library of inventions, and are a resource for constant improvement to technology. It is, therefore, important that inventors referring to such literature are careful that their new inventions do not infringe existing patents.

This workshop considered various ways to go about designing around an existing patent; issues relating to claim construction under Markman, literal infringement, Doctrine of Equivalents, Festo, how patent applicants can anticipate design around strategies, etc. were also covered.

The expert faculty members were Dr. Thomas Pontani, founding member, Mr. Martin Pavane and Dr. Kent Cheng, all from the reputed law firm of Cohen Pontani Lieberman and Pavane LLP of U.S.A.

September 2007

2 Day Workshop on U.S Patent Prosecution
The workshop provided an in-depth and detailed analysis of the U.S. Patent Prosecution process, and enabled participants to become familiar with the statues, regulations, practice, and customs that guide this prosecution process. Expert faculty from Schwegman, Lundberg, Woessner & Kluth conducted highly interactive sessions where cases were discussed and individual questions addressed.

August 2007

2 day workshop on Pharmaceutical Claim Drafting
This workshop designed for pharma professionals focused on improving patent claim drafting and amendment writing skills. The faculty, Dr. Marcus Engelhard of Boehmert & Boehmert and Mr. S. Majumdar of S. Majumdar & Company, laid the grounding by speaking on general patentability requirements and Section 3d of the Indian Patent Act first. Thereafter, participants were made to actually draft out patent applications. This hands-on approach was followed for more than 75 percent of the workshop time, and areas included the written description, enablement and best mode requirements, advanced strategies for drafting claims directed to pharmaceutical formulations, as well as claim strategies for avoiding disclaimer of subject matter.

July 21, 2007

A Convocation was held for the successful participants of the Post Graduate Diploma in Patent Management – 2006 programme. Faculty Dr. Prabuddha Ganguly and Mr. Himanshu Kane gave away the Diplomas, the Most Promising Student and the Best Dissertation Awards.

June 2007

Two day Seminar on Polymorphism and Crystallization
 In response to demand from alumni / industry, AIPS organized the subject seminar wherein expert faculty from academia and the industry took participants through sessions on the basics of crystal structure, factors leading to polymorphism, methods to characterize a polymorphic form, etc. and also on the patenting aspects of polymorphs, strategy for defense against potential litigation, etc.

May 2007

A one day Seminar on U.S. Patent Prosecution was held on May 9, 2007.
The Speaker, Ms Gabriela Coman, is an Associate at a leading law firm in the U.S. and after giving an overview of the USPTO, focused on issues relating to Claim Drafting, the U.S. Patent Application procedures etc. The sessions were interactive, and the faculty shared insights gained from her many years of prosecuting experience.

April 2007

3 day workshop on CTD and e CTD Formats
Expert faculty from Dr. Reddys Laboratories and Infotehna took participants through sessions on how to comply with the policies, governing statutes and regulations, and understand the technicalities used in the preparation and filing of drug submission in the e-CTD format established by the International Conference on Harmonization

January 2007

4 day Workshop on Drafting Non-Infringing, Freedom to Operate and Validity Opinions
The workshop helped participants in understanding the various issues involved in reaching a sound and knowledgeable non-infringing opinion. The expert faculty took the participants through various in-depth sessions spread over 4 days, providing both practical and tactical advice from the perspective of in-house as well as outside counsel on the issues to be considered and the strategies to be adopted. Both Indian and International perspectives vis a vis infringement analysis were covered.

Flexi Post Graduate Diploma in Patent Management
Commencement of the one-year, part time programme designed to provide a specialization in Patents. Both the theory and practice elements are addressed, and this in-depth course offers an excellent platform for those wanting to master the complex field of patents.

Online Guide for the Patent Agent Examination
A Distance-learning programme, this online guide will take participants through the Indian Patent Act.

October 2006

Weekend workshop on Patent Strategy and Management
The workshop dealt with the Patent strategy to be adopted in the context of various practical issues facing executives having to manage patents in an "in house" situation. The issues relating to Patent Portfolio Management Systems, third party issues, budgeting, searching, collecting innovations, financials, managing litigation matters etc were addressed. The faculty Dr. Win Eyles, Founder and MD of NetsPat U.K. , and Mr. Adam Wylie also conducted various exercises devised specifically to provide hands on experience on a patent management software, using some dummy data and exercises

Contact sessions for Patent Agent Examination
The sessions are designed to provide a clear understanding of the Patent Act and filing procedures, and an understanding of the principles underlying claim drafting involved in patent specifications.

September 2006

Moot Court
Participants of the PGD in Patent Management were once again tested in their knowledge of Patent law and strategy. Teams were required to both defend and prosecute cases given to them, and make their presentation to the Judge. This event is an integral feature of the course, intended to provide the participants with a first hand experience of the legal intricacies that they must be aware of when working in IP / Patent cells.

6 day Workshop on Patent Specification Drafting

A highly interactive programme with faculty Bill Lloyd spending 5 days to develop skills in the 'art and craft' of patent drafting. A firm grounding in the nature and function of patent claims, including novelty and infringement, was provided. Working first in groups and then individually, the participants worked on multiple exercises of drafting of actual patent claims, such that hands-on learning and expertise was generated. Since the majority of the participants were from the pharmaceutical field, one day of the workshop was devoted exclusively to pharma patenting.

July 2006

Opposition Proceedings for the participants of the PGD in Patent Management 2006 programme. 'Opponent' and 'Applicant' teams were given hypothetical cases, and had to argue the same in terms of the Indian Patent Act, in the presence of a 'Controller'. A real life "Opposition hearing in the Patent Office" like situation was thus simulated, providing the participants with crucial insight into this critical aspect of Patent Management. Four teams participated in the competition this year, and each was required to furnish related Search reports and other documentation in support of arguments. The 'Controller' for the event was Mr. N.K.Garg, Asst Controller, Patent Office Mumbai.

May 2006

Commencement of the Certificate in Intellectual Property Management--Workshop Series. The following workshops are included in the Series.

1) Workshop on Trademarks and Geographical Indications
2) Workshop on Copyright Fundamentals and Practice
3) Workshop on Patent Fundamentals and Practice
4) Workshop on Industrial Design, Trade Secrets

Executives from a cross-section of the industry, students and academicians participated in the workshops. The faculty comprised experts with requisite industry related experience and skills.

April 2006

5 day Certificate Course on International Drug Regulatory Affairs.
A niche skills programme to provide a practical insight into the international regulatory framework, with the participants learning and assimilating from the experts. Leading Regulatory officials from the industry formed the faculty panel.

February 2006

5 day Workshop on Patent Fundamentals and Practice.
An interactive training programme specifically designed for executives whose scope of work calls for a broad working knowledge of patents. The sessions included individual and group assignments to facilitate learning.
Invited faculty members included Mr. H. Subramaniam, Mr. G. Natraj, Dr. Pradeep Paranjpe, Dr. Mangala Venkatramani, Mr. Adarsh Nigam and Mr. M.A.Jose.

January 2006

Commencement of one year weekend Post Graduate Diploma in Patent Management. The inaugural session was taken by Dr. Prabhudda Ganguli, a leading IP consultant and expert. The year long programme is expected to impart required skills to the participants in all aspects relating to Patents.