Hatch-Waxman Boot Camp

ACI Hatch-Waxman Series Presents…

Hatch-Waxman Boot Camp

A Primer on IP Basics and Regulatory Fundamentals Relative to Small Molecules and Biologics for Brand Names, Generics and Biopharmas

Monday, May 24 to Tuesday, May 25, 2010
ACI, The Nation’s Premier Provider of Life Sciences Intellectual Property Conferences, is pleased to bring the first installment of its renowned Hatch-Waxman Series to San Diego.
Understand the interplay of IP and FDA regulation relative to pharma/biotech patents vis-à-vis Hatch-Waxman and a proposed FOB scenario.
A thorough understanding of Hatch-Waxman is absolutely essential to anyone working in the biopharmaceutical industry. This knowledge sets the foundation for the protection of small molecules and small proteins and provides the tools to comprehend an IP and regulatory framework for what lies beyond the realm of traditional pharmaceuticals. The highly regulated nature of the products which the pharmaceutical and biotechnology industries manufacture dictates that the patenting of these products be closely tied to the FDA approval process. Anyone who works in the life sciences industry — or who even remotely deals with its IP — must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.
You cannot afford to be left in the dark regarding the interconnection of IP law and FDA regulation in these industries.
Garner the winning edge — boost your life sciences IP and regulatory IQ.
ACI’s Hatch-Waxman Boot Camp has been designed to give counsel and advisors to brand name and generic drug companies — and biopharmas — critical insights into commercialization and the pre-approval process, and also provide an in-depth review of Hatch-Waxman and other IP basics relative to small molecules and biologics. This conference will lay the necessary foundation for you to comprehend thoroughly the dynamics of the relationship between patent life cycles for pharmaceutical and biopharmaceutical products and business development plans.
Master the intricacies of the patent and regulatory framework for drugs and biologics.
A faculty of top-notch IP and regulatory counsel — all having a wealth of experience through working for brand names and generics as well as biopharmas — will share their knowledge on:

  • The organization and jurisdiction of the FDA and the PTO and their interplay in the patenting of drugs and biologics
  • How the approval process for drugs and biologics is connected to the patenting of these products
  • Pre-patent considerations relative to R&D and patent portfolio and patent life cycle management
  • How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs — and how follow-on biological products may add a new dimension to this schematic
  • The relationship between patent and non-patent exclusivity
  • The importance of patenting bioequivalence characteristics in certain drug products
  • The ‘ins and outs’ of patent term extension under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791

Also, i n response to your requests, we have added a special Master Class on Follow-On Biologics which will lead you through every IP and regulatory consideration in this complex and impending area.

Attend this conference and learn to navigate your way through the IP and regulatory mazes that play such a crucial role in your practice areas. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online at www.AmericanConference.com/HWBootCamp



The Symbiosis International Legal Essay Writing Competition

The Symbiosis International Legal Essay Writing Competition envisages to promote and develop the ability of a law student to think on a global scale. The competition is unique in a way, in which any full-time law student in any degree college/institution from around the world may participate. Participants may author an essay on any one to the following topics:-

  • Health Care and Intellectual Property
  • Intellectual Property Laws Vs. Anti Trust Laws
  • Cyber Warfare and Cyber Terrorism
  • Binding Nature and Enforcement Mechanism of Different Types of Electronic Contracts
  • The North – South Divide in the world of Intellectual Property Protection

The essays must be typed with Times New Roman, Font size 12, Double spacing, on A4 size paper. Maximum Abstract Word Limit – 250 words Minimum Essay Word Limit – 2000 words Maximum Essay Word Limit – 4000 words. A maximum of two individuals who may send a joint essay. However only one entry allowed per student.
The Symbiosis International Legal Essay Writing Competition envisages to promote and develop the ability of a law student to think on a global scale. The competition is unique in a way, in which any full-time law student in any degree college/institution from around the world may participate. The topics of the competition have been carefully chosen so that they possess global relevance as well as encourage the participant’s freedom to analyze and convey their thoughts and probable solutions on the same.
About Tech Legal Cell

The Tech Legal Cell of Symbiosis Law School is a student body which aims to spread knowledge and awareness on the topics of Intellectual property Rights, Cyber Laws and Legal Perspective towards Innovation and Technology in the institute and the student population at large which the means of seminars, competitions, publication (In-house Journal – IPR Chronicle) and research projects. We also collaborate with Microsoft India for research and scholarship projects.

Participants may author an essay on any one to the following topics:-

  • Health Care and Intellectual Property
  • Intellectual Property Laws Vs. Anti Trust Laws
  • Cyber Warfare and Cyber Terrorism
  • Binding Nature and Enforcement Mechanism of Different Types of Electronic Contracts
  • The North – South Divide in the world of Intellectual Property Protection


  • 1st Prize – INR 10,000
  • 2nd Prize – INR 5,000
  • 3rd Prize – INR 3,000
  • Best Abstract – INR 2,000
  • Top 10 essays shall be published in the journal of “Law and Innovation” by Symbiosis Law School, Pune.

Terms And Conditions
Participants by submission of essays accepts all the terms and conditions mentioned in entirety and shall abide by the same throughout the competition.

Organiser Symbiosis Law School Pune
Last Date is 20th March 2010

For further details Click here:


The National Law School of India University (NLSIU), Bangalore instituted
in the year 1997 aGold Medal in the name of the distinguished jurist, late H.M.
Seervai for thebest original essaywritten on the themes specified in Indian
Constitutional Law. Over the years since 1997,this essay writing competition has
become a prestigious event for the law students all over India.
The significant rise every year in the number of contributions from the student
community shows their mark of respect and tribute to one of the greatest legal
luminaries of our country – H.M. Seervai.
The theme selected for 2010 is "PROTECTION OF THE SCHEDULED
The Competition is open only for LL.B. students studying in any of the recognised
Law Schools /Colleges / Departments of the Universities in India. The essay that is
adjudged to be the best will be awarded a Gold Medal at the Annual Convocation
of NLSIU, Bangalore.Essay should be original (not published earlier or extracted
from other sources) in English, not exceeding 10,000 words (approximately 30
double space typed pages, New Times Roman, font size 12) including footnotes
and references, typed on one side of the A4 size papers.
We request you to staple all the pages with an additional white page for first
(title cover) and last page. Plastic wrappers and spiral bounds are generally
discouraged to follow the eco-friendly practice.
Four copies of the essay should be sent to the following address on or before
June 15, 2010 (5.00 P.M. ) to
Prof. V. S. Mallar
C/o. Examination Department
National Law School of India University
Nagarbhavi, Bangalore – 560 242

A soft copy of the same should also be sent to before the last date. Both the
hard copy and the soft copy should be submitted before the last date.
Students should also produce a bonafide certificate through the Principal or
Head of the institution. The covers may be properly sealed and
superscribed – "HM Seervai Gold Medal Essay Competition" .
Those who participate will be informed of any other details or subsequent
changes to their email addresses which they have used for sending the essay
to the above mentioned email address.
The NLSIU may award Certificates of Merit to select essays which receive the
commendation from the panel of judges. Essay may also be considered for
publication in the National Law School journal.
For any further information or clarification, please contact:

Nagarbhavi, P.B. No. 7201, Bangalore – 560 242
Phone : 91-80-23160525 /2316 0532/33/35
Fax : 91-80-23160525

Prof. V.S. Mallar,
Tel. No. 080-23160525, 23160532 / 33 –
Email : mallarvs

ABA 25th Intellectual Property Law Conference April 2010

Welcome to the one annual conference that IP lawyers cannot afford to miss. Now in its 25th anniversary year, the Annual Intellectual Property Law Conference of the ABA Section of Intellectual Property Law provides a gathering of the foremost authorities on the state of intellectual property law, including judges, government officials, in-house counsel, academics, and private practitioners.

Pick up an entire year’s worth of CLE credits during the 2 ½ days of quality IP programming on the issues critical to your practice. Some program highlights include:

  • The future of patent reform
  • ITC IP mediation project
  • Google books settlement
  • Defending depositions in trademark cases
  • Duty of disclosure to USPTO
  • Patent damages
  • Opinion of counsel
  • Legal aspects of social media marketing
  • Biosimilars
  • Venue transfer & forum selection
  • Interfacing with clients

The conference will also feature ample opportunities to network with your IP colleagues, whether at our Young Lawyers Welcome Reception, Corporate Counsel Reception, Women’s Networking Dinner, or the popular reception at the Dolley Madison House at the U.S. Court of Appeals for the Federal Circuit. In addition, a very special 25th Anniversary Gala Dinner with entertainment and dancing is planned to fete a quarter century of this preeminent conference.

Registration details will be available on the website soon. We hope you will take advantage of the opportunity to enhance your expert knowledge of IP while growing your professional and social network.

For further details log on to : http://www.abanet.org/intelprop/spring2010/springbrochure10.pdf

Digital Economy Bill Changes of UK Threat to File Sharing on Internet

Internet freedom campaigners have reacted with dismay to the proposed changes to the Bill. Supporters of Open Rights Group, warned many websites could be forced offline simply by the prospect of expensive legal proceedings. Individuals and small businesses would be open to massive ‘copyright attacks’ that could shut them down, just by the threat of action. It is pertinent to mention that the Digital Economy Bill of UK was announced in the Queen’s speech in November 2009, with a major section dedicated to how best to deal with illegal file sharing. The Bill, currently in the report stage at the House of Lords before its third reading in the Commons, proposes a solution of several steps, which begins with a warning letter sent to those illegally downloading from their internet service provider and could end with the internet connection being temporarily suspended.

Under amendments to the Digital Economy Bill the High Court could be given the power to issue an injunction against a website accused of hosting “substantial” amounts of copyright-infringing material. It means popular websites, such as YouTube, which often unwittingly carry content uploaded without the permission of copyright holders, could be “blocked” or forced offline if the amendment is upheld.

The Internet Service Providers Association, which represents ISPs, said it was “outraged” by the plans, while TalkTalk said the plans would force ISPs to restrict access to specific sites.

The proposed law do not restrict access to a few sites but only in the most serious cases, for instance those involving child pornography or issues of national security. But more to the point, making the restriction of websites a more widespread policy would be dangerous given its major impact on internet users’ human rights, freedom of expression and privacy.

However the changes would be welcomed by content creators. This is going to send a powerful message to the creative industries that the value what they do, is well respected and it is not censoring the internet, but a genuine approach to copyright protection on internet. The companies like Google, which do major file sharing are planning to face the challenges.