ACI Biosimilars Conference on June 7-8, 2011 in New York City

Re-posted by Houston Lawyer and Law News - American Conference Institute invites you to join your peers and colleagues at the 2nd edition of its Biosimilars conference. Brian Malkin from FLH will be presenting at this timely industry-leading forum where counsel and advisors for brand name and generic companies will discuss positioning strategies in light of the FDA's current stance on the biosimilar pathway, in addition to some of the most pressing and recent controversies surrounding implementation of the pathway:

Determining what level of clinical data biosimilar applicants must provide to prove safety and efficacy
Demonstrating interchangeability and proving or disproving similarity based upon the heightened statutory standard
Preparing for the inevitability of biosimilar patent litigation
Evaluating the impact that the 12-year exclusivity period will have on competition and research and development
Scrutinizing the success of biosimilars globally so far and comparing various regulatory models which may influence the FDA
Assessing the financial viability of biosimilars in light of potential regulatory hurdles and forecasting potential profit margins

This event -- which is the definitive forum on dissecting the science, the law, the regulatory, commercial and international framework for biosimilars and which also serves as the annual meeting place for the "who's who" of biosimilars players -- is now the single forum on which industry leaders wishing to blaze a biosimilar trail can rely for answers during this turbulent time in which the balance of power between traditionally branded companies and generic companies may completely unravel. Come to this conference and get the up-to-the minute information that you need to strategically situate your company and protect and increase market share in anticipation of the attacks on IP and litigation sure to come.

Do not miss your opportunity to enhance your learning and networking experience by attending one or both of our hands-on, informative and practical workshops:

Biologics Science 101:Understanding and Deconstructing the Complicated Scientific Principles Behind Biosimilars- At this primer, leading scientists and academics will translate the technical and scientific complexities behind biosimilars into useable data to factor into your business plan.
In-Depth Breakdown of the Biosimilar Framework in the EU- At this Master Class, leading EU practitioners will delve into the commercial and regulatory specifics of the already-launched EU biosimilar framework. In addition to providing a nuanced look into EU law for companies launching a biosimilar abroad, our expert faculty will give best practices from actual launches to incorporate into U.S. biosimilar strategies. [ACI Biosimilars Conference on June 7-8, 2011 in New York City - http://www.fdalawyersblog.com]

Re-posted by Houston Lawyer and Law News

Boston Criminal Lawyers Blog - New Post: Massachusetts Bus Driver Arrested on Drug Charges

Re-posted by Houston Lawyer and Law News - Cynthia King, 46, of Brockton, was arrested on Massachusetts Drug Crimes Charges after Boston Police conducted a search of her car at the MBTA bus yard in South Boston.

The investigation against Cynthia King reportedly began in May of 2010, when a confidential information allegedly told police that a driver for the MBTA was selling crack cocaine from the bus. Based on that information and subsequent surveillance by the Boston Police Drug Control Unit, the police were able to obtain and execute search warrants of King's car and her person when she arrived to work and recovered crack cocaine, cash and other alleged drug paraphernalia, including digital scales and two cell phones.

Cynthia King as been formally charged with Unlawful Possession with Intent to Distribute a Class B Substance. Following her arraignment today in the Dorchester District Court, she was released on $1,000 cash bail.

King has been employed as a bus driver with the MBTA since 2002, but was suspended following her arrest on these drug charges. It's unclear whether she was allegedly dealing drugs as she was driving buses for the MBTA, but that is presumed to be a matter under investigation. [http://www.bostoncriminallawyersblog.com]

Re-posted by Houston Lawyer and Law News

Artificial Food Dyes Should Not Receive Warnings FDA Committee Decides

Re-posted by Houston Lawyer and Law News - On March 31, FDA's Food Advisory Committee concluded its two-day hearing with a 8-6 vote that foods that contain synthetic food dyes do not need special warning labels to suggest that the dyes may cause hyperactivity and behavioral problems in some children. FDA had not asked the Committee to consider a ban, reports Gardiner Harris from The New York Times.

During the hearing, commentary lined up as expected. Michael Jacobson, Ph.D., Executive Director of the Center for Science and the Public Interest ("CSPI") asked, "Why are these dyes in foods anyway? I would push for having them taken out completely. But if that can't be done, why not warn the public and parents that these dyes could have some effects?" reports CNN Medical Producer, Val Willingham. Harris reports that Dr. Jacobson, though disappointed by the outcome of the hearing, was encouraged that FDA was starting to acknowledge the debate still exists: "At least FDA is now acknowledging that dyes affect some children. That is a big change."

Industry representatives, however, rallied behind the conclusion, fearful that warnings might unduly alarm consumers without adequate data to substantiate the claims or create a market with less appealing food choices. For example, in a statement, David Schmidt, President and CEO of the International Food Information Council said, "Food colors add to our enjoyment of food by maintaining or improving their appearance. Without sufficient scientific evidence that a causal link truly exists between food colors and hyperactivity in children, communication that suggests a link could have unintended consequences, including unnecessarily frightening consumers about safe ingredients that are consumed every day," writes Health Day reporter Steven Reinberg. [www.fdalawyersblog.com]

The debate is probably not over, as the Committee said more research was needed in light of the evidence and suggestion by some researchers that hyperactivity may be triggered by artificial food dyes in combination with other factors, such as preservatives, and ongoing consumer concerns. During the public session, CNN reports, parents "from all over the United States" had stories to tell about how their children experienced hyperactivity or behavioral problems when exposed to artificial dyes that appeared to disappear when such dyes were eliminated from their diets.

Re-posted by Houston Lawyer and Law News

Booking now - PSC elective - P.I. - Employers' Liability

Re-posted by Houston Lawyer and Law News - CPD/Events
College of Law
Welcome to your CPD/Events Update
College of Law is delighted to bring Lawyer CPD/Events Business & Management Skills subscribers details of 'PSC elective - P.I. - Employers' Liability'.
PSC elective - P.I. - Employers' Liability
Course Details
Date from 15 April 2011
Date to 15 April 2011
Event time 09:30 - 17:30
Location The College of Law, 2 Bunhill Row, London
Postcode EC1Y 8HQ
Date from 11 May 2011
Date to 11 May 2011
Event time 09:30 - 17:30
Location The College of Law, Bishopthorpe Road, York
Postcode YO23 2GA
Date from 26 May 2011
Date to 26 May 2011
Event time 09:30 - 17:30
Location The College of Law, 2 New York Street, Manchester
Postcode M1 4HJ

Course overview

Practice area: Contentious skills - Personal Injury

This one-day course examines the key elements of employers' liability law including common law negligence, vicarious liability and breach of statute (focusing on the health and safety regulations).

The course deals with a number of case studies to give practical examples of this area of law.

Our PSC electives

The College of Law offers a wide range of regularly-updated PSC electives, covering areas such as:

Practice skills
Dispute resolution
Personal injury
Employment law
Criminal law
Family law
Commercial law and intellectual property
Corporate law
Commercial property
Probate

Please visit our website to check out our full range of courses, dates and locations: www.college-of-law.co.uk/psc

Our PSC

The College of Law is the leading national provider of the Professional Skills Course. Our flexible PSC is designed and delivered by qualified practitioners to ensure trainees and their employers gain maximum benefit from the training:

Choice of specialist routes for Client Care & Professional Standards - corporate, commercial & private and in-house lawyers
Wide range of electives
Specialist options including Higher Rights of Audience training
Fast-track programme for the core modules
Delegate numbers capped to maximise participation
Wide range of dates and venues across the country

PSC courses can be booked individually, but delegates can save over £600 if they book their full programme of core modules and electives at once as a block booking.

For more information on our PSC, please visit www.college-of-law.co.uk/psc

Further Details
Delegate Rate £185 + VAT
More information London 15 April 2011 Click here »
York 11 May 2011 Click here »
Manchester 26 May 2011 Click here »
Related Categories
Topics Management Course - Stage 1
London
15 April 2011


York
11 May 2011


Manchester
26 May 2011
[www.thelawyer.com]

Re-posted by Houston Lawyer and Law News

FDA Lawyers Blog - New Post: Patent Reform Faces Fight in Lower Chamber

Re-posted by Houston Lawyer and Law News - House Judiciary Chairman Lamar Smith, R-Texas, recently unveiled H.R. 1249, the America Invents Act, the long-awaited House companion to S.23. Despite overwhelming support for S.23, the Senate version of the U.S. Patent Reform bill that passed by a margin of 95-5 earlier this month, the House's companion bill could face significant opposition from both sides of the aisle. While the House version bears substantial similarity to its Senate companion--transitioning to a first-to-file system, establishing post-grant review procedures, and providing more fee-setting authority to the U.S. PTO--several key differences have led to early disagreements between lawmakers and industry groups.

For example, the House bill expands prior user rights, which provide a defense against claims of infringement in certain cases for products and processes in commercial use for at least a year. The current system limits the application of prior user rights to the context of business method patents, while the House version of the bill would make such rights applicable to essentially all technological inventions. Rep. Jim Sensenbrenner, R-Wis., worried that expansion of prior user rights could be tantamount to legalizing piracy, calling it a "get out of jail free card" for Chinese intellectual property pirates. Executive Vice President of the Association of American Universities John Vaughn claims such an expansion could severely damage universities' ability to protect their patents, and that companies should be free to choose to develop products via a trade secret route, but should be aware of the risks in doing so. Cisco Systems Inc. Senior Vice President and general counsel Mark Chandler provided the other side of the argument, saying a switch to first-to-file without an expansion of prior user rights would allow challengers to hold companies hostage with bogus claims on improvements to existing products.

Procter & Gamble Co. Vice President and general counsel for intellectual property Steven Miller cited the prior user rights issue among a number of provisions that could lead to stakeholders pulling their support for the legislation. Other provisions Miller said would contribute to discord included the higher threshold set in the bill for post-grant reviews, and provisions limiting venue and establishing a loser-pays regime in the transnational program handling business method patents. Among the squabbling, Chairman Smith called on lawmakers to "maintain a broader perspective if we want to enact a bipartisan, bicameral bill to modernize the patent system." Even if the House bill moves to a vote and passes, differences between the House and Senate versions will necessitate further negotiations regarding the final language in conference. Most experts, however, expect that the bill, in some form, will reach President Obama's desk sometime this year, perhaps within the next few months. [http://www.fdalawyersblog.com]

Re-posted by Houston Lawyer and Law News