Today we announced the publication of the first paper to provide an in-depth analysis of patent reexamination in the biotechnology, chemical, and pharmaceutical industries, an increasingly significant patent enforcement source and rapidly developing area of patent litigation practice. Reexamination Practice of Biotech/Pharma Patents in Group Art Unit 3991 provides the first detailed analysis on what is happening to patents being reexamined within this unit of the United States Patent & Trademark Office (USPTO). Download the PDF above to read the press release or click here to read the full article.

This paper addresses reexamination practice of patents in the Biotechnology/Pharmaceutical arts, specifically Group Art Unit 3991 (AU 3991) of the Central Reexamination Unit (CRU) of the United States Patent and Trademark Office (USPTO). To read the full paper download the PDF above.

The court's Jan. 7 panel ruling in Wyeth v. Kappos upholds a September 2008 ruling in the U.S. District Court for the District of Columbia.

Click here to read the full article and to hear what SKGF's Eric Steffe had to say about this topic.

Reproduced with permission from BNA's Patent, Trademark & Copyright Journal, 79 PTCJ 220 (Jan. 1, 2010). Copyright 2010 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com>

Today we announced the expansion of our Litigation Practice Group with the addition of four attorneys: Director H. Keeto Sabharwal, Of Counsel Daniel E. Yonan, and Associates Nirav N. Desai and Dennies Varughese. For the full story download the PDF above.

The emphasis of the review is on the eight CLP domains, the practice exam questions and the participant’s results. Three experienced LES members that have achieved CLP™ status present the one-day, face-to-face course. Each one-hour webinar provides another opportunity for the test registrants to review the domains and to ask questions of the LES experts.

Click here to see the full program schedule or to register.

Mr. Featherstone will also participate in a panel discussion on “Global Intellectual Property Issues for Nanotechnologies”. This panel will focus on the major challenges in patenting nanotechnologies and the potential for a legal structure that accurately reflects their innovative characteristics. The panel will be chaired by Pr. Michael Bennett, Vassar College, whose research focuses on IP and nanotechnologies.

For more information, or to register for the conference, click here.

SKGF Director, Kevin W. McCabe Will be Speaking on April 27th at 2:00pm on  the topic of Pleadings and Considerations.

To read more about the conference or to see the full agenda click here.

The Course Covers:

• IP Basics: patents, trademarks, know-how, trade secrets and more

• Smart strategies for creating, organizing, managing and securing IP assets

• Commercialization — Bringing IP to market

• Royalties and ideas for maximizing IP value and making money!

• A licensing game with an interactive deal negotiation — a hands-on opportunity for you!

Click here to register. 

Through a series of presentations and panels, participants will increase their knowledge of: the decision-making process at the Board, how to avoid mistakes commonly made when appearing before the Board, how to properly and persuasively present evidence by way of affidavits and the inter partes reexamination process. Participants will also hear from Chief Judge Paul R. Michel and Circuit Judge Randall R. Rader of the U.S. Court of Appeals for the Federal Circuit on the role of the Board in the development and advancement of the patent system.

The Technology Managers for Global Health serves as a share-and-learn platform to:

1. Encourage licensing policies, partnering/negotiation strategies, and invention management practices that address humanitarian concerns (e.g., assuring fair access for new technologies that address treatments for neglected tropical diseases and other afflictions widely prevalent among the world's poorer populations); 
2. Feature individuals, programs, and case studies representing the evolving contexts within which academic innovation management frameworks [delete-need to be] creatively design[ed] and thougtfully implement[ed] such policies to address, for example, the [in a] complex and dynamic field of [such as] global health; and
3. Improve understanding of the ongoing challenges and opportunities of being engaged in transnational and multi-sector initiatives aimed at advancing global health causes.

Please visit www.tmgh.org for further information.

Prof. Sam Oddi, of Akron, will moderate a panel discussion on patentable subject matter and Bilski.  Panelists are Prof. Osenga, Prof. Carl Moy, Mike Dzwonczyk, and SKGF's Robert Greene Sterne.

To see the full conference agenda or to register click here.

• Update on progress of biosimilars legislation through the U.S. House
  and Senate
• Analysis of the provisions of the competing U.S. bills
• Comparison of the proposed biosimilars legislation to small molecule regulation under Hatch-Waxman
• Views of affected constituencies (biopharma companies, generics companies, health care providers, patients)
• Comparison of the proposed US regulatory scheme to those in other parts of the world (especially Europe and Japan)

• How innovative companies can overcome two major obstacles:
  • Create and protect technologies that are both functionally and economically feasible particularly in industries with a low profit margin like the biofuel industry
  • Navigate relevant technology patents that are issued or pending
• Explore steps that emerging biofuel and other cleantech companies must take in order to avoid the kind of patent problems that have plagued and ultimately destroyed many new innovative companies

In light of the Supreme Court's Quanta v. LG decision, is it possible to avoid patent exhaustion when licensing IP?  Mr. Lee will present on the topics of licensing and patenting approaches including the effect of covenants not to sue.   James J. Kulbaski of Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P., will also be presenting on the issues of using a patent trust with respect to MPEG LA v Multimedia Patent Trust.

For more information including a full schedule of events and directions click here.

THE SEDONA CONFERENCE® "VOICES FROM THE DESERT" WEBINAR SERIES PRESENTS THE PATENT REFORM WEBINAR - WEDNESDAY, DECEMBER 16, 2009 AT 2:00 PM EASTERN

While generating less-widespread attention than other proposals before Congress, the pending patent reform legislation has produced huge debate and concern in the patent community. The faculty from the recent Tenth Annual Sedona Conference® on Patent Litigation wants to share its best thinking on three key areas in which fundamental changes have been proposed: (1) willfulness; (2) post-grant review and expanded inter partes reexamination; and (3) first to file.

Our annual conference on patent litigation (like our other regular season conferences) is strictly limited to 45 participants so we have decided to provide webinars on various issues discussed to bring the benefit of the collective wisdom generated to the broader Bench and Bar. We chose the topic of patent reform legislation to be the first topic from this year's patent litigation conference because some are of the opinion that a form of legislation may actually pass early in 2010, so now is the time for those interested to get up to speed on the potential changes that may come to both patent prosecution and patent litigation.

Thus, the webinar will address the following:

Agenda:

2:00 - 2:50 EST

*Proposed changes with regard to the law on willfulness;

*Proposed changes with regard to the law on post-grant review and expanded inter partes reexamination

*Proposed changes with regard to the law on invention date (elimination of the "first to file" rule)

2:50 - 3:00 EST Question-and-comment session

This webinar will be moderated by Richard G. Braman (Executive Director, The Sedona Conference®) and includes a distinguished panel featuring the Honorable Chief Judge Paul R. Michel (U.S. Court of Appeals for the Federal Circuit, Washington, DC), Maximilian A. Grant (Latham & Watkins, Washington, DC), Rachel Krevans (Morrison & Foerster, San Francisco, CA), and Robert G. Sterne (Sterne Kessler Goldstein & Fox, Washington, DC).

• Exploring methods for obtaining an order to pursue discovery in various jurisdictions
• Evaluating what forms of discovery are available in the jurisdiction in which you are litigating
  • civil law vs. common law
  • interrogation and cross examination
  • seizures vs. preservation of evidence
• Seeking discovery on the basis of a foreign pharmaceutical patent
  • working around unique issues that may arise when pursuing discovery of information only attainable from a non-U.S. office or employee
  • complying with various local and country-specific requirements when seeking discovery of information in various jurisdictions
• Becoming familiar with foreign discovery timetables
• Maintaining a reasonable discovery budget
• Determining whether or not evidence obtained in one country can be:
  • used to pursue discovery in another country
  • used as evidence in a parallel or separate but related suit in another country

To see the full conference agenda, click here.

The Conference will be held at LUISS (Libra Universita Instituto Science Sociale) Guido Carli- a private Social Sciences University in Rome.

• Establishing your witness as an expert skilled in the art
  • drawing attention to the expert’s experience developing and dealing with the type of product at issue
  • stressing the expert’s reputation in the industry as a well-respected leader
• Getting the witness to distinguish the inventive nature of the product by highlighting the non-obvious nature of the invention to one of ordinary skill in the art
• Exploring and dispelling the signifi cance of all prior art – demonstrating through the NDA record how the patentee overcame stumbling blocks to ultimately secure drug approval
• Anticipating the opposition’s cross examination by showing that the science underlying the patent is valid, unique and non-obvious

To learn more about the event, click here.

During this session, patent litigators experienced in representing both brand name and generic manufacturers will discuss proven strategies for preparing for your next paragraph IV case. Topics of discussion will include:

• Evaluating triggering events that ultimately effect the timing of the lawsuit
  • strength of patents – what patents to assert and what patents to challenge?
  •  discussing fi ling strategies – identifying and evaluating the criteria for deciding where to bring suit
• Multiple ANDA filers – dealing with and positioning yourself as one of several ANDA filers
• Witness and expert selection
  • identifying key points on which the opinion of an expert will be sought by both sides
  • locking up the right experts in advance of fi ling
• Scope of discovery
  • what to exclude, what to allow, what to ask for
  • at what point is a discovery request over burdensome?
• Summary Judgment
  • strategy considerations
  • selecting the right (and ripe) issues
• Markman Hearing and claim construction
  • assessing whether Markman hearings should take place before or after expert reports and discovery
  • arguing disputed claims before the judge – what to argue and what to save for trial
• Weighing the pros and cons of agreeing to a judge’s tutorial

To learn more about the conference, click here.

• How innovative companies can overcome two major obstacles:
  • Create and protect technologies that are both functionally and economically feasible particularly in industries with a low profit margin like the biofuel industry
  • Navigate relevant technology patents that are issued or pending
• Explore steps that emerging biofuel and other cleantech companies must take in order to avoid the kind of patent problems that have plagued and ultimately destroyed many new innovative companies

Patents provide owners with monopoly rights to exclude.  This provides an artificial barrier to competition.  How that barrier is constructed and maintained greatly defines a company's ability to protect its market share.  This talk will explore the steps that companies must take in order to develop a strategic patent portfolio and the benefits derived from such, including increased market revenue and share, increased brand recognition, and the potential for licensing revenue.

To learn more about the conference, click here.

To see the full conference schedule, click here and for more info on the presentation, click here.

1. Re-exam and Litigation
2. Obviousness
3. Inequitable Conduct
4. Injunctive Relief & Damages for Future Infringement
5. Reasonable Royalties
6. Process Forum: Local Rules Developments and Model CMO's
7. Extraordinary Relief
8. Patent Reform Legislation Update

To learn more about the meeting, click here.

To learn more about the meeting, click here.

• Extension of patent term under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
• Exploring the viability of extension applications to:
  • basic and combination compounds; secondary patents
• Important benchmarks in the drug’s developmen tand patent timelines
• Eligibility for patent term extension
• Regulatory review period determinations
• How to calculate the patent term restored
  • respective roles of the FDA and the PTO in granting patent extensions
  • third-party challenges – “diligence”
• Patent term extensions outside the U.S.
• Examining patent term adjustment due to delays in prosecution before the USPTO
  • strategies for:
    • diligence in prosecution by the patent applicant
    • calculating the adjustment period
• Understanding the link between patent extensions and exclusivity
  • extensions obtained through FDA Pediatric Exclusivity and Orphan Drug Exclusivity
• Obtaining patent coverage for pharmaceuticals through the use of second-generation patents, e.g.,
  • maintaining patent position for second-generation products
  • approaches taken by pharmaceutical companies in obtaining second-generation patents
  • enforcement of second-generation patents
• Assessing the impact of the PTO Rule regarding elimination of continuation practice on pharmaceutical patent extensions

Patent reform, the new administration, evolving case law, and the current economic climate have converged on the biotech industry to create the perfect storm, catapulting biotech patent practitioners into murky waters surrounded by unknowns. This interactive session will help you to navigate the political system with an in-depth analysis of the evolving legal standards and changing players including:

• Evaluating the Tafas decision and the impact of the proposed PTO rules on the biotech sector
  • Predicting howTafas will eventually be resolved
  • Determining what the practical application of the new PTO rules will be after Tafas
• Analysis of proposed patent reform legislation and its impact on the industry
• Understanding how the courts are addressing the issue of patent reform in the absence of congressional action
• Discerning the priorities of the Obama administration and the impact on biotech
  • New PTO Commissioner
  • How will the administration help to promote innovation in biotech?
• Reconciling the needs of the biotech industry with the emerging new rules
• Regulatory and Statutory Reexamination Reforms
• Incorporating deferred patent prosecution
• Strategically preparing a long-term plan to account for further reform in opposition to biotech’s goals

To view the conference brochure and register for the event click here.

More and more infringement litigation defendants seek parallel patent reexaminations at the USPTO.  The USPTO ex parte and inter partes reexamination process is explained.  Understand the impact of reexamination on litigation strategy and tactics; cutting-edge issues including collateral estoppel and intervening rights; conflicts between reexamination and court findings, NTP v. RIM and eBay v. MercExchange; and motions for stay based on pending reexamination proceedings.

To learn more about the event, click here.

To learn more about the conference, click here.

 To learn more about the invite visit http://www.law.gmu.edu/events/hottopics/2009 or see the brochure.

To learn more about the conference, click here.

• What are the “value-creating” events/milestones during the drug development process?
• From an implementation perspective, what activities should be performed, and when, to achieve these milestones?
• How can a biopharma company best leverage these milestones in its efforts to raise capital to achieve the next clinical milestone?

To register for the event, click here.

 To learn more about the conference, click here.

• How innovative companies can overcome two major obstacles:
  • Create and protect technologies that are both functionally and economically feasible particularly in industries with a low profit margin like the biofuel industry
  • Navigate relevant technology patents that are issued or pending
• Explore steps that emerging biofuel and other cleantech companies must take in order to avoid the kind of patent problems that have plagued and ultimately destroyed many new innovative companies

To learn more about this panel presentation click here.

To view the conference brochure, click here.

•  What coaching is (and isn’t).
• What Coaching Certification Programs have to offer.
• How coaching has been used (if at all) at our firms.
• Coach Training.
• Getting Management Buy-in.
• Development of Career Coaching Materials.
• Coaching Examples - Those We Coach.

To learn more about the National Adult Education Professional Development Consortium, click here.

The webinar will cover:

• Background of the case and brief analysis of the proposed final rules: 78, 114, 75 & 265
• Analyzing the details, reasoning and nuances of Tafas v. Doll, including:
  • Distinguishing between substantive versus procedural rules
  • Explaining the conflict between Section 120 of the Patent Act and Final Rule 78 limiting continuations
  • Contrasting the court’s reasoning for holding Rule 78 invalid while upholding the rules regarding claims, ESDs, and RCEs  
  • Examining the criteria discussed for the lower court to consider upon remand  
•  Evaluating possible statutory reasons for why Rule 75 could also be under attack
•  What happens next and where do we go from here?

To learn more about the webinar, click here. 
To register for the event, click here.

• Taking advantage of Expired Patents 
• Leveraging the ideas found in International Patents
• Finding Licensing Opportunities of U.S. Patents
• Clearing Products and Designing Around Unexpired U.S. Patents
• Procuring Patents for Core Technologies
• Obtaining Patents for Revolutionary Ideas 
• Obtaining Patents for Evolutionary Ideas
• Using Special Provisions of the Patent Rules

 To learn more about the conference, click here.

Provided bleow is the article and PowerPoint presentation from the conference.

To learn more about the webinar, click here.

 To learn more about the conference, click here.

To learn more about the event, click here.

To learn more about this seminar, click here.

To learn more about the event, click here. 
To view the agenda, click here.

To learn more about the seminar, click here.

To learn more about this conference, click here.

 To view more information on the conference, click here.

• European Commission proposed patent reform
• Examining proposals to change the US Patent Office rules
• Assessing the GlaxoSmithKline v USPTO injunction
• Developments regarding revival of applications for unintentional versus unavoidable abandonment
• Scope and application of written description requirements

• When does IP management become a critical stage for commercialization and investment?
• Challenges impacting the vaccine IP environment through private investment.
• What does it mean to both the investor and investee when engaging in partnerships?

With patents of profitable products set to expire, pharmaceutical companies are incorporating new delivery systems to existing products as an extension strategy. This session explores some of the issues to be aware of during this process.

• The Vanities: Dealing with rankings - Chambers, Supers, Best ofs – Maria Nanis (Dechert)
• Experience Databases: We know we did it, but who did what with whom, when, how and how much do we charge for it anyway? - Vickie Gray (Ober) & Nathan Darling (Van Ness Feldman)
• Client & Industry Service Teams: How they work and how to run them - Ellen Musante (Steptoe)
• RFPs / Proposals / Preferred Provider Surveys: Best practices - Mona Zeiberg (Morgan Lewis) & Suzette Bradbury (Venable)
• Business Plans: Process and Follow Ups  - Tim Delaney (WilmerHale) & Mary Kimber (Patton Boggs)
• Managing Up, Managing Down and Sideways all at the same time - Kelly Stuart (Morrison & Foerster)
• Research:  What's it all about? - Kimberly Bell (Nixon Peabody)
• Going Green: Great idea, how do you do it? - Tammy Mangan (Sterne Kessler)
• PR - How do I get above the fold? - Jonathan Groner (Jenner & Block) & Ellen Katkin (Gilbert Randolph)
• Building a Great Team - Mark Greene (Nixon Peabody)
• CRM Issues & Features - Don’t you just love them? Gail Hageman (Sutherland)
  

 To view the presentation click here.

• When does IP management become a critical stage for commercialization and investment?
• Challenges impacting the vaccine IP environment through private investment.
• What does it mean to both the investor and investee when engaging in partnerships?