Patent Law

BPAI Conference

Posted on February 20, 2010
The Board of Patent Appeals and Interferences (BPAI) will be holding its First Annual Board Conference on April 7, 2010 in Alexandria, VA. The conference will include presentations on the following topics: ? State of the Board -- Chief Judge Michael Fleming ? A View Behind the Curtain -- Vice Chief Judge James Moore, Vice Chief Judge Allen MacDonald, Judge Ken Hairston, and Judge Murriel Crawford ? Practice Tips: Top Ten Mistakes (panel discussion) -- Judge Linda Horner (moderator), Gary Harkcom of Greenblum & Bernstein, P...

PhRMA Representative Questions Follow-on Biologics Paper

Posted on February 19, 2010
By Donald Zuhn -- In a letter to the editor published in this week's edition of The New England Journal of Medicine, Dr. David Wheadon, Senior Vice President of the Pharmaceutical Research and Manufacturers of America (PhRMA) Scientific & Regulatory Affairs team, attempts to set the record straight regarding a follow-on biologics (FOB) paper published in that medical journal last fall...

Biotech/Pharma Docket

Posted on February 18, 2010
By Suresh Pillai -- Court Denies Bid for Bench Trial in RNAi Patent Suit The U.S. District Court for the District of Massachusetts has denied the bid of defendants Whitehead Institute for Biomedical Research, the University of Massachusetts, and the Massachusetts Institute of Technology to have the merits of their patent dispute with plaintiffs Max Planck Institute and Max Planck licensee Alnylam Pharmaceuticals, Inc...

Gates Foundation Seeks to Make This "The Decade of Vaccines"

Posted on February 17, 2010
By Donald Zuhn -- Last month, Bill and Melinda Gates kicked off the new decade by announcing that their Foundation will be pledging $10 billion over the next ten years to help research, develop, and deliver vaccines to the world's poorest countries. The announcement came at the World Economic Forum's annual meeting in January...

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FTC Disapproves of "Pay-for-Delay" Drug Deals

Posted on February 16, 2010
By Kevin E. Noonan -- Last month, the Federal Trade Commission released a report about so-called "pay for delay" arrangements, agreements between branded pharmaceutical companies and generic drug companies that delay entry of generic versions of branded drugs...

USPTO Solicits Public Comment on Information Collection

Posted on February 16, 2010
By Sarah Fendrick -- As part of its effort to reduce paperwork, the U.S. Patent and Trademark Office is seeking public comment on its current continuing information collection systems. The first information collection system includes information collected to pay fees for issued patents, to request corrections of errors in issued patents, and to submit applications for reissue patents...

Court Report

Posted on February 15, 2010
By Sherri Oslick -- About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Genetic Technologies Ltd. v. Beckman Coulter, Inc. et al. 3:10-cv-00069; filed February 12, 2010 in the Western District of Wisconsin ? Plaintiff: Genetic Technologies Ltd...

Patent Profile: NexBio Granted U.S. Patent for Flu Therapeutic

Posted on February 15, 2010
By James DeGiulio -- Last week, NexBio, Inc. announced the issuance of U.S. Patent No. 7,645,448, entitled "Class of Therapeutic Protein Based Molecules." The '448 patent, issued January 12, 2010, is the company's first issued U.S. patent. The patent covers NexBio's sialidase pharmaceutical compositions, including its lead compound DAS181 (Fludase®) and methods of treating or preventing viral infection by influenza and parainfluenza with such compositions...

Conference & CLE Calendar

Posted on February 15, 2010
February 17-18, 2010 - Biotech & Pharmaceutical Patenting (IIR) - Munich, Germany February 24-25, 2010 - 2nd Expert Forum on ITC Litigation & Enforcement (American Conference Institute) - New York, NY March 1-2, 2010 - 4th Annual Patent Law Institute (Practising Law Institute) - New York, NY March 2-4, 2010 - 6th Annual Biosimilars Conference (Visiongain) - Boston, MA March 17-18, 2010 - 18th Forum on Biotech Patenting (C5) - Munich, Germany March 18-19, 2010 - 4th Summit on Biosimilars and Follow-on Biologics*** (Center for Business Intelligence) - Washington, DC March 22-23, 2010 - 4th Annual Patent Law Institute (Practising...

PRG Advanced Patent Courses

Posted on February 13, 2010
Patent Resources Group (PRG) will be holding its next group of Advanced Courses between April 11-17, 2010 in Bonita Springs, Florida. Among the courses being offered are: ? ANDA Litigation: Critical Issues and Winning Strategies - April 14 ? Fundamental Building Blocks for Creating and Enforcing the FDA Orange Book Listable U...

BIO Sends Letter on SACGHS Report to HHS Secretary Sebelius

Posted on February 12, 2010
By Donald Zuhn -- Last week, the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) issued its long-awaited report on gene patents. While the report, entitled "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests," indicates that gene patents and licensing practices concerning such patents have not had an adverse impact on patient access to genetic tests, it nevertheless includes a number of controversial recommendations...

Debating Gene Patents - Round Four

Posted on February 11, 2010
By Donald Zuhn -- In January, the gene patenting debate returned to National Public Radio when WBUR's "On Point" became the fourth NPR program to tackle the issue since last May, when a group of patients, physicians, academic researchers, and medical societies filed suit against the U...

USPTO Remains Closed For February 11, 2010

Posted on February 11, 2010
By Sarah Fendrick -- As a result of two recent blizzards in Washington DC, the city broke a record for annual snowfall on Wednesday that had stood for more than 120 years. The old record of 54.4 inches, set in 1888-89, has now been surpassed by the 54...

USPTO Closed on Monday and Tuesday, February 8-9, 2010

Posted on February 10, 2010
By Sarah Fendrick -- On Monday and Tuesday, February 8-9, 2010, the U.S. Patent and Trademark Office was closed due to weather. As a result of the closing, the USPTO will consider each of Monday and Tuesday, February 8-9, 2010 to be a "Federal holiday within the District of Columbia" under 35 U...

Court Report

Posted on February 10, 2010
By Sherri Oslick -- A note to our readers: In an effort to catch up with recently filed biotech and pharma cases following a brief hiatus, Patent Docs presents this additional installment of Court Report. Teva Women's Health, Inc. v. Lupin, Ltd. et al...

Patent Profile: Fate Therapeutics to Receive First U.S. Patent for Induced Pluripotent Stem Cell Technology

Posted on February 10, 2010
By James DeGiulio -- This week, Fate Therapeutics of San Diego, CA was issued a Notice of Allowance for U.S. Application No. 10/997,146 (U.S. Patent Application Publication No. 2008/0280362), titled "Methods for Reprogramming Somatic Cells." With a priority date of November 26, 2003, the application is believed to contain the earliest allowed claims in the United States for induced pluripotent stem cell technology...

Patent Office Remains Closed for February 10, 2010

Posted on February 10, 2010
By Sarah Fendrick -- The U.S. Patent and Trademark Office remains closed today, February 10, 2010, due to weather. The USPTO will consider February 10, 2010 to be a "Federal holiday within the District of Columbia" under 35 U.S.C. § 21(b) and 37 C.F.R...

Newsweek = Newspeak on Gene Patenting

Posted on February 09, 2010
By Kevin E. Noonan -- Newsweek has always been Avis to Time Magazine's Hertz -- evidenced by an increasing difference in subscriptions (3.3 million versus 1.97 million on 2009). So it isn't surprising that the magazine needs to do something to tweak its readership, even if that something is to distort its reporting on an important issue...

Court Report

Posted on February 09, 2010
By Sherri Oslick -- A note to our readers: In an effort to catch up with recently filed biotech and pharma cases following a brief hiatus, Patent Docs presents this additional installment of Court Report. Eli Lilly and Company v. Fresenius Kabi Oncology PLC 1:10-cv-00147; filed February 4, 2010 in the Southern District of Indiana Infringement of U...

Court Report

Posted on February 08, 2010
By Sherri Oslick -- A note to our readers: Patent Docs apologizes to our readers for the recent Court Report hiatus. This Court Reporter was away at trial and has just now been able to come up for air. We will catch our readers up in the next few postings...

USPTO Budget Request for FY 2011 and Perspectives from the Patent Community

Posted on February 08, 2010
By Christopher P. Singer -- On February 1, 2010, the U.S. Patent and Trademark Office issued a press release announcing President Obama's $2.3 billion budget request for the USPTO for fiscal year 2011. According to the statement, the amount of the budget request is intended to support and achieve the strategic objectives of the five-year plan for the USPTO as mapped out by Director Kappos and Commerce Secretary Locke...

USPTO Extends Period for Public Comment and Period of Effectiveness for Recent Programs

Posted on February 08, 2010
By Sarah Fendrick -- The U.S. Patent and Trademark Office has extended the time for public comment for two recent Office initiatives and has extended the period of effectiveness for a third Office initiative. Extension of Period for Comments on Enhancement in the Quality of Patents In December 2009, the USPTO published a notice in the Federal Register seeking public comment on the enhancement in quality of patents...

Conference & CLE Calendar

Posted on February 08, 2010
February 9, 2010 - Patent Prosecution: Best Practices for Reducing Costs While Improving Patent Quality (Technology Transfer Tactics) - 1:00 - 2:30 PM (EST) February 17-18, 2010 - Biotech & Pharmaceutical Patenting (IIR) - Munich, Germany February 24-25, 2010 - 2nd Expert Forum on ITC Litigation & Enforcement (American Conference Institute) - New York, NY March 1-2, 2010 - 4th Annual Patent Law Institute (Practising Law Institute) - New York, NY March 2-4, 2010 - 6th Annual Biosimilars Conference (Visiongain) - Boston, MA March 17-18, 2010 - 18th Forum on Biotech Patenting (C5) - Munich, Germany March 18-19, 2010 -...

Paragraph IV Disputes Conference

Posted on February 06, 2010
American Conference Institute (ACI) will be holding its 4th Annual Paragraph IV Disputes conference on April 27-28, 2010 in New York, NY. The conference will allow attendees to: ? Identify patents for small molecules and small proteins that may be ripe for a Paragraph IV challenge; ? Recognize an ANDA applicant's initial obligations and reevaluate Orange Book tactics; ? Incorporate post-KSR obviousness considerations into Paragraph IV litigation strategies; ? Develop a plan of action for Notice Letter delivery and Post-Notice Letter deliberations; ? Master techniques for drafting the initial Paragraph IV pleadings; ? Understand the criteria for 180-day exclusivity and...

BIO Comes out Swinging against SACGHS Report - Updated

Posted on February 05, 2010
By Donald Zuhn -- In a press conference held earlier today, the Biotechnology Industry Organization (BIO) expressed concern about recommendations to be issued on Friday with a report on gene patents. The report, entitled "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests," is being issued by the Secretary's Advisory Committee on Genetics, Health and Society (SACGHS), which is charged with advising the Secretary of Health and Human Services on human health and societal issues raised by the development and use of genetic technologies...

Biotech/Pharma Docket

Posted on February 05, 2010
By Suresh Pillai -- Settlement Announced in Focalin® Infringement Suit Celgene, Novartis Pharmaceuticals, and Teva Pharmaceuticals have filed three separate stipulations in the U.S. District Court for the District of New Jersey that will, if approved by the Court, put an end to all claims among the parties...

GSK Announces "Open Innovation" Strategy to Combat Neglected Tropical Diseases

Posted on February 04, 2010
By Donald Zuhn -- In January, GlaxoSmithKline announced a series of initiatives for developing new medicines to combat diseases that disproportionately affect the world's poorest countries. The initiatives, which comprise GSK's "open innovation" strategy, were outlined in a speech given by GSK Chief Executive Andrew Witty to the Council on Foreign Relations on January 20th...

Letter to Congressional Leaders Seeks Patent Protections

Posted on February 03, 2010
By Donald Zuhn -- In a letter sent to Speaker of the House Nancy Pelosi (D-CA), House Majority Leader Steny Hoyer (D-MD), and House Minority Leader John Boehner (R-OH) earlier today, Representatives Mike Michaud (D-ME), Don Manzullo (R-IL), Dana Rohrabacher (R-CA), and Marcy Kaptur (D-OH) urged the House leaders to "remember the importance of patent protections" as the House begins the process of crafting legislation to promote job creation...

Everybody Knows -- The Boston Globe Weighs in on Gene Patenting

Posted on February 02, 2010
By Kevin E. Noonan -- Fifteen hundred years ago everybody knew the Earth was the center of the universe. Five hundred years ago, everybody knew the Earth was flat, and fifteen minutes ago, you knew that humans were alone on this planet. Imagine what you'll know tomorrow...

Follow-on Biologics News Briefs - No. 12

Posted on February 01, 2010
By Donald Zuhn -- BIO CEO Asks President to Focus on Unresolved Issues in Health Care Debate Writing for True/Slant earlier this month, Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood provided his organization's take on recent efforts by President Obama to re-write the biosimilars provisions of the House and Senate health care bills ("Health Care Reform Negotiations: Focus on Unresolved Issues")...

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