•     By Sherri Oslick

    Gavel_34
    About
    Court Report:  Each week we will report briefly on recently filed
    biotech and pharma cases, and a few interesting cases will be selected
    for periodic monitoring.


    Apotex Inc. v. Astrazeneca Pharmaceuticals LP et al.

    8:08-cv-00213; filed January 31, 2007 in the Middle District of Florida

    Declaratory judgment of non-infringement of U.S. Patent No. 6,316,460 ("Pharmaceutical Compositions," issued November 13, 2001) in conjunction with Apotex’s filing of an ANDA to manufacture a generic version of AstraZeneca’s Crestor® (rosuvastatin calcium, used to treat high cholesterol).  View the complaint here.


    Forest Laboratories, Inc. et al. v. Mylan Pharmaceuticals Inc.

    1:08-cv-00073; filed January 31, 2008 in the Northern District of West Virginia

    Forest Laboratories, Inc. et al. v. Lupin Pharmaceuticals, Inc. et al.
    1:08-cv-00239; filed January 28, 2008 in the District Court of Maryland

    Forest Laboratories, Inc. et al. v. Upsher-Smith Laboratories, Inc.
    0:08-cv-00253; filed January 28, 2008 in the District Court of Minnesota

    Forest Laboratories Inc. et al. v. Dr. Reddy’s Laboratories Inc. et al.
    1:08-cv-00052; filed January 25, 2007 in the District Court of Delaware

    Infringement of U.S. Patent No. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), following a paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of Forest’s Namenda® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer’s type).  The complaints in these cases are substantially identical.  View the Dr. Reddy’s Laboratories Inc. complaint here.


    Monsanto Company et al. v. Woods

    4:08-cv-00137; filed January 29, 2008 in the Eastern District of Missouri

    Monsanto Company et al. v. Schaffnit
    3:08-cv-03023; filed January 23, 2008 in the Central District of Illinois

    Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendant’s use of soybean seed produced from earlier planted Roundup Ready® soybean seed.  The complaints in these cases are substantially identical.  View the Schaffnit complaint here.


    United States of America v. Institut Pasteur et al.

    1:08-cv-00161; filed January 25, 2008 in the District Court of the District of Columbia

    Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Institute Pasteur in the interference between U.S. Patent Application No. 06/693,866 ("Cloning and Expression of HTLV-III DNA," filed January 23, 1985), assigned to the United States as represented by the Secretary of the Department of Health and Human Service and U.S. Patent Application No. 07/999,410 ("Cloned DNA Sequences, Hybridizable with Genomic RNA of Lymphadenopathy-Associated Virus (LAV)," filed December 31, 1992), assigned to Institut Pasteur and the Centre Nationale de la Recherche Scientifique.  View the complaint here.


    Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.

    1:08-cv-00057; filed January 25, 2008 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 5,662,933 ("Controlled Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456 (same title, issued September 28, 1999) following a paragraph IV certification as part of Impax’s filing of an ANDA to manufacture a generic version of Endo’s Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.  [NB: As reported here, Endo challenged Impax’s original paragraph IV certification notices.  Impax subsequently amended its ANDA and reissued its paragraph IV notification.]


    Glaxo Group Limited v. Amneal Pharmaceuticals, L.L.C. et al.

    2:08-cv-00493; filed January 25, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 5,068,249 ("Aqueous Ranitidine Compositions Stabilized With Ethanol," issued November 26, 1991) following a paragraph IV certification as part of Amneal’s filing of an ANDA to manufacture a generic version of Glaxo’s Zantac® Syrup (ranitidine hydrochloride, used to treat gastroesophageal reflux disease in children).  View the complaint here.

  •     By Donald Zuhn –-

    Senate_floor
    Last week, we reported on nine letters that were sent to the Senators of eight states between December 12, 2007 and January 29, 2008 by a collection of universities, businesses, and organizations.  In the letters, the signatories contend that the Senate’s patent reform bill will harm innovation and result in the loss of American jobs.  While the signatories represent a wide array of technologies, we were specifically interested in the number and identity of biotech and pharma companies that had signed the letters.  To this end, we determined that of the 211 different signatories, 58 are biotech or pharmaceutical companies.  In view of the common perception that patent reform will have a disparate impact on the biotech/pharma industry, it is somewhat surprising — but perhaps pleasantly so — that only 27.5% of the signatories are biotech and pharma companies.  The biotech and pharma signatories include (with an indication of the letters each company signed; see key below):

    A:  Letter to Senators Chambliss and Isakson (2007-12-12) – 10 signatories
    B:  Letter to Senator Allard (2007-12-17) – 33
    C:  Letter to Senators McCain and Kyl (2008-01-18) – 28
    D:  Letter to Senator Hutchinson (2008-01-22) – 54
    E:  Letter to Senators McConnell and Bunning (2008-01-23) – 51
    F:  Letter to Senators Reid and Ensign (2008-01-23) – 19
    G:  Letter to Senators Specter and Casey (2008-01-24) – 29
    H:  Letter to Senator Cornyn (2008-01-27) – 54
    I:  Letter to Senators Alexander and Corker (2008-01-29) – 15

    Last month, we also reported on a letter in opposition to the Senate bill that was sent on October 23, 2007 to Senate Majority Leader Harry Reid (D-NV) and Senate Minority Leader Mitch McConnell (R-KY).  That letter was signed by 437 universities, businesses, and organizations.  We are currently analyzing the list of signatories to the October 23 letter, and hope to supplement the above list in the coming week.

  •     By Kwame Mensah

    Last month, the Director-General of Thailand’s Department of Intellectual Property, Ms. Puangrat Asavapisit,  announced that the Thailand National Legislative Assembly had unanimously voted to become a member of the Paris Convention and Patent Cooperation Treaty (PCT).  Thailand’s Ministry of Foreign Affairs has now begun legal proceedings on the accession process with the World Intellectual Property Organization (WIPO).  The PCT system provides a clearinghouse for patent applicants in which WIPO conducts an initial examination of applications before they are distributed for examination in countries the applicant has previously designated.  Thailand will gain membership within 90 days if there are no objections from the existing 138 members of the Paris Convention and PCT.

    Wipo
    Previously, comprehensive registration of Thai patents abroad was difficult because of the additive high costs of registering an application individually in multiple countries.  Membership in the Paris Convention will allow Thai inventors to obtain global patent protection more easily and at a lesser cost.  The Director-General estimates that costs may be lowered by as much as 70 percent.  An additional benefit for Thai inventors is that the PCT will give them time to develop plans for commercial use of their patents, such as authorizing foreign companies to use their rights.  The hope is that this will lead to an increase in national capital that can be used to further invest in research and development.  In turn, membership in the Paris Convention may also encourage registration of foreign patents in Thailand since inventors will not need to apply separately to the Thailand Department of Intellectual Property.

    Efforts are currently being conducted to get Thai inventors and the Thailand Department of Intellectual Property up to speed on the patent application process via the PCT.  More information on patent registration in Thailand can be found here.

  • Calendar_33
    February 15, 2008 – Patent Claim Construction (Law Seminars International) – Chicago, IL

    February 25-26, 2008 – Pharma/Biotech Patent Claim Drafting and Prosecution (American Conference Institute) – New York, NY***

    February 25-26, 2008 – Strategic Intellectual Property Planning (American Conference Institute) – Scottsdale, AZ

    March 30-April 1, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    April 3-5, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    April 10-12, 2008 – 23rd Annual Intellectual Property Law Conference (American Bar Association) – Arlington, Virginia

    June 17-20, 2008 – BIO International Convention (Biotechnology Industry Organization) – San Diego, CA

    ***Patent Docs is a media sponsor of this conference or CLE.

  •     By Sherri Oslick

    Glaxosmithkline_gsk
    Last week, GlaxoSmithKline and Cypress Pharmaceutical filed a joint stipulation of dismissal in their pending lawsuit over generic Zantac® syrup.  The suit was filed on June 25, 2007 in the Southern District of New York (see our previous report).

    Cypress_pharmaceutical_2
    Under the terms of the settlement, GSK has agreed not to assert its patent against Cypress’ new alcohol-free generic ranitidine oral syrup.  Cypress expects to launch its generic product as soon as it receives final approval from the FDA.  The patent-in-suit, U.S. Patent No. 5,068,249 ("Aqueous Ranitidine Compositions Stabilized with Ethanol," issued November 26, 1991) will expire on November 26, 2008.  With Glaxo’s six months of pediatric exclusivity, Cypress will not receive final FDA approval until May 26, 2009.

    For additional information regarding the settlement, please see:

  • Updated Information about Digital Certificates

        By Christopher P. Singer

    Efsweb
    In an e-mail notification sent January 31, 2008, the U.S. Patent and Trademark Office provided its latest e-Commerce Update, which included a link to recent information regarding the use and recovery of digital certificates, which are required to access Private PAIR and use EFS-Web.  The link provides several categories of FAQs all relating to EFS-Web.  The FAQ page has five questions and answers that relate specifically to the topic of digital certificates, which will be relevant for any practitioner preparing to use EFS-Web or Private PAIR for the first time.  Even though the initial setup can be a bit of a headache, I have found that EFS-Web is well worth the effort and encourage everyone to give it a try.  The FAQs and answers are reproduced below.

    Q1.  How long do customers have to use the authorization code and reference number initially received from the Electronic Business Center (EBC) to create and download their digital certificate?
    A1.  120 days.

    Q2.  What should a customer do if the 120 days has passed and the authorization code and reference number have expired?
    A2.  The customer should contact the EBC, who will reissue the authorization code and reference number.  Reissue should take five to six business days.

    Q3.  What is the life of a digital certificate?
    A3.  The certificate expires 27 months after it was originally issued or recovered.  If the customer uses the digital certificate during the last 100 days of this time period, the certificate will be updated automatically.  Once updated, the certificate will be renewed for another 27 months.  This renewal process continues indefinitely.  If the certificate is not used by the customer during that 100-day period, it will expire and the customer must use either self recovery or must have an EBC-assisted recovery.

    Q4.  What if multiple copies of the digital certificate exist?
    A4.  Only one copy of the digital certificate will be renewed through the automatic update process.  Any other copy, on a customer’s alternate computer or disk drive, will not be renewed.  Copies not renewed will stop working when the certificate was originally set to expire.  Customers may make copies of the renewed certificate.

    Q5.  How can a customer determine when the 100-day automatic update time period begins and whether a copy of the digital certificate was automatically renewed?
    A5.  There is no automatic notification.  Customers should contact the EBC for renewal information by calling 1-866-217-9197.

  •     By Jason Derry —

    Epoepc
    The Administrative Council of the European Patent Organisation (EPO) recently decided to amend the rules relating to fees that may substantially increase filing costs for certain European patent applications.  In December, the EPO announced that it will increase the fees for all claims in excess of 15, effective April 1, 2008.  The new claim fees will be EUR 200 for each claim above 15.

    The EPO also announced an additional increase that will become effective April 1, 2009.  In the 2009 increase, each claim 16 to 50 will cost EUR 200, and each claim above 50 will cost EUR 500.

    In view of these increasing costs, applicants having PCT applications with upcoming national phase deadlines falling after April 1, 2008, might consider filing EP applications prior to the deadline, or start analyzing their claim sets to determine if excess claim fees can be avoided or reduced.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.

  •     By Kevin E. Noonan 

    Senate_floor
    The rising tide has now become a flood of U.S. universities, businesses, and individuals in opposition to the patent "reform" bill poised for a vote in the Senate (S. 1145).  And the mechanism for this opposition is the traditional way Americans petition their government for redress — the letter.  Like our previous reports on earlier letters (see "U.S. Senate Mailbox Filling with Letters against Passage of Patent ‘Reform’ Bill" and "An Update"), Senators from eight states have now received letters (see below) signed by hundreds of interested parties.  These Senators include Specter (R) and Casey (D) of Pennsylvania, Chambliss (R) and Isakson (R) of Georgia, Alexander (R) and Corker (R) of Tennessee, Allard (R) of Colorado, McCain (R) and Kyl (R) of Arizona, Cornyn (R) and Hutchinson (R) of Texas, Ensign (R) of Nevada, Bunning (R) of Kentucky, and both Majority Leader Reid (D-NV) and Minority Leader McConnell (R-KY).

    The letters are similar in content.  Each asserts that the legislation will harm innovation and American business and cost jobs.  They are consistent in opposing the damages and post-grant opposition proceedings, as well as calling for inequitable conduct reform along the lines of the recommendations in the National Academy of Sciences (NAS) report.  Some of the letters also challenge the venue provisions, interlocutory appeals, and the expanded search and analysis provisions, and the letter to Texas Senator Kay Bailey Hutchinson mentions the Supreme Court decisions and Patent and Trademark Office regulatory initiatives undertaken in 2007.  The letter suggests that the cumulative effect of the combination of these decisions and regulations and the changes contained in the legislation would harm rather than reform patent law.

    Significantly, the letter containing the most extensive discussion of the deficiencies of S. 1145, and suggestions for how the bill should be amended or rewritten, is the letter to Senate Minority Leader McConnell.  Like the others, this letter highlights damages, venue, inequitable conduct, and the search and analysis provisions of the bill as being harmful to U.S. innovation and the economy, but it also contains some suggestions.  These include:  elimination or curtailment (along the lines of H.R. 1903, the corresponding patent "reform" bill passed by the House of Representatives last year; see "Patent ‘Reform’ Bill Passes House of Representatives") of the "second window" for patent oppositions; maintaining a court’s discretion on calculating damages; affirmatively not granting the Patent and Trademark Office any substantive rulemaking authority (S. 1145 limits the PTO’s authority to fee-setting), eliminating the enhanced prior art search and characterization requirements or tying such requirements to changes (such as those suggested by the NAS in its 2004 report) in the thresholds and activities that constitute inequitable conduct, and permitting venue in patent infringement cases to lie in districts where the claimant has its principal place of business or has engaged in substantial research, development, or manufacturing activities.

    It is apparent that large segments of the U.S. technology industry are opposed to this bill, and that activities by the Judiciary Committee Chairman, Senator Leahy (D-VT), and Majority Leader Reid to bring the bill to a vote have galvanized the signatories to action.  Letter-writing may not be enough, however;  although their letters are appropriately respectful and focused on their concern for the American economy and innovative technology, it should not be too much for these signatories to suggest, in this election year, that there will be a political price to be paid by any legislator who fails to heed these concerns.

    To view any of the nine letters, please see:

    • Letter to Senators Alexander and Corker
    • Letter to Senator Allard
    • Letter to Senators Chambliss and Isakson
    • Letter to Senator Cornyn
    • Letter to Senator Hutchinson
    • Letter to Senators McCain and Kyl
    • Letter to Senators McConnell and Bunning
    • Letter to Senators Reid and Ensign
    • Letter to Senators Specter and Casey

    For additional information regarding this topic, please see:

    For Patent Docs‘ series on specific sections of the Senate’s draft report, please see:

  •     By Donald Zuhn

    Epoepc
    The European Patent Office (EPO) announced today that the London Agreement will go into force as of May 1, 2008.  Under the London Agreement, which was adopted last fall (nearly seven years after being ratified by the Agreement’s initial signatories), certain EPC contracting states have agreed to waive the requirement for translations of granted European patents in their national language, and will now accept specifications of granted patents in one of the three official EPO languages (i.e., English, French, or German).  A state having a national language other than English, French, or German may require a translation of the granted claims in that state’s national language.  According to the EPO, the Netherlands, Sweden, and Denmark will require that granted claims be supplied in their national languages.  By reducing a large portion of the costs associated with registering a European patent in the various member states — the EPO estimates that translations can constitute up to 40% of overall patent costs  — the Agreement should significantly reduce the expense of patenting in Europe.

    Epc_states

  •     By Jason Derry —

    Stem_cell_sciences_logo
    Stem Cell Sciences plc
    has announced an agreement with Myelin Repair Foundation (MRF) to develop methods for generating sustainable cultures of human brain cells.  Under the terms of the agreement, MRF will work on developing methods for culturing neural stem cells, and inducing the stem cells to differentiate into neurons, oligodendrocytes, and astrocytes.  The cultures and techniques developed through the agreement should be useful for research, validating targets, and drug screening studies.  Although Stem Cell Sciences will have the first right of negotiation with respect to commercializing any potential products that are derived Myelin_repair_foundation
    under the agreement, the parties are hoping that the neuroscience community at large will benefit from the source of brain cells and methods discovered during the collaboration.

    Stem Cell Sciences is a research and development company that focuses on stem cell research.  The company’s mission is to discover and develop stem cell-based therapeutics.

    Myelin Repair Foundation is a non-profit organization that is focused on research and development of myelin repair therapeutics for the treatment of multiple sclerosis and other neurological diseases.

    Jason Derry, Ph.D., who graduated with honors from DePaul University
    College of Law, is a molecular biologist and founding author of Patent Docs.