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  • Biovail and Watson Settle Cardizem® Suit

        By Sherri Oslick —

    Biovail
    Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, and Watson Pharmaceuticals, Inc., have announced that they have reached a settlement agreement in Biovail’s lawsuit against Andrx Pharmaceuticals, Inc., a subsidiary of Watson.  The lawsuit was filed following a paragraph IV certification as part of Andrx’s filing of an ANDA to manufacture a generic version of Biovail’s Cardizem® LA (diltiazem), which is used to treat hypertension and for the management of chronic stable angina.

    Logo_watson
    Under the terms of the settlement, Watson, which has been awarded an exclusive license to the patents covering Cardizem® LA, will not enter the market until April 1, 2009.  At that time, Biovail will receive a royalty based on Watson’s sales of its generic diltiazem.  Other details of the settlement agreement, which is subject to court approval, have not been disclosed.

    For additional information regarding the settlement, please see:

  • Oracle Healthcare Acquisition and Precision Therapeutics Announce Merger

        By Donald Zuhn —

    Precisiontherapeuticslogo
    Oracle Healthcare Acquisition Corp. and Precision Therapeutics, Inc. announced today that the companies have entered into a merger agreement.  Precision Therapeutics, Inc. is a privately-owned life sciences company based in Pittsburgh, PA that focuses on the development and commercialization of tests for use in individualizing cancer therapy.  Oracle Healthcare Acquisition is a publicly-traded special purpose acquisition company based in Greenwich, CT, which was formed in 2005 for the purpose of acquiring an operating business in the healthcare industry.

    Under the merger agreement, Precision Therapeutics, Inc. will be the surviving corporation, and Oracle Healthcare Acquisition will change its name to Precision Therapeutics Corp. and operate as a subsidiary of Precision Therapeutics, Inc.  The combined company will be based in Pittsburgh.  Further details concerning the merger can be found in the companies’ statement.

    Precision Therapeutics President and CEO Sean McDonald stated that the merger "would provide the financial resources to capitalize on the progress we have made in commercializing our ChemoFx test."  ChemoFx® is a chemoresponse test that uses a patient’s tumor cells to assess the patient’s likelihood of responding to various cancer drugs, or drug combinations.  The test measures both the sensitivity and resistance of a patient’s tumor cells to single or multiple chemotherapeutic agents, thereby allowing for the formulation of an optimal therapy choice for the patient.  According to Precision Therapeutics’ website, ChemoFx® is currently being used to analyze fifteen different solid tumors, including breast, ovarian, endometrial, colorectal, genitourinary, head and neck, lung, brain, pancreas, and hepato-biliary.

    Precision Therapeutics’ patent portfolio includes seven U.S. patents and four U.S. patent application publications.

  • Court Sets Summary Judgment Schedule in New Rules Case

        By Kevin E. Noonan —

    Eastern_district_of_virginia_seal
    Gene Quinn from the PLI blog reports today that Judge Cacheris has set the briefing schedule for summary judgment motions in the challenge to the claims and continuation rules enjoined by the Court on October 31st (see Patent Docs report).  All parties must file summary judgment motions and any briefs in support of those motions by December 20th (see Court’s Order).

    Glaxosmithkline_gsk
    This deadline also applies to any amicus briefs to be filed in support of either party.  Opposing briefs are due on January 22, 2008, and reply briefs due on February 1, 2008.  The hearing on motions is scheduled for February 8th, but GSK counsel has informed the Court that it is scheduled for trial in another matter on that day.  Thus, the Court’s Order schedules an alternative date of the first Friday following February 15th that the Judge has available for the hearing.

    In view of this schedule, it is possible that there will be a decision in late winter or early spring.  It is unlikely that the matter will go to trial, since there will be no discovery and it is difficult to see what issues remain for trial.  Since it can be expected that the losing party will appeal, it is conceivable that the ultimate fate of the "new rules" will not be determined until next summer.

    For additional information on this topic, please see:

  • Patent Profile: Vaccinex Announces Issuance of European Patent Covering ActivMAb® Antibody Discovery Technology

        By Donald Zuhn —

    Print_logo
    Last Friday, Vaccinex, Inc. announced that it had been granted European Patent No. 1 340 088.  According to the statement released by Vaccinex, the ‘088 patent covers the Rochester, New York-based company’s ActivMAb® antibody discovery technology platform, which can be used for the discovery and development of new monoclonal antibody therapies, and which Vaccinex has used to identify four of its lead therapeutic antibodies.

    Vaccinex President and CEO Dr. Maurice Zauderer stated that "[t]his European patent, and related patents already awarded in the United States and elsewhere, underscores the novelty of our discovery technology, which gives Vaccinex important advantages over competitors in the area of therapeutic antibodies."  Vaccinex estimates that the market for antibody therapies in 2007 will be $25 billion, and projects the market to reach $43 billion by 2012.

    Activmab
    Vaccinex describes its ActivMAb® technology as allowing for the direct selection of high-affinity, fully human antibodies using a unique vaccinia virus-based vector to express antibodies in mammalian cells, thereby providing extremely high levels of combinatorial diversity of immunoglobulin heavy and light chains.  A video outlining Vaccinex’ antibody technology can be viewed here.  Representative independent claim 1 of the ‘088 patent recites:

    1.  An in vitro method of selecting polynucleotides which encode an antigen-specific immunoglobulin molecule, or antigen-specific fragment thereof, comprising:

    (a)  introducing into a population of eukaryotic host cells capable of expressing said immunoglobulin molecule a first library of polynucleotides encoding, through operable association with a transcriptional control region, a plurality of first immunoglobulin subunit polypeptides, each first immunoglobulin subunit polypeptide comprising:

    (i)  a first immunoglobulin constant region selected from the group consisting of a heavy chain constant region and a light chain constant region,
    (ii)  an immunoglobulin variable region corresponding to said first constant region, and
    (iii)  a signal peptide capable of directing cell surface expression or secretion of said first immunoglobulin subunit polypeptide;

    (b)  introducing into said host cells a second library of polynucleotides encoding, through operable association with a transcriptional control region, a plurality of second immunoglobulin subunit polypeptides, each comprising:

    (i)  a second immunoglobulin constant region selected from the group consisting of a heavy chain constant region and a light chain constant region, wherein said second immunoglobulin constant region is not the same as said first immunoglobulin constant region,
    (ii)  an immunoglobulin variable region corresponding to said second constant region, and
    (iii)  a signal peptide capable of directing cell surface expression or secretion of said second immunoglobulin subunit polypeptide, wherein said second immunoglobulin subunit polypeptide is capable of combining with said first immunoglobulin subunit polypeptide to form an immunoglobulin molecule, or antigen-specific fragment thereof;

    (c)  permitting expression of immunoglobulin molecules, or antigen-specific fragments thereof, from said host cells;
    (d)  contacting said immunoglobulin molecules with an antigen; and
    (e)  recovering those polynucleotides of said first library which express immunoglobulin molecules, or antigen-specific fragments thereof, specific for said antigen.

  • Senate May Act on Patent “Reform” Bill in the New Year

        By Kevin E. Noonan —

    Capitol_building_2
    Breda Lund, writing in the November 28th edition of The Generic Line, reports that the Senate may consider its version of the patent "reform" bill, S. 1145, during the next session of the 110th Congress when it convenes next January.  According to Ms. Lund, Matthew Sandgren, counsel to Senator Orrin Hatch (R-Utah), spoke on the likelihood of Senate consideration at the Center for Business Intelligence (CBI) "Forum on Effective Patent, Intellectual Property and Trademark Strategies" earlier this month.

    Sandgren_matthew_2
    Ranking members of both parties, including Senator Hatch and Senator Patrick Leahy (D-Vt.) are "intent" on bringing the bill to a vote, Mr. Sandgren (at left) said.  Although the bill has been successfully voted out of the Judiciary Committee, it will not come to the floor for a vote until several "outstanding issues" have been addressed.  These include post-grant review, inequitable conduct, changes in how damages are calculated, elimination of the "best mode" requirement, and granting the U.S. Patent and Trademark Office substantive rulemaking authority (lack of the power to be granted by the latter provision is one basis for Judge Cacheris’ injunction imposed on October 31st blocking implementation of the "new rules" concerning continuations and claim limits promulgated by the Office on August 21st; see Patent Docs report).  Each of these provisions is also a part of the corresponding bill already passed by the House (H.R. 1908) (see "Patent ‘Reform’ Bill Passes House of Representatives").

    There are several differences between the House and Senate bills.  For example, the Senate bill grants a "second window" of post-grant review, while the House version does not.  The House bill eliminates "best mode" while the Senate version does not, and there are differences, and disagreements, between how the House and Senate bills change apportionment of damages.  Mr. Sandgren asserts that Senator Hatch is "the champion on inequitable conduct reform," and that differences between the House and Senate versions of the bill with regard to inequitable conduct must be resolved.

    Most heartening to patent applicants is the prediction by Mr. Sandgren that the provisions expanding the Office’s substantive rulemaking powers will likely be removed from the final version of the bill.  If true, Office management will have one less avenue for imposing its misguided "new rules" in whatever form they may take after Judge Cacheris makes his final determination.  And removal of these provisions will make it more difficult (if not impossible) for the Office to prevail, either before Judge Cacheris or the Federal Circuit, with its argument that it has such substantive rulemaking authority already.

    A useful comparison between the House and Senate bills can be found at the Intellectual Property Owners Association (IPO) website.

    For additional information on this topic, please see:

  • Court Report

        By Sherri Oslick —

    Gavel_3
    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.


    Novartis Vaccines and Diagnostics, Inc. v. United States Department Of Health and Human Services et al.
    1:07-cv-02138; filed November 27, 2007 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 defendants in the interference between U.S. Patent 6,531,276 ("Methods for Detecting Human Immunodeficiency Virus Nucleic Acid," issued March 11, 2003), assigned to Novartis, and U.S. Patent Application No. 06/693,866 ("Cloning and Expression of HTLV III DNA), assigned to DHHS.  View the complaint here.


    Schering Corporation v. Anchen Pharmaceuticals, Inc.
    3:07-cv-05649; filed November 27, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,100,274 ("8-chloro-6,11-dihydro-11-] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine Oral Compositions," issued August 8, 2000) and 6,709,676 ("Extended Release Oral Dosage Composition," issued March 23, 2004) following a paragraph IV certification as part of Anchen’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex-D® 12-hour (desloratidine and pseudoephedrine sulfate, used to treat allergies).  View the complaint here.


    Lonza Group AG v. Northwest Biotherapeutics, Inc.
    8:07-cv-03177; filed November 27, 2007 in the District Court of Maryland

    Infringement of U.S. Patent Nos. 5,122,464 ("Method for Dominant Selection in Eucaryotic Cells," issued June 16, 2992), 5,591,639 ("Recombinant DNA Expression Vectors," issued January 7, 1997), 5,658,759 (same title, issued August 19, 1997), 5,770,359 ("Recombinant DNA Sequences, Vectors Containing Them and Method for the Use Thereof," issued June 23, 1998), 5,827,739 (same title, issued October 27, 1998), 5,879,936 ("Recombinant DNA Methods, Vectors and Host Cells," issued March 9, 1999), 5,891,693 (same title, issued April 6, 1999), and 5,981,216 ("Transformed Myeloma Cell-Line and a Process for the Expression of a Gene Coding for a Eukaryotic Polypeptide Employing Same," issued November 9, 1999) based on Northwest’s manufacture, use, and sale of its DCVax® products, including DCVax®-Prostate, used to treat prostate cancer.  View the complaint here.


    Aventis Pharmaceuticals Inc. et al. v. Wockhardt Limited et al.
    2:07-cv-05647; filed November 26, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,113,942 ("Pharmaceutical Composition for Piperidinoalkanol Compounds," issued September 5, 2000), 5,855,912 (same title, issued January 5, 1999), and 5,738,872 (same title, issued April 14, 1998) following a paragraph IV certification as part of Dr. Reddy’s filing of an ANDA to manufacture a generic version of Aventis’ Allegra (fexofenadine hydrochloride) and Allegra-D® 12 Hour (fexofenadine hydrochloride/ pseudoephedrine) (both used to treat allergies).  View the complaint here.


    King Pharmaceuticals, Inc., et al. v. Teva Pharmaceuticals USA, Inc.
    2:07-cv-05618; filed November 21, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 5,061,722 ("Cis-Endo-2-Azabicyclo-[3,3,0]-Octane-3-Carboxylic Acids, A Process For Their Preparation, Agents Containing These Compounds and Their Use," issued on October 29, 1991), following a paragraph IV certification as part of Teva’s filing of an ANDA to manufacture a generic version of King’s Altace® (ramipril, used to lower cardiovascular risk and to treat hypertension).  View the complaint here.

  • Norway to Join EPO in 2008

        By Robert Dailey —

    Epoepc
    Norway will become the 33rd member of the European Patent Organization on January 1, 2008.  Therefore, any European patent applications filed on or after January 1, 2008 may designate Norway as a contracting state.

    No retroactive designations will be permitted.  Nevertheless, the EPO will accord applications filed in December 2007 a filing date of January 1, 2008, if the applicant expressly makes such a request.

    This also means that European patents for Norway may issue from PCT applications filed on or after January 1, 2008.  For PCT applications filed prior to that date, however, any resulting European "national phase" patents will not provide patent protection in Norway.  In those instances, applicants will still need to prosecute a separate national phase application in Norway.

    Official notice from the EPO Official Journal can be found here.  The EPO Journal will provide further details on Norway’s implementing legislation.

  • Conference & CLE Calendar

    Calendar_3
    December 3, 2007 – 18th Annual Conference on U.S. Patent and Trademark Office Law and Practice – PTO Day (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    December 4, 2007 – Biotechnology Chemical Pharmaceutical (BCP) Art Group Meeting (U.S. Patent and Trademark Office)

    December 13, 2007 – Pharmaceutical and Biotech Patent Law: Recent Developments (Practising Law Institute)

    January 4-8, 2008 – 25th Annual National CLE Conference (law Education Institute, Inc.) – Vail, CO

    January 9, 2008 – Patent Claim Construction (Law Seminars International) – San Francisco, CA

    January 25-26, 2008 – Buying, Selling and Licensing Patents: New Case Law, Rules, Legislation and Markets (Law Seminars International) – San Francisco, CA

    January 30-February 1, 2008 – Pharma/Biotech IP Due Diligence (American Conference Institute) – New York, NY***

    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

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

  • USPTO Announces Agenda for Next BCP Meeting

    USPTO Seal As reported earlier this month on Patent Docs, the biotechnology, chemical, and pharmaceutical technology groups at the USPTO will hold the next quarterly meeting next Tuesday, December 4, 2007.  The Patent Office has posted the official announcement which includes the list of topics and speakers:

    Morning Session (9:00-noon EST):

    • Greeting and Overview
    • Invention Secrecy Program — presenter:  Don Hajec, Director, TC3600
    • KSR: Overview — presenter:  Kathleen Fonda, OPLA
    • KSR: Technology Center-Specific Examples of its Application — presenter:  Jean Witz, QAS, TC1600

    Afternoon Session (1:15-4:00 EST):

    • Issues in Small Organic Molecules — presenter:  Michael Hartley, SPE, Art Unit 1618
    • 101 Sequence Homology — presenter:  Dave Nguyen, QAS, TC1600
    • Restriction:  Combination/Subcombination — presenter:  Julie Burke, QAS, TC1600
    • Closing Remarks/Discussion

    The presentation can be attended in person at Madison East GIPA (Global Intellectual Property Academy) large lecture room on the second floor (600 Dulany Street, Alexandria, VA).  However, in order to attend the meeting in person, you must have confirmed your attendance with Cecilia Tsang by phone (571-272-0562), fax (571-273-0562), or e-mail (Cecilia.Tsang@uspto.gov) by last Tuesday.  The meeting will also be broadcast on-line here using "guest" access, or it can be accessed through the link provided by the USPTO in its announcement.  Additional information (including downloadable copies of presentations and slide shows) relating to this meeting as well as prior BCP meetings can be found here.

  • ACI Pharma/Biotech Patent Claim Drafting and Prosecution Conference

    New York #1 American Conference Institute (ACI) will be holding a conference on Pharma/Biotech Patent Claim Drafting and Prosecution on February 25-26, 2008 in New York, New York.  The conference will provide information on:

    • The status of Tafas v. Dudas and the fate of the U.S. Patent and Trademark Office's claims and continuation rules.
    • Analyzing the interplay between critical rules and proposed legislation that impact patent drafting and prosecution strategies.
    • Rethinking your view on restrictions and making them work in favor of your patent strategy.
    • Employing evolving canons of claim construction to your advantage.
    • Ensuring satisfaction of the enablement, written description, and utility requirements.
    • Overcoming obviousness rejections in the face of shifting standards.
    • Adjusting timing strategies to maximize options in an ever changing statutory and rulemaking environment.
    • Drafting claims that cover the proper scope in light of constraints on claim language.

    In particular, ACI's faculty will offer presentations on the following topics:

    • 851l08nyc_pharma_biotech_patent_c_2
      Emerging patent reforms:  What you need to know now.
    • Revisiting restriction practice:  Weighing the cost-benefit of making restrictions work in favor of your patent strategy.
    • Innovative approaches for identifying patentable subject matter to optimize protection.
    • Evolving canons of claim construction and application — the post-Philips/Festo world.
    • Aligning your patent timing strategies with business objectives in order to maximize your patent lifecycle.
    • Avoiding allegations of inequitable conduct when prosecuting patent applications.
    • Preventing obviousness rejections post-KSR and its progeny.
    • Getting it right the first time:  Best practices for demonstrating utility (to be presented by this Patent Docs author).
    • Surviving 35 U.S.C. § 112 rejections:  Written description, enablement and best mode.
    • Drafting claims to include varying degrees of scope.
    • USPTO speaks.
    • Wrap up and interactive strategy session:  Pulling it all together to secure effective coverage of inventions in the current patent environment.

    An additional master class entitled: "Perfecting Claim Drafting and Prosecution in Life Sciences Patent Applications" will be offered on February 27, 2008.  The master class will allow conference attendees to apply the lessons learned from the conference's previous sessions to a mock patent drafting scenario.

    The agenda for the Pharma/Biotech Patent Claim Drafting and Prosecution conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

    American_conference_institute_aci
    The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and master class).  Those registering on or before December 19, 2007 will receive a $300 discount off the registration fee and those registering on or before January 25, 2008 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media sponsor of ACI's Pharma/Biotech Patent Claim Drafting and Prosecution conference.