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  • Court Report

    October 7, 2007

        By Sherri Oslick —

    Gavel_12
    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.


     Elan Corporation PLC v. Intellipharmaceutics Corporation et al.

    1:07-cv-00603; filed October 1, 2007 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a paragraph IV certification as part of Intellipharmaceutics’ filing of an ANDA to manufacture a generic version of Novartis’ Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Warner Chilcott Company, Inc. v. Watson Pharmaceuticals, Inc. et al.

    2:07-cv-04697; filed October 1, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive," issued December 23, 2003) following a paragraph IV certification as part of Watson’s filing of an ANDA to manufacture a generic version of Warner Chilcott’s Femcon Fe® (formerly Ovcon® 35 Fe, norethindrone and ethinyl estradiol tablets, and ferrous fumarate tablets, used for oral contraception).  View the complaint here.


    Eli Lilly and Company v. Aurobindo Pharma Ltd.

    1:07-cv-05488; filed September 28, 2007 in the Northern District of Illinois

    Infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/ Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of Lilly’s Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder).  View the complaint here.


    Hoffmann-La Roche Inc. v. Genpharm Inc. et al.

    2:07-cv-04661; filed September 28, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 7,192,938 ("Method of Treatment Using Bisphosphonic Acid," issued March 20, 2007) and 6,294,196 ("Pharmaceutical Composition Containing Diphosphonic Acid or Salt Thereof," issued September 25, 2001) following a paragraph IV certification as part of Genpharm’s filing of an ANDA to manufacture a generic version of Roche’s Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the complaint here.


    Sanofi-Aventis et al. v. Torrent Pharma Inc. et al.

    1:07-cv-00969; filed September 27, 2007 in the Western District of Michigan

    Infringement of U.S. Patent Nos. 4,661,491 ("Alfuzosine Compositions and Use," issued April 28, 1987) and 6,149,940 ("Tablet with Controlled Release of Alfuzosine Chlorhydrate," issued November 21, 2000) following a paragraph IV certification as part of Torrent’s filing of an ANDA to manufacture a generic version of Sanofi-Aventis’ Uroxatral® (alfuzosin hydrochloride, used to treat benign prostatic hyperplasia).  View the complaint here.


    Sepracor Inc. et al. v. Orchid Chemicals & Pharmaceuticals Ltd. et al.

    3:07-cv-04623; filed September 26, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 7,211,582 ("Methods for treating urticaria using descarboethoxyloratadine," issued May 1, 2007), 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007), and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough, following a paragraph IV certification as part of Orchid’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

  • Conference & CLE Calendar

    October 7, 2007

    Calendar_11
    October 10-12, 2007 – Stem Cells European Business Summit – Edinburgh, Scotland

    October 12, 2007 – Intellectual Property Law Summit 2007 (West LEGALWorks and Intellectual Property Law Association of Chicago) – Chicago, IL

    October 16, 2007 – New Patent Rules Update: Implications of Compliance (World Research Group)

    October 25-26, 2007 – Biotech and Pharma Public-Private Partnerships Forum (American Conference Institute) – Washington, D.C.***

    October 25-27, 2007 – Biotechnology: Patent Prosecution, Licensing, Litigation & Hatch-Waxman (Patent Resources Group) – Palm Springs, CA

    November 13-15, 2007 – Pharma and Biotech Collaborative Agreements (American Conference Institute) – New York, NY***

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

  • Is the Patent Office Starting to Blink?

    October 5, 2007

        By Kevin E. Noonan —

    Uspto_seal_no_background
    Among the many new requirements contained in the U.S.
    Patent and Trademark Office’s recently-promulgated new rules on continuation
    application filing and claim number restrictions (see links below), the Office has imposed a
    deadline of February 1, 2008 for all pending applications to satisfy two
    reporting requirements.  First,
    applicants must identify (in every pending application) every commonly-owned
    application or patent that names at least one inventor in common and was filed
    or claims priority to an application that was filed within two months of the
    subject application.  Second, for every
    commonly-owned patent application sharing a common inventor and "substantially
    overlapping" subject matter, a rebuttable presumption will arise that
    there is at least one patentably-indistinct claim in each application (using a
    one-way obviousness test) (see new rules notice, p. 46,785).  Although reasons can be imagined for the purpose of these requirements,
    it is not unreasonable to assume that the burden imposed by these requirements
    may motivate applicants to simply cancel any application that is not
    sufficiently important to them to incur the expense of complying with the
    reporting requirements.  It is likewise
    not unreasonable to presume (in view of the Office’s invocation of the
    "overwhelming" backlog of pending cases as justification for the new
    rules) that this economic disincentive to maintaining what are perceived to be
    "unnecessary" applications is precisely the intended purpose of these
    rules.

    Biotechnology_industry_organization
    While heretofore strangely quiet on the subject of the
    new rules (see "Breaking A Very Long Silence"), recognition of the reality of the impending
    economic burden appears to have influenced the behavior of at least two major
    patent interest groups.  The Intellectual
    Property Owners (IPO) posted yesterday on their website the results of a
    survey of 37 member organizations relating to the extent of the burden these
    new rules would impose.  In addition, reliable sources have told Patent Docs that the
    Biotechnology Industrial Organization (BIO), joined by IPO and perhaps other
    groups, recently met with Patent Office officials to discuss the extraordinary
    burdens of complying with these rules.  As a result, these sources tell Patent Docs that the Office has promised
    to revisit this aspect of the recent rulemaking, and to either modify the Ipo_2
    rule
    or extend the deadline.  Although either
    would be welcome, the Office’s acknowledgement of the justification of IPO’s
    and BIO’s complaints appears to contradict their representations to the Office
    of Management and Budget (and that Office’s subsequent decision) that the rules
    imposed no significant economic impact.

    It is unlikely that there will be any major retrenchment
    of the new rules absent court action (which the major organizations have
    abdicated to a sole inventor in a single action, and which has withdrawn a
    motion for an injunction or stay of implementing the rules) or a change in the
    administration.  The possibility that the
    rules will be relaxed is, however, consistent with this Administration’s
    penchant for taking and pressing extreme positions with little factual
    justification, and retrenching only when faced with public pressure (political
    or otherwise).  This track record
    suggests that members of the patent community, including the patent bar, had
    better get busy if they will have any hope of adequately protecting U.S. patent
    rights in the face of a Patent Office administration that seems openly hostile.

    For additional articles in this series, please see:

    • "An Analysis of the New Rules: 37 C.F.R. § 1.142(c): Increasing the Chances of Submitting a Successful Suggested Restriction Requirement (SRR)," October 4, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.145: "Provoking a Restriction Requirement," October 3, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
    • "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
    • "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
    • "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

    For additional information on this and other related topics, please see:

    • "Breaking A Very Long Silence," October 1, 2007
    • "It Ain’t Necessarily So," September 28, 2007
    • "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
    • "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
    • "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
    • "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
    • "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
    • "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part II," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I," August 23, 2007
    • "New Continuation and Claims Rules Published," August 22, 2007
    • "More on M.P.E.P. § 710.06," August 20, 2007
    • "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
    • "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
    • "Procuring Patent Protection from the Present USPTO," August 15, 2007
    • "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
    • "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
    • "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006
  • An Analysis of the New Rules: 37 C.F.R. § 1.142(c): Increasing the Chances of Submitting a Successful Suggested Restriction Requirement (SRR)

    October 4, 2007

        By Christopher P. Singer —

    Uspto_seal_no_background
    On August 21, 2007, the U.S. Patent and Trademark Office published new
    rules concerning continuation and claims practice that will undoubtedly
    have a profound effect on the way patent attorneys and agents prosecute
    applications before the Patent Office.  In view of the 128-page Federal Register notice
    regarding the new rules, the Patent Office’s nearly two hour webcast on
    August 23, 2007 (and the webcast’s accompanying 113-page presentation), and the Office’s 63-page list of Frequently Asked Questions, Patent Docs
    believes it may be helpful to examine the rules piece-by-piece in an
    attempt to identify areas where patent attorneys and agents will need
    to modify their patent prosecution practice.


    37 C.F.R. § 1.142(c) Guidance:

    We have previously discussed the requirements and implications of the new suggested restriction requirement (SRR) provision of new rule 1.142(c).  The particulars of this rule are relatively straightforward and an applicant should not have any trouble complying with the requirements of the rule.  Nevertheless, what can an applicant do to increase the persuasiveness of the SRR and the chances that it will be accepted by an Examiner?  The Patent Office’s recently released Frequently Asked Questions (FAQs) provides some nice guidance regarding what content an applicant should consider submitting in the SRR.

    Federal_register_cover
    First, you should make sure that your SRR complies with the rule and its various elements.  In order for the SRR to be timely and considered by the Office, the SRR must be submitted prior to receiving the earlier of either an Office action on the merits or a restriction requirement.  Another (rather obvious) requirement is that the application must have pending claims that are drawn to two or more independent and distinct inventions.  The SRR should clearly identify the claims which correspond to the various independent and distinct inventions.  The SRR also needs to contain an election of invention, which must be made without traverse, and identify the claims directed to the elected invention.  Further, the claims of the elected invention must comply with the 5/25 claim rule.

    As far as the explanation concerning the patentably distinct nature of the various inventions, Applicants should detail why the inventions are independent or distinct as claimed and not merely make conclusory statements that "the claims are independent and distinct."  For guidance and tests for determining when inventions are independent or distinct, Applicants should refer to M.P.E.P. §§ 802.01, 806, 806.05-806.05(j), 806.06, and 808.01.  To strengthen the argument, an applicant can also explain why the Examiner would be burdened if the restriction is not required.  Arguments relating to the burden aspect can be based on M.P.E.P. §§ 803.02, 808, and 808.02.  The Office’s FAQs provide a couple of examples relating to the burden, such as providing an appropriate explanation of separate classification of claimed subject matter, or highlighting that the subject matter has separate status in the art, or that the subject matter would require a different field of search as defined in M.P.E.P. § 808.02.  While the Patent Office suggests that this type of argument be included with the SRR, and could be adequate on its own to induce acceptance of an SRR, it is probably advisable to review the rationale employed by the Office in issuing prior restriction requirements, leaving "no stone unturned."

    Divisional applications are likely to be very important in prosecution strategies under the new rules, and the SRR could very well be a key tool for applicants, allowing them to position entire application families in a way that they wish.  Thus, it makes sense to include in the SRR as complete and persuasive an argument as possible regarding the patentable distinctiveness of claims an applicant wishes to restrict.

    For additional articles in this series, please see:

    • "An Analysis of the New Rules: 37 C.F.R. § 1.145: "Provoking a Restriction Requirement," October 3, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
    • "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
    • "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
    • "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

    For additional information on this and other related topics, please see:

    • "Breaking A Very Long Silence," October 1, 2007
    • "It Ain’t Necessarily So," September 28, 2007
    • "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
    • "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
    • "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
    • "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
    • "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
    • "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part II," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I," August 23, 2007
    • "New Continuation and Claims Rules Published," August 22, 2007
    • "More on M.P.E.P. § 710.06," August 20, 2007
    • "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
    • "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
    • "Procuring Patent Protection from the Present USPTO," August 15, 2007
    • "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
    • "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
    • "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006
  • An Analysis of the New Rules: 37 C.F.R. § 1.145: “Provoking” a Restriction Requirement

    October 3, 2007

        By Donald Zuhn —

    Uspto_seal_no_background
    On August 21, 2007, the U.S. Patent and Trademark Office published new
    rules concerning continuation and claims practice that will undoubtedly
    have a profound effect on the way patent attorneys and agents prosecute
    applications before the Patent Office.  In view of the 128-page Federal Register notice
    regarding the new rules, the Patent Office’s nearly two hour webcast on
    August 23, 2007 (and the webcast’s accompanying 113-page presentation), and the Office’s 63-page list of Frequently Asked Questions, Patent Docs
    believes it may be helpful to examine the rules piece-by-piece in an
    attempt to identify areas where patent attorneys and agents will need
    to modify their patent prosecution practice.


    37 C.F.R. § 1.145:

    In view of the "2 + 1" rule, which allows an applicant to file only two continuation or continuation-in-part applications and only one RCE per application family without any justification, applicants will likely be looking for ways to file divisional applications, each of which forms the basis of a new application family.  However, as the new rules make clear, a divisional application is "a continuing application . . . that discloses and claims only an invention or inventions that were disclosed and claimed in a prior-filed application, but were subject to . . . a requirement for restriction under 35 U.S.C. 121 in the prior-filed application."  Section 121, in turn, states that "[i]f two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions."  Therefore, under the new rules, a proper divisional application can only be filed after a restriction requirement has been issued.

    Federal_register_cover_2
    A divisional application filed in the absence of a restriction requirement – which the Patent Office refers to as a "voluntary" divisional application – is not really a divisional application at all, but rather, is a continuation application.  That is, unless an applicant has already used his or her allotment of continuations, in which case the continuation is merely a stand-alone application, lacking the benefit of its prior-filed predecessor.

    In addition, as we have discussed previously (see "37 C.F.R. § 1.142: Suggested Restriction Requirements"), an applicant cannot file a suggested restriction requirement after a first Office action on the merits or an Office action that contains a restriction requirement has been mailed.  So what does an applicant do when he or she has disclosed, but not claimed, a distinct and independent invention, and has already received an Office action on the merits or an Office action containing a restriction requirement?

    A number of commentators have suggested that an applicant faced with such a dilemma could provoke a restriction requirement by filing an amendment adding claims directed to the independent and distinct invention.  It has also been suggested that the Examiner’s response to such an amendment will be to issue a restriction requirement.  However, an analysis of the new rules (and the latest version of the M.P.E.P.) does not indicate that such a strategy would necessarily produce the desired results.  Instead, it’s possible that an Examiner would request that the applicant cancel the added claims as being drawn to a non-elected invention (particularly if an Office action containing a restriction requirement had been previously issued).

    The relevant new rule, Rule 145, states that when an applicant presents claims to a distinct and independent invention in an application that has already received an Office action on the merits, the applicant may be required to restrict the claims to the invention previously claimed (in the new version of Rule 145, the phrase "the applicant may be required" replaces the phrase "the applicant will be required").  Unfortunately, one cannot definitely conclude that the phrase "restrict the claims to the invention previously claimed" means that the Examiner will issue a restriction requirement.

    The prior version of Rule 145 is discussed in M.P.E.P. § 821.03.  While this section simply begins by noting that "[c]laims added by amendment . . . to an invention other than previously claimed, should be treated as indicated by 37 CFR 1.145," it provides the following form paragraph:

    ¶ 8.04 Election by Original Presentation
    Newly submitted claim [1] directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: [2]
    Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.  Accordingly, claim [3] withdrawn from consideration as being directed to a non-elected invention.  See 37 CFR 1.142(b) and MPEP § 821.03.

    Does the first part of form paragraph 8.04 constitute a restriction requirement?  Can an applicant who receives an Office action containing such a statement file a proper divisional application directed to the distinct and independent claims?  Unfortunately, applicants may have to wait until well into 2008 for answers to these questions.  In the meantime, applicants might be wise to submit claims (at least representative claims) to every distinct and independent invention disclosed in an application, file suggested restriction requirements where possible, and perhaps utilize continuations to introduce claims to distinct and independent inventions (along with claims to patentably indistinct subject matter), thereby avoiding Rule 145.

    For additional articles in this series, please see:

    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
    • "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
    • "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
    • "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

    For additional information on this and other related topics, please see:

    • "Breaking A Very Long Silence," October 1, 2007
    • "It Ain’t Necessarily So," September 28, 2007
    • "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
    • "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
    • "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
    • "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
    • "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
    • "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part II," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I," August 23, 2007
    • "New Continuation and Claims Rules Published," August 22, 2007
    • "More on M.P.E.P. § 710.06," August 20, 2007
    • "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
    • "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
    • "Procuring Patent Protection from the Present USPTO," August 15, 2007
    • "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
    • "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
    • "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006


    Changes to Rule 145:

    If, after an Office action on the merits on an application, the applicant presents claims directed to an invention distinct from and independent of the invention previously claimed, the applicant may be required to restrict the claims to the invention previously claimed if the amendment is entered, subject to reconsideration and review as provided in §§ 1.143 and 1.144.

  • Alethia Licenses Antibodies for Treating Cancer

    October 3, 2007

        By Jason Derry —

    Logo_alethia_francois
    Alethia Biotherapeutics Inc. has announced a licensing agreement with the National Research Council Biotechnology Research Institute (NRC-BRI).  Under the terms of the agreement, Alethia receives exclusive worldwide rights to a family of monoclonal antibodies that specifically block activity of secreted clusterin.  Alethia plans to move the anti-clusterin antibodies, which have demonstrated efficacy in animal models, into pre-clinical and clinical development.  NRC-BRI will provide access to its know-how in the fields of antibody humanization and therapeutic antibody development to assist Alethia in Institute_en_3
    moving the antibodies through the clinical stage.  Alethia is a biotechnology company based in Montreal, and focuses on developing and discovering therapeutics for cancer and associated disorders.

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

  • Patent Profile: MorphoSys Announces Issuance of Human Combinatorial Antibody Library (HuCAL) Patent

    October 2, 2007

        By Donald Zuhn —

    Morphosyslogo
    Last week, MorphoSys AG announced that it had been granted U.S. Patent No. 7,264,963.  The ‘963 patent, which relates to the preparation of a library of human-derived antibody genes by the use of synthetic consensus sequences that cover the structural repertoire of antibodies encoded in the human genome, is the twelfth U.S. patent to be awarded to the Munich, Germany-based biotech company.

    According to the statement released by MorphoSys, the ‘963 patent provides extended protection to the company’s "core technology" by capturing MorphoSys’s HuCAL (Human Combinatorial Antibody Library) modular system at the DNA level.  MorphoSys’ HuCAL libraries, which the company currently markets as HuCAL GOLD, comprise diverse, fully human synthetic antibodies that are engineerable through their modular complementarity determining region (CDR) design.

    The ‘963 patent issued from U.S. Application No. 09/490,064, filed January 24, 2000, and claims the benefit of U.S. Application No. 09/025,769, filed February 18, 1998, which issued as U.S. Patent No. 6,300,064, and International Application No. PCT/EP96/03647, filed August 19, 1995.  Representative independent claims 1 and 5 of the ‘963 patent recite:

    1.  A modular replicable vector, comprising a plurality of vector modules, wherein each vector module is (a) flanked by DNA cleavage sites unique within said vector, and (b) essentially devoid of DNA cleavage sites comprised in a nucleotide sequence selected from the group consisting of V-kappa-1 (SEQ ID NO: 42), V-kappa-2 (SEQ ID NO: 44), V-kappa-3 (SEQ ID NO: 46), V-kappa-4 (SEQ ID NO: 48), V-lambda-1 (SEQ ID NO: 50), V-lambda-2 (SEQ ID NO: 52), V-lambda-3 (SEQ ID NO: 54), VH1A (SEQ ID NO: 56), VH1B (SEQ ID NO: 58), VH2 (SEQ ID NO: 60), VH3 (SEQ ID NO: 62), VH4 (SEQ ID NO: 64), VH5 (SEQ ID NO: 66), and VH6 (SEQ ID NO: 68) at the boundaries between each consensus framework region and each complementarity determining region.

    5.  A modular replicable vector, comprising (i) a nucleotide sequence encoding an immunoglobulin variable region, comprising a modular sequence of four consensus framework regions interspaced by three complementarity determining regions CDR1, CDR2, and CDR3, wherein said nucleotide sequence comprises DNA cleavage sites at the boundary of each consensus framework region and each complementarity determining region, and (ii) a plurality of vector modules, wherein each vector module is flanked by DNA cleavage sites, wherein each of said DNA cleavage sites of (i) and (ii) is unique within said vector, and wherein said immunoglobulin variable region is a heavy chain or a light chain.

  • Bristol-Myers Squibb Acquires Adnexus Therapeutics

    October 2, 2007

        By Sherri Oslick —

    Bristolmyers_squibb_1
    Last week, Bristol-Myers Squibb Co. of Princeton, NJ announced that it would acquire biotechnology company Adnexus Therapeutics Inc. of Waltham, MA for $430 million in cash (with an additional $75 million to be paid provided Adnexus meets certain regulatory milestones).  Adnexus is a privately held company developing a proprietary class of protein-based targeted biologics called Adnectins.

    Pic_global_logo
    Following acquisition, Adnexus will be a subsidiary of BMS.  Adnexus’ portfolio includes oncology biologic Angiocept, an antagonist of the VEGFR-2 pathway currently in Phase I trials.  Adnexus’ patent portfolio includes over 100 issued and pending patent properties relating to Adnectins and PROfusion, Adnexus’ proprietary protein engineering system.

    For more information, please see:

    • Adnexus press release
    • BMS press release
  • Breaking A Very Long Silence

    October 1, 2007

        By Kevin E. Noonan —

    Biotechnology_industry_organization
    A curious aspect of the recently-promulgated new prosecution rules (see links below) has been the relative silence of the major interest groups in opposition.  Perhaps lulled by pundits who declared the new rules "dead" as recently as six months before they were issued, or because the focus was on Capitol Hill initiatives such as "patent reform" or the various biogenerics proposals, the fact is that (except for the overwhelmingly number of negative comments provided to the Office) the major groups who might have been expected to be significantly more vocal (such as the Biotechnology Industrial Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA)) before the rules were finally issued were silent.  Indeed, the head of BIO appeared to be unprepared for a Patent Docs question regarding litigation challenging the new rules (see "BIO CEO Provides Briefing on Follow-On Biologics and Phrma_2
    Patent Reform
    ").  Perhaps this inertia can be explained as the rational response to this Administration’s notorious resistance to anything resembling consensus-building or debate that extends beyond blind obedience – from the tenor of the townhall meetings roadshow at the time the new rules were proposed to the efforts (both in person and in various "webcasts" from the Office) thereafter, it is clear that institution of these rules was foreordained and inevitable.  Indeed, the only legal efforts to overturn the rules were not taken by any of these trade organizations (not even the legal ones such as the AIPLA), but by an individual inventor (see "Rules Challenger Amends Complaint and Withdraws PI Motion").

    Ipo_2
    "Once bitten, twice why" is the adage, and the response of the patent community to other Patent Office "initiatives" has been decidedly different.  The Intellectual Property Owners (IPO) organization submitted and published on their website their objections to the proposed appeals rules, and the National Association of Patent Practitioners have also objected and made their objections public.  In both cases, the major objections are: 1) that the appeals rules were recently revised (in August, 2004; 69 Fed. Reg. 49960) and that there is no evidence that the new revisions are necessary; 2) the rules are unduly complex and the page restrictions unnecessary and contrary to the thorough determination of patentability that applicants are entitled to; 3) the lack of concomitant page number restrictions on the Examiner’s Answer are unfair and prejudicial to applicants; 4) the rules continue the recent Office trend of shifting the procedural and substantive examination burdens onto applicants; and 5) that the timing of these rules are unfortunate in view of the expected increase in appeals occasioned by the limitation on the number of continuations in the rules promulgated on August 21, 2007 (effective on November 1, 2007).

    Uspto_seal
    In view of the reluctance of the Office to be dissuaded from its mission to provide more "effective" examination by adopting rules seemingly intended to reduce pendency and the application backlog "by all means possible," regardless of its effect on innovation or the integrity of the U.S. patent system, it is unlikely that these efforts in opposition to the proposed rules will have any noticeable effects.  It is heartening, however, to see groups who should have an important voice in these deliberations finally attempting to be heard, even if their entreaties will be unlikely to have any positive effects until the current administration is replaced in January, 2009.  With any luck, the more deleterious effects of the present regime will be amenable to being reversed once the focus of the Patent Office returns to protecting American innovation rather than meeting merely bureaucratic metrics.

    For additional articles in this series, please see:

    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
    • "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
    • "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
    • "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
    • "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

    For additional information on this and other related topics, please see:

    • "It Ain’t Necessarily So," September 28, 2007
    • "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
    • "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
    • "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
    • "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
    • "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
    • "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part II," August 24, 2007
    • "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I," August 23, 2007
    • "New Continuation and Claims Rules Published," August 22, 2007
    • "More on M.P.E.P. § 710.06," August 20, 2007
    • "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
    • "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
    • "Procuring Patent Protection from the Present USPTO," August 15, 2007
    • "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
    • "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
    • "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006
  • USPTO News: Patent Office Tweaks Fees Some More

    October 1, 2007

        By Donald Zuhn —

    Uspto_seal_background
    On August 28, 2007, we reported that the U.S. Patent and Trademark Office would be adjusting patent fees to reflect fluctuations in the Consumer Price Index (CPI), and that the new fees would become effective on September 30, 2007.  Last Friday, the PTO published a notice in the Federal Register to correct errors in the Office’s previous notice.  A listing of the revised fees can be obtained here.  As with the previous fee adjustment, the revised fees went into effect yesterday.

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