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  • LEI National CLE Conference (and Skiing!)

    Skiing Law Education Institute, Inc. (LEI) will be holding the 25th Annual National CLE Conference on January 4-8, 2008 in Vail, Colorado.  The Intellectual Property program of the conference, which will be held at the Vail Marriott Resort and Spa, will offer presentations on a number of topics, including:

    • Valuation of intellectual property.
    • Declaratory judgment actions after Sandisk.
    • KSR and its progeny:  In the courts and the PTO.
    • Judges panel:  View from the bench.
    • Corporate panel:  Patent issues keeping in-house counsel awake at night.
    • Willful infringement and opinions of counsel after Knorr Bremse, Echostar, and In re Seagate.
    • Recent patent law developments at the Supreme Court and Federal Circuit.
    • PTO rules update.
    • Patent legislation update.
    • European patent litigation and procuring and enforcing patents in China.

    Law_education_institute_lei
    An agenda and list of speakers for the Intellectual Property program of the conference can be found here.  A complete brochure for the Intellectual Property program, including an agenda, list of speakers, and registration form can be downloaded here.

    The registration fee for the conference is $729.  Those registering before December 15, 2007 will receive a $100 discount off the registration fee.  Those interested in registering for the conference can do so here or by calling either 1-303-860-0608 or 1-888-860-2531.

  • ACI Strategic Intellectual Property Planning Conference

    Arizona #3 American Conference Institute (ACI) will be holding a conference on Strategic Intellectual Property Planning on February 25-26, 2008 in Scottsdale, Arizona.  The conference will share insights on:

    • Applying current legal and legislative trends to your IP practices.
    • Identifying which IP protections are available.
    • Using competitive intelligence to drive market and IP strategy.
    • Improving contracting and negotiating practices to ensure maximum protection.
    • Managing the flow of proprietary information when employees join and/or leave the company.
    • Strategic planning for small businesses.
    • Valuing and monetizing assets.
    • Best practices in mergers and acquisitions.

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

    • 849l08sco
      Current legal and legislative trends:  A catalyst or hindrance for maximizing IP protection?
    • Aligning strategic IP decision-making with company culture, and projecting potential outcomes.
    • Facilitating the creation of an IP strategy.
    • Using competitive intelligence to drive market and IP strategy and manage risk.
    • Increasing IP leverage and mitigating risks with careful and thorough negotiations and contracting.
    • Strategic planning session for small and growth companies.
    • The mobile employee:  Managing the flow of IP coming into and out of the company.
    • Valuing and monetizing IP assets and knowing when conducting an audit is necessary.
    • Controlling the impact of global media networking and the management of IP rights.
    • Ensuring best IP strategies in mergers and acquisitions.
    • Leveraging and protecting proprietary information overseas:  Conforming company culture to operate on a global scale.

    An additional pre-conference workshop entitled: "Covering all the Angles: Creating a Strategic IP Plan from Inception to Implementation (And Everything In Between)" will be offered on February 26, 2008.  The pre-conference workshop will focus on every phase of the strategic IP planning process using a series of hypothetical scenarios to set the stage for the conference.

    The agenda for the conference on Strategic Intellectual Property Planning 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_2
    The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and pre-conference workshop).  Those registering on or before December 26, 2007 will receive a $300 discount off the registration fee and those registering on or before January 30, 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.

  • Supreme Court Declines to Review CAFC Limits on Certificates of Correction

        By Robert Dailey —

    Section 255 of the Patent Act provides a mechanism for correcting typographical or minor errors in an issued patent.

    Whenever a mistake of a clerical or typographical nature, or of minor character, which was not the fault of the Patent and Trademark Office, appears in a patent and a showing has been made that such mistake occurred in good faith, the Director may, upon payment of the required fee, issue a certificate of correction, if the correction does not involve such changes in the patent as would constitute new matter or would require reexamination.

    Federal_circuit_seal
    In Superior Fireplace Co. v. Majestic Products Co. (Fed. Cir. 2001), the Federal Circuit held (over the dissent of Judge Dyk) that additional requirements apply when the correction would result in any broadening of the claims.  These additional limitations include the following:

    • Broadening is evaluated by a text-to-text comparison of the pre-correction claim text to the post-correction claim text, i.e., without consideration of whether the prosecution history demonstrates that the applicant and the PTO had agreed to a narrower meaning of the pre-correction claim term;
    • For mistakes "of minor character," the PTO may issue no Certificates that would broaden the claim scope;
    • For mistakes "of a clerical or typographical nature," the PTO may only issue Certificates that broaden the claim scope when one of skill in the art, having the intrinsic record at his disposal, would (1) recognize that the mistake has occurred; and (2) know from the intrinsic record how to correct that mistake.

    Judge Dyk issued a dissent in the case.  The majority articulated these additional limitations out of a fear that patentees could use Certificates of Correction to obtain changes that would be unavailable under the Reissue provisions of Section 251.  Judge Dyk showed how Sections 255 and 251 could be harmonized without reading the additional limitations into the statutory text.

    In the 2007 case of Central Admixture Pharmacy Services, Inc. v. Advanced Cardiac Solutions, P.C., the Federal Circuit had the opportunity to revisit its Superior Fireplace holding.  In the original patent, the patentee had claimed concentration ranges in terms of osmolarity, but had intended to claim the ranges in terms of osmolality.  The PTO issued the Certificate of Correction, which resulted in a 2% downward shift in the claimed concentration ranges.

    But the Federal Circuit chose to stand by its precedent.  Because the scope of the corrected claim was not entirely encompassed by the pre-correction claim (i.e., 2% shift), the Court held that this constituted broadening.  Thus, the Superior Fireplace limitations apply.  In this instance, one of skill in the art would not necessarily have recognized that use of "osmolarity" was a mistake, even if claiming concentrations in terms of "osmolality" may have made more sense.  Because the mistake was not apparent on its face, the patentee could not make the change.

    Supreme_court_building_2
    Superior Fireplace     remains good law, as the Supreme Court has declined to hear the appeal.  Therefore, practitioners are probably advised to avoid using Certificates of Correction for making changes to the claim language.  "Broadening" does not mean that the whole claim is broader; the claim just needs to read on one embodiment that was not previously encompassed.  And when claims are broadened, courts will only uphold a Certificate of Correction when it corrects blatant typographical errors.  So, if you’ve claimed a concentration range in terms of "miles," use a Certificate of Correction.  Otherwise, use a Reissue.

  • Patent Profile: Metagenics Awarded Three U.S. Patents For Anti-Inflammatory Compounds

        By Suresh Pillai —

    Metagenics_2
    Metagenics, Inc. of San Clemente, California has been awarded U.S. Patent Nos. 7,270,835 ("Compositions that treat or inhibit pathological conditions associated with inflammatory response," issued September 18, 2007);  7,195,785 ("Complex mixtures exhibiting selective inhibition of cyclooxygenase-2," issued March 27, 2007) and 7,205,151 (same title, issued April 17, 2007), three patents that cover discoveries relating to selective kinase response modifiers that have anti-inflammatory properties.  These patents extend to thirty the number of U.S. Patents awarded to both Metagenics, Inc. and its Metaproteomics® Nutrigenomics Research Center subsidiary.

    Inflammation via the cyclooxygenase pathway (COX-2) contributes to numerous maladies, including osteoarthritis, reduction of bone mineral density, and autoimmune disease.  COX-2 also plays a housekeeping role within certain cellular pathways; therefore, any treatment targeted to inhibit COX-2-mediated inflammation should not similarly inhibit COX-2-mediated cellular housekeeping.  One method for targeted regulation of COX-2 pathways is through the use of selective kinase response modifiers (SKRMs).  SKRMs inhibit the induction of inflammation via the selective alteration of COX-induced signaling cascade phosphorylation profiles.  The primary benefit of using SKRMs is that, although the inflammation pathways are inhibited, other COX-mediated signaling pathways, including those responsible for normal cellular housekeeping tasks, remain intact.

    The ‘835 patent covers both Metagenics’ proprietary compound Luduxin, which consists of rho iso-alpha acids derived from hops, and the use of Luduxin in preserving joint health.  The ‘785 and ‘151 patents cover both Metagenics’ proprietary compound Tetrase, which consists of tetrahydro-isohumulone (a tetrahydro iso-alpha acid derived from hops), and the use of Tetrase in supporting the management of inflammation.

    The ‘835 patent issued from U.S. Application No. 10/689,856, which was filed on October 20, 2003, and which claims the benefit of Provisional Application No. 60/420,383, filed October 21, 2002.  Independent claim 1 recites:

    1.  A method of preserving the health of joint tissues comprising administering to a patient, group consisting of oleanolic acid and ursolic acid, and a component selected from the group consisting of rosemary, an extract derived from rosemary, and a compound derived from rosemary.

    The ‘785 patent issued from U.S. Application No. 10/480,145, which was filed on June 20, 2002.  Independent claim 1 recites:

    1.  A method of treating inflammation comprising administering to an animal suffering symptoms of inflammation a pharmaceutical grade extract of hops comprising an effective amount of tetrahydroisohumulone, and an effective amount of essential oils, fats or waxes, wherein said administration provides about 0.01 to 100 mg per kg body weight per day of tetrahydroisohumulone.

    The ‘151 patent issued from U.S. Application No. 09/885,721, which was filed on June 20, 2001.  Independent claim 1 recites:

    1.  A composition comprising a pharmaceutical grade extract of hops comprising an effective amount of tetrahydroisohumulone, and an effective amount of at least one component selected from the group consisting of essential oils, fats and waxes, wherein said pharmaceutical grade extract provides 15 to 45 weight % of tetrahydroisohumulone of the composition.

    Suresh Pillai, Ph.D., is a molecular biologist and a third-year law
    student at DePaul University College of Law.  Dr. Pillai
    was a member of MBHB’s 2007 class of summer associates, and is currently working as a law clerk at MBHB.

  • Exiqon to Acquire Oncotech

        By Jason Derry —

    Logo
    Exiqon A/S     and Oncotech Inc. have announced that Exiqon will acquire Oncotech for approximately $45 million.  Oncotech provides diagnostic tests that help physicians optimize treatment regimens for cancer patients.  Exiqon provides a number of products to assist in analyzing gene expression, including microRNA profiling products and services.  Through the acquisition, Exiqon and Oncotech will combine their respective expertise to Title_oncotech
    develop molecular diagnostic tests based on microRNA biomarkers.  The companies expect at least one such test to be available within the coming year.

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

  • InterMune Buys out License Agreement for Pirfenidone

        By Christopher P. Singer —

    Intermunelogo
    In a November 26, 2007 press release, InterMune Inc.
    announced that it will purchase patent rights to pirfenidone from Marnac, Inc. and KDL GmbH.  This acquisition includes patent rights that InterMune had been licensing from Marnac and KDL as well as other international IP rights relating to pirfenidone that were not part of the prior existing license agreement.  Those additional IP rights include patents that relate to TNF-alpha based activities of pirfenidone.  Currently, pirfenidone is under two large phase 3 clinical trials to determine the safety and efficacy in the treatment of idiopathic pulmonary fibrosis (IPF).  Both the FDA and European Medicines Evaluation Agency (EMEA) have granted pirfenidone orphan drug status for treatment of IPF.

    Pirfenidone
    The buyout and purchase does not affect rights to pirfenidone (at left) in Japan, Korea, and Taiwan, which rights remain licensed by Marnac to Shionogi & Co. Ltd.  The terms of the purchase include upfront payments from InterMune totaling $13.5 million, and could include an additional $53.5 million in payments if pirfenidone achieves positive Phase 3 data and is registered in the U.S. and Europe.  All of InterMune’s milestone and royalty payments under the prior license agreement are extinguished by this purchase.

  • Astellas to Acquire Agensys,Inc.

        By Sherri Oslick —

    Astellas
    Astellas Pharma Inc. of Tokyo, has announced an agreement between its U.S. subsidiary, Astellas U.S. Holding of Deerfield, IL and Agensys, Inc. of Santa Monica CA under which Astellas will acquire Agensys for $387 million in cash, with up to an additional $150 million dependent upon Agensys’ achievement of various milestones.  Agensys is a privately held biotechnology company focused on therapeutic antibody research and development in the area of cancer.

    Agensys
    Agensys’ portfolio includes 30 proprietary cancer targets to 14 different tumor types, and an antibody targeting prostate, pancreatic, and bladder cancers in Phase Ib clinical trials, and several candidate antibodies in the late preclinical stage.  Agensys develops human monoclonal antibodies through the use XenoMouse®, a human antibody-producing transgenic mouse in-licensed from Abgenix.  Agensys’ patent portfolio includes over 100 issued patent or allowed applications and over 300 pending patent applications.

    For additional information regarding Astellas’ sacquisition of Agensy, please see:

  • GSK to Acquire Reliant Pharmaceuticals

        By Sherri Oslick —

    Glaxosmithkline
    GlaxoSmithKline     of London, UK and Philadelphia, PA and Reliant Pharmaceuticals of Liberty Corner, NJ have announced an agreement under which GSK will acquire Reliant for $1.65 billion in cash.  Reliant is a privately held pharmaceutical company focused on cardiovascular therapeutics.

    Reliant_pharm
    Reliant’s therapeutic portfolio has been developed through in-licensing and development of cardiovascular medicines.  Included in its portfolio is Lovaza (formerly Omacor®; omega-3-acid ethyl esters), which is used to treat adult patients with very high triglyceride levels, and which was launched in 2005 and is licensed (in the U.S. and Puerto Rico) from Pronova BioPharma ASA of Norway.  Lovaza will compliment GSK’s primary cardiovascular therapeutic, Coreg CR® (carvedilol phosphate), which is used to treat heart failure and hypertension.

    In addition to Lovaza, Reliant’s portfolio includes DynaCirc CR® (isradipine) and InnoPran XL® (propanolol hydrochloride), both of which are used to treat hypertension, Rythmol® SR (propafenone hydrochloride), which is used to treat arrhythmia, and Axid® (nizatidine), which is used to treat ulcers  The acquisition is expected to be completed by the end of the year, pending FTC approval.

    For additional information regarding GSK’s acquisition of Reliant, please see:

  • No Discovery in New Rules Case

        By Kevin E. Noonan —

    Eastern_district_of_virginia_seal
    Gene Quinn from the PLI blog reports today that Judge Cacheris
    denied from the bench Plaintiffs’ motion for discovery in the challenge to the
    claims and continuation rules enjoined by the Court on October 31st (see "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)").  Patent Office officials, including Director
    Jon Dudas and Patent Commissioner John Doll will not have to sit for
    deposition, nor will the Office be required to produce documents or a privilege
    log for any documents it seeks to withhold.  Plaintiff GlaxoSmithKline (GKS) and Dr. Triantafyllos Tafas have until December 20th to file their summary judgment
    motions.  While the Court did not
    explicitly state that amici are under the same deadline, prudence suggests they
    proceed with the understanding that later-filed briefing may not be considered
    by the Court.

    Glaxosmithkline_gsk
    Although somewhat of a surprise, the "victory"
    is a double-edged sword for the Office.  On the one hand, they will not be subject to the burden of fighting over
    privilege logs, something that could be expected in any litigation but would be
    almost a certainty for this administration.  And Mssrs. Dudas and Doll should be happy to stay out of the witness
    chair.  However, it will be especially
    difficult for the Office to assert any additional evidence in support of either
    their opposition to any GSK/Tafas summary judgment motions or in their own
    motions.  And as Mr. Quinn notes in his piece,
    GSK still has its Freedom of Information Act request pending, which may raise
    the privilege issue.  One possibility
    (from a reliable source) is that the Office doesn’t have any responsive
    documents; in this scenario, the Office proposed the rules in disregard for the
    requirement for the kind of agency activities that would have produced
    documents in the first place.  If that is
    the case, it would be relevant to GSK/Tafas’s argument that the Office violated
    the statutory mandates of the APA when promulgating the "new rules."

    Uspto_seal
    In addition, the absence of discovery should prevent the
    Office from a "December surprise" of additional information that
    might be persuasive to Judge Cacheris.  Being limited to the facts as they now exist, it’s hard to see how the
    Office will be able to craft a more compelling argument than the one they
    asserted in the preliminary injunction hearing.  (Although it will be interesting to see if the Solicitor’s office sends
    someone more senior or better prepared to rebut GSK/Tafas’s arguments.)

    And for the Grinches in the crowd, remember that some
    poor junior lawyers will have their holidays ruined preparing the Office’s
    response to plaintiffs’ motions.  Since the Office has argued that the
    entire case should be expedited so the issues can be resolved and the new
    rules, heaven forbid, be implemented as quickly as possible, it might be
    hard to get Judge Cacheris to grant an additional time for responding.

    For additional information on this topic, please see:

  • Alnylam Announces Grant of German RNAi Patent

        By Donald Zuhn —

    Alnylam
    Alnylam Pharmaceuticals, Inc. announced today that it has received a German patent (DE 10080167) in the "Kreutzer-Limmer I" patent series.  According to the Cambridge, Massachusetts-based RNA interference (RNAi) therapeutics company, the Kreutzer-Limmer I patent series is one of three "fundamental patent" families that Alnylam has exclusively licensed and which the company "believes will be most important in providing competitive advantage and product exclusivity with respect to RNAi therapeutics" (see "Science & Technology – Intellectual Property" at Alnylam’s website).  The other two "fundamental patent" series include the Crooke and Tuschl II series of patents.  While the latter two series include U.S. patents (U.S. Patent Nos. 5,898,031; 6,107,094; 7,056,704; and 7,078,196), the Kreutzer-Limmer I series does not include a U.S. patent.

    According to Alnylam’s statement, the German Kreutzer-Limmer I patent contains 52 claims providing broad coverage of medicaments and uses of small interfering RNAs (siRNAs) of between 15 and 49 nucleotides in length.  Alnylam noted that the Kreutzer-Limmer I series has been licensed to the company’s four pharmaceutical collaboration partners, seven biotechnology companies in Alnylam’s InterfeRx program, and 15 companies in the research reagent and services market.