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  • Patent Profile: Dermatologically Related U.S. Patents to Barrier Therapeutics & Provectus Pharmaceuticals

        By Christopher P. Singer

    On February 21, 2007 two companies announced that they had either received a Notice of Allowance or an issued patent for dermatologically related technologies.

    Barrier_therapeutics_logo
    Barrier Therapeutics, Inc.     announced the issuance of U.S. Patent No. 7,179,475 titled "Anhydrous Topical Skin Preparations."  Barrier stated that this patent covers a formulation of ketoconazole, which is marketed under the trade name Xolegel® for the treatment of seborrheic dermatitis.  According to its press release, this product was approved by the FDA in July 2006 and was launched by Barrier last November.

    The ‘475 patent claims priority back to December 4, 1998 as a continuation-in-part application of U.S. Patent No. 6,238,683.  Briefly, the patent claims relate to compositions, methods of delivery, and methods of treatment comprising anhydrous gel formulations containing ten components, including ketoconazole.  Representative independent claim 1 recites:

    1.  An anhydrous composition formulated for topical delivery consisting of: (a) propylene glycol, (b) polyethylene glycol, (c) glycerin, (d) about 1.0 to about 50 percent by weight of ethanol, (e) ketoconazole, (f) PPG-15 stearyl ether, (g) hydroxypropyl cellulose, (h) ascorbic acid, (i) butylated hydroxytoluene, and (j) citric acid, wherein the composition is formulated as a gel.

    Provectus_logo_2
    Provectus Pharmaceuticals, Inc.     announced that it has received a Notice of Allowance for its U.S. patent application covering formulations and uses of topical cosmetic and medicinal compositions for treatment of facial acne.  Provectus stated that the claims cover its over-the-counter product, Pure-Stick®, a solid formulation used for treating acne.  The company is looking to license or sell its non-prescription products, such as Pure-Stick® and its anti-microbial spray, Pure-ific®, in certain markets.

  • The Future of DNA Patenting

        By Kevin Noonan

    Recently, patenting human DNA has been the subject of
    questionable legislation and alarmist opinion pieces in the U.S.  Meanwhile, a team of British researchers has
    assessed the past, present, and likely future of gene patenting worldwide, and has come to dramatically different conclusions.

    Sussex_uni_s
    The study, by members of the Science and Technology
    Policy Research faculty at the University of Sussex, England, confirm the
    impression that gene patenting has been more extensive in the U.S. than in
    Europe or Japan.  The authors identified
    a total of 15,603 patent families claiming human DNA sequences during the time
    period from 1980 to 2003.  Of these,
    5,669 patent families have one or more patents granted worldwide, and 94% of
    these include at least one granted U.S. patent.  In contrast, only 750 of the patent families contain a granted European
    patent, and 494 contain a granted Japanese patent.

    Once granted, most of these gene patents are maintained
    worldwide (92% in the U.S; 96% in Europe), indicating their continuing value to
    assignees.  In the U.S., however, these
    percentages decrease as the patents mature, with only 70% of patents granted in
    the early 1990’s being maintained in 2005 (i.e., at the third, and most
    expensive, maintenance fee payment).

    In Europe, grant rates are actually decreasing: 45% of human gene patents filed in the 1980’s
    were eventually granted (meaning that 55% of these patents were not granted in
    Europe).  The grant rate fell to 8% for
    applications filed between 1996-2000, which may increase somewhat since some of
    these patent applications are pending.  However, 44% of these
    1996-200 vintage gene patents have been withdrawn or lapsed during pendency in
    Europe, a reflection of cost, long pendency, and falling grant rates.

    Patent application rates are also falling in all three
    patent offices, as a consequence of the publication of the human genome
    sequence database in 2001.  The authors
    also attribute these changes in Europe to the relatively "high
    hurdles" existing for human gene patents in the European Patent Office,
    and in the U.S. due to increased stringency with which the U.S. Patent and
    Trademark Office has applied the utility requirement under 35 U.S.C. 101 since
    2001.  This is a particular problem for
    U.S. patent applications filed during the explosion of DNA sequence information
    provided by the Human Genome Project but before promulgation of the guidelines:
    some U.S. applications may now be deemed insufficient to satisfy requirements not
    existing when the applications were filed.  These decisions increase the costs and amount of disclosure required for
    successfully patenting human genes.

    Statistics on average pendency (30-60 months in the U.S.,
    60-120 months in Europe and Japan) and the fact that only
    "well-established" assignees such as Amgen, Genentech, and the U.S.
    National Institutes of Health have had success in obtaining gene patents in
    Europe and Japan commensurate with their success in the U.S. further
    distinguish patenting behavior between these patent offices, despite the high
    numbers of applications that have been or are being filed in each.

    The authors also point out that 60% of human gene patents
    have claims to research tools, the value of which has diminished as a result of
    all three patent offices disallowing so-called "reach-through"
    claiming.  Such claims (for example, for
    a method of identifying a drug compound that interacts with the product of a
    patented gene) attempt to "reach through" the claim to capture the drug
    (all drugs) discovered by the patented method.  All three patent offices agreed, in the Trilateral Study of 2001, that
    such claims were only patentable to the extent that applicants disclosed drugs
    discovered using the claimed method.  This decision is reflected in the U.S. in the Pfizer v. University of
    Rochester     case, and in a different context, in the Supreme Court’s Merck v.
    Integra     decision.  Other DNA claims, such
    as those for expressed sequence tags (ESTs), have recently had their
    patentability, and hence their value, diminished in the U.S. (In re
    Fisher    ; see In re Fisher: EST Utility Redux and In re Fisher (Fed. Cir. 2005) summary).

    The authors conclude that the fears raised by some about
    the negative impact of human gene patenting have been, in the event,
    overstated.  They raise the issue of
    patenting specific mutations, such as the BRCA1 breast cancer gene and other
    single nucleotide polymorphisms, but conclude that there is insufficient
    evidence that there is a general problem caused by such patents.  Moreover, they acknowledge that what evidence
    does exist indicates that the "anticommons" effects anticipated by
    some were exaggerated.

    It can only be hoped that this sober analysis of the
    state of human DNA patenting has a quieting effect on the current uproar in the
    U.S., which is based more on politics than on science or sound public policy.

    Dr. Noonan has written a number of Patent Docs articles on the issue of gene patenting, including:

  • Cargill, Inc. v. Canbra Foods, Ltd. (Fed. Cir. 2007)

    Extreme Caution Needed When Overcoming Inherent Anticipation Rejections

        By Robert Dailey

    Last week the Federal Circuit affirmed a District Court
    finding of inequitable conduct against Cargill in its prosecution of U.S.
    Patent Nos. 5,969,169 and 6,201,145.  The
    case highlights the continuing instability in the Federal Circuit’s inequitable
    conduct jurisprudence.

    At the broadest level, Cargill’s patents cover:

    A non-hydrogenated canola oil having a polyunsaturated
    fatty acid content of from about 7% to about 17%, an oleic acid content of
    about 74% to about 80% and an oxidative stability of from about 35 AOM to about
    40 AOM hours in the absence of added antioxidants.

    The Examiner initially rejected the claim as being
    anticipated by an oil composition disclosed in a European patent.  Since the prior art oil had a composition
    similar to that of one of Cargill’s examples (IMC-30), the Examiner reasoned
    that the two oils must also have a similar oxidative stability.  Hence, the Examiner’s anticipation rejection
    rested on the proposition that one can predict the oxidative stability of an
    oil simply based on its fatty acid composition (i.e., that fatty acid
    composition necessarily determines oxidative stability).

    Cargill sought to demonstrate that the Examiner’s
    scientific proposition is false.  This
    could have been done through a variety of means.  Cargill decided to point to data disclosed in
    its own application.  Another example
    (IMC-29) showed another oil which also had a similar composition to the prior
    art oil, but whose oxidative stability differed strikingly from that of
    IMC-30.  Cargill pointed to IMC-29 for
    one specific purpose: to demonstrate that fatty acid composition does not
    necessarily determine oxidative stability.  The Examiner eventually accepted this argument, and allowed the claims.

    All would seem to be well.  The inherency rejection was unwarranted, the
    applicant pointed out the flaw in the Examiner’s scientific logic, and the PTO
    allowed the claims.  But the Federal
    Circuit’s analysis went further.  Cargill
    had done extensive testing on IMC-29.  In
    some of these tests, chemists had simply refined the oil at the lab bench – a
    process that yields oil with a higher oxidative stability than oil refined commercially.  Although the data were sketchy, some of the
    bench-refined IMC-29 had oxidative stability values comparable to commercially
    refined IMC-30.

    The Court held that the "reasonable examiner"
    might have wanted to have access to the data of these bench tests.  Thus, they are material to patentability
    under this malleable "reasonable examiner" standard.  But would a reasonable examiner find these
    data material to patentability?  In the
    case at bar, the Examiner was making an inherent anticipation rejection, not an
    obviousness rejection.  Hence, the
    applicant would appear to be under no burden to show that IMC-30 is patentably
    better than IMC-29.  Rather, the
    applicant simply needs to show that the Examiner’s scientific proposition
    regarding composition and oxidative stability is untenable.  Cargill did that.  In fact, these bench tests appear to bolster
    Cargill’s inherency argument: two
    batches of the same IMC-29 refined in two different ways yielded oils having
    very different oxidative stability values.

    The case illustrates the continued problems with the
    "reasonable examiner" approach for determining materiality.  What would a reasonable examiner want?  Is candor in responding to the Examiner’s
    rejections not sufficient?  In this
    instance, Cargill exercised complete candor in responding to the inherent
    anticipation rejection.  The situation
    would be different if the IMC-29 data in the application had been
    doctored.  But it wasn’t.

    What’s the moral, then?  Be careful when referring to your own data to defeat an inherency
    rejection!  Point to treatises or other
    scientists’ work, or use inventor and/or expert declarations.  Or bury the examiner under a weight of case
    law.  Just don’t appeal to your own
    experimental data.  Otherwise, the court
    may hold you responsible for knowing every experiment that any technician ever
    performed in your client’s labs on a given composition.

    In short, the Court seems to be saying: "Deal with
    examiners as lawyers, and not at all as scientists."  But is that really what the "reasonable
    examiner" desires?

        Cargill, Inc. v. Canbra Foods, Ltd. (Fed. Cir. 2007).

        Additional information regarding this case can be found at Patently-O.

        Robert Dailey, Ph.D., is a physical chemist and a third-year law
    student at the University of North Carolina at Chapel Hill.  Dr. Dailey
    was a member of MBHB’s 2006 class of summer associates, and is a
    regular Patent Docs contributor.

  • Novozymes A/S v. Genencor Int’l, Inc. (D. Del. 2007)

    Novozymes Prevails on Willful Infringement Action Involving Enzyme for Ethanol Production

        By Robert Dailey

    In an opinion issued last Friday, Judge Kent Jordan
    awarded Novozymes reasonable royalty damages and double damages for willful
    infringement for Genencor’s infringement of U.S. Patent No. Novozymes_logo_1
    6,867,031.  Reuters reports that Genencor, a wholly owned
    subsidiary of Danisco, will need to pay about $4 million in damages.

    Novozymes had already prevailed in an earlier trial that
    found three claims of the patent valid and infringed by Genencor.  Last Friday’s opinion results from a separate
    October 2006 trial that focused on remedies.

    The Novozymes patent covers alpha-amylases useful in the
    manufacture of fuel-grade ethanol.  In
    particular, three of the claims cover engineered Bacillus stearothermophilus
    alpha-amylases that have a specific deletion of two amino acids.  Genencor’s product, Spezyme Ethyl®, used
    such an enzyme.  Novozymes filed suit
    against Genencor on the day that the patent issued, and notified Genencor of
    its infringement.  Yet Genencor continued
    selling its product for 18 more months.

    Genencor defended its conduct by arguing that it was
    relying on an opinion of counsel that held that the Novozymes claims were
    obvious in light of a 1989 journal article that disclosed the same amino acid
    deletion on a different bacterium.  Genencor also claimed that it had relied on Judge Jordan’s initial decision
    not to issue a preliminary injunction.

    The district court rejected these arguments.  Even though Genencor claimed to be relying on
    its invalidity opinion, it was also prosecuting a patent application before the
    USPTO directed to the same amino acid deletion in another Bacillus stearothermophilus
    alpha-amylase.  Under the Knorr-Bremse
    analysis, courts may look at the broad context of the defendant’s conduct in
    determining whether its reliance on an opinion of counsel is indeed reasonable.  In this instance, the court held that
    Genencor could not simultaneously argue that the Nonozymes’ technology is
    obvious and make the opposite representation to the PTO regarding its own
    patent application.  Genencor could not
    explain away this conduct except to argue that this is only one factor.  The judge agreed, but held that it is one
    very substantial factor.

    The district court issued a permanent injunction against
    further sales of infringing alpha-amylases.  This should benefit Novozymes immensely. Prior to Genencor’s introduction of Spezyme Ethyl® in 2004, Novozymes
    had controlled 80% of the market for these enzymes.

        Novozymes A/S v. Genencor Int’l, Inc.,
    No. 05-cv-160-KAJ
    (D. Del. 2007).

        Robert Dailey, Ph.D., is a physical chemist and a third-year law
    student at the University of North Carolina at Chapel Hill.  Dr. Dailey
    was a member of MBHB’s 2006 class of summer associates, and is a
    regular Patent Docs contributor.

  • Court Report

        By Sherri Oslick

    Gavel A note to our readers: Patent Docs apologizes to our
    readers for the recent Court Report hiatus.  This Court Reporter was deeply immersed in very intensive preliminary
    injunction proceedings and has just now been able to come up for air.  We will catch our readers up in the next few
    postings.  Patent Docs thanks our readers
    for their patience.

    Rite Aid Corp. v. Purdue Pharma L.P. et. al.*
    1:06-cv-15034; filed December 19, 2006 in the Southern
    District of New York

    Safeway Inc. v. Purdue Pharma L.P. et. al.*
    1:06-cv-15326; filed December 20, 2006 in the Southern
    District of New York

    The complaints in these two cases are substantially
    identical.  Declaratory judgment of
    invalidity and unenforceability of U.S. Patent Nos. 5,508,042 ("Controlled
    Release Oxycodone Compositions," issued April 16, 1996), 5,549,912 (same
    title, issued August 27, 1996), and 5,656,295 (same title, issued August 12,
    1997) covering controlled release formulations of oxycodone hydrochloride
    (Purdue Pharma's OxyContin®, used to treat pain).  As noted in the complaint, the litigation
    history of these patents is extensive.  View the Rite Aid complaint here.

     *Note to our readers: Court report will be periodically monitoring the progress of these cases.


    Novartis Corp. et. al. v. Par Pharmaceutical Co., Inc.
    et. al.
    2:06-cv-06283 ; filed December 29, 2006 in the District
    Court of New Jersey

    Infringement of U.S. Patent No. 6,162,802
    ("Synergistic Combination Therapy Using Benazepril and Amlodipine for the
    Treatment of Cardiovascular Disorders and Compositions Therefor," issued
    December 19, 2000) following a paragraph IV certification as part of Par's
    filing of an ANDA to manufacture a generic version of Novartis' Lotrel®
    (amlodipine besylate/benazepril hydrochloride, used to treat
    hypertension).  View the complaint here.  (Novartis has also sued Lupin Ltd.
    in on the same grounds; view our report here).


    Novartis Vaccines and Diagnostics, Inc. v. Institute
    Pasteur et. al.
    1:07-cv-00034; filed January 5, 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 Institute Pasteur in the
    interference between U.S. Patent 6,532,276 ("Methods for Detecting Human
    Immunodeficiency Virus Nucleic Acid"), owned by Novartis Vaccines and
    Diagnostics, Inc. (formerly Chiron), and U.S. Patent Application 07/999,410
    ("Cloned DNA Sequences, Hybridizable with Genomic RNA of
    Lymphadenopathy-Associated Virus (LAV)").  View the complaint here.

  • The Motley Fool’s Biotech Awards for 2006

        By Christopher P. Singer

    Logo_motley
    In keeping with the spirit of Hollywood’s award season,
    Brian Lawler, a contributor to The Motley Fool wrote up his list of biotech "winners" for 2006.  The article provides a nice snapshot of a few of the biotech stories
    over the past year.  Using categories more familiar to Hollywood Glitterati than
    to C.E.O.s and Ph.D.s, Mr. Lawler provides his reasons for selecting the
    winners as well as reasons for naming some losers.  Among the companies taking home a
    "Lawler" were Celgene, Vertex Pharmaceuticals, Elan, BiogenIdec,
    Genmab, GlaxoSmithKline, and Genentech.

  • Don’t Be An April Fool: PCT Rule Changes Effective April 1, 2007

        By Christopher P. Singer

    Uspto_seal_9
    A notice in the Federal Register published on Friday, February 16, 2007 announced certain rule changes to the Patent Cooperation Treaty (PCT) that will take effect on April 1, 2007.  The changes will (a) restore an Applicant’s right to make a priority claim under certain circumstances, and (b) allow an Applicant to insert a missing portion of an application without the loss of filing date if certain conditions are met.  Portions of 37 C.F.R. likely amended by these changes include 37 C.F.R. §§ 1.17(t); 1.57(a)(2); 1.437(a)-(c); 1.445(a); 1.452(a)-(d) (to be added); and 1.465(b)-(c).  While the following provides a brief synopsis of the changes, more details can be found in the Federal Register notice.

    Regarding the restoration of Applicant’s right to claim priority under certain situations, international applications which have been filed between twelve and fourteen months after the priority date and in which the delay in filing the international application was either in spite of due care or unintentional, can now claim priority to the earlier filed priority document.  However, any restoration of this right Wipo_1
    of priority by the U.S. Receiving Office, or by any other Receiving Office under PCT Rule 26bis.3, will not entitle applicants to a right of priority in any national stage application (35 U.S.C. § 371) or in any application filed under 35 U.S.C. § 111(a), which claims benefit under 35 U.S.C. §§ 120 and 365(c) to an international application in which the right of priority has been restored.  Thus, the Applicant’s right to priority will still be governed by whether they have satisfied 35 U.S.C. §§ 119, 120, and 365.  In such a situation, all PCT time limits (e.g., 30-month National Phase deadline) are calculated based on this claimed "priority date."

    PCT Rules 4 and 20 have been amended to allow an "incorporation by reference" statement on the PCT Request Form, which provides the basis for the changes relating to inserting a missing portion of the application as filed without loss of the international filing date.  Applicants can rely on this statement to insert portions of the application that were missing at the time of filing.  The USPTO will grant international filing dates in accordance with PCT Rule 20 (and 37 C.F.R. § 1.437(b)).

    No public hearing will be held relating to these rule changes, however the public can submit comments on these rule changes on or before March 19, 2007 to the following e-mail address: AC9.comments@uspto.gov.

    P.S., As a point of clarification to the above post:  The changes taking effect are to the PCT Rules, which
    necessitates that portions of the C.F.R. be amended (as noted in the post) to
    reflect these changes as they apply to the U.S.  The rule
    amendments were originally     announced in the PCT Gazette (Feb. 23, 2006,
    pp. 5496-541) and affect portions of PCT Rules 2 and 4.  More explanation to these changes can be found in the Gazette link.

  • Bird Flu Flying to WHO Again

        By Kevin Noonan

    Who_new
    The Indonesian health ministry agreed to resume supplying samples of H5N1 influenza virus to the World Health Organization, having received assurances from the agency that affordably flu vaccines would be made available to Indonesia and other poor countries, The New York Times reported Saturday.

    Earlier, Indonesia had suspended these supplies, complaining that they were not going to give the samples away for free, only to have Western companies use them to make flu vaccine its citizens couldn’t afford.  See "Postscript: When Flu Is for Sale, Who Should Pay?"

    Samples will not be provided until Indonesia is guaranteed access to "affordable" vaccines, something that will be worked out among WHO and several Asian nations some time next month.

    The arrangement was negotiated by Dr. David L. Heymann, WHO chief of communicable diseases, who said he had been assured that Indonesia would not "hold WHO hostage to the virus," according to wire service reports.  Health Minister Siti Fadilah Supari confirmed that Indonesia agrees to "responsible sharing practices" that would commence "soon."

    This settles for now the dispute between Indonesia and the West about inequities involved in poor countries providing biological samples used by Western companies to make vaccines unaffordable in those poor countries.  It remains to be seen whether WHO and Indonesia can work out the issues, particularly in view of the necessity of getting cooperation from company representatives ultimately responsible for producing the vaccines.

  • 3M Acquires Acolyte Biomedica Ltd.

        By Mark Chael

    3m_logo_2
    3M    , headquartered in Minnesota, recently announced that it has acquired the U.K. biotechnology firm, Acolyte Biomedica Ltd.  According to the press release dated February 14, 2007, this acquisition is a natural extension of 3M’s infection prevention technologies and 3M expects to continue expanding their diagnostic testing platforms through complementary acquisitions such as these.

    On esp@cenet, Acolyte is listed as the applicant for at least 3 patent application families related to microbiological testing.  Acolyte’s website states that they hold the "exclusive worldwide rights to AK Rapid® technology in clinical microbiology."  Additional information about the adenylate kinase (AK) detection system can be found here.  One advantage of the AK Rapid® system is that it significantly reduces the time that it takes to identify dangerous bacterial strains, particularly strains resistant to one or more antibiotics.

    Acolytelogosmall

  • Conference & CLE Calendar

    Calendar February 20, 2007 – "Potential
    Licensing Responses to MedImmune: The Supreme Court's Latest Word on
    Declaratory Judgment Actions Challenging Patent Validity    " (ABA CLE)

    February 22, 2007 – Intellectual Property Valuation Teleconference (National Constitution Center)

    February 23, 2007 – John Marshall Law School 51st Annual IP Law Conference – Chicago, IL

    February 27-28, 2007 – Patent Portfolio Management (American Conference Institute) – New York, NY

    March 21-22, 2007 – Complex IP & Technology Transactions Conference (Law Seminars International) – Chicago, IL

    March 25-29, 2007 – American Chemical Society National Meeting – Chicago, IL

    April 16-18, 2007 – Biotechnology: Patent Prosecution, Licensing, Litigation &
    Hatch-Waxman     (Patent Resources Group) – Orlando, FL

    April 27, 2007 – Patent Claim Construction Workshop (Law Seminars International) – Atlanta, GA

    May 6-9, 2007 – BIO International Convention – Boston, MA