•     By Christopher P. Singer

    165pxus_government_accountability_o
    Back in September, the U.S. Government Accountability Office (GAO) published a report to the Ranking Member of the House Committee on Oversight and Government Reform detailing how current U.S. Patent and Trademark Office hiring efforts are likely insufficient to reduce the current application backlog.  The report identifies that examiner attrition, particularly among examiners with less than five years of experience, along with the USPTO’s outdated production goals are key factors that have exacerbated the application backlog.  New examiners are relied on primarily for the initial examination of new applications, and the GAO found that 70 percent of the examiners that had left the USPTO from 2002-2006 had fewer than five years of experience.  While Patent Office management believed that examiners leave the Office primarily for personal reasons (e.g., family reasons), 67 percent of the 1,100+ examiners surveyed believed that the unrealistic production goals were a primary reason for attrition.  From this survey information, the GAO report’s sole recommendation was that the "USPTO undertake a comprehensive evaluation of the assumptions that the agency uses to establish its production goals."

    Uspto_seal_no_background
    The Department of Commerce submitted comments to GAO (attached as Appendix III of the report above) that instead of focusing on efforts to re-evaluate current production goals (established in the 1970’s) to curb examiner attrition, chose to leverage the conclusion that hiring efforts alone will not reduce the backlog in order to highlight the Office’s "productivity" initiatives (i.e., the continuation and claims rule changes and the proposed changes to IDS and Markush claims practice).  According to the Department’s comments, once the effect of these productivity initiatives can be assessed, the PTO will then reconsider the assumptions it makes in establishing examiner production goals.  Seemingly, this was simply a polite way of saying: "GAO, your recommendation has been considered, but determined to be unpersuasive."

    There is little debate that these changes will shift much of the current examination burden from examiners to the applicant and prosecuting attorneys, which should allow for a more rapid examination.  However, even with this reapportioned burden, a real and immediate effect on the backlog will likely only be realized if:  (1) the examining corps is prepared to handle the new issues that arise under the new rules, and (2) if there are adequate numbers of examiners to do the work.

    Interestingly, several comments published in response to a Patently-O post regarding 35 USC § 120 indicate that the USPTO has not adequately prepared the examining corps to deal with implementation of the new continuation and claims rule changes, which take effect November 1 (tick-tock, tick-tock) (see, e.g., comments from "Examiner X" and "another examiner").  How, then, can Patent Office management assert that it has done its part in preparing the examiners to deal with application processing under the terms of the new rules?  As evidenced by the 100+ pages of commentary in the Federal Register notice attached to the publication of the new rules, the 67 pages of FAQs (which have been modified since their initial publication), and the huge amount of discussion from other sources, these new rules are very complex and difficult to interpret.  Examiners who are not prepared to deal with the mechanics and consequences of these rule changes should probably expect to spend at least the same amount of time on any given application under the new rules as they do now.  It seems that practitioners, applicants, and examiners will all be dealing with the fallout from these rules for the months to come.

    So, by the end of the week (assuming GSK is unable to provide us all with a Halloween treat), applicants will be left to deal with a brave new world of patent prosecution under the new rules, and examiners will be expected to maintain the same production goals under a radically new system, with minimal training.  Let the gnashing of teeth continue.

  •     By Sherri Oslick

    In a nonprecedential opinion, the CAFC has affirmed the decision of the Board of Patent Appeals and Interferences dismissing the interference at issue after finding the appellant’s claims invalid for failure to comply with the written description requirement of 35 U.S.C. § 112, first paragraph.

    In 1995, Adang and Kemp filed U.S. Patent Application No. 08/461,240, claiming plants containing insecticidal resistance genes.  Later in prosecution, Firoozabady was added as an inventor, and in 2001 the applicants (collectively "Adang") added five new claims, on the basis of which they requested an interference against U.S. Patent Nos. 5,004,863 and 5,159,135, both to Umbeck.  Thereafter, Adang added three additional claims and filed a renewed request for an interference against the Umbeck patents.  The Board declared an interference in November 2005, with the count directed to cotton plants transformed to contain "selected foreign DNA."

    Umbeck moved to have Adang’s involved claims ruled unpatentable for failure to meet the written description requirement, arguing that Adang’s specification only supported plants transformed with insecticidal resistance genes, not plants transformed with "selected foreign DNA" as recited in the count.  The Board granted Umbeck’s motion, and because claims must meet the requirements of 35 U.S.C. § 112, first paragraph, in order to be part of an interference, the Board dismissed the interference as Adang no longer had standing to continue.

    Adang argued two points on appeal.  First, Adang argued that Umbeck had failed to present any expert testimony on the issue of how one of skill in the art would have interpreted the Adang specification.  Noting that invalidity for failure to meet the written description requirement can be based solely on the language of the specification, and that the Board conducted a thorough review of the Adang specification and carefully documented its factual findings, the CAFC concluded that the Board’s position that the application’s intrinsic evidence did not provide adequate written description was supported by substantial evidence in the record.

    Adang next argued that the Board erred in finding that a particular reference cited in the specification was not incorporated by reference; the reference was Firoozabady’s U.S. Patent Application No. 07/076,339.  According to Adang, the teachings of the ‘339 application, along with the disclosure in the ‘240 specification, fulfilled the written description requirement of the involved claims.  Umbeck countered by asserting that the Board correctly found that the ‘240 application did not specifically identify the portions of the ‘339 application Adang intended to incorporate, and that the reference in the ‘240 application was insufficient to incorporate the entirety of the ‘339 application.  The relevant passage read: "[c]otton was transformed essentially as disclosed by Firoozabady, E. et al. (1987) Plant Mol. Biol. 10: 105-116, and Firoozabady, E. U.S. patent application serial no. 076,339."  The CAFC agreed with the Board that it was not clear that Adang intended to incorporate any part of the ‘339 application, noting that the ‘240 specification used the phrase "incorporated by reference" eight times, but not with reference to the ‘339 application.  As such, the CAFC concluded that Adang intended to treat the ‘339 reference differently than those incorporated by reference using specific incorporation language.

    Adang v. Umbeck (Fed. Cir. 2007)
    Nonprecedential disposition
    Panel: Circuit Judge Bryson, Senior Circuit Judge Friedman, Chief District Judge Keeley
    Per curiam

  •     By Robert Dailey

    Ipo_2
    The Intellectual Property Owners Association (IPO) has finally weighed in on the new Markush rules that were released this August (see 72 Fed. Reg. 44992 (Aug. 10, 2007); "Patent Office Proposes New Rules for Alternative Claiming").

    Uspto_seal
    The comments center on two themes:  (1) that the new rules have the unwanted effect of increasing Examiner workload; and (2) that the rules unduly limit inventors’ abilities to define the nature of their inventions.  Specifically, the IPO makes the following comments regarding each proposed rule change.


    I. Single invention explanation

    The new rules encourage applicants who submit alternative claims to provide an explanation as to why the claim is directed to a single invention.  The PTO suggests that applicants may do this in one of two ways:  (1) explain that the species share a substantial feature of common utility; or (2) explain that the species are prima facie obvious over each other.

    The IPO points out that the second of these options leads the applicant directly into a trap.  In re Ruff, 118 U.S.P.Q. 340, 347 (C.C.P.A. 1958), states: "[t]o rely on an equivalence known only to the applicant to establish obviousness is to assure that his disclosure is a part of the prior art."  In other words, if applicants admit that their species are prima facie obvious over each other, then they could not excise an anticipated species from the list of alternatives.


    II. Long lists of named compounds

    The new rules permit Examiners to reject claims directed to large lists of named compounds.  Under such a rejection, the Examiner would reject the claim and ask the applicant to present a common structural feature of the listed compounds.  IPO suggests that applicants may avoid the effect of this rule by claiming lists of structures rather than lists of names.


    III. Single invention rule of 37 C.F.R. § 1.75(a)

    The new rules would prevent Examiners from examining claims that contain more than one invention.  IPO suggests that the rule should be permissive, allowing Examiners the liberty to examine multi-invention claims if it would pose no undue burden on the PTO.  The rules should not force Examiners to reject claims that can easily be examined.  This would have the unwanted effect of increasing the PTO’s workload.


    IV. "Difficult to construe" rule of 37 C.F.R. § 1.75(j)(1)

    The new rules permit alternative claiming only when "[t]he number and presentation of the alternatives in the claim does not make the claim difficult to construe."  IPO rejects this rule as too vague.  No standard is provided for "difficult," and applicants are given no basis upon which they can rebut a determination that their claims are difficult to construe.


    V. Nested alternatives ban of 37 C.F.R. § 1.75(j)(2)

    The new rules provide that "no alternative be defined as a set of further alternatives within the claim."  IPO points out that nesting often shortens claim length, and places limits on the manner in which applicants can claim their inventions.  In place of the rigid ban, IPO recommends that Examiners be permitted to review nested claims unless the examination would be unduly burdensome.


    VI. Double inclusion ban of 37 C.F.R. § 1.75(j)(3)

    The new rules require that no alternative be encompassed by another alternative within the list of alternatives.  IPO accepts this rule as consistent with existing PTO practice.


    VII. "Substitutable for one another" rule of 37 C.F.R. § 1.75(j)(4)

    The new rules requires that each alternative in a list be substitutable for the other alternatives.  IPO rejects this rule as a contradiction of M.P.E.P. § 2173.05(h):

    Where a Markush expression I applied only to a portion of a chemical compound, the propriety of the grouping is determined by consideration of the compound as a whole, and does not depend on there being a community of properties in the members of the Markush expression.

    The new rule would encourage the PTO to ignore what one knows about the molecule as a whole.  For example, an R-group at the active site of a drug would be judged no differently than an R-group on a side chain.  IPO suggests that this rule be rejected in favor of the current practice outlined in M.P.E.P. § 2173.05(h).


    VIII. Rule 140: "Substantial feature essential for a common utility"

    The new rules require that an alternative claim "share a substantial feature essential for a common utility."  Otherwise, the claim is deemed as containing multiple inventions.  Although the PTO purports to rely on In re Harnisch, 631 F.2d 716 (C.C.P.A. 1980) for this rule, IPO points out that Harnisch never recites such a requirement.  Furthermore, IPO sees the rule as vague, and asserts that the rule offers no advantages over current practices for defining a single invention (i.e., that a single invention is one that is independent and distinct).

    For additional information on this topic, please see:

  •     By Kevin E. Noonan

    Glaxosmithkline_gsk
    The patent blogging team of John White and Eugene Quinn will be doing their part to keep the rest of us informed about the progress of the temporary restraining order/preliminary injunction hearing to be held on Wednesday in GlaxoSmithKline’s lawsuit against Jon Dudas and the U.S. Patent and Trademark Office.  As announced last week by White and Quinn, Mr. White will be in the gallery for the hearing, and will be contacting Mr. Quinn by telephone periodically.  Updates will be provided on the pair’s website.  The hearing is scheduled to start at 10:00 am on October 31st.

    For additional information on this topic, please see:

  •     By Donald Zuhn

    Logosubsid_ryog_2
    Ryogen LLC announced today that it had been granted U.S. Patent No. 7,273,718.  The ‘718 patent, which relates to an isolated genomic polynucleotide fragment that encodes human soluble (cytosolic) aminopeptidase P, appears to be the Suffern, New York-based genomics company’s second U.S. patent.  According to Ryogen’s website, the company, which is a portfolio company of IP Holdings LLC, was formed for the purpose of licensing U.S. Patent No. 6,399,349, which is directed to the human aminopeptidase P gene.

    The ‘718 patent issued from U.S. Application No. 10/457,715, filed June 9, 2003, and claims the benefit of U.S. Provisional Application No. 60/386,941, filed June 7, 2002.  Representative independent claims 1 and 8 of the ‘718 patent recite:

    1.  An isolated genomic polynucleotide, wherein said polynucleotide can be isolated from human chromosome 10 and is selected from the group consisting of:
        (a) a polynucleotide consisting of the nucleic acid sequence set forth in SEQ ID NO:2,
        (b) a polynucleotide consisting of the sequence of nucleotides from position 12803 to position 55760 of SEQ ID NO:2, and
        (c) a polynucleotide which is the complement of a polynucleotide of (a) or (b) and encodes a polypeptide having aminoacyl prolyl peptidyl hydrolase activity.

    8.  An isolated polynucleotide consisting of a nucleic acid sequence selected from the group consisting of
        (a) a sequence of at least 5000 contiguous nucleotides within the region consisting of the sequence of nucleotides from position 1 through position 12802 of SEQ ID NO:2,
        (b) a sequence of at least 2000 contiguous nucleotides within the region consisting of the sequence of nucleotides from position 55761 through position 58735 of SEQ ID NO:2,
        (c) a sequence of nucleotides complementary to the nucleotide sequence of (a), and
        (d) a sequence of nucleotides complementary to the nucleotide sequence of (b).

  •     By Sherri Oslick

    Gavel_8
    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.


    Purdue Pharma Products LP et al. v. Par Pharmaceutical Inc. et al.
    1:07-cv-00666; filed October 24, 2007 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,254,887 ("Controlled Release Tramadol," issued July 3, 2001) following a paragraph IV certification as part of Par’s filing of an ANDA to manufacture a generic version of plaintiffs’ Ultram® ER (tramadol hydrochloride, used to treat moderate to moderately severe chronic pain).  View the complaint here.  As reported here and here, plaintiffs have previously asserted this patent against Par Pharmaceutical; the present complaint includes an additional dosage included in Par’s ANDA.


    Alcon Manufacturing, Ltd et al. v. Barr Laboratories, Inc.

    1:07-cv-01377; filed October 23, 2007 in the Southern District of Indiana

    Infringement of U.S. Patent Nos. 5,641,805 ("Topical Ophthalmic Formulations for Treating Allergic Eye Diseases," issued June 24, 1997) and 5,116,863 ("Dibenz[b,e]oxepin Derivative and Pharmaceutical Compositions Thereof," issued May 26, 1992) following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Alcon’s Patanol® (an ophthalmic solution containing olopatadine hydrochloride, used to treat allergic conjunctivitis).  View the complaint here.


    Sciele Pharma Inc. et al. v. Mylan Pharmaceuticals Inc. et al.

    1:07-cv-00664; filed October 22, 2007 in the District Court of Delaware

    Infringement of U.S. Patent No. 4,892,741 ("Press coated DHP tablets," issued January 9, 1990) following a paragraph IV certification as part of Mylan’s filing of an ANDA to manufacture a generic version of Sciele’s Sular® (nisoldipine, used to treat hypertension).  View the complaint here.


    Schering Corporation v. Dr. Reddy’s Laboratories, Inc. et al.

    3:07-cv-05062; filed October 19, 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 Dr. Reddy’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.


    Schering Corporation v. Dr. Reddy’s Laboratories, Inc. et al.

    3:07-cv-05038; filed October 19, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 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) following a paragraph IV certification as part of Dr. Reddy’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex (desloratidine, used to treat allergies).  View the complaint here.


    King Pharmaceuticals Inc. et al. v. Actavis, Inc. et al.

    2:07-cv-05041; filed October 18, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 6,066,339 ("Oral Morphine Particulate Formulation," issued May 23, 2000) following a paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of King’s Avinza® (morphine sulfate extended release capsules, used for the once-daily treatment of moderate-to-severe chronic pain).  View the complaint here.


    Sepracor Inc. et al. v. Mylan Pharmaceuticals, Inc. et al.

    3:07-cv-05017; filed October 18, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 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 Mylan’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

  •     By Kevin E. Noonan

    Amgen
    Amgen’s recombinant erythropoietin (EPO) franchise (Aranesp® and Epogen®, as well as Johnson & Johnson’s Procrit®) survived another challenge last week, when a jury found that Hoffmann-LaRoche’s pegylated EPO preparation (Mircera®) infringed three Amgen patents:  U.S. Patent Nos. 5,547,933 (the ‘933 patent), 5,441,868 (the ‘868 patent), and 5,618,698 (the ‘698 patent).  Two other patents asserted in the litigation were found not invalid:  U.S. Patent Nos. 5,955,422 (the ‘422 patent, claim 1) and 5,756,349 (the ‘349 patent, claim 7); and the jury did not reach a determination with respect to infringement and validity for U.S. Patent No. 5,621,080 (the ‘080 patent).

    A jury found that the following claims valid and infringed:

    The ‘933 patent:

    3.  A non-naturally occurring glycoprotein product of the expression in a mammalian host cell of an exogenous DNA sequence comprising a DNA sequence encoding human erythropoietin said product possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells.

    7.  The glycoprotein product according to claim 3 . . .  wherein the host cell is a non-human mammalian cell.

    8.  The glycoprotein product according to claim 7 wherein the non-human mammalian cell is a CHO cell.

    12.  A pharmaceutical composition comprising an effective amount of a glycoprotein product effective for erythropoietin therapy according to claim 7 and a pharmaceutically acceptable diluent, adjuvant or carrier.  [Infringed under the Doctrine of Equivalents.]

    The ‘868 patent:

    1.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    (a) growing, under suitable nutrient conditions, mammalian host cells transformed or transfected with an isolated DNA sequence encoding human erythropoietin; and
    (b) isolating said glycosylated erythropoietin polypeptide therefrom.

    2.  The process according to claim 1 wherein said host cells are CHO cells.

    The ‘698 patent:

    6.  A process for the production of a glycosylated erythropoietin polypeptide having the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells comprising the steps of:
    a) growing, under suitable nutrient conditions, vertebrate cells comprising amplified DNA encoding the mature erythropoietin amino acid sequence of FIG. 6; and
    b) isolating said glycosylated erythropoietin polypeptide expressed by said cells.

    7.  The process of claim 6 wherein said vertebrate cells further comprise amplified marker gene DNA.

    8.  The process of claim 7 wherein said amplified marker gene DNA is Dihydrofolate reductase (DHFR) gene DNA.

    9.  The process according to claims 2, 4 and 6 wherein said cells are mammalian cells.

    Amgen has previously prevailed on these same patents in the same court (and before the same judge, the Honorable William G. Young) against Hoechst Marion Roussel; indeed, the Court had the parties address the precedential effect vel non of Judge Young’s prior claim construction (and those portions thereof that had been affirmed by the Federal Circuit) of the asserted claims.  Amgen v. Hoffman LaRoche Ltd., 480 F. Supp. 2d 462 (Fed. Cir. 2007).  Ironically, in view of the ultimate result, the Court noted:

    There is more to this motion practice than meets the eye.  Amgen has largely prevailed in an earlier jury-waived action before this session of this Court.  See Amgen, Inc., v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1295-97 (recounting procedural history).  That exhaustive litigation involved the same patents that are here at issue.  It is not surprising therefore, given the permissive venue requirements for patent cases, 28 U.S.C. 1400(b), that Amgen brought the instant declaratory judgment action in the District of Massachusetts and denominated it a "related" case pursuant to Local Rule 40.1(G)(1)-(3) so that it would be assigned to this session of the Court.  Amgen filed a declaratory action seeking only equitable relief, for which there is no right to a trial by jury.

    Roche/Hoffmann has a different agenda.  For all the reasons Amgen seeks this judge in this Court, Roche/Hoffmann naturally prefers a fresh fact-finder, to wit, an American jury.  What is more, in a case with both equitable (non-jury) and legal (jury) issues, the jury determination may govern the equitable decree.  Dairy Queen, Inc. v. Wood, 369 U.S. 469, 479, 82 S. Ct. 894, 8 L. Ed. 2d 44 (1962).

    These principles markedly change the potential complexion of this case.  No matter how shallow the antitrust claims — and, while they survive this motion to dismiss, they appear somewhat wanting — they insure (as long as they remain in the case) that the patent issues (e.g., anticipation, infringement) will be tried to a jury.  This Court will assiduously insure that the jury has presented to it all those issues which it must resolve.  See, e.g., MacNeill Engineering Co., Inc. v. Trisport, Ltd., 126 F. Supp. 2d 51 (D. Mass. 2001) (case tried to a jury); MediaCom Corp. v. Rates Technology, Inc., 34 F. Supp. 2d 76 (D. Mass. 1998) (case for the jury).

    The victory at trial comes at a particularly good time for Amgen.  Regulatory concerns, both over risks of long-term EPO administration and the costs incurred by public payors such as Medicare and Medicaid have buffeted the company over the past several months.  Since Amgen’s EPO products accounted for about half of Amgen’s revenues last year, these events have had negative effects on Amgen’s stock price as well as its bottom line.  The loss comes at a particularly bad time for Roche, since the Food and Drug Administration was reportedly ready to approve Mircera® for sale in the U.S. as early as November 14th (the product was approved for sale in Europe in July).

    Roche_2
    Amgen has indicated that it will ask the Court for a permanent injunction prohibiting sales of Mircera® until the last of the infringed patents expire (which will not occur before 2017); the injunction hearing is scheduled for November 15th.  However, certain purported advantages of Roche’s product – specifically, a less-frequent administration schedule due to the longer in vivo persistence of the pegylated version of EPO – may reduce the likelihood that the Court will grant an injunction, or that the injunction will be upheld on appeal, in view of the Supreme Court’s proscriptions on granting injunctions in patent cases.  See eBay Inc. v. MercExchange, LLC.  One of the factors Judge Young will be required to balance in deciding whether to grant an injunction is the public interest, which may be weighed against Amgen in the injunction calculus.  For now, however, Amgen’s clear victory can be expected to keep Mircera® off the market for the foreseeable future.

  •     By Christopher P. Singer

    Aryx_logo
    As reported last Tuesday, October 23, 2007, ARYx Therapeutics set its planned initial public offering at 5 million shares for an estimated price of $14 to $16 each.  In the filing, ARYx indicated that Morgan Stanley, CIBC World Markets, Jefferies & Co, and Leerink Swann were underwriting the IPO.  At that price point, the company anticipates to raise about $67.8 million in proceeds after expenses.  The underwriters have the option to buy an additional 750,000 shares to cover over-allotments.  ARYx plans to list its stock on the Nasdaq under the symbol "ARYX".

    ARYx has several drug candidates in clinical Phase II testing, which are based on its RetroMetabolic "ARM" technology.  This approach seeks to identify and design an "ideal metabolite" which is non-toxic, water soluble, and pharmacologically inactive and is not metabolized through a typical metabolic pathway.  This strategy avoids any metabolic "bottlenecks" and associated build-up of drug levels.

  • Calendar_8
    November 8, 2007 – Trilateral Cooperation: Successes, Opportunities, and Challenges (Intellectual Property Owners Association) – Washington, D.C.

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

    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.

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

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

  •     By Kevin E. Noonan

    2054
    The Subcommittee on Court, the Internet and Intellectual
    Property of the House of Representative’s Judiciary Committee has scheduled a
    hearing entitled "Stifling or Stimulating – The Role of Gene Patents in
    Research and Genetic Testing
    " for Tuesday, October 30, 2007.  While not stating so on the hearing notice,
    the testimony to be solicited is no doubt intended to be used in deciding
    whether the House should consider Congressman Becerra’s wrong-headed ban on
    human gene patenting (see "The Continuing Threat to Human Gene Patenting").

    Readers of Patent Docs know our position on the bill and
    the neo-vitalist provocateurs like Michael Crichton that are behind it.  In view of the penchant for this Congress to
    dabble in patent "reform" (in the absence of the political power or
    courage to address more pressing national concerns), this hearing and this bill
    have the potential to seriously injure U.S. biotechnology and pharmaceutical
    companies, universities, and their ancillary industries, as well as remove a
    significant American advantage in the development of new drugs and disease
    diagnosis and treatment methods.

    29hewlett6002
    The witness list has not been published on the website as
    yet, which suggests that Patent Docs readers can do themselves and the country a
    service.  Set forth below are the names
    and e-mail addresses of the members of the subcommittee.  Write them, asking that the witness list be a
    fair representation of the differing points of view on the issue.  People like Michael Crichton and Lori Andrews
    are, frankly, a waste of time – they have great name recognition and may
    favor the hearings with extra C-SPAN coverage, but their own views are
    well-known and they are unlikely to tell the subcommittee anything its members
    don’t already know.  What the
    subcommittee needs is a dose of reality, provided by the people who have the
    experience to understand the scope of the problems that exist and the benefits
    the country has obtained by being at the forefront of allowing genes to be
    patented freely.  And quoting some of our
    earlier Patent Docs posts may be an quick and painless way to get this point of
    view on the members’ radar screens.

    Set forth below are the names of the members of the subcommittee:

    Berman (D-CA, 28th Dist.)
    Boucher (D-VA, 9th Dist.)
    Cannon
    (R-UT, 3rd Dist.)
    Chabot
    (R-OH, 1st Dist.)
    Coble
    (R-NC, 6th Dist.)
    Cohen (D-TN, 9th Dist.)
    Conyers (D-MI, 14th Dist.)
    Feeney (R-FL, 24th Dist.)
    Gallegly
    (R-CA, 24th Dist.)
    Goodlatte (R-VA, 6th Dist.)
    Issa
    (R-CA, 49th Dist.)
    Jackson Lee (D-TX, 18th Dist.)
    Johnson (D-GA, 4th Dist.)
    Keller (R-FL, 8th Dist.)
    Lofgren (D-CA, 16th Dist.)
    Pence (R-IN, 6th Dist.)
    Schiff (D-CA, 29th Dist.)
    Sensenbrenner
    (R-WI, 5th Dist.)
    Sherman (D-CA, 27th Dist.)
    Smith (R-TX, 21st Dist.)
    Sutton (D-OH, 13th Dist.)
    Watt (D-NC, 12th Dist.)
    Weiner (D-NY, 9th Dist.)
    Wexler (D-FL, 19th Dist.) – co-sponsor of the Becerra bill

    If you reside in any of these representatives’
    Congressional districts, you can contact your representative directly by e-mail
    or telephone; contact info can be obtained here.  If
    not, comments to the subcommittee can be submitted here.

    This may be the best opportunity to influence whether the
    Becerra bill will be another patent law mistake visited on American innovation
    by a motivated group with its own interests at heart.  Let’s make some noise.

    For additional information on this topic, please see: