• Alexandria American Conference Institute (ACI) will be holding its USPTO Boot Camp: Patent Edition conference on September 22-23 in Alexandria, VA.  The conference will allow attendees to:

    • Identify the subject matter of an applicant's proposed patent;
    • Define "prior art" for the practical purpose of conducting a search and anticipating an examiner's rejections;
    • Examine changes in the USPTO's rules to set your patent prosecution strategy;
    • Understand what examiners look for in a patent application;
    • Set a tone of advocacy for the patent application instead of being an adversary of the examiner;
    • Design a consistent patent record keeping strategy for the patent portfolio;
    • Build a patent prosecution record that could serve as the basis of future patent litigation;
    • Prosecute patents effectively by seeing the application from the patent examiner’s point of view;
    • Allocate realistic resources in the client’s budget to meet the rigorous demands of patent prosecution;
    • Tackle the challenges of obtaining a patent in a post-KSR world;
    • Evaluate the options best suited for overcoming rejections in Office Actions;
    • Negate the patent examiner’s argument with thoughtful, meaningful, and persuasive language; and
    • Translate legalese into winning language for the patent application.

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

    Uspto_boot_camp
    • Eliciting the critical information from the applicant to effectively prosecute the patent;
    • Conducting a prior art search to uncover potential obstacles to a successful patent application;
    • Luncheon keynote speech — Robert Oberleitner, Assistant Deputy Commissioner for Patent Operations, U.S. Patent and Trademark Office;
    • Look before you leap:  Deconstructing the impact of the PTO’s rules in a post-Tafas vs. Dudas world;
    • Drafting the USPTO patent application with winning claims — to be presented in part by Patent Docs author Donald Zuhn;
    • Probing the underlying reason, purpose, and effect of a USPTO Office action;
    • Getting a firm grasp on obviousness and overcoming Office action rejections;
    • Best practices for conducting interviews with examiners at the USPTO:  Don’t get lost in the bureaucracy;
    • View from the USPTO — Robert Clarke, Director, Office of Patent Legal Administration, U.S. Patent and Trademark Office; Jessica Harrison, Special Program Examiner, Technology Center 3700, U.S. Patent and Trademark Office;
    • Mapping out a realistic, practical, and beneficial record keeping strategy in patent prosecution; and
    • Looking beyond drafting the patent application to arguing a patent dispute at the USPTO and beyond.

    The agenda for the USPTO Boot Camp: Patent Edition conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

    American_conference_institute_aci
    The registration fee for the conference is $2,195.  Those registering on or before July 27, 2008 will receive a $300 discount off the registration fee and those registering on or before August 29, 2008 will receive a $200 discount off the registration fee.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media sponsor of ACI's USPTO Boot Camp: Patent Edition conference.

  •     By Kevin E. Noonan

    Coalition_for_patent_fairness
    The so-called Coalition for Patent Fairness has been one of the principal voices lobbying Congress for the now-becalmed Senate "patent reform bill (S. 1145) and the House version of the bill (H.R. 1938), passed last September.  The Coalition is comprised of "high technology" companies like Apple, Cisco, Intel, Microsoft, Sun Microsystems, and others, and its message is decidedly patent-unfriendly.  Patents harm innovation, subject productive companies to nuisance lawsuits by patent trolls, and the Republic would be much better off if there was a lot less patenting, according to the Coalition.

    Unless we start talking about them, of course.  The extent to which these companies eschew the childhood adage "what’s sauce for the goose is sauce for the gander" is clearly set forth in a report, released today, from the Intellectual Property Owners.  That report contains a numerical ranking of the companies that own the most patents granted in 2007.  The extent of the rhetorical impact of the Coalition’s lobbying can be seen in the somewhat pathetic disclaimer in the report that "IPO DOES NOT INTEND TO ENCOURAGE MORE PATENTING IN THE U.S." (emphasis in original).  Not unnecessary patenting, or frivolous patenting, but all patenting.  A remarkable statement for an organization comprised of intellectual property owners.  The report lists the top 300 organizations that were granted U.S. patents in 2007, and a related Patent Docs post discusses the biotech and pharma companies on the list.  Here, we will concentrate on those organizations having 1,000 issued patents in 2007.

    It is unlikely the results presented in the report would be found in a world in which peoples’ behavior matched their political positions.  Since that is clearly not the world we live in, these top patent procurers should come as no surprise:

    1000_or_more

    It is notable that several Coalition members have found their way on the list, and that they continue to have thousands of published applications, in view of their efforts to reduce the effectiveness of U.S. patents.

    Also notable in this list is the predominance of companies headquartered outside the U.S.  These companies are not a part of the Coalition, and apparently believe that the U.S. patent system is robust enough to justify their considerable investment in filing patent applications in this country.  Even though they are no less subject to the vicissitudes of U.S. patent litigation or the other ills supposedly besetting high technology companies in the U.S.  The contrast is ironic:  the strengthening of the U.S. patent system is one of the factors that permitted nascent U.S. high technology companies to compete in the 1980’s with Japanese and German companies that were at the zenith of their market penetration in the U.S.  The success of the nurturing the patent system provided then can be seen on any street corner now:  iPods, not Walkmans.  In view of their rhetoric and behavior, it seems that there is a childhood adage the member companies of the Coalition subscribe to:  eating your cake and having it too.

  • "Biotech/Pharma" Top 47

        By Donald Zuhn

    Ipo_2
    The Intellectual Property Owners Association (IPO) released its 25th annual list of the top 300 organizations receiving U.S. patents.  Readers may recall that the U.S. Patent & Trademark Office stopped releasing its annual list of top patent recipients in 2006 in order to "discourag[e] any perception that we believe more is better."

    The IPO stated that while it does not intend for the report to "encourage or discourage patenting," it would continue to publish its annual list of top recipients because "the number of patents granted is one of the few objective measures of the patent system as a whole and the patenting activities of individual industries and companies."  The IPO compiled its list by counting the number of utility patents granted during 2007 on which an organization or its subsidiary was listed as the owner on the face of the patent.  However, the IPO attributed patents that were granted to two or more organizations jointly to the organization listed first on the patent.  The IPO noted that 153,283 patents were issued in 2007, which was a decline from the 173,771 patents that were issued in 2006.

    As in 2007, we have used the IPO’s list of the top 300 patent holders to compile a list of the top "biotech and pharma" companies and organizations receiving U.S. patents in 2007 (this year, we were only able to fill out a list of 47 biotech/pharma companies and organizations).  Each organization’s IPO top 300 ranking is indicated in the "IPO Rank" column.  Please note that some of the companies and organizations listed below may be involved in non-biotech or non-pharma work, and therefore, that a portion of the patents granted to these companies may be directed to other than biotech and pharma-related inventions.  In addition, our list is a little inclusive in that we included medical device companies.

    Chart_2

    For additional information on this topic, please see:

    • "IPO Posts List of Top 300 Patent Holders," April 20, 2007

  •     By Kevin E. Noonan

    One of the hopes of the members of the patent community who have been paying attention is that the passing of the current administration may result in better times for the U.S. patent system.  Political appointees like Secretary of Commerce Guttierrez, USPTO Director Jon Dudas, and Undersecretary of Commerce Margaret Peterlin will certainly be packing up their desks next January.  However, we can expect that the Congress will be similarly constituted as it is now, and that could result in efforts for even more dubious patent reform schemes.

    Wegner_harold
    This message is delivered by Professor Harold Wegner (at right) in a cover story article published in ipFrontline (see "Keys to 111th Congress Patent Reform").  The source of his concern is the patent economics tome Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk by James Bessen and Michael J. Meuer.  The work has been lauded by patent academia:  Professor Dennis Crouch excerpted it extensively on his Patently-O blog prior to publication, and the published work carries glowing accolades from the darling of patent academia, Professor Mark Lemley of Stanford University.  While the approval of the academic patent intelligentsia is one thing, more worrisome is that Patent Failure thesis, the familiar "the patent system is broken," is gaining traction among policymakers.

    The basis for this influence can be summarized in this graph (from Professor Wegner’s article):

    Hwegner_080512_2

    The graph purports to show not just that the patent system is broken, but calls into question the system’s value to innovation and the U.S. economy.  The graph is based on two statistics:  the positive value of patent protection versus the negative effects of patent litigation.  The message of the graph – that patents cost more than they are worth – seems simple and empirical.  While acknowledging that patents seem to benefit certain industries, like biotechnology and pharmaceutical companies, the message of this analysis is that the majority of American "mainstream" industries suffer more harm than benefit from the patent system.

    But as Professor Wegner notes, there are some indications that the data don’t completely support the message.  For example, the profits ascribed to the pharmaceutical industry are only $15 billion, citing his analysis of the data from his review of Patent Failure in The Financial Times:

    The fraction of patents in the biotech/pharma and chemistry sectors may be small in terms of numbers of patents but that is where patent exclusivity is most vigorously enforced and where the bulk of all patent rent value lies.  The authors estimate the global patent value for US companies in the chemicals (including pharmaceuticals) sector in 1999 was $[15 billion] compared with only $3.2 [billion] for all other sectors.  In fact, the $[15 billion] figure is ridiculously low:  sales of the top 10 drugs account for roughly $40 [billion] in domestic sales alone – with no patent protection, that $40[billion] would vanish.

    ("The right medicine for a flawed system," May 8, 2008).

    Further, Professor Wegner notes that when Eli Lilly and Company lost its patent on Prozac® in 2001, "its market cap dropped $36 billion in one day, roughly triple what the authors say is the annual profit for the entire pharmaceutical and chemistry industries in one year."  He also identifies the reason for this discrepancy:  "the auhors have explained the seemingly low figure of $15 billion in annual patent profits in pharmaceuticals and chemicals by stating that their figures are calculated based upon "patent ‘rents’ not sales and not patent value.  . . .  In economic theory it is the rents from patents, not the associated sales, that provide the reward to inventors."  One way of looking at this analysis is to say that patent rents are the measure of the difference between the profits that are made with patent protection and the profits that would be made in the absence of patents.  Another way is to recognize that it assumes that there would be profits for pharmaceuticals in the absence of patents, an analysis that ignores the reality that pharmaceutical companies (and their investors) need patents to ensure sufficient return on investment (ROI) necessary to justify the risk created by the supranormal costs of bringing a drug to market.

    Patent_failure
    As noted in an earlier Patent Docs post, the BessenMeurer analysis is at odds with the results of a study by the European Commission reported in 2005 and directed to the very question of the economic value of patents in Europe (the study was entitled "Study on Evaluation the Knowledge Economy – What are Patents Actually Worth?").  The study was comprehensive, surveying 9,000 patent owners who had used the European Patent Office to obtain patents between 1993 and 1997.  The study showed that the median value (half the respondents reporting more and half less) of the patents produced was €300,000, and 10% of the respondent patent owners reported values of €10 million or more.

    As an antidote – or perhaps a prophylactic – to "reforms" driven by the Bessen-Meuer analysis, Professor Wegner proposes the following changes in U.S. patent law that might be sufficient to appease the patent "reformers" while not wreaking extensive havoc on innovation:

    • Establish a patent maintenance fee system along the lines of the ones in most European countries, where patents are subject to an increasing annuity for each year of patent life; this would impose a much higher cost on patent "trolls" and discourage acquisition of patents merely to assert them against mainstream industries.

    • Permit delayed examination (up to seven years) to let commercial activities weed out those applications that are not necessary to protect a product or provide a competitive advantage.  Professor Wegner opines that the failure to enforce most patents indicates substantive examination is an "extreme waste of money" for most patents.  He even proposes a "spoonful of sugar" for the USPTO, where the examination fees would still be collected and subject to only an 80% refund if an applicant decides not to pursue examination.

    • In an effort to balance the interests of patent-dependent industries like biotech/pharma with those industries that may suffer more of a burden than a benefit, Professor Wegner proposes giving intervening rights to anyone who commercializes an invention more than 30 months after an application filing date (i.e., one year after the application publishes), while permitting applicants to obtain an "unlimited" extension of prosecution of a pending application.  The latter would purportedly be beneficial to biotech and pharma companies, by giving them time to collect clinical trial results.  An additional benefit, according to Professor Wegner, would be that "the majority" of patent applications would be abandoned prior to prosecution.

    • In the event these reforms are implemented, Professor Wegner proposes that all continuation applications (excluding divisional applications) be prohibited at any time after 18 months from filing.

    • He would also bolster inter partes reexamination, which has not been particularly successful.  The Professor blames the PTO for the "bottleneck"; the estoppel provisions in the 1999 law provide an equally likely explanation not mentioned by Professor Wegner.  His proposal would put all inter partes reexaminations under a single administrative patent judge and have all proceedings take place before the Board, with the examining corps providing "designated examiners" to assist in the initial reexamination.  As part of this reform (but justified in its own right) there would be a substantial increase in the number of APJ’s.

    The viability of these ideas, as well as the veracity of Bessen-Meuer’s analysis, will be the subject of future posts (and Patent Docs has, in fact, already discussed several of these ideas).  For now, Professor Wegner’s article merely reinforces the message that we all need to remain vigilant in protecting the integrity of U.S. patent system.  Or maybe to put it more bluntly:  it’s not over.

  • Federal_circuit
    Earlier this month, we reported that the U.S. Patent and
    Trademark Office had filed a Notice of Appeal with the Court of Appeals for the
    Federal Circuit, challenging the decision of Judge William Cacheris of the U.S.
    District Court for the Eastern District of Virginia to permanently enjoin the
    Patent Office’s continuation and claims rules package in the consolidated cases
    of Tafas/Smithkline Beecham Corp. v. Dudas.  Judge Cacheris’ ruling was based on his determination that the
    continuation and claims rules "are substantive in nature and exceed the
    scope of the USPTO’s rulemaking authority under 35 U.S.C. § 2(b)(2)."

    The Federal Circuit has now issued a Notice of Docketing,
    which sets some of the deadlines for the appeal.  Among the deadlines that have been set are
    the following:

    • June 2:  The
    Appellants (Dudas and the USPTO) must serve on the Appellees (Tafas and GSK) a
    designation of materials from which the appendix will be prepared;

    • June 18:  The parties must file a Docketing Statement,
    indicating inter alia the relief being sought and providing a brief statement
    of the issues to be raised on appeal;

    • July 3:  The
    parties must file a Certificate of Compliance with Federal Circuit Rule 11(d),
    which requires the parties to review the record to determine whether any
    portions subject to a protective order must remain protected on appeal; and

    • July 18:  Under
    Federal Circuit Rule 31, the Appellants have sixty days from the docketing date
    to serve and file their opening brief.

    The Appellees’ briefing (and subsequent briefing) will be
    cued off the date by which the Appellants file their opening brief, so those
    dates are yet to be determined.  However,
    assuming that the parties each take the maximum time to file their briefs, and
    seek no extensions, the Appellees’ brief would be due on August 27th (the
    Appellees have forty days after the Appellants’ brief is served to file their
    own brief), and the Appellants’ reply brief would be due on September 10th (the
    Appellants have up to fourteen days to serve and file a reply brief,
    though the time to file a reply can be shortened to ensure that the reply is
    served in advance of oral argument).  The
    principal briefs are limited to 30 pages, or up to 14,000 words, and the reply
    brief is limited to 15 pages, or 7,000 words.

    Sherri Oslick, Benjamin Huber, and Donald Zuhn
    contributed to this report.

    For information regarding this topic, please see:

    • "USPTO to Appeal Tafas/GSK v. Dudas," May 7, 2008
    • "BIO Responds to Events of the Day," April 1, 2008
    • "No April Fool’s Joke — Tafas and GSK Win on Summary Judgment," April 1, 2008
    • "PLI’s John White Discusses Tafas/GSK v. Dudas," February 11, 2008
    • "Judge Cacheris Takes GSK Case under Advisement," February 8, 2008
    • "GSK Summary Judgment Hearing Set for Friday Morning," February 7, 2008
    • "New Briefing Deadline Set In PTO Rules Case," December 18, 2007
    • "Court Sets Summary Judgment Schedule in New Rules Case," December 3, 2007
    • "No Discovery in New Rules Case," November 27, 2007
    • "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)," October 31, 2007
    • "USPTO Late to Its Own Party," October 31, 2007
    • "GSK Secures Injunction," October 31, 2007 (includes links to Court’s Order and Opinion)
    • "Senator Schumer Sends a Signal," October 30, 2007
    • "GSK TRO/Preliminary Injunction Hearing," October 29, 2007
    • "AIPLA Supports GSK’s Lawsuit Against the Patent Office’s New Rules," October 25, 2007
    • "GSK Brings Out the Big Guns Opposing the New Continuation and Claims Rules," October 24, 2007
    • "Hooray! – (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
    • "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
    • "Inventor Sues PTO to Prevent New Continuation and Claims Rules from Taking Effect," August 30, 2007

  •     By Donald Zuhn

    San_franscisco_chronicle
    With the BIO International Convention less than a month away, a report in the San Francisco Chronicle is predicting that the U.S. biotech industry may be looking at some rough times ahead.  The Chronicle’s prediction is interesting given its citation of a recent Ernst & Young study that noted that U.S. biotech companies had secured $21.3 billion in financing in 2007.  The portion of this total coming from venture capital firms ($5.5 billion) topped the record set in 2000 at the height of the Human Genome Project.

    Showing a hint of partisanship, the Chronicle observed that the Bay Area ("where the industry was born") had topped all other regions in funding in 2007, with Boston coming in second.  In particular, the Bay Area biotech cluster consists of the 77 biotech companies having 40% of the market value of U.S. biotech companies, and the New England biotech cluster consists of 62 companies having 17.6% of the market value.

    Ersnt_young
    The Chronicle’s less than sunny forecast was based on comments from Ernst & Young’s U.S. life sciences director, Scott Morrison, who noted that many factors could lead to a downturn in financing in 2008.  Among these factors is the subprime mortgage meltdown, which Morrison said was partly to blame for a 60% decrease in biotech funding this year.  Morrison noted, however, that the industry was well-prepared for a financing squeeze, as almost half of the 386 U.S. traded biotech companies have more than two years of cash reserves on hand, and more than a quarter have five years of cash reserves.

    And it may not even be necessary to tap into these cash reserves, since, according to Morrison, venture capital funding continues to be strong.  The primary reason for the steady VC funding appears to be the desire by big drug makers to replace drugs that will soon be going off patent with new therapeutics, a quest that often finds the big drug makers acquiring or partnering with VC-funded smaller companies.  (The Ernst & Young report noted that the value of biotech mergers, acquisitions and drug development alliances was nearly $60 billion in 2007, which was a new high.)

    San_jose_mercury_news
    The San Jose Mercury News also reported on the Ernst & Young report, focusing on the fact that biotech companies once again spent more money than they took in, losing almost $2.7 billion last year.  On the bright side, this was down from the $7.4 billion in losses the industry suffered in 2006.

  •     By Donald Zuhn

    Congress
    The Senate patent reform bill may or may not be dead (see "Bush Administration Continues Attempt to Destroy U.S. Patent System").  However, if the bill’s time has indeed come and gone (at least as far as the 110th Congress is concerned), its passing will be due in no small part to the efforts of biotech and pharma companies to aggressively lobby against the bill.

    For the past few months, we have been reporting on the recent lobbying expenditures of a number of biotech and pharma companies.  For example, we noted that Millennium Pharmaceuticals, Genentech, AstraZeneca, and Abbott Laboratories spent between $1.28 million and $4.4 million on lobbying in 2007.  Most of these funds presumably went to lobby on the patent reform and follow-on biologics bills that were being considered by Congress last year.  More recently, we reported that Abbott spent $880,000 on lobbying in the first quarter of 2008.

    Cephalon_2
    Two more reports regarding first quarter spending can now be added to the list.  First, the Houston Chronicle reported last Friday that Cephalon, Inc. spent $512,000 on lobbying in the first quarter.  While the Frazer, PA-based biotech company lobbied in favor of more funding for the FDA and for new standards for alcoholism treatments (Cephalon markets the injectable drug Vivitrol® for treating alcoholism), it also lobbied against the Senate patent reform bill.

    Amgen
    Topping both Abbott and Cephalon, however, was Amgen Inc.  Forbes.com reported that the Thousand Oaks, CA-based biotech company spent $2.5 million on lobbying in the first quarter.  Amgen’s lobbying efforts were aimed in part at the patent reform and follow-on biologics bills.  With respect to the follow-on biologics legislation, Forbes.com indicated that Amgen was pushing for a compromise before the fall elections, when Democrats are expected to pick up additional seats in Congress.

    However, as we noted earlier this month, with the patent reform bill seemingly stalled in the Senate, the follow-on biologics legislation on the backburner (notwithstanding the biotech industry’s desire to negotiate a compromise), and the economy struggling, it will be interesting to see if biotech and pharma companies begin to cut back on lobbying in the second quarter.

    For additional information regarding this topic, please see:

    • "Abbott’s First Quarter Lobbying Tab Hits $880,000," May 2, 2008
    • "Abbott Spent $4.4 Million on 2007 Lobbying Effort," March 17, 2008
    • "Biotech and Pharma Companies Spent Millions on Lobbying in 2007," March 5, 2008
    • "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008

  •     By Donald Zuhn

    Etc_group
    Last week, both The Washington Post and Nature News reported on the efforts of biotech companies to secure patents directed to gene-altered crops that are designed to withstand the effects of global warming.  The impetus behind both articles was a 30-page report entitled "Patenting the ‘Climate Genes’ . . . and Capturing the Climate Agenda," which was released by the Erosion, Technology and Concentration (ETC) Group, an activist organization based in Ottawa, Ontario, on May 13th.  (Patent Docs readers are no doubt familiar with the ETC Group, as we have reported on a few of the Group’s other initiatives; see links below.)

    According to the ETC Group, biotech and agrochemical companies such as BASF, Monsanto, Bayer, Syngenta, and Dupon have been "stockpiling hundreds of monopoly patents on genes in plants," and that the companies intend to market genetically engineered crops containing such genes (i.e., "climate ready" plants) as being able to withstand environmental stresses such as drought, heat, cold, floods, and saline soils.  The ETC Group contends that the above companies have thus far filed 532 patent applications worldwide (in 55 patent families) on such genes, and warns that "[i]n the face of climate chaos and a deepening world food crisis, the Gene Giants are gearing up for a PR offensive to re-brand themselves as climate saviours."  The Group argues, however, that "patented techno-fix seeds will not provide the adaptation strategies that small farmers need to cope with climate change," and that the so-called "Gene Giants" are merely engaging in "climate change profiteering."

    To prevent such "profiteering," the ETC Group is pushing for a worldwide suspension of patent grants for climate-related genes and traits.  The Group hopes that such action might be taken at either the U.N. Convention on Biological Diversity on May 19-30 or the United Nations-FAO High-Level Conference on World Food Security and the Challenges of Climate Change and Bioenergy on June 3-5, and that following the implementation of such a suspension, world governments would initiate an investigation into the social and environmental impact of patents directed to climate ready genes and plants.  The ETC Group is also urging "inter-governmental bodies to identify and eliminate policies such as restrictive seed laws, intellectual property regimes, contracts and trade agreements that are barriers to farmer plant breeding, seed-saving and exchange."

    Monsanto
    Not surprisingly, the companies accused by the ETC Group of engaging in "climate change profiteering" see their role in a much different light.  According to The Washington Post article, the biotech companies seeking gene patents contend that climate ready plants will be critical to solving the problem of world hunger and that absent patent protection, such plants will not be developed.  In addition, a spokesperson for Monsanto noted in the Post report that Monsanto and BASF were participating in a project, funded by the Bill and Melinda Gates Foundation, to develop drought-resistant corn that would be made available to African farmers royalty-free.

    One of the ETC Group’s criticisms regarding the 532 filed applications is that these applications contain claims that are far too broad, encompassing numerous plants and a litany of environmental stresses.  However, because the vast majority of these applications have yet to issue as patents, the actual claim scope that the applicants will be able to secure remains unclear.  ETC Group executive director Pat Mooney concedes this point in the Nature News article, admitting that "the companies are casting the net as wide as they possibly can, and then they will sort it out afterwards."

    Bennett_alan
    Dr. Alan Bennett (at left), a plant geneticist at the University of California, Davis and the head of the the Public Intellectual Property Resource for Agriculture (PIPRA), a non-profit initiative supporting agricultural innovation for both humanitarian and small-scale commercial purposes, put the debate between the ETC Group and the agricultural-biotech industry  into some perspective in the Nature News report.  Calling the introduction of the global warming angle nothing more than a public relations stunt, Dr. Bennett observed that the agricultural-biotech industry was merely engaging in business as usual; namely, focusing on the search for hardy crops that survive in harsher environments (i.e., poor soils, less water, fewer fertilizers), and the genes responsible for conferring such traits.

    For additional information regarding other related topics, please see:

    • "Playing the Bioterror Card in the Synthetic Biology Debate," December 19, 2007
    • "The Synthetic Biology Sky is Not Falling," December 16, 2007
    • "Patent Life (Really)," June 11, 2007

  •     By Kevin E. Noonan

    Gutierrez_carlos
    Just when you thought it was safe to stop worrying about the stalled "patent reform" bill in the Senate (S. 1145), along comes Secretary of Commerce Carlos Gutierrez (at right), trying to reenergize the IT community in Silicon Valley to push for passage of this misguided bill.

    Last week, Mr. Gutierrez announced his intention to meet with leaders of the IT community in an op-ed piece published in the San Jose Mercury News (see "Get moving on patent reform measure stalled in Senate").  Mr. Gutierrez bemoaned that negotiations over the bill had stalled and that the legislation was unlikely to pass this year (see "Senate Patent Reform Bill: R.I.P.?").  The Mercury_news_logo_3
    Secretary emphasized the importance of intellectual property protection to the U.S. economy, citing a value of $5.5 trillion corresponding to 40% of the U.S. economy and employing 18 million Americans.  All important and vital statistics, sadly misapplied in defense of a bill guaranteed to put those jobs and technology at risk.

    Tellingly, the Secretary cites "products such as cell phones and blenders, to high-technology microchips and heart valves" as deserving protection.  Not surprisingly, he neglected the contributions of the biotechnology and pharmaceutical industries and the importance of patent protection to those industries; these industries do not comprise the intended Silicon Valley audience.  He then set forth "a way forward" to pass legislation "streamlined" to contain only some of the many provisions contained in S. 1145.  (Some provisions, such as Senator Sessions’ "patent infringement ‘get out of jail free’" portion of the bill, has already been deleted.)  The Secretary’s "way forward" includes these provisions of the bill (as presented in the Secretary’s op-ed article):

    • Damages:  The debate has largely focused on how different business models win or lose under the current system.  This is the wrong way to approach the issue.  Our patent system must work to encourage innovation in all sectors of the economy, and it shouldn’t tilt toward one industry or another.  Most agree on reforms that would give judges additional authority to direct juries as to which factors they may consider in determining the compensation for infringement.  Judicial guidance will help ensure more rational decisions while protecting judicial discretion.

    • Post-grant review:  Most agree that establishing cost-effective alternatives to litigation after a patent is granted would be a significant improvement.  One way to accomplish this is to provide a venue for patent holders and patent challengers to resolve their differences in front of experts at the Patent and Trademark Office.  This should include protections to ensure that it does not become a vehicle to harass the patents of competitors.

    • Patent quality:  The Senate bill currently includes language that emphasizes the importance of patent quality at the front end of the process.  This reform is essential.  Our patent system faces increasingly complex applications, which is why – despite significant productivity initiatives – the patent office currently has a backlog of 760,000 patents and the average patent exam takes 31 months.  Requiring quality on the front end will allow us to speed the flow of new ideas through our innovation pipeline.

    Secretary Gutierrez calls these the provisions "where there is broad agreement on the need for reform."  Many would differ with this assessment (see "Commerce Secretary ‘Entirely Wrong’ on Inequitable Conduct Reform").  The Secretary’s bill would include Applicant Quality Submissions, placing the examination burden on applicants rather than the Office.  Anyone with any real experience knows that the philosophical underpinning for these provisions, that applicants are in the best position to know the relevant prior art, is deeply flawed and any factual basis is due to the overwhelmingly high percentage of recently hired new examiners.  And this situation is the result of mismanagement and years of insufficient funding for the Office.  These transient circumstances are not an acceptable or adequate basis for twisting the fundamental balance between applicants and the Office, a conclusion seemingly beyond the ken of those in the Administration fomenting for this dubious reform.

    The other patent-unfriendly provisions provide post-grant review for an Office without any apparent confidence in the integrity of the examination process, and a damages provision demonstrating a similar lack of confidence in the ability of the judiciary to determine the fair and proper amount of damages for patent infringement.

    Once again, in this election year it is important for those in the patent community with actual experience, who are not career bureaucrats looking to improve performance statistics or political employees padding their resumes for the next government job or K Street consultancy, to contact their Senator and tell them the "compromise" offered by the Secretary is merely the "worst of" S. 1145.  Passage would not represent compromise but rather capitulation, to those whose intention is to gut rather than bolster the U.S. patent system.  It is still time for us to remain vigilant.

  •     By Sherri Oslick

    Gavel_19
    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.


    Salix Pharmaceuticals, Inc. et al. v. Novel Laboratories, Inc.

    3:08-cv-02311; filed May 14, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 7,169,381 ("Colon Cleansing Compositions and Methods," issued January 30, 2007) following a paragraph IV certification as part of Novel’s filing of an ANDA to manufacture a generic version of Salix’s MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid oral solution, used for cleansing of the colon as a preparation for colonoscopy).  View the complaint here.


    Bayer Schering Pharma AG et al. v. Sandoz, Inc.

    1:08-cv-00980; filed May 12, 2008 in the District Court of Colorado

    Infringement of U.S. Patent No. 5,569,652 ("Dihydrospirorenone as an Antiandrogen," issued October 29, 1996) following a paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Bayer’s Yasmin® (drospirenone and ethinyl estradiol, used as oral contraception).  View the complaint here.


    Novartis Pharmaceuticals Corporation et al. v. Roxane Laboratories, Inc.

    2:08-cv-02272; filed May 9, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 5,840,763 ("Treatment of a Latent Infection of Herpes Viruses, issued November 24, 1998), 5,916,893 (same title, issued June 29, 1999), and 5,866,581 ("Penciclovir for the Treatment of Post Therapeutic Neuralgia," issued February 2, 1999) following a paragraph IV certification as part of Roxane’s filing of an ANDA to manufacture a generic version of Novartis’ Famvir® (famciclovir, used for the treatment of acute herpes zoster (shingles), the treatment or suppression of recurrent genital herpes in immunocompentent patients, the treatment of recurrent herpes labialis (cold sores) in immunocompetent patients, and the treatment of recurrent mucotaneous herpes simplex infections in HIV-infected patients).  View the complaint here.


    Pamlab, L.L.C. et al. v. Hi-Tech Pharmacal Co., Inc. et al.

    1:08-cv-00967; filed May 8, 2008 in the District Court of Colorado

    Infringement of U.S. Patent No. 6,528,496 ("Compositions Treating, Preventing, or Reducing Elevated Metabolic Levels," issued March 4, 2003) based on defendants’ manufacture and sale of its Folamin, allegedly the same as Pamlab’s Foltx® (vitamin B12, vitamin B6, and folic acid, used to treat hyperhomocysteinemia).  View the complaint here.