•     By Donald Zuhn

    Abbott_laboratories
    In 2007, patent reform and biologics legislation became front burner issues.  Not surprisingly, this did not escape the notice of many biotech and pharmaceutical companies, and for the past few months we have been paying close attention to reports concerning the lobbying efforts of such companies.  We have already discussed the money spent on lobbying by Millennium Pharmaceuticals ($1.28 million), Genentech ($1.8 million), and AstraZeneca ($4.1 million).  Most of these funds presumably went to lobby on the patent reform and biologics bills that were being considered by Congress last year.

    Last week, Forbes.com reported that Abbott Laboratories has vaulted to the front of the pack by spending $4.4 million on lobbying.  Not all of Abbott’s lobbying costs were applied to the patent reform and biologics bills, however, as the company also lobbied for changes to the tax code that would reward businesses for investing in research, and supported funding to raise kidney disease awareness and help purchase AIDS medication.

    For additional information regarding this topic, please see:

    • "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

    Uspto_seal
    The U.S. Patent and Trademark Office announced today that it will be changing its procedure for handling requests from a practitioner of record to withdraw from representation.  The Office also clarified its procedure for handling a request to withdraw from representation made by a practitioner who is not of record, but who has acted in a representative capacity under 37 C.F.R. § 1.34.

    Under the Patent Office’s revised procedure, the Office is replacing the requirement that there be at least 30 days between an approved request to withdraw and the latest extendable date for responding to a pending Action with a certification from the practitioner of record that the practitioner has:

    (1)  given reasonable notice to the client, prior to the expiration of the reply period, that the practitioner intends to withdraw;

    (2)  delivered to the client (or the client’s representative) all papers and property (including funds) to which the client is entitled; and

    (3)  notified the client of any replies that may be due and the time frame within which the client must respond.

    If a practitioner cannot make all of the above certifications, the practitioner must include an explanation detailing why the certification cannot be made with the request to withdraw (e.g., a practitioner that has been terminated by the client may be unable to certify to item 1).

    The Office noted that it would be changing Form PTO/SB/83 ("Request For Withdrawal As Attorney or Agent and Change of Correspondence Address") to include a section for making the above certification, and will be amending M.P.E.P. § 402.06 accordingly.  The Notice states that requests filed after an application is abandoned or a patent issues will be placed in the file, but generally will not be treated on the merits.  The Notice also states that in the absence of a power of attorney, the Patent Office will no longer accept practitioner address changes with requests to withdraw.  The revised procedure will take effect on May 12, 2008.

    With respect to requests to withdraw from practitioners who are not of record, but are acting in a representative capacity under 37 C.F.R. § 1.34, the Patent Office noted that it will no longer approve of such requests.  The Office explained that such requests are unnecessary since the practitioner was only responsible for the correspondence the practitioner filed.

    More information regarding the new procedure can be found in the Notice.

  • Patent Docs Readers:

    Normally, we do not address the online tools that make it possible to bring Patent Docs to a browser, RSS reader, or e-mail client near you.  However, because we have become aware of some issues regarding the delivery (or lack thereof) of our e-mail newsletter, we would like to make an exception this one time.  Like a lot of other weblogs out there, we use an online tool called Feedburner to allow you to receive an RSS feed of Patent Docs, or subscribe to our e-mail newsletter.  In the past few weeks, we have become aware that some of our readers are either not receiving their e-mail newsletters or are receiving them many hours or even days later than expected.  We have alerted the folks at Feedburner regarding this problem, and have been informed that they are working to resolve the issue.  It is our hope that as a result of last year’s acquisition of Feedburner by Google, Feedburner will be provided with the resources it needs to better handle its growing number of "customers" (we use this term loosely since even Feedburner’s PRO services, which used to be available for a monthly charge, are now free to all publishers).  In the meantime, please be assured that we will continue to do our best to post new and original content nearly every day of the week.  So, until Feedburner resolves its delivery issues, we ask that you please bookmark our address and check back with us on a regular basis.   

    We thank you for your patience.

  •     By Sherri Oslick

    Gavel_28
    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.


    Cellectis SA v. Precision BioSciences, Inc.

    5:08-cv-00119; filed March 13, 2008 in the Eastern District of North Carolina

    Infringement of U.S. Patent Nos. 7,309,605 ("Nucleotide Sequence Encoding the Enzyme I-SceI and the Uses Thereof," issued December 18, 2007) and 6,610,545 (same title, issued August 26, 2003), both licensed to Cellectis, based on Precision’s use of its Directed Nuclease Editor technology.  View the complaint here.


    Wyeth v. Watson Laboratories Inc. et al.

    1:08-cv-00145; filed March 12, 2008 in the District Court of Delaware

    Infringement of U.S. Patent No. 6,500,814 ("Hormonal Contraceptive," issued December 31, 2002) following a paragraph IV certification as part of Watson’s filing of an ANDA to manufacture a generic version of Wyeth’s Lybrel® (levonorgestrel/ethinyl estradiol, used as oral contraception).  View the complaint here.


    Sanofi-Aventis et al. v. Sandoz Inc.

    2:08-cv-01190; filed March 7, 2008 in the District Court of New Jersey

    Infringement of U.S. Patent No. 6,514,531 ("Controlled-release Dosage Forms Comprising Zolpidem or a Salt Thereof," issued February 4, 2003) following a paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Sanofi-Aventis’ Ambien CR® (controlled release zolpidem tartrate, used to treat insomnia).  View the complaint here.


    Pfizer Inc. et al. v. IMPAX Laboratories, Inc.

    1:08-cv-02177; filed March 4, 2008 in the Southern District of New York

    Infringement of U.S. Patent Nos. 5,382,600 ("3,3-Diphenylpropylamines and Pharmaceutical Compositions Thereof, issued January 17, 1995), 6,630,162 ("Pharmaceutical Formulation and Its Use," issued October 7, 2003), and 6,770,295 ("Therapeutic Formulation for Administering Tolterodine with Controlled Release," issued August 3, 2004) following a paragraph IV certification as part of Impax’s filing of an ANDA to manufacture a generic version of Pfizer’s Detrol LA® (extended release tolterodine tartrate, used to treat overactive bladder).  View the complaint here.


    Pfizer Inc. et al. v. Gelfand

    1:08-cv-02018; filed February 28, 2008 in the Southern District of New York

    Declaratory judgment of non-infringement, unenforceabilty and/or invalidity of U.S. Patent No. 5,837,688 ("Use of Thrombolytic Reagents for Prevention of Vascular Disease," issued November 17, 1998) in conjunction with Pfizer’s manufacture and sale of its Lipitor® (atorvastatin calcium, used to treat high cholesterol) and Caduet® (amlodipine and atorvastatin, used to treat high blood pressure and high cholesterol).  View the complaint here.

  • Calendar_27
    March 17, 2008 – Recent Decisions: How They Affect Your Corporate IP Practice (Intellectual Property Owners Association) – Arlington, VA

    March 30-April 1, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    March 31-April 1, 2008 – Document Management, E-Discovery, and Litigation Readiness (American Conference Institute) – New York, NY

    April 1-2, 2008 – IP Summit (Ocean Tomo) – San Francisco, CA

    April 3-5, 2008 – Advanced Courses (Patent Resources Group) – Bonita Springs, FL

    April 7, 2008 – Successful Mulitlateral Patents (Law Seminars International) – Arlington, VA

    April 10-12, 2008 – 23rd Annual Intellectual Property Law Conference (American Bar Association) – Arlington, Virginia

    April 25, 2008 – Patent Claim Construction (Law Seminars International) – Atlanta, GA

    April 30-May 1, 2008 – Pharma/Biotech Collaborative Agreements (American Conference Institute) – San Francisco, CA

    May 28-30, 2008 – PharmaBiotech IP Summit (Worldwide Business Research) – Philadelphia, PA

    June 17-20, 2008 – BIO International Convention (Biotechnology Industry Organization) – San Diego, CA

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

  •     By Christopher P. Singer

    Ocean_tomo_auction_paddle
    Ocean Tomo will be holding its Live IP auction this spring at the Ritz-Carlton in San Francisco on April 1-2, 2008.  The two day program is divided into two separate tracks, with one track titled "Leveraging IP for Investors" and the other titled "Corporate IP Strategies."  The scheduled programs will include over 50 speakers from an array of corporations, law firms, and universities.  The schedule for each track, including topics and speakers, can be viewed here.  The Live IP Auction is scheduled to be held on the afternoon of April 2.  The online edition of the Auction Catalogue can be viewed here.

  •     By Kevin E. Noonan

    Manbeck_harry
    Harry Manbeck
    , name partner of the Rothwell, Figg, Ernst and Manbeck firm and former Commissioner of the Patent and Trademark Office (1990-1992) has written a letter to Senators Leahy (D-VT) and Specter (R-PA), chairman and ranking member of the Judiciary Committee.  The letter concerns provisions of S. 1145, the patent "reform" bill pending in the Senate, that propose changing the sanctions available for inequitable conduct.  These proposals, as previously discussed on Patent Docs would limit the current sanction, unenforceability of all claims in a patent where the applicant or her counsel had violated the duty of candor, to those situations where one or more patent claims had been found invalid.

    Mr. Manbeck’s letter reviews for the Senators the development of the current sanction regime, particularly focusing on A.B. Dick Co. v. Burroughs Corp., 798 F.2d 1392 (Fed. Cir. 1986).  In that case, inequitable conduct was found, even though the undisclosed prior art had been independently uncovered by the examiner and all claims rendered invalid by that art were cancelled before the patent granted.  The rationale, according to Mr. Manbeck, is that the conduct (intentionally withholding references from the examiner) was enough to merit the sanction, even though none of the granted patent claims had been obtained as a result of the misconduct.  According to Mr. Manbeck, this result discouraged "mischief" during patent prosecution, and is an important check on the temptation to gain an unwarranted advantage by withholding relevant prior art.

    Mr. Manbeck recognizes the other side of the issue — that the inequitable conduct doctrine was intended to discourage misconduct, not unintentional mistake.  While urging that the Senators not adopt a "but for" approach to inequitable conduct, Mr. Manbeck also suggests that sanctions less severe than unenforceability be considered.  Specifically, Mr. Manbeck suggests that infringed claims in a patent "tainted" with inequitable conduct but containing valid and infringed claims be limited to reasonable royalty instead of lost profits damages.  Mr. Manbeck urges that the inequitable conduct doctrine not be weakened by legislation that would bar sanctions for patents containing only valid claims despite evidence of the kind of "mischief" found in A.B. Dick.  According to Mr. Manbeck, this type of misconduct should provoke a sanction so as to maintain its influence in discouraging inequitable conduct.

    While ably presenting the case for keeping inequitable conduct sanctions regardless of whether a misbehaving applicant or her counsel is successful or not, neither the letter nor the pending legislation addresses how to prevent honest mistakes during prosecution from being elevated to an inequitable conduct allegation.  Until such a proposal is made, the problem with inequitable conduct will not be solved.

  •     By Donald Zuhn

    House_of_representatives_seal
    Earlier this month, we reported on the appearance of Robert Budens, the President of the Patent Office Professional Association (POPA) at an oversight hearing on the USPTO held by the House Subcommittee on Courts, the Internet, and Intellectual Property in late February.  We also reported on appearances by Jon Dudas, the Undersecretary of Commerce for Intellectual Property and Director of U.S. Patent and Trademark Office, and Alan Kasper, the First Vice President of the American Intellectual Property Law Association (AIPLA) (our report on Mr. Dudas’ testimony can be found here and our report on Mr. Kasper’s testimony can be found here).  The second witness appearing before the Subcommittee was Robin Nazzaro, the Director of National Resources and Environment for the U.S. General Accountability Office (GAO).  Today, we conclude our coverage of the PTO oversight hearing by discussing Ms. Nazzaro’s statement.

    Government_accountability_office_ga
    Ms. Nazzaro’s testimony focused on the findings of the GAO’s 2007 report entitled "U.S. Patent and Trademark Office: Hiring Efforts Are Not Sufficient to Reduce the Patent Application Backlog," which was based in part on a survey of 1,420 patent examiners.  Not surprisingly, the GAO report provides ample support for POPA’s position that the USPTO’s antiquated production goals are the reason for the Patent Office’s high examiner attrition rate (the GAO reports that from 2002 to 2006, one patent examiner left the USPTO for nearly every two the Office hired).  Among the specific findings of the GAO survey were:

    • 67% of the examiners surveyed said that the Patent Office’s production goals were among the primary reasons they would consider leaving the USPTO.
    • 62% of the examiners surveyed are very dissatisfied or generally dissatisfied with the time the USPTO allots to achieve their production goals.
    • 50% of the examiners surveyed are very dissatisfied or generally dissatisfied with how the agency calculates production goals.
    • 59% of the examiners surveyed believed that the production system should be reevaluated.
    • 70% of the examiners surveyed reported working unpaid overtime during the past year in order to meet their production goals (some putting in more than 15 hours of unpaid overtime per week).
    • 59% of the examiners surveyed identified the amount of unpaid overtime that they have to put in to meet their production goals as a primary reason they would choose to leave the USPTO.
    • 37% of the examiners surveyed identified the amount of time they must work during paid leave in order to meet their goals as a primary reason they would choose to leave the USPTO.

    With respect to the USPTO production system, Ms. Nazzaro explained that examiners receive a "count" for each first Office action and each disposal (e.g., allowance), and that production goals are assigned on the basis of the number of production units (a production unit being equal to two counts) that an examiner is expected to achieve in a two-week period.  Ms. Nazzaro also noted that production goals vary depending upon an examiner’s experience and the technology center in which the examiner works.  As Mr. Budens noted during his testimony, the production goals currently being applied by the USPTO were developed more than 30 years ago.

    Touching on the USPTO application backlog, Ms. Nazarro explained that at the end of each fiscal year, patent applications that have not been reviewed for at least a first action are counted towards the backlog.  She also stated that even if the Office were to satisfy its hiring estimate of 1,200 examiners in each of the next five years, the backlog would grow from about 730,000 applications in 2006 to 1.3 million applications in 2011.  In fact, Ms. Nazarro noted that even if the Office hired 2,000 examiners in each of the next five years, the backlog would still rise to over 950,000 applications by 2011.  According to Ms. Nazarro, "the agency has acknowledged that it cannot hire its way out of the backlog and is now focused on slowing the growth of the backlog instead of reducing it."  (This, of course, explains a number of the new rules packages that the Office has introduced in the past nine months.)

    Focarino_margaret
    One of Ms. Nazarro’s most interesting observations was the statement the GAO received from the Deputy Commissioner for Patent Operations (Margaret Focarino; at right) when she was asked about the need for examiners to use unpaid overtime in order to meet their production goals.  The Deputy Commissioner told the GAO:  "As with many professionals who occasionally remain at work longer to make up for time during the day spent chatting or because they were less productive than intended, examiners may stay at the office (or remote location) longer than their scheduled tour of duty to work."  The GAO, however, does not agree with the Deputy Commissioner’s view on this issue, recommending instead that "the agency comprehensively evaluate the assumptions it uses to establish patent examiner production goals and revise those assumptions as appropriate."

  •     By Christopher P. Singer

    Ipauctions
    IpAuctions, Inc. recently announced that it will seek to sell U.S. Patent No. 6,645,525, which relates to drug delivery technology.  The patent is titled "Ionically Formulated Biomolecule Microcarriers," and is assigned to Sedum Laboratories, Inc.  The technology, called "Bi-Acervation" which can encapsulate, stabilize, and provide sustained release of small molecule drugs, biomolecules (e.g., nucleotides and peptides), and vaccines.

    The patent contains fifteen total claims, three of which are independent.  The independent claims relate to a microparticle composition, a method for producing microparticles, and a method for delivering a biomolecule to a human or animal.  Representative claim 1 recites:

    1.  A microparticle composition for delivery of a biomolecule comprising a biomolecule incorporated in a complex comprising a cationic polymer ionically complexed with an anionic polymer, wherein the cationic polymer is polyethyleneimine and the anionic polymer is dextran sulfate.

    According to the description provided by IpAuctions, the technology combines aqueous biodegradable polymers with an active agent to create micro matrix formulations that are less expensive to produce, more bioactive, and better tolerated than pharmaceuticals formulated with other methods.  IpAuctions Inc. will hold an online auction March 13, 2008 thru March 20, 2008.  More information can be obtained about this and other patent auctions from IpAuctions by phone at 775-826-1300 or by e-mail at info@ipauctions.com.

  •     By Kevin E. Noonan

    The patent community got its biggest scare in quite a while late last year, when a rules package thought to be dead for almost a year was released on August 21, 2007 (see "New Continuation and Claims Rules Published").  And even then, initially the only member of our community that stepped forward to challenge the rules was sole inventor Dr. Triantafyllos Tafas, who was eventually joined by GlaxoSmithKline (see "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect" and "Hooray! – (Finally) the Big Dogs Have Joined the Hunt").  Only an 11th-hour decision on the eve of the new rules being implemented by Judge Cacheris of the Eastern District of Virginia prevented those rules from coming into force, with all of the negative consequences they would have had (and, in truth, might still have).

    Leahy_patrick
    The patent community is approaching another critical deadline regarding how the U.S. patent system goes forward.  The Intellectual Property Owners Association (IPO) and other sources report that Senator Patrick Leahy (D-VT) (at right), chairman of the Judiciary committee, and Senator Harry Reid (D-NV) (at left), Senate Majority leader, intend to bring the Senate’s patent "reform" bill (S. 1145) to a vote in the eight weeks after the Senate reconvenes from its spring recess.  At present, Senator Leahy is working on several amendments, and intense lobbying continues:  the oxymoronic Coalition for Patent Fairness has Reid_harry
    written the Senator to propose statutory requirements for damages apportionment (seemingly unwilling to give judges the leeway to fashion equitable remedies under the current proposals), former commissioner Harry Manbeck has written to Senator Leahy and Senator Specter (R-PA, the ranking committee Republican) on the inequitable conduct provisions, and other stakeholders are similarly exercising their right to petition their government for a bill that favors their interests.

    Senate_seal
    There is much not to like about S. 1145; however, no matter what your views, now is the time to let your Senator know.  The bill won’t come to a vote unless there are 60 votes to close debate, and several Senators have exercised their prerogative to place a "hold" on the bill.  Senator Leahy has said he will not pursue patent reform next year if this bill does not pass (and with a new administration, his committee may be busy addressing a backlog of judicial appointments).

    So, the time is now.  Let your Senators know how you feel.  And remind them, if you can, that they are up for re-election this year.  Since 33 of them will be "at risk" in this way, maybe there is a chance they will listen.