•     By Donald Zuhn

    The following is part of a continuing series on how to address the
    very real problems facing the U.S. Patent and Trademark Office.

    Uspto_seal
    A day after the day of rejoicing for inventors, patent practitioners,
    examiners, and seemingly all of civilization, fair-minded people will
    concede that the U.S. Patent and Trademark Office faces a daunting
    task.  After years of neglect – from Congress raiding the users’ fees,
    an inadequate number of examiners, technology-driven increases in the
    number of applications filed, and a "count" system that has not
    rewarded a style of examination that encourages prosecution to a
    definitive end point – the Office is facing a massive backlog of
    applications without sufficient resources to process them in a timely
    manner.

    If the patent bar is gladdened by District Court Judge Cacheris’
    decision enjoining implementation of the new rules – representing an
    attempt, albeit a misguided one, on the part of the Office to address
    the pendency and backlog problems – it behooves us to propose
    alternatives.  Patent Docs
    will be posting a series of such proposals, and we invite our readers
    to provide their own ideas.  As they used to say in the days of the
    counterculture, "if you are not part of the solution, you are part of
    the problem."  Patent Office management clearly thinks the patent bar
    is part of the problem; it would be satisfying to prove them wrong.

    Deferred examination

    Patent Docs readers have proposed a number of suggestions for helping the U.S. Patent and Trademark Office deal with its pendency and application backlog problems (we’ll have more on readers’ suggestions in another article).  One proposal that has been frequently suggested is that the Patent Office allow applicants to defer examination.

    Such a deferred examination system exists in Japan, where an applicant can put off examination for up to three years after filing (see "Procedures for Obtaining a Patent Right" at the JPO website).  If an applicant has not requested examination within three years of filing, however, the application will be regarded as irretrievably withdrawn.  By requiring applicants to request examination, and thereby defer examination by withholding such a request, the Japan Patent Office does not waste valuable examination resources on an application the applicant may later deem to be of little value.  In addition, an applicant can request examination immediately after filing in order to expedite prosecution of applications the applicant deems to be more valuable.

    Two Patent Docs readers noted that the U.S. Patent Office already has a deferred examination system in the form of the suspension of action provisions of 37 C.F.R. § 1.103.  Under Rule 103(a), an applicant may request a suspension of action of up to six months "for good and sufficient cause," provided that a reply by applicant to a pending Office action is not outstanding.  Under Rule 103(b), an applicant can secure a three-month suspension, but only for a continued prosecution applications (CPA).  Under Rule 103(c), an applicant can request a three-month suspension upon filing a request for continued examination (RCE).  The provision of Rule 103 that the two astute readers were specifically pointing to, however, is 103(d), which permits an applicant to defer examination for up to three years provided that the applicant has not filed a nonpublicaton request (or has rescinded the nonpublication request), the application is in condition for publication, and the Patent Office has not issued an Office action under 35 U.S.C. § 132 or a notice of allowance.  For the deferred examination request under Rule 103(d), the Patent Office even provides a form:  PTO/SB/37.

    It seems, therefore, that the U.S. Patent Office already has a deferred examination system that appears to be the equal of Japan’s deferred examination system.  So why are these provisions of the rules (especially Rule 103(d)) so little known and so little used?  Perhaps it has something to do with the Patent Term Adjustment ramifications of requesting a suspension of action or deferred examination under Rule 103(a)-(d).  According to M.P.E.P. § 709, such a request "will cause a reduction in patent term adjustment accumulated (if any) under 37 CFR 1.703."  More likely, however, it’s because the system has one significant difference from Japan’s deferred examination system.

    In Japan, the default is no examination and an applicant can request examination at any time after filing.  Thus, in Japan, an applicant can request examination immediately, wait three years to request examination, or wait anytime in between to request examination.  In the U.S., however, the default is examination, an applicant must request deferral, and at the time of this request, must specify a deferral period of up to three years.  According to M.P.E.P. § 709:

    Once the deferral of examination has been granted, the application will not be taken up for action by the examiner until the suspension period expires.  For example, if an applicant files a request for deferral of examination under 37 CFR 1.103(d) for the maximum period permitted under the rule in an application that claims priority of a foreign application filed 1/3/00, the action by the Office on the application will be suspended and the application will automatically be placed in a regular new case status on the examiner’s docket on 1/4/03 (36 months from the effective filing date of the application, i.e., 1/3/00).

    Thus, it would seem from this portion of the M.P.E.P. that in the U.S., an applicant will be stuck with the deferral period originally requested.  In other words, if an applicant chooses a deferral period of three years and circumstances change, tough luck; the applicant could be out three years of patent term adjustment.  However, as usual with the USPTO, everything is not always as it seems.  According to M.P.E.P. § 709(D), an applicant can "submit[] a request for termination of the suspension of action prior to the end of the suspension period," and such a termination "will be effective when an appropriate official of the Office takes action thereon."  Of course, it’s unclear how long the Patent Office might take to terminate the suspension of action, and for certain biotech or pharma patents, the loss of even a few months of adjusted patent term could cost a patentee millions.

    Clearly, U.S. applicants would be better off with a Japanese-style deferred examination system in which no examination is the default, examination must be requested, and an examination request can be lodged at anytime between filing and three years after filing.  Because the current U.S. deferred examination system appears to see so little use (Patent Docs readers who have requested deferred examination in the U.S. are encouraged to submit comments regarding their experience), the USPTO might also benefit from the implementation of a Japanese-style deferred examination system by allowing the USPTO to expend examination resources on applications that applicants deem to be the most valuable.

    For additional articles in the "Post-GSK" series, please see:

  •     By Kevin E. Noonan

    It’s getting harder and harder for patentees, applicants, and their counsel to know who their friends are.  First there was the silence of the major industry groups in the face of the new continuation and claim limitations rules since enjoined by Judge Cacheris in the Federal District Court in Virginia (see "Breaking A Very Long Silence").  This situation has improved noticeably, however, since GlaxoSmithKline sued the Patent Office.  Several amici filed briefs in support of GSK’s (and Dr. Tafas’) preliminary injunction motion, and several others have sought leave from the court to file amicus briefs in support of GSK’s (and Dr.Tafas’) substantive allegations in their respective complaints.

    Marca
    Now comes the Intellectual Property Owners, specifically their President, Marc Adler (at right), who has taken the opportunity at this time to support (unwittingly or not) the fanciful bases the Patent Office has used to justify its ill-conceived new rules.  In an address to the Trilateral Public Users Conference in Washington last Thursday, Mr. Adler admonished patent applicants and their counsel to join with the different patent offices represented at the conference (the U.S., Japanese, and European Patent Offices) to improve the "quality" of patents obtained by applicants.  In this, Mr. Adler sounded vaguely like Patent Commissioner Doll, who has defended the new rules, even when his evidence seemed contradictory (see "They Just Don’t Get It – ‘Patent Reform’ at the USPTO") on the grounds that the Office was trying to improve patent "quality."  The general substance of Mr. Adler’s talk (his presentation is available here) was sufficiently generic to resemble patent platitudes.  However, the talk also presented as justification for its admonitions some survey results produced by the IPO directed to patent "quality."  Those results and the way they were used suggest, charitably, a certain naiveté concerning the zeitgeist of the patent world today.

    Ipo_1
    The survey asked a seemingly innocuous question:  how do you rate the quality of patents being issued in the U.S. today in your industry or field of technology?  The responses were reported as follows:  0% outstanding; 3.8% more than satisfactory; 40% satisfactory; 47.5% less than satisfactory; and 3.8% poor.  On its face, this survey thus indicates that more than 50% of respondents thought the quality of patents granted in the U.S. were less than satisfactory.  However, upon closer inspection there are a number of deficiencies in this analysis.  First, the survey responses date from September 2005, and since the question it asks requires a determination that must have been developed over time, the impressions forming the basis of the answers must be even older, towards the turn of the century.  It is certainly the case that the Office was dealing with several challenges over that timeframe that could have negatively affected quality.  These include considering for the first time business method patents in the wake of the Federal Circuit’s State Street decision; the tidal wave of human gene patenting applications resulting from the culmination of the Human Genome Project; the changes in patent examination resulting from new utility and written description guidelines promulgated January 6, 2001; the changes in patent law caused by the American Inventor Protection Act; and the cumulative effect of more than 15 years of Congressional fee diversion that left the Office ill-equipped to effectively deal with these challenges.

    However, this reasoning concedes that there is (or was) objectively a patent quality problem.  Unfortunately the survey was not objective; it asked for a subjective evaluation (and a qualitative one at that) of patent "quality."  There is no indication that the survey defined what the elusive attribute called "quality" is, and indeed in this context "quality" is like beauty – although it is probably in the purse rather than the eye of the beholder.  There are also self-interest issues involved:  a respondent (all of whom were corporations) could believe that the "quality" of U.S. patents had gone down because for the first time competitors were using patents to prevent such corporations from doing what they liked without interference.  Citing "quality" issues also provides a bit of a fig leaf for an entity that wants to appear to support the patent system (particularly for its own patents) but cast doubt or aspersions on patents of others, especially when those others are asserting their rights to the corporation’s detriment.  Perhaps a more telling way of asking the question would have been to ask:  how do you rate the quality of patents being issued in the U.S. today to you in your industry or field of technology?  Of course, it is unlikely that the responses would have been quite the same if the question had been asked like this.

    The bigger problem with Mr. Adler’s remarks is that they presuppose (much like the Patent Office presupposes) that the problems with the U.S. patent system are caused by patent applicants and their counsel.  (This is a little like saying the problem with poverty in this country is poor people.)  It is likely that almost without exception American patent applicants want "quality" patents, if the term "quality" is defined as patents containing sufficient disclosure and claims of appropriate scope to satisfy the statutory requirements of patentability.  There are a number of practical reasons why this is so.  The most obvious is that a patent that fails to satisfy these requirements is invalid, and no one wants to incur the significant costs of trying to enforce an invalid patent.  Moreover, Rule 56, the duty of candor, and the threat of an inequitable conduct charge provides ample incentive for applicants and their counsel to provide to the Patent Office whatever information is known to them.  The frequency with which inequitable conduct is charged in patent cases (Judge Markey’s "veritable plague" has only gotten worse in the intervening 20 years since he made the comment) has resulted in some inefficiencies such as providing cumulative references to the Office.  However, this practice is self-correcting since it is at least as likely that overciting cumulative references will provoke a charge of "hiding" the most relevant art from the Examiner.  In actuality, of course, most criticisms on these grounds come from failure to cite a critical reference, putting into question the significance of cumulative reference citing to any patent "quality" problem.

    Mr. Alder and the IPO are apparently victims of the sea change that the current Patent Office management has effected in the relationship between itself and its customers.  The IPO has been for 35 years at the forefront of efforts to facilitate applicant/PTO interactions and cooperation, sponsoring numerous conferences such as the annual PTO Day every December.  Cooperation, however, is not the hallmark of the current Patent Office regime.  As is evident to anyone who has read the proposed continuation and claim limitation rules as they were published for comment in January 2006, or attended any of the "town hall" meetings held by Commissioner Doll and Mr. Taupin, the Office’s legal counsel, or read the Office’s reaction to the comments in the rules as promulgated on August 21st, or read the Office’s briefs submitted to the District Court or considered their argument at the preliminary injunction hearing, Patent Office management has identified the enemy and they are patent applicants and their counsel.  It is understandable that an organization like the IPO with a history of fostering cooperation with the Office could be caught unawares by this Patent Office about-face, and have difficulty responding to the new reality (at least for now).  But it is equally true that the IPO needs to consider these new realities and the impact that it can have, as a preeminent voice of intellectual property owners, when it speaks about patent "quality."  These days, doing so undermines the very people it intends to represent.

  • USPTO Seal The biotechnology, chemical, and pharmaceutical technology groups at the U.S. Patent and Trademark Office are scheduled to hold the next quarterly meeting on December 4, 2007.  The proposed topics for discussion include:

    Morning Session (9:00-noon EST)

    • Patent Corp Security Program — (presenter: Don Hajec, Director, TC3600)
    • KSR Overview, Court Opinion and PTO Guidelines, and Technology Center-Specific Examples of its Application — (presenters: Kathleen Fonda, OPLA and Jean Witz, QAS, TC1600)

    Afternoon Session (1:15-4:00 EST)

    • Issues in Small Organic Molecules — (presenter: Michael Hartley, SPE, Art Unit 1618)
    • 101 Sequence Homology — (presenter: Dave Nguyen, QAS, TC1600)
    • Restriction: Combination/Subcombination — (presenter: Julie Burke, QAS, TC1600)

    These topics may change or additional topics may be added before the schedule is finalized.  The presentation can be attended in person at Madison East GIPA (Global Intellectual Property Academy) large lecture room on the second floor (600 Dulany Street, Alexandria, VA).  In order to attend the meeting in person, you must confirm your attendance by November 27, 2007 with Cecilia Tsang by phone (571-272-0562), fax (571-273-0562), or email (Cecilia.Tsang@uspto.gov).  The meeting will also be broadcast via the web.

  •     By Kevin E. Noonan

    The following is part of a continuing series on how to address the
    very real problems facing the U.S. Patent and Trademark Office.

    Uspto_seal
    A day after the day of rejoicing for inventors, patent practitioners,
    examiners, and seemingly all of civilization, fair-minded people will
    concede that the U.S. Patent and Trademark Office faces a daunting
    task.  After years of neglect – from Congress raiding the users’ fees,
    an inadequate number of examiners, technology-driven increases in the
    number of applications filed, and a "count" system that has not
    rewarded a style of examination that encourages prosecution to a
    definitive end point – the Office is facing a massive backlog of
    applications without sufficient resources to process them in a timely
    manner.

    If the patent bar is gladdened by District Court Judge Cacheris’
    decision enjoining implementation of the new rules – representing an
    attempt, albeit a misguided one, on the part of the Office to address
    the pendency and backlog problems – it behooves us to propose
    alternatives.  Patent Docs
    will be posting a series of such proposals, and we invite our readers
    to provide their own ideas.  As they used to say in the days of the
    counterculture, "if you are not part of the solution, you are part of
    the problem."  Patent Office management clearly thinks the patent bar
    is part of the problem; it would be satisfying to prove them wrong.

    Identification of co-owned, co-pending applications

    One of the little-discussed provisions of the new rules enjoined by Judge Cacheris of the District Court of the Eastern District of Virginia on October 31st were two disclosure provisions.  37 C.F.R. § 1.78(f)(1) required that applicants prosecuting an application must identify other commonly owned applications or patents having (a) an inventor in common with the application being prosecuted, and (b) a claimed filing or priority date within two months of the claimed filing or priority date of the application being prosecuted.  This rule was comprehensive, in the sense that for an application having an actual filing date of December 1, 2006, claiming the benefit of a nonprovisional application filed on June 1, 2004 and a foreign application filed on June 1, 2003, an applicant would be responsible for identifying all co-owned applications naming one inventor in common that were filed within two months of each of the December 1, 2006, June 1, 2004, and June 1, 2003 dates, according to an example published in the Federal Register to illustrate the rules.

    The impetus for this reporting requirement was to prevent an applicant from "cheating" on the new rules by filing related applications naming the same inventors.  This aspect was most directly evidenced by subsection 78(f)(2) of the new rules, which created a rebuttable presumption that an application being prosecuted and other commonly owned application or patent contain at least one patentably indistinct claim when the application being prosecuted and the commonly owned application or patent have (a) an inventor in common, (b) substantial overlapping disclosure, and (c) the same claimed filing or priority date.  Subsection 78(f)(1), however, was broader than was required to identify relevant co-owned and co-pending applications, since it did not encompass the requirement for "substantial overlapping disclosure" (which at least could be understood to be an indication that the applications were sufficiently related to raise the rebuttable presumption.

    All this has been discussed at length in earlier posts (see, e.g., "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents"), and with Judge Cacheris’ injunction granted October 31st they are (at least for now) in abeyance.  Assuming the preliminary injunction becomes permanent after the parties have had a chance to fully litigate the issue, the question becomes whether any part of these reporting requirements could or should survive?  On the one hand, providing this information (particularly under the ministerial guise of submitting a pre-approved Patent Office form) would enable applicants to satisfy at least a good portion of the disclosure requirements implicated in the Federal Circuit’s McKesson Information Solutions, Inc. v. Bridge Medical, Inc. decision (see Patent Docs report on that case).  Absent the specific circumstances the Court noted in its decision to uphold a finding of inequitable conduct based on an applicant’s failure to disclose the existence of co-pending applications, it should be difficult for an infringer to argue that a patentee committed McKesson inequitable conduct in the face of specific disclosure of such applications pursuant to 37 C.F.R. § 1.78(f)(2) (or some judicially-sanctioned equivalent).

    Paradoxically, these disclosure requirements that so concerned members of the patent bar (and their clients) might be useful for reducing the backlog of unexamined patents.  In order to comply with the identification requirement, practitioners would need to know about the existence, content, and priority claims of all commonly owned applications or patents having an inventor in common with the application the practitioner is prosecuting.  This raised a burden under the now-enjoined new Rule 78(f) for practitioners who prosecute applications for larger assignees that employ the services of multiple outside counsel.  For each application, Outside Counsel A prosecuting a first application would need to know the identities of all other applications being prosecuted by Outside Counsels B through Z (and, of course, the converse).  This requirement to merely identify co-owned and co-pending applications is less burdensome in the absence of the more extensive analysis required to comply with now-enjoined new Rule 78(f)(2), but still could represent an administrative nightmare for a corporation such as IBM which has, according to its amicus brief filed in the consolidated Tafas v. Dudas and GSK v. Dudas case, 30,000 pending applications.

    And this is where the convergence of the rule and the backlog might take place.  It is at least possible that a company like IBM would conclude that a portion of these pending applications are not sufficiently valuable to justify the administrative costs incurred by complying with the notification rule.  This does not imply that these applications were filed improperly or unnecessarily.  However, it is the case that some applications lose value over time, either because the inventions they protect have not had the expected or hoped-for commercial success, or because these inventions have been overtaken by "new and improved" embodiments (that are the subject of their own applications), or for other business reasons.  It is impossible to know the magnitude of this category of cases, but if it is as little as 10% of IBM’s pending  application, the backlog would be reduced by 3,000 applications from just this one applicant.  If this pattern were to apply across the spectrum of just the large companies, by this one administrative device alone the patent backlog could be reduced by 75,000 applications.  This is close to the number (11% of the backlog, or about 82,500 applications) that the Office has said contain more than 5 independent claims and 25 total claims, or more than the number of applications having more than 2 continuations.

    There are several advantages to this approach.  First, small, high-tech start-up companies and other small entities (including universities) would be relatively unaffected by the rule, since these companies typically do not have 30,000 pending applications, and the burden of complying with the rules is reduced exponentially the fewer the number of pending applications an applicant has.  Second, it is voluntary.  Third, it does not negatively impact patent rights or the ability to apply for as many patents as an applicant may want.  Fourth, it is not merely an administrative device since it facilitates compliance with disclosure rules highlighted in the McKesson decision.  And lastly, by eliminating the rebuttable presumption portion of now-enjoined new Rule 78(f)(2), it imposes no requirement that an applicant provide statements on the prosecution history record that could be (mis)interpreted later by an infringer to be an admission useful to support an inequitable conduct or invalidity challenge.

    It is certainly the case that implementation of this rule would impose some costs on applicants, particularly those with large portfolios of pending applications.  However, this aspect of the rule as a certain equitable attractiveness; although it is not the case that large portfolio applicants are "the problem" (as Patent Office sentiment would have it), these applicants are certainly part of the backlog burden.  Encouraging them to do what they can to help ease the backlog is not unreasonable.

    For additional articles in the "Post-GSK" series, please see:

  •     By Sherri Oslick

    Gavel_6
    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.


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

    1:07-cv-00718; filed November 7, 2007 in the District Court of Delaware

    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.


    Connetics Corporation et al. v. Pentech Pharmaceuticals, Inc.

    1:2007cv06297; filed November 6, 2007 in the Northern District of Illinois

    Infringement of U.S. Patent Nos. 6,126,920 ("Method of Treating a Skin Disease with a Corticosteroid-Containing Pharmaceutical Composition," issued October 3, 2000) and 7,078,058 ("Corticosteroid-Containing Pharmaceutical Composition," issued July 18, 2006) following a paragraph IV certification as part of Pentech’s filing of an ANDA to manufacture a generic version of Connetics’ Luxiq® (betamethasone valerate foam, used to treat dermatoses of the scalp).  View the complaint here.


    Bayer Healthcare Pharmaceuticals Inc. v. Watson Pharmaceuticals, Inc. et al.

    2:07-cv-01472; filed November 5, 2007 in the District Court of Nevada

    Infringement of U.S. Patent Nos. 6,787,531 ("Pharmaceutical Composition for Use as a Contraceptive," issued September 7, 2004), RE37,564 ("Composition for Contraception," issued February 26, 2002), and RE37,838 (same title, issued September 10, 2002) following a paragraph IV certification as part of Watson’s filing of an ANDA to manufacture a generic version of Bayer’s Yaz® (drospirenone & ethinyl estradiol, used for oral contraception).  View the complaint here.


    Glaxo Group Ltd. et al. v. Teva Pharmaceuticals USA Inc.

    1:07-cv-00713; filed November 2, 2007 in the District Court of Delaware

    Infringement of U.S. Patent No. 5,859,021 ("Antiviral Combinations," issued January 12, 1999) following a paragraph IV certification as part of Teva’s filing of an ANDA to manufacture a generic version of Glaxo’s Combivir® (lamivudine and zidovudine, used in the treatment of HIV-1 infection).  View the complaint here.


    Sepracor Inc. et al. v. Lupin Limited et al.

    3:07-cv-05265; filed November 1, 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 Lupin’s filing of an ANDA to manufacture a generic version of Schering-Plough’s Clarinex® (desloratidine, used to treat allergies).  View the complaint here.

  • Calendar_6
    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 9, 2008 – Patent Claim Construction (Law Seminars International) – San Francisco, CA

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

    February 15, 2008 – Patent Claim Construction (Law Seminars International) – Chicago, IL

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

  •     By Christopher P. Singer

    Ocean_tomo_auction_paddle
    On October 30, 2007, Ocean Tomo Auctions, LLC (the auctions arm of Ocean Tomo LLC) announced the results of its live IP auction, held on October 25, 2007 in Chicago.  The announcement indicated that sales from the open bidding session and transactions that immediately followed the open bidding totaled $11,599,500.  Thirty-seven of the 75 lots available were sold on the day of the event, making it one of Ocean Tomo’s most successful IP auction to date, based on percentage of lots sold during the event.  The lots not receiving bids meeting the seller’s minimum reserves could be traded privately.  The average sale price per lot was $305,250, with the highest sale price being $1,925,000.  Ocean Tomo’s next live auction is scheduled for April 1-2, 2008 at the Ritz-Carleton in San Francisco.  Intellectual property owners can submit their IP for consideration by calling 312-377-4851 or by visiting http://www.oceantomoauctions.com.

  • Birthday_cupcake
    One year ago today, the authors listed on the sidebar to the left — Donald Zuhn, Kevin Noonan, Jason Derry, Chris Singer, and Sherri Oslick — began publishing Patent Docs, a weblog focusing on recent developments in biotech and pharma patent law.  Chris Singer penned the first new Patent Docs article, which discussed the electronic submission of Sequence Listings via the EFS-Web.

    In the year since our first new post, we have published over 600 more articles covering changes in Patent Office rules and procedures affecting biotech and pharma patent prosecution, summarizing court decisions impacting biotech and pharma patent litigation and prosecution, reporting on biotech and pharma news, and highlighting newly issued biotech and pharma patents.  Over the past year, Patent Docs has provided in-depth coverage of the new continuation and claims rules and the GSK case, the KSR decision and the Patent Office’s response to KSR, proposals for improving the U.S. patent system, patent reform, the gene patenting and stem cell debates, biologics legislation and biosimilars, and compulsory drug licensing.  We have also reported on every biotech or pharma patent lawsuit filed in the past year.

    We would like to thank Dennis Crouch of Patently-O for all of his help in getting this project off the ground.  We would also like to thank Mark Chael, Rob Dailey, Baltazar Gomez, Kwame Mensah, Suresh Pillai, and Brad Crawford for their contributions.  More importantly, however, we would like to thank all of you for reading Patent Docs, as well as everyone who has taken the time to submit comments and those who have subscribed to the Patent Docs e-mail newsletter (if you haven’t yet subscribed, you can do so by entering your e-mail address in the box to the left).  We enjoy hearing from readers, so if there’s anything you want to tell us or if there’s a topic or issue that you think we should be writing about, please feel free to contact us at: PatentDocs@gmail.com.

  •     By Kevin E. Noonan

    The following is part of a continuing series on how to address the
    very real problems facing the U.S. Patent and Trademark Office.

    Uspto_seal
    A day after the day of rejoicing for inventors, patent practitioners,
    examiners, and seemingly all of civilization, fair-minded people will
    concede that the U.S. Patent and Trademark Office faces a daunting
    task.  After years of neglect – from Congress raiding the users’ fees,
    an inadequate number of examiners, technology-driven increases in the
    number of applications filed, and a "count" system that has not
    rewarded a style of examination that encourages prosecution to a
    definitive end point – the Office is facing a massive backlog of
    applications without sufficient resources to process them in a timely
    manner.

    If the patent bar is gladdened by District Court Judge Cacheris’
    decision enjoining implementation of the new rules – representing an
    attempt, albeit a misguided one, on the part of the Office to address
    the pendency and backlog problems – it behooves us to propose
    alternatives.  Patent Docs
    will be posting a series of such proposals, and we invite our readers
    to provide their own ideas.  As they used to say in the days of the
    counterculture, "if you are not part of the solution, you are part of
    the problem."  Patent Office management clearly thinks the patent bar
    is part of the problem; it would be satisfying to prove them wrong.

    Increased filing fees for continuation applications

    Under the current fee regime, Patent Office filing fees can be broken down into fixed and variable, where the fixed fees are charged for every application but the variable fees are applicant-dependent.  For example, the fees for a utility application containing no more than 3 independent claims and 20 total claims is made up of the basic filing fee ($310.00, 37 C.F.R. § 1.16(a)(1)), a search fee ($510.00, § 1.16(k)), and an examination fee ($210.00, § 1.16(o)); all values are for large entities, and the basic filing fee is waived if the application is filed electronically.  Applicant-dependent fees include fees for filing more than 3 independent claims ($210.00 per claim, § 1.16(h)), total claims in excess of 20 ($50.00 per claim, § 1.16(i)) and a surcharge for filing multiply-dependent claims ($370.00, § 1.16(j)).  The Office also charges more for extra sheets of an application ($260.00 per 50 sheets in excess of 100 total; specification, claims, abstract and drawings), a fee reduced for applications filed electronically.

    Several comments received at Patent Docs have suggested that one way of handling the backlog of unexamined applications would be to charge applicants a series of increasing fees for each additional continuation or request for continued examination (RCE) filed in an application.  Suggestions have included a 25% surcharge for the second continuation or RCE, a 50% surcharge for the third, a 100% surcharge for the fourth, etc.  Similarly, it has been suggested that claims in excess of 25 have an additional surcharge (some suggestions are as much as $200 per claim, and double that for claims in excess of 50).  The rationale is that these applications are the cause of the backlog and Patent Office burden, using (maybe even overusing if not actually abusing) Office resources that cannot be used for other (presumably more deserving) applicants, and that our capitalist system supports such a "pay-as-you-go" or "pay-for-play" approach.

    The difficulty with these suggestions is that they fall into the same trap that caused (or at least encouraged) the ill-conceived Patent Office "new rules."  First, they blame the applicant for years of neglect, underfunding, and mismanagement at the Office.  Second, they are to be applied indiscriminately against applicants with inventions that legitimately require more than 25 claims to fully protect them.  And while they are frankly intended to influence behavior, brief consideration suggests that the behavior they produce will not solve the problem.  For applicants, burdensome excess claims fees will encourage multiple filings, on the same day, of the same application with claims directed towards different aspects of the invention (compositions, methods of making, methods of using, etc.).  It is unlikely that the problems in the Patent Office will be solved by encouraging more applications to be filed.  Examiner behavior will also be influenced; if an examiner "knows" that an invention isn’t patentable, but cannot craft an Office action that does not provoke an applicant to abandon the application or appeal the asserted rejection(s), the examiner will simply be able to continue to reject the claims until the cost of another RCE or continuation becomes too burdensome.  And the examiner will be increasing fees for the Office, a behavior unlikely to be discouraged by PTO management.  The experience of applicants in the biotechnology arts relating to restriction practice is indicative of the problem:  during the past 10 years it has not been uncommon for the Office to issue multiple (in excess of 10) restricted groups, with a view towards reducing examiner burden and increasing divisional application filings (having claims of more restricted scope).  Any policy that encourages examiners to "stick to their guns" with a negative consequence for applicants is no better than the new rules the Office promulgated on August 21st; they would put a premium on intransigence among those examiners who believe they "know something is unpatentable when they see it."  This result would also be expected to increase pendency times.

    Any system of increasing fees would have to protect those applicants who can least afford excessive patent filing fees.  Exempting small entities is one possibility in this regard.  However, it is not clear that even large corporations (like GSK) would be able to continue to pursue their applications if the fees, and the time in prosecution, increased dramatically.  GSK’s strongest argument was that an applicant, any applicant large or small, has an expectation of fair and timely examination, and that this expectation (and any resulting patent) is the benefit obtained in exchange for full disclosure of the claimed invention.  One of the great weaknesses in the new rules was that they frustrated this reasonable expectation, and it would be unfortunate indeed if this frustration became a part of any proposal to address the real problems the Patent Office faces.

    For additional articles in the "Post-GSK" series, please see:

  •     By Sherri Oslick

    Ranbaxy
    Ranbaxy Laboratories, Astellas Pharma US, Inc., and Boehringer Ingelheim Corporation have announced their agreement to enter into a joint stipulation of dismissal without prejudice in their lawsuit over FLOMAX® (tamsulosin hydrochloride, used to treat benign prostatic hyperplasia). 
    Under the terms of the settlement agreement, Ranbaxy will have the opportunity to launch its generic tamsulosin on March 2, 2010, eight weeks prior to the expiration of the expected pediatric exclusivity.  Ranbaxy received tentative approval for its tamsulosin product on June 20, 2007.

    Astellas_2
    The case is 3:05-cv-02563, filed May 13, 2005 in the District Court of New Jersey, and was filed by Astellas and Boehringer in response to Ranbaxy’s paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of FLOMAX®.  The patent in suit is U.S. Patent No. 4,703,063 ("Sulfamoyl Substituted Phenethylamine Derivatives and Process of Producing Them," issued October 27, 1987).  On February 21, 2007, the district court entered final judgment in favor of plaintiffs, and Ranbaxy appealed.  The parties briefed the case before the Federal Circuit, and oral arguments were held on August 8.  On October 30, the parties filed a motion with the CAFC to remand the case to the lower court Boehringer_logo_2
    for further action to effectuate the settlement.  On November 7 the parties moved the lower court to vacate its prior order and dismiss the case; the motion was granted the same day.

    For additional information regarding this case, please see: