•     By Sherri Oslick

    Gavel_5
    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.


    Eisai Co., Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al.
    2:07-cv-05489; filed November 14, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 4,895,841 ("Cyclic Amine Compounds with Activity Against Acetylcholinesterase," issued January 23, 1990) following a paragraph IV certification as part of Teva’s filing of an ANDA to manufacture a generic version of Eisai’s Aricept® (donepezil hydrochloride, used in the treatment of mild to severe dementia of the Alzheimer’s type).  View the complaint here.


    Celgene Corporation v. Barr Laboratories, Inc. et al.

    2:07-cv-05485; filed November 14, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 6,045,501 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued April 4, 2000), 6,561,976 (same title, issued May 13, 2003), 6,315,720 ("Methods for Delivering a Drug to a Patient While Avoiding the Occurrence of an Adverse Side Effect Known or Suspected of Being Caused by the Drug," issued November 13, 2001), 6,561,977 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug by Patients for Whom the Drug May be Contraindicated," issued May 13, 2003), 6,755,784 (same title, issued June 29, 2004), 6,869,399 (same title, issued March 22, 2005), and 7,141,018 (same title, issued November 28, 2006) following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Celgene’s Thalomid® (thalidomide, used to treat multiple myeloma and erythema nodosum leprosum).  View the complaint here.  As reported here, Celgene has previously asserted these patents against Barr; the present complaint includes an additional dosage included in Barr’s amended ANDA.


    Orion Corporation v. Sun Pharmaceutical Industries Inc. et al.

    3:07-cv-05436; filed November 13, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent No. 6,500,867 ("Pharmaceutical Composition Comprising Entacapone, Levodopa, and Carbidopa," issued December 31, 2002) following a paragraph IV certification as part of Sun’s filing of an ANDA to manufacture a generic version of Orion’s Stalevo® (marketed by Novartis in the U.S.) (entacapone, levodopa, and carbidopa mixture, used to treat Parkinson’s disease).  View the complaint here.

    BASF AGRO B.V. et al. v. CIPLA Limited et al.
    3:07-cv-00125; filed November 13, 2007 in the Middle District of Georgia

    Infringement of U.S. Patent Nos. 5,232,940 ("Derivatives of N-Phenylpyrazoles," issued August 3, 1993) (licensed exclusively to Merial in the veterinary field) and 6,096,329 ("Insecticidal Combination to Control Mammal Fleas, in Particular Fleas on Cats and Dogs," issued August 1, 2000) based on defendants’ manufacture and/or sale of CIPLA’s Protecktor products, allegedly generic versions of Merial’s Frontline® products (fipronil, used in veterinary applications to treat fleas).  View the complaint here.


    Aventis Pharma S.A. et al. v. Hospira Inc.

    1:07-cv-00721; filed November 9, 2007 in the District Court of Delaware

    Infringement of U.S. Patent Nos. 5,714,512 ("Compositions Containing Taxane Derivatives," issued February 3, 1998) and 5,750,561 (same title, issued May 12, 1998) following a paragraph IV certification as part of Hospira’s filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Aventis’ Taxotere® (docetaxel, used to treat breast, lung, prostate, gastric, and head and neck cancers).  View the complaint here.


    Monsanto Company et al. v. Ledbetter et al.

    3:07-cv-01881; filed November 9, 2007 in the Northern District of Texas

    Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendant’s use of cotton seed produced from earlier planted Roundup Ready® cotton seed.  View the complaint here.


    Sanofi-Aventis U.S. LLC et al. v. Pharmachemie B.V. et al.

    3:07-cv-05408; filed November 9, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 5,338,874 ("Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) Having Optically High Purity," issued August 16, 1994), 5,420,319 ("Cis-oxalato(trans-1-1,2-cyclohexanediamine) Pt(II) Complex Having High Optical Purity and Process of Preparing Same," issued May 30, 1995), 5,290,961 ("Platinum Compound and Process of Preparing Same," issued March 1, 1994), and 5,959,133 ("Process for the Preparation of Platinum Compounds," issued September 28, 1999) following a paragraph IV certification as part of Pharmachemie’s filing of an ANDA to manufacture a generic version of plaintiffs’ Eloxatin® (oxaliplatin for injection, used to treat colorectal cancer).  View the complaint here.


    Celgene Corporation et al. v. Actavis South Atlantic LLC et al.

    3:07-cv-05367; filed November 8, 2007 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), and 6,635,284 (same title, issued October 21, 2003), all licensed exclusively to Novartis in certain fields of use, following a paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Novartis’ Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.


    Eastern Virginia Medical School v. Cytogen Corporation

    1:07-cv-01130; filed November 6, 2007 in the Eastern District of Virginia

    Infringement of U.S. Patent No. 5,153,118 ("Monoclonal Antibodies Having Binding Specificity to Human Prostate Tumor-Associated Antigens and Methods for Employing the Same," issued October 6, 1992) based on Cytogen’s manufacture and sale of its ProstaScint® Kit, which includes a monoclonal antibody known as ProstaScint®.  View the complaint here.

  • Calendar_5
    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.

    December 13, 2007 – Pharmaceutical and Biotech Patent Law: Recent Developments (Practising Law Institute)

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

    January 25-26, 2008 – Buying, Selling and Licensing Patents: New Case Law, Rules, Legislation and Markets (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

    In a November 9, 2007 press release, the U.S. Patent and Trademark Office announced that the European Patent Office (EPO), the Japan Patent Office (JPO), and the USPTO signed a memorandum of understanding that is designed to address the global workload challenges arising from the growth and complexity of patent applications worldwide.  Several of the specific topics addressed in the memorandum include efforts to (a) coordinate work sharing; (b) develop a means to improve quality of applications; (c) coordinate electronic business developments; (d) harmonize or standardize search strategies, tools and procedures; and (e) promote dissemination of patent information.

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    Relating to work sharing, the Offices are considering a pilot project that would similar to the Patent Prosecution Highway between the USPTO and the JPO, which will be permanently implemented in January 2008.  Under this program, an applicant receiving a decision from either the JPO or the USPTO that at least one claim in an application is patentable can request that the other Office fast track the examination of the same claims in the corresponding application.

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    The Offices also agreed on a common application format (yet to be disclosed) which will allow applicants to prepare a single acceptable application format in each of the three Offices.

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    Certain aspects regarding the initiative to cooperate in examination include collaboration among examiners; development of comparative studies; development of uniform search guidelines; and exploration of use of common search tools, techniques, and resources; and continual collaboration after the development of products.

  • Practising Law Institute (PLI) #1 Practising Law Institute (PLI) will be offering a audio-only webcast entitled: "Pharmaceutical and Biotech Patent Law: Recent Developments" on December 13, 2007 from 1:00-2:00 PM (EST).  The presentation is part of PLI's One-Hour Patent Hot Topic Briefing series.  Speakers David K. Barr and Daniel L. Reisner of Kaye Scholer LLP, co-editors of the PLI treatise "Pharmaceutical and Biotech Patent Law," will provide an overview of the patent law issues that arise in the drug approval process, from research and development through FDA approval, and will then discuss recent case law decisions that particularly affect the pharmaceutical and biotech industries.  In addition, the speakers will cover the following topics and issues:

    • The drug development process and the types of patents that result from that process.
    • The patent issues that arise during the various phases of the development of a drug product, including early-stage research in drug discovery, preclinical development, clinical trials, and the FDA approval process.
    • Recent case law developments, including:
      • KSR v. Teleflex — the Supreme Court's reevaluation of the law of obviousness,
      • Takeda v. Alapharm — the Federal Circuits first pharmaceutical case following KSR,
      • Significant decisions governing the patentability of active pharmaceutical ingredients, including: Sanofi-aventis v. Apotex, Pfizer v. Apotex, and Aventis v. Lupin,
      • In re Seagate Technology — which redefined the standard for establishing willful infringement in patent infringement cases

    The registration fee for this webcast is $299, and registrants will be entitled to a 40% discount off the price of the PLI treatise "Pharmaceutical and Biotech Patent Law."  Those interested in registering for the webcast, can do so here.

  • San Francisco #5 Law Seminars International (LSI) will be holding a conference entitled "Buying, Selling and Licensing Patents: New Case Law, Rules, Legislation and Markets" on January 25-25, 2008 in San Francisco, CA.  The conference will provide tips and strategies for managing the patent transaction process and conducting due diligence.  In particular, the conference's speakers will offer presentations on the following topics:

    • Patent reform: Update on changes in patent law that will fundamentally change patent strategies and the patent marketplace.
    • The growing variety of patent purchase and sale business models: Assessing the value they bring and their impact on the market.
    • Understanding patent investors.
    • Practical pointers for buyers and sellers.
    • Buyer's due diligence.
    • Case study: Lessons learned from the MOSAID-Agere patent sale.
    • Enhancing the value of your portfolio.
    • Running an effective corporate patent purchasing program.
    • Understanding the impact of contractual encumbrances.
    • Maximizing the bottom line: Tax and accounting considerations.
    • Optimizing patent licensing preparations and engagements to maximize success: Tips for engagement strategies.

    LSI - Law Seminars International - blue The agenda for LSI's conference on Buying, Selling and Licensing Patents can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

    The registration fee ranges from $497.50 (students and new employees) to $995 (regular tuition).  Discounts are available for government employees and groups of two or more registrants.  Those interested in registering for the conference can do so here.

  •     By Donald Zuhn

    Uspto_seal_no_background
    The U.S. Patent and Trademark Office released its FY 2007 Performance and Accountability Report today and announced that the Office had posted record-breaking numbers for 2007.  According to the Patent Office, the year-end numbers "reveal historic improvement in the quality of patent and trademark reviews and subsequently the quality of issued patents and registered trademarks."

    The Performance and Accountability Report indicates that the Office examined the highest number of applications (362,227) in its history.  The report also notes that about 50% of patent applications were filed electronically via the EFS-Web, which is up from less than 2% in 2005.  In addition, the report shows that patent examiner decisions were upheld by the Board of Patent Appeals and Interferences 69% of the time in 2007, up from 51% in 2005.

    According to USPTO Director Jon Dudas, "[t]he sustained trend of quality improvements are a tribute to the internal quality initiatives of our managers and employees," adding that "the quality of patent and trademark examination is a shared responsibility that begins with the application."  While stating that "[t]he USPTO will work tirelessly to ensure high quality agency actions,"  Director Dudas cautioned that "we must make progress to ensure examiners are presented with applications that clearly depict the claimed invention and relevant prior art is presented to the examiner in a timely manner."

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    In support of the Office’s argument that patent quality was on the rise, the release notes that only 51% of patent applications were allowed in 2007, down from a record high of 72% in 2000 (and down from 54% in 2006 as we reported last year).  According to the Patent Office, "[t]he allowance rate is a function of many aspects, including the quality of the applications received."  However, the Patent Office was willing to take some credit for the historically low allowance rate, since the release states that "[t]he USPTO’s focus on internal quality controls is primarily responsible for the lowered grant rate over the past several years."

    Not all of the news was bad (or "good" if you equate dwindling allowance rates with patent quality).  For example, the average pendency to a first Office Action in Tech Center 1600 (biotechnology and organic chemistry) was down to 22.7 months in 2007 from last year’s 23.5 months, while the average total pendency remained the same at 34.4 months.  Unfortunately, the overall average pendency to a first Office Action jumped from 22.6 months in 2006 to 25.3 months in 2007 and the overall average total pendency increased from 31.1 months in 2006 to 31.9 months in 2007.  Interestingly, the report states that in 2007, only 15.6% of the patent business group’s total costs had gone to the prosecution of biotechnology (7.1%) and chemical (8.5%) utility patents.  In 2006, the patent business group devoted 7.8% and 9.5% to biotech and chemical patents.

  •     By Donald Zuhn

    Cellcytelogobtm
    Last week, CellCyte Genetics announced that it had been granted U.S. Patent No. 7,282,222, which relates to methods for delivering stem cells to a target tissue in a mammal using glycoconjugate to traffic the cells to a desired organ.  According to CellCyte’s press release, the Kirkland, Washington based biotech company, which has exclusively licensed the ‘222 patent from the U.S. Department of Veterans Affairs, plans to use the patented technology to develop stem cell enabling therapeutic products for efficient delivery and significantly increased retention of adult stem cells to target organs such as the heart.

    CellCyte’s first product in development, CCG-TH30, is designed to target autologous bone-marrow-derived (adult) stem cells to the heart of patients after a heart attack/  CellCyte Chief Scientific Officer Dr. Ronald Berninger noted that CCG-TH30 has been shown in preclinical models to increase stem cell retention to 77% as opposed to the 6% retention level of conventional methods.  In addition, unlike conventional methods that require an invasive procedure, CCG-TH30 can be delivered intravenously.  A video outlining the CellCyte’s technology can be viewed here.

    The ‘222 patent issued from U.S. Application No. 10/388,964, filed March 14, 2003, and claims the benefit of U.S. Provisional Application No. 60/364,498, filed March 15, 2002.  Representative independent claims 1, 3, 5, and 7 of the ‘222 patent recite:

    1.  A method for targeting a hematopoietic stem cell to the heart of a mammal comprising administering an asialoorosomucoid to the mammal prior to administration of the cell to the mammal, whereby the cell is directed to the heart.

    3.  A method for targeting a mesenchymal stem cell to the heart of a mammal comprising administering an orosomucoid to the mammal prior to administration of the cell to the mammal, whereby the cell is directed to the heart.

    5.  A method for targeting a hematopoietic stem cell to the liver of a mammal comprising administering an orosomucoid to the mammal prior to administration of the cell to the mammal, whereby the cell is directed to the liver.

    7.  A method for targeting a mesenchymal stem cell to the liver of a mammal comprising administering an asialoorosomucoid to the mammal prior to administration of the cell to the mammal, whereby the cell is directed to the liver.

  •     By Kevin E. Noonan

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    Continuing its obliquely negative coverage of U.S. Patent law, Peter Lattman of The Wall Street Journal is shocked (shocked!) to find that the University of California is immune from patent infringement suits, despite being an avid participant in obtaining patents on technology developed by its faculty researchers.  In an article entitled "Critics Take Aim at California’s Patent Shield" published yesterday, Mr. Lattman accurately reports that the University receives more patents than any other American university:  it has made $521 million in royalty and fee income over the past five years, and received almost 29,000 "foreign and domestic" patents over that period.  (Of course, the foreign patents are irrelevant to the point of the article, but they certainly inflate the numbers.  According to the U.S. Patent and Trademark Office website, the number of U.S. patents granted to the Board of Regents of the University of California over this 5-year period is actually 2,567 patents.)

    California
    California has benefited from patent protection because it can (and does) sue infringers in federal court.  The article specifically mentions major settlements from suits against Genentech ($200 million), Monsanto ($185 million) and Microsoft ($30 million).  Conversely, and what has roused Mr. Lattman’s ire, is that California cannot be sued for its own infringement, terming the University, and the State of California "Teflon."  (Curiously, without using the ® symbol.)  Prompting the article is a recent decision by the Court of Appeals for the Federal Circuit affirming a decision from the District Court for the Northern District of California, Judge Marilyn Hall Patel presiding, that California was immune from a lawsuit by Biomedical Patent Management Corp. over a patent on a method for screening fetuses for birth defects.  Judge Patel, Mr. Lattman reports, was unhappy with this immunity, noting that private universities "enjoy no such advantage."

    And, Mr. Lattman reminds us, the problem is not limited to California (citing Texas and Massachusetts as other examples of state universities invoking the immunity) because all state universities have been held to fall within the scope of the immunity.  This is relevant because, since passage of the Bayh-Dole Act in 1980 permitting (actually, encouraging) universities to patent the technological results of their faculty’s research, state universities "have become major players in the patent world," with "vast amounts of intellectual property."  This has resulted in "billions of dollars in revenue" garnered from patent licensing to private enterprise.

    But Mr. Lattman’s problem is not with the U.S. patent system, it is with the Constitution.  As the article acknowledges, the source of the immunity is the 11th Amendment to the Constitution, which reads:

    The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.

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    The concept of sovereign immunity stems from British common law, banning lawsuits against the king.  Although not explicitly stated in the Amendment, the Supreme Court has interpreted 11th Amendment immunity to extend to actions of a citizen against the state in which she resides.  Hans v. Louisiana, 134 U.S. 1 (1890).  The rationale behind the immunity conferred by the Amendment is that the "States entered the federal system with their sovereignty intact," Blatchford v. Native Village of Noatak, 501 U.S. 775 (1991), and that "the sovereign immunity of the States neither derives from nor is limited by the terms of the Eleventh Amendment.  Rather, . . . the States’ immunity from suit is a fundamental aspect of the sovereignty which the States enjoyed before the ratification of the Constitution, and which they retain today," Alden v. Maine, 527 U.S. 706 (1999).  Although Alden sets out this rationale for the scope of the immunity, it is important to recognize that Alden was a 5-4 decision, with the dissenting justices believing that the States had surrendered sovereign immunity when they ratified the Constitution.  The immunity is also limited to state action, and is not shared by "lesser" jurisdictional entities like municipalities or counties.

    Moreover, the immunity is not absolute.  It can be waived, and many states (as well as the federal government) have waived sovereign immunity in suits for tort and contract.  Certain U.S. Constitutional provisions trump the immunity, such as the Bankruptcy Clause and the 14th Amendment.  However, patent law does not fall within any federal law exemption, and the Supreme Court has recently decided expressly that States enjoy sovereign immunity against suits for patent infringement.  Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank, 527 U.S. 627 (1999).

    But sovereign immunity is not limited to patent infringment lawsuits, and indeed there are even more "outrageous" consequences of applying the doctrine.  For example, sovereign immunity is expected to shield Virginia Tech (a state school) from liability resulting from the shooting rampage that killed several students in April.  Pursuant to Virginia’s limited waiver of sovereign liability for torts, suits will be limited to proof of state negligence and are capped at a maximum recovery of $100,000.

    Thus, the issue is the Constitution, not patent law.  The Supreme Court has not seen fit to include patent law within the power of Congress or the federal judiciary to abrogate; indeed, Justice Kennedy, writing for the Court in the Alden case, expressed the belief that Congress lacked the power to force States to waive sovereign immunity in patent cases.  Although bills have been introduced to force States to waive sovereign immunity in order to be eligible for patent protection, Congress has never passed one.  The only sure remedy would be to amend the Constitution, something there appears to be little political impetus or will to do.

    ADDENDUM:

    As Mark Rosen properly notes, there are instances where Congress can impose waiver of sovereign immunity on a state, but it isn’t as simple as legislation that would require waiver in order for states to be entitled to patent protection.

    If there was a pattern or record of states violating the 14th (due process) or 5th (takings/eminent domain) Amendments with regard to property rights, then the Court in Florida Prepaid could consider the action constitutional.  The quotation from the case reads as follows (emphasis added):

    Thus, under the plain terms of the Clause and the clear import of our precedent, a State’s infringement of a patent, though interfering with a patent owner’s right to exclude others, does not by itself violate the Constitution.  Instead, only where the State provides no remedy, or only inadequate remedies, to injured patent owners for its infringement of their patent could a deprivation of property without due process result.

                                          * * *

    Congress, however, barely considered the availability of state remedies for patent infringement and hence whether the States’ conduct might have amounted to a constitutional violation under the Fourteenth Amendment.  It did hear a limited amount of testimony to the effect that the remedies available in some States were uncertain.

    It isn’t clear whether the law could be selective (along the lines of "if a state is found to provide no or inadequate remedies for patent infringement") or whether it would require a finding that state were generally providing no or inadequate patent infringement remedies.  It does point to a relatively clear path for Congress to address the question without having to amend the Constitution.

  •     By Donald Zuhn

    Roche
    Last summer, we reported that Roche had made an offer to acquire Ventana Medical Systems, Inc. for $75 per share, or approximately $3 billion.  In response, Ventana’s Board of Directors announced that it had determined that Roche’s offer was "inadequate in multiple respects and contrary to the best interests of Ventana’s stockholders," and therefore, was recommending that its stockholders not tender their shares to Roche.  Since July, Roche has extended its tender offer four times, and following Roche’s fourth extension in October, Ventana announced that more than 99.5% of its investors had turned down Roche’s overtures.

    Ventana_medical_systems
    On the heels of Roche’s fourth extension, Ventana released a statement on Tuesday that it had entered into a confidentiality agreement with Roche which "will allow Roche to commence due diligence and have appropriate access to non-public information regarding Ventana to better understand the Company’s business prospects and the inherent value in companion diagnostics."  Ventana’s Board of Directors took the opportunity to reiterate that Roche’s $75 offer was "grossly inadequate . . . as reflected by that fact that Ventana’s share price has consistently traded well above Roche’s offer and our stockholders have overwhelmingly rejected that offer four times."

    Reuters reported today that, according to some analysts, Ventana could be worth as much as $90 per share as a stand-alone business, and therefore, that Roche may have to increase its bid to $100 if it intends to close the deal.  Ventana’s stock closed at $88.94 on Wednesday.

    Ventana’s patent portfolio includes at least 51 U.S. patents and 36 U.S. patent application publications.

    For additional information regarding this topic, please see:

  •     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.

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    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.

    Accelerated examination

    A little more than one year ago, the Patent Office revised the procedures relating to accelerated examination.  Prior to the change, an applicant could file a "Petition to Make Special" in certain circumstances, including applicant age (if the inventor was at least 65 years old), ongoing activities of a third party that would constitute infringement once a patent was granted, and for certain technologies including treatments for cancer and acquired immune deficiency syndrome.  The Office abolished this system effective August 26, 2006 (while continuing the old practice on the basis of health or age) in favor of a pilot program permitting an applicant to obtain accelerated examination if the applicant was willing to satisfy certain new requirements.

    The benefit of accelerated examination is a "promise" that the applicant would obtain a patent within 12 months from filing.  The requirements are:  the application must be complete upon filing, be filed electronically, and specifically request accelerated examination; that it contain no more than 3 independent claims and 20 total claims and not contain a multiply-dependent claim; applicants agree to telephone restriction requirements, and to pursue claims to only one invention (i.e., not to traverse the restriction), and further that applicants agree to telephone interviews even prior to a first Office Action on the merits; and that a pre-examination search is performed.  Examination occurs with "special dispatch" and all actions except a final rejection are subject to a one-month shortened period for response; extensions of time are not allowed except for unavoidable delay, and failure to timely respond results in abandonment.  The most burdensome aspect of the process is that a simple information disclosure statement does not suffice to bring prior art to the examiner’s attention.  Rather, applicants are required to provide a detailed explanation of the art, along the lines of the "examination support document" that is a part of the Office’s new rules enjoined by Judge Cacheris of the District Court on October 31st.

    The Office has touted this program as a way for an applicant to avoid long pendency times for inventions that would benefit from having patent protection obtained rapidly.  There are certainly technologies that have (relatively) rapid obsolescence times and that could benefit from this program (see "Could Creating a U.S. ‘Utility Model’ Patent Fulfill the ‘Need’ for Patent Law Reform?"); according to Office statistics, 650 applications have been designated for the program and the Office has granted 97 patents since the program went into effect (see "AE Petitions Status").

    As has become its penchant recently, the Office seems to be onto something here, but its own bureaucratic approach and some fundamentally flawed assumptions have prevented it from using the accelerated examination procedure more broadly (and some of this depends on unnecessarily burdensome requirements).  The program could be useful in addressing the Office’s major problem – the backlog of unexamined applications – with only a few small changes.  First, permit an applicant to designate any application, especially pending ones, to fall within the scope of the modified accelerated examination schedule proposed here.  Second, have the decision point be at 18 months rather than one year, to give applicants and the Office sufficient time for a proper examination.  Third, retain the limitations to a single invention but with a total of 5 independent and 25 total claims, as in the enjoined new rules.  Fourth, retain the expedited examination schedule (shortened statutory response periods and limitations on extensions-of-time) to prevent the program from failing to meet its main goal, reducing the backlog.  Fifth, continue the emphasis on telephone conferences between the Examiner and applicant’s representative and require all formal submissions to be made using the electronic filing system (EFS).

    The major difference between the current system and the one proposed here is that an applicant would not file an examination support document.  Instead, as part of the telephonic interview the examiner and applicant’s counsel would fully and frankly discuss the art and, in short, provide verbally all of the substantive information now required in the document.  The difference is that none of this would become part of the written record.  While seemingly counterintuitive, such a scheme is the only way, in view of the current status of the law regarding inequitable conduct, that counsel would be comfortable having the type of discussion required to expedite examination.

    Although seemingly radical, on reflection this concept is much less so.  For example, it is true that such a system would run counter to the prevailing trend to increase transparency in the examination process, including such features as publishing pending U.S. applications and making the prosecution history publicly available upon publication.  However, it is informative to remember that less than 10 years ago U.S. applications were not published, and the Republic survived the prior two hundred twenty-four years with a patent system of confidential, ex parte prosecution.  Moreover, the American Inventor Protection Act of 2000, which required U.S. patent applications be published, did not require the Office to make a published application’s file history publicly available prior to grant.  It gave the Office the authority to do so but did not require it, and consequently many applicants had their counsel file applications prior to the November 2000 deadline date to prevent public access to their "ex parte" prosecution files.  Similarly, it has only been in the past decade that the Office had required applicants and examiners to put formal interview summaries in the prosecution file history; prior to this change, interview summaries like "prior art discussed with applicant’s counsel and agreement reached" were common, with no additional information being available.

    Additionally, present practice is replete with applicants and their representatives putting qualifying language on the record to prevent courts and accused infringers from misconstruing statements that could later be taken out of context.  Phrases like "without acquiescing to the asserted grounds of rejection" and "although applicants dispute the interpretation of the art in the Action" and "solely in an effort to expedite prosecution of the pending claims to allowance" are frequently encountered in the remarks section of many Office Action responses.  This tendency has been exacerbated by the expansive view of prosecution history estoppel, both with regard to claim interpretation as well as the application of the doctrine of equivalents, espoused by the Federal Circuit over the past decade or so.  The purpose of this qualifying language is merely to prevent an accused infringer from making an ex post facto argument that prosecution was undertaken in bad faith.  This is the risk every applicant and their counsel takes, since allegations of inequitable conduct have been and continue to be a "veritable plague" on the patent system.

    Even though almost always alleged, however, inequitable conduct is rarely proven.  While this is due in part to the heavy burden required to establish inequitable conduct, the burden is no heavier than the burden required to prove invalidity (i.e., clear and convincing evidence).  Yet invalidity is found more frequently than inequitable conduct.  While a number of explanations can be proffered for this result, the most likely one is also the simplest:  that the overwhelming majority of applicants and their counsel simply do not commit inequitable conduct.  For applicants, the potential costs (including Walker Process damages) of an inequitable conduct determination by a District Court discourages any tendencies towards committing inequitable conduct, while most counsel are unlikely to risk their livelihoods and the disqualifying wrath of Mr. Harry Moatz and the Office of Enrollment and Discipline for any one patent or client.  Indeed, one of the paradoxical accusations raised against applicants and their counsel as a justification for ESDs is submission of cumulative art, which is almost always motivated by the fear of an inequitable conduct allegation.  Thus, it is reasonable to assume that for the vast majority of cases there would be no enhanced risk of inequitable conduct should the Office permit an applicant’s representative to have an ex parte, off-the-record, full and frank discussion of the art with an Examiner.

    The benefits of this practice are just all of the purported benefits of the proposed (and enjoined) ESD system.  Examiners would benefit from having applicants prioritize the prior art based on how close the art is to the claimed invention, and would also benefit from being able to have applicants point out the portions of the art that disclose elements of the claimed invention.  Good-faith applicants, the overwhelming majority, would be in the best position to know the patentable distinctions with the art and thus have no substantive impediment towards pointing out where the art disclosed, and did not disclose, the elements of the claimed invention.  Moreover, knowing this discussion was part of the patentability process would encourage applicants to have their counsel perform a pre-filing search, which would result in more focused claims in these applications.

    The Office could also reserve the right, upon good cause provided, for the Examiner to propose that certain portions of the information covered in such an ex parte discussion become part of the prosecution file history, most probably without attribution.  Applicants could always have the opportunity to drop out of the accelerated examination program should they disagree with an examiner’s decision to make such information of record.  Applicants would retain the right to prevent the Office from disclosing the nature of any such admissions upon request, although doing so would result in foreswearing the advantages of the accelerated examination program.  For applicants, the advantage is obtaining patents more rapidly.  For the Office, the advantage is eliminating some portion of the backlog within 18 months, as well as the possibility of expanding the program to maximize the number of applications choosing to exercise this option.

    Whether one thinks that this scheme has merit will depend on whether they believe that the overwhelming majority of applicants and their counsel engage in good-faith efforts to zealously obtain the greatest extent of protection that their invention legitimately deserves, or if one believes that applicants and their counsel routinely engage in inequitable conduct during patent prosecution (despite empirical evidence to the contrary).  Put more bluntly, if one believes (as current Office management seems to) that their customers and counsel are liars and thieves actively trying to "game" the system to obtain a benefit they don’t deserve, then the scheme proposed herein will appear hopelessly naïve and unworkable.  If however, as both evidence and common sense would persuade the unbiased observer, it is the best interests of applicants and their counsel to honestly prosecute patent applications to allowance, and if that is in fact what happens in almost all instances, then perhaps it would be possible to actually craft a system where the Office and their customers work together to ensure that granted U.S. patents are valid and enforceable.  The Office declaims loudly that such a cooperative effort is what they want; it is time they took steps that would help us believe them.

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