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  • Procuring Patent Protection from the Present PTO

        By Kevin E. Noonan —

    Uspto_seal_2
    Although the final version of the new continuation rules have not been issued (see "New Continuation and Claims Rules to Be Published in Late Summer"), it is clear that the limitations on the right to file continuation applications (and perhaps Requests for Continued Examination) will act to focus patent prosecutors on ways of avoiding final rejections.  After all, if the Patent Office was willing to issue a sufficient number of Office Actions for an applicant to have a fair chance at meaningful prosecution before encountering a Final Rejection, much of the angst attendant with the new rules would be alleviated.

    Mpep1_2
    Since it is unlikely that the internal rules governing examination will change (since the Office would, no doubt, think issuing more than one Action before a Final Rejection could only reflect a lack of efficiency), it is incumbent upon patent prosecutors to understand the procedural avenues available to address improvidently-issued Office Actions.  A more detailed compendium of the relevant procedures will appear once the new continuation rules are issued.  For now, however, a relatively new provision of the Manual of Patent Examining Procedure (M.P.E.P.) provides a way to send particularly inadequate Actions back to the Office without responding (and thus without risking receiving a Final Rejection).

    The rule is M.P.E.P. § 710.06, which reads:

    710.06 Situations When Reply Period Is Reset or Restarted [R-3]

    Where the citation of a reference is incorrect or an Office action contains some other error that affects applicant’s ability to reply to the Office action and this error is called to the attention of the Office within 1 month of the mail date of the action, the Office will restart the previously set period for reply to run from the date the error is corrected, if requested to do so by applicant.  If the error is brought to the attention of the Office within the period for reply set in the Office action but more than 1 month after the date of the Office action, the Office will set a new period for reply, if requested to do so by the applicant, to substantially equal the time remaining in the reply period.  For example, if the error is brought to the attention of the Office 5 weeks after mailing the action, then the Office would set a new 2-month period for reply.  The new period for reply must be at least 1 month and would run from the date the error is corrected.  See MPEP § 707.05(g) for the manner of correcting the record where there has been an erroneous citation.

    Where for any reason it becomes necessary to remail any action (MPEP § 707.13), the action should be correspondingly redated, as it is the remailing date that establishes the beginning of the period for reply.  Ex parte Gourtoff, 1924 C.D. 153, 329 O.G. 536 (Comm’r Pat. 1924).  For Image File Wrapper (IFW) processing, see IFW Manual.

    A supplementary action after a rejection explaining the references more explicitly or giving the reasons more fully, even though no further references are cited, establishes a new date from which the statutory period runs.

    M.P.E.P. § 710.06 (emphasis added).

    This provision should be useful for any of a variety of situations commonly encountered in prosecution, including for example:

    • the Action states that there is no support for a claim term explicitly defined in the specification;
    • the Action holds as indefinite a claim term explicitly defined in the specification;
    • the Action asserts a reference under § 102 that clearly lacks a recited element of the claims;
    • the Action makes statements or arguments that are unsupported by any evidence of record (where the request can include citation of 37 C.F.R. § 1.104(d)(2) for information known to any Office employee);
    • the Action asserts that limitations or properties of the claimed invention are inherent without establishing any basis for the assertion;
    • the Action rejects an independent claim and dependent claims, where the limitations of a dependent claim would clearly overcome the asserted rejection;
    • the Action does not support a rejection with evidence or argument, but merely makes bald assertions without support in the record.

    This list is exemplary and not exhaustive; there are, of course, many other types of deficiencies in many Office Actions that would fall within the scope of the rule.

    The critical deadline for invoking this rule is that a request for a corrected Action be submitted within one month of the mailing date.  The rule also contains provisions for instances where an Action is delayed, for example by postal service disruptions or inefficiencies, but generally Actions are received with sufficient time for a petition to be filed within the one-month window of opportunity.  This option permits a prosecutor to avoid having to address improvidently-issued Actions, and to not waste time, effort, and client funds in responding (and risking an early final rejection).  It requires the prosecutor to review Office Actions as soon as they are received, to ascertain whether there is any basis for submitting a request for correcting such errors.  However, the advantages in receiving a better-prepared Action, where the real patentability issues can be addressed without distraction, is worth whatever minor inconvenience may be occasioned by early review of each Action.  Having been given this procedural advantage, good practice demands that patent prosecutors are aware of it and use it extensively, in partnership with the Patent Office in their efforts to improve the quality of examination and, consequently, the patents issued by the Office.  It seems the least we can do.

    My thanks to David Boundy at Cantor Fitzgerald for directing my attention to this provision (which he calls the "30-day, money-back guarantee’).

  • USPTO News: USPTO to Begin Electronic Transfer of Priority Documents to International Bureau

        By Donald Zuhn —

    Uspto_seal
    On Tuesday, the U.S. Patent and Trademark Office (USPTO) announced that beginning August 31, 2007, the Patent Office will begin to electronically transfer certified copies of U.S. priority applications to the International Bureau (IB) of the World Intellectual Property Organization (WIPO) for International applications filed in the U.S. Receiving Office (RO), provided that a request has been made in accordance with PCT Rule 17.1(b) and 37 C.F.R. § 1.451(b).  The USPTO has even Wipo_2
    waived the fee under 37 C.F.R. § 1.19(b)(1)(iii)(A) for the electronic transfer of such priority applications.  To request electronic transfer of priority applications, applicants must only check the box on the Request (Form PCT/RO/101) requesting that the U.S. RO transmit a certified copy of a U.S. priority application to the IB.

  • USPTO News: Latest EFS Web Tips from the EBC

        By Christopher P. Singer —

    Uspto_seal
    The USPTO sent out an "e-Commerce e-Alert" by e-mail on August 14, 2007.  The e-Alert discussed several issues relating to the Patent Office’s electronic commerce initiatives, including updates concerning the e-Office Action Pilot Program; New Document Description for a Letter Accompanying an Information Disclosure Statement; International Application Filing Standards; Terminal/Statutory Disclaimer Fee Payment; Upcoming e-Commerce Events; and Document Indexing Hints.

    e-Office Action Pilot Program:

    This program has been ongoing for some time, and is approaching "Phase IV" on August 31, 2007.  The USPTO is offering open enrollment in the upcoming phase of the program to a limited number of new participants.  If interested, contact the USPTO by e-mail at PAIR@uspto.gov.  [Author’s note:  several months ago, I talked to someone about the e-Office action program.  Unfortunately (for me), the program is based on a practitioner’s customer number(s), meaning that any application associated with that customer number will become part of the program.]

    e-Filing Tips:

    Efsweb
    • IDS Letter Document Description:  A new document description is now available on the EFS-Web for practitioners filing letters along with an Information Disclosure Statement (IDS) form.  Such letters should be described as follows:  under the "category" drop-down menu, choose "IDS/References," and under the "document description" drop-down menu, choose, "Information Disclosure Statement Letter."  The Office asks that you DO NOT use "Information Disclosure Statement (IDS) Filed" from the document description menu when filing these letters.

    • International Application Filing Standards:  When filing any International or PCT Application using EFS-Web, all the documents in that application and associated with the filing should be formatted and sized for A4-sized paper (8.27 x 11.69 inches).

    • RCE Indexing:  As a helpful tip, the EBC noted that proper indexing of the Request for Continued Examination (RCE) fillable form (SB30; http://www.uspto.gov/web/forms/sb0030_fill.pdf) as "Request for Continued Examination" under the document description tab will help expedite processing.  That description can be found under either the "Amendment" or "Petition" categories.

    • Terminal/Statutory Disclaimer Fee Payment:  When paying a Disclaimer fee, practitioners should use the correct fee code (1814) under "Statutory Disclaimer" located in the "Post Issuance and Post Allowance Fees" section of fee calculation page on EFS-Web.  Currently, the Large Entity Statutory Disclaimer fee is available when filing a follow-on submission.  The Small Entity fee option will be made available through follow-on submissions once EFS-Web version 1.2 is released (expected later this year).  Until that time, the Office suggests that small entity filers submit a fee transmittal form indicating their deposit account number as a substitute for paying the fee through EFS-Web.  In order to pay by credit card, the Office requests that you send the fee transmittal form along with the Credit Card Payment Form (Form PTO-2038) by fax to the Central Fax (571-273-8300) after the Disclaimer document is filed via EFS-Web, or alternatively by Express Mail to Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.  The Office asks practitioners to refrain from using EFS-Web to file the credit card authorization form.

  • More on the Global Drug Patenting Crisis

        By Kevin E. Noonan —

    Euflag
    The effects of the global crisis in patented drug pricing were evident recently in two actions (or inactions) in the European Union.

    In the first, the Committee on International Trade of the European Parliament delayed voting on the Trade Related Intellectual Property Rights protocol promulgated by the World Trade Organization (WTO).  This (in)action was taken Europeanparliament_3
    over a dispute regarding the role Europe will play in facilitating delivery of "essential" medicines to developing countries.  The activities of the European Commission and Council in negotiating drug prices within the WTO patent framework were at issue, reflecting the political divisions that have arisen under the TRIPS framework (see "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries").  These divisions have pitted those advocating measures to facilitate patented drug delivery, particularly with regard to anti-AIDS drugs, to developing countries, against pharmaceutical companies trying to protect their investment in developing these drugs and to take advantage of the purportedly pro-patent provisions of the GATT treaty negotiated more than 10 years ago.

    Wto_logo
    As reported here extensively, in practice the WTO scheme has not resulted in the degree of patent protection in developing countries envisioned by many in the industrialized nations of the world during the GATT negotiations.  As the result of provisions of implementing laws in several major developing nations (such as Brasil) that contained compulsory licensing provisions, and the WTO’s Doha declaration, that permit parallel importing of drugs under conditions of "medical emergency" (such as the AIDS crisis in many countries, and prospectively, an influenza pandemic), patent protection in developing countries may actually have diminished (see "Trying to Find a Solution to the Global Drug Pricing Crisis").  Patent-owning innovator drug companies have found themselves vilified (to varying degrees) unless they capitulate to developing nation’s demands for drastically-reduced drug pricing (see "Worldwide Drug Pricing Regime in Chaos").

    Dwbmsf
    The source of this vilification has not been limited to the developing world.  Western nongovernmental organizations groups, such as Doctors without Borders have cast the debate as "saving poor people" versus  "profiteering" by Western drug companies, which makes an incendiary headline but does little to address the underlying problems posed by these competing interests.  This type of political sentiment is prevalent in Europe and is the basis in part for the inaction by the European Parliament.  Parliamentary delegates have expressed the desire for Europe to be a "world leader" in making affordable drugs available in the developing world, and Parliament passed a resolution earlier this summer that member states offer financial support to drug companies in developing countries (thereby aiding and abetting these countries’ compulsory licensing schemes).  More ominous, perhaps, is a further directive that member states restrict the power of the European Commission to negotiate drug pricing with developing countries; the resolution specifically called out activities such as "data exclusivity, patent extensions and limitation of grounds of compulsory licenses" for these prohibitions.  The Commission has responded by agreeing not to include TRIPS provisions that could inhibit access to patented drugs in any of its economic partnership agreements.

    The proposed WTO protocol would permit generic drug companies to export copies of patented drugs to those countries that do not have their own generic drug industry to benefit from national compulsory licensing laws.  It would incorporate the most patent-unfriendly provisions of the Doha Declaration, and be a boon for nascent (and not so nascent) generic drug industries in countries such as India and China (although that in itself may be a qualified or ambiguous boon to the populations of developing countries in light of adulterated drug problems from these sources (see "The Effect of Foreign Generics on the U.S. Drug Supply" – Part I, Part II, and Part III).  It would also fundamentally change the balance struck by the TRIPS agreements, that permitted compulsory licensing as a way for developing countries to develop their own native pharmaceutical industries, in favor of foreign (albeit a different, cheaper foreign) sources of patented (nee generic) drugs.

    In contrast (and much more in keeping with the European Commission’s traditional role), commission regulators sent a warning letter to the government of Thailand regarding it’s compulsory licensing scheme for patented drugs.  As reported here yesterday, the Commission objected to Thailand’s requirement that these drugs be priced no higher than 5% more than the cost of an equivalent generic version of the drug.  Among the companies facing these requirements is France’s sanofi-aventis, whose heart medication Plavix® is the first non-anti-AIDS drug that any developing country has subjected to compulsory licensing under provisions of the Doha Declaration relating to a "national medical emergency."  These actions by the European Commission parallel actions by the U.S. Trade Representative in May, where Thailand was put on a "watchlist" of countries that were "serious offenders" of international patent laws and treaties.  Under the current international regime, however, there is little either the U.S. or Europe can do to foreclose this type of anti-patent activity even in WTO member countries.  Indeed, similar efforts to reduce patented drug prices are on-going in the U.S., and the fact that the Federal Circuit recently (see "Biotechnology Indus. Org. v. District of Columbia (Fed Cir. 2007)") struck down a District of Columbia law permitting sanctions and civil liability in cases where a company charged "excessive prices" for a patented drug should give no comfort to those who understand the balance between consumers and innovators.  The medical needs of the sick, and the political impact of allegations that the sick and needy cannot receive the medicine due to profit-hungry drug companies, means that similar efforts will continue, at least until the crisis in striking the appropriate balance between drug companies and their customers can be struck.

    For additional information regarding this and other related topics, please see:

  • EU Trade Commissioner Sends Warning Letter to Thailand

        By Donald Zuhn —

    As we reported in May, the U.S. Trade Representative issued a report on the state of intellectual property rights worldwide, identifying Thailand as one of twelve countries on a "priority watch list."  Thailand had been placed on the list as a result of its aggressive moves with respect to anti-AIDS drugs (and non-AIDS-related drugs such as Plavix®), compulsory licensing, and parallel imports.

    Now it appears that the European Union has joined the fray.  As reported by the Financial Times on Friday, European Union Trade Commissioner Peter Mandelson (at lower left) sent a letter to the Thai government in July, warning that it should refrain from taking further action to force drugmakers to drop drug prices.  Mr. Mandelson called Thailand’s demand that drug companies offer their drugs at no more than 5% above the generic cost "a matter of concern for the European Union" and labeled this approach "detrimental to the patent system, and so to innovation and the Captsgejrd53100807052932photo00ph_2
    development of new medicines."  Mr. Mandelson stated that Thailand’s recent moves contravened World Trade Organization regulations, and encouraged the Thai government to negotiate with drug companies, such as sanofi-aventis the maker of Plavix®, rather than issue compulsory licenses or import cheaper generic versions of their drugs.

    According to the Financial Times, Thailand has yet to respond to Mr. Mandelson’s letter.

    For additional information regarding this and other related topics, please see:

  • Biotechnology Indus. Org. v. District of Columbia (Fed. Cir. 2007)

        By Kevin E. Noonan —

    The cost of prescription drugs, and the proper apportionment of these costs between innovator drug companies (who frequently possess patent protection of their products) and consumers (who have access to political and other sources of resistance to increased drug costs) poses a policy problem that has been brewing for a generation.  In the U.S., the Federal government has acted to promote the development of a generic drug industry (for example, through the Hatch-Waxman Act, 35 U.S.C. §§ 156 and 271(e)(1)) and to require pharmaceutical companies to comply with formulary and rebate programs under the auspices of Medicaid (42 U.S.C. § 1396 et seq.).  States (including most notably Florida, Michigan, and Maine) have enacted additional measures, including using "prior authorization" requirements for drugs not listed in a formulary, and expanding the beneficiaries to include "medically needy" and, in Maine, all state residents.  Although pharmaceutical companies have resisted states’ efforts to impose rebates and other financial penalties directed at reducing drug costs (through their trade group, the Pharmaceutical Research and Manufacturers of America, PhRMA), for example, in Pharmaceutical Research and Manufacturers of America v. Walsh, 538 U.S. 644 (2003); Pharm. Research & Mfrs. of Am. v. Meadows, 304 F.3d 1197(11th Cir. 2003); and Pharm. Research & Mfrs. of Am. v. Thompson, 362 F.3d 817 (D.C. Cir. 2004), they have been unavailing.  Specifically, courts have rejected PhRMA’s arguments focusing on theories of pre-emption (under Federal Medicaid law) and Commerce clause violations.

    The District of Columbia is the latest government entity to attempt to institute regulations directed towards reducing drug costs.  The city ordinance, the Excessive Pricing Act, reads as follows:

    It shall be unlawful for any drug manufacturer or licensee thereof, excluding a point of sale retail seller, to sell or supply for sale or impose minimum resale requirements for a patented prescription drug that results in the prescription drug being sold in the District for an excessive price.

    D.C. Code § 28-4553 (emphasis added).

    The statute does not explicitly define what constitutes "an excessive price," but does provide a formula: "[a] prima facie case of excessive pricing shall be established where the wholesale price of a patented prescription drug in the District is over 30% higher than the comparable price in any high income country in which the product is protected by patents or other exclusive marketing rights," D.C. Code § 28-4554(a), where a "high income country" was defined as one of "the United Kingdom, Germany, Canada, or Australia." § 28-4552(2).

    The legislative intent behind this ordinance was clear:

    The excessive prices of prescription drugs in the District of Columbia is threatening the health and welfare of the residents of the District as well as the District government’s ability to ensure that all residents receive the health care they need, and these excessive prices directly and indirectly cause economic harm to the District and damage the health and safety of its residents.  . . .  [I]t is incumbent on the government of the District of Columbia to take action to restrain the excessive prices of prescription drugs.

    § 28-4551.

    And the penalties were significant:

    (1) Temporary, preliminary, or permanent injunctions to enjoin the sales of prescription drugs in the District at excessive prices;
    (2) Appropriate fines for each violation;
    (3) Damages, including treble damages;
    (4) Reasonable attorney’s fees;
    (5) The cost of litigation; or
    (6) Any other relief the court deems proper, § 28-4555(b),

    and were available as a remedy for any "affected party," including "any person directly or indirectly affected by excessive prices of patented prescription drugs, including any organization representing such persons or any person or organization representing the public interest."  § 28-4552(1).

    Logoblack
    PhRMA, joined by the Biotechnology Industry Organization (BIO) sued in Federal District Court in D.C.  In this case, PhRMA had a new argument with regard to pre-emption:  instead of focusing their attack on Medicaid or other Federal laws directed to drug pricing per se, they argued that the laws being pre-empted were the nation’s patent laws, Biotechnology_industry_organization
    which granted exclusivity to a patentee to prevent others from "making, using, selling, offering to sell or importing" a patented drug, 35 U.S.C. §271(a).  The District Court found for plaintiffs, holding that the ordinance to be pre-empted by U.S. patent law and issuing an injunction preventing the District from enforcing the law.  406 F. Supp. 2d 56 (D.D.C. 2005).

    Federal_circuit_seal
    The District appealed, first to the Court of Appeals for the D.C. Circuit, which Court transferred the appeal to the Federal Circuit as being within the Court’s exclusive jurisdiction.  In its unanimous opinion (by Judge Gajarsa) affirming the District Court’s decision, the Federal Circuit first addressed the questions of its own jurisdiction and the parties’ standing.  In finding in favor of its own jurisdiction the Federal Circuit applied the Supreme Court jurisdictional standards enunciated in Shaw v. Delta Air Lines, Inc., 463 U.S. 85, 96 (1983) (rather than the "mirroring" standard of Franchise Tax Board v. Construction Laborers Vacation Trust for Southern California, 463 U.S. 1, 16 (1983)), finding that the plaintiffs’ "well-pleaded complaint" was founded in patent law.  The two organizational plaintiffs satisfied the standing requirements, since their members (specifically, at least one member) would have standing to bring the lawsuit.  The Federal Circuit found that there existed "some threatened or actual injury resulting from the putatively illegal action" for at least one member of these organizations, and that this was sufficient.

    Turning to the substantive question, the Federal Circuit noted an important distinction with cases dealing with pre-emption of state law by Federal law:  the District is not a state, but rather it is a "federal territory whose self-governance is authorized by Congress"; however, the Federal Circuit stated that Federal supremacy principles still applied, when a conflict arose between a District law and laws enacted by Congress.  Don’t Tear It Down, Inc. v. Pa. Ave. Dev. Corp., 642 F.2d 527, 534 n.65 (D.C. Cir. 1980).  Despite the characteristically "negative" nature of the patent right (i.e., it does not confer on a patentee any affirmative right to practice an invention), the Federal Circuit analyzed the statute "as a whole" in light of the objectives of the patent laws.  The CAFC first cited the Constitutional mandate "to promote the progress of science and the useful arts," and the importance of the patent laws to protect the pecuniary interests of inventors which provided an incentive for their inventive activities.  The Federal Circuit found support for the proposition that these principles formed the basis of Congressional objectives for the patent statutes, inter alia, in the legislative history of the Hatch-Waxman Act (1984).  Although this objective (providing investment incentive for invention) was in "dialectic tension" with the ultimate purpose of the patent system to promote progress by encouraging disclosure, the Federal Circuit found that the provisions of the patent law reflected a balance by Congress of these competing objectives:

    Congress, as the promulgator of patent policy, is charged with balancing these disparate goals.  The present patent system reflects the result of Congress’s deliberations.  Congress has decided that patentees’ present amount of exclusionary power, the present length of patent terms, and the present conditions for patentability represent the best balance between exclusion and free use.

    Congressional supremacy extends even in instances, such as here implicating the police power of the District, because the Federal Circuit understood the District to be rebalancing "the statutory framework of rewards and incentives insofar as it relates to inventive new drugs."  The CAFC found this to be impermissible.

    The political urgency regarding patented drug prices exists worldwide and is the source and motivation for governmental and international activities directed at alleviating the problem, usually to the detriment of the patent holder (see "The Law of Unintended Consequences Arises in Applying TRIPS to Patented Drug Protection in Developing Countries").  Although there have been various proposals for addressing these issues with regard to poor and developing countries (see "A Modest Proposal Regarding Drug Pricing in Developing Countries"), "excessive pricing" is relative, and political pressure against rising drug prices is also felt in the relatively prosperous U.S. (because that prosperity is not evenly distributed).  While the Federal Circuit’s decision striking down the District of Columbia ordinance suggests a more fruitful approach to be taken when countering analogous actions by the States, sorely needed is a way to strike an acceptable balance between the costs of developing new drugs and the costs of benefiting from them.

    Biotechnology Indus. Org. v. District of Columbia (Fed. Cir. 2007)
    Panel:  Senior Circuit Judge Plager and Circuit Judges Bryson and Gajarsa
    Opinion by Circuit Judge Gajarsa

    Additional information regarding this case can be found at Patently-O.

  • Biotechs Facing New Challenges

        By Donald Zuhn —

    San_franscisco_chronicle
    Last Friday, The San Francisco Chronicle reported on new challenges facing the biotech industry.  In an article by Bernadette Tansey entitled "As biotech patents run out, innovation and competition may thrive," the Chronicle addressed the expiration of key biotech patents, increased competition being applied by generic manufacturers, and new biologics legislation making its way through Congress (although possibly stalled until 2008).  According to the article, biotech companies are trying to overcome these challenges through innovation by developing next-generation drugs to supplant their original biotech drugs.

    Amgen
    The article cites Amgen as an example of a biotech company that has begun to develop next-generation products – in particular, the anemia drug Aranesp, a longer-acting version of Amgen’s Epogen, for which injections can be given less frequently.  According to the article, Amgen’s U.S. sales of Aranesp and Epogen totaled $2.8 billion and $2.5 billion, respectively, in 2006.

    To provide additional time for the development of such next-generation drugs, biotech companies are attempting to convince Congress to enact legislation that guarantees them at least 14 years following FDA approval of a biologic before a generic version can be sold.  This would give biotechs an advantage that traditional pharmaceutical companies have not enjoyed.

    Surprisingly, the push by biotech companies to develop next-generation drugs doesn’t seem to have affected the generic drug manufacturers much.  For example, Jake Hansen, vice president of governmental affairs for generic drug manufacturer Barr Pharmaceuticals noted that "everybody wins" as a result of such innovation since it "fills [Barr’s] future pipeline, and consumers benefit from better medicines."

    For additional information on this topic, please see:

  • USPTO News: Patent Office Proposes New Rules for Alternative Claiming

        By Donald Zuhn —

    Uspto_seal_3
    On Friday, the U.S Patent and Trademark Office (USPTO) announced that it was proposing new rules that "will improve an examiner’s ability to focus the examination process for claims that contain more than one independent and distinct invention."  According to the USPTO announcement, the proposed rules, which were published in the Federal Register, "would require applicants to identify, with more specificity, the claimed invention to be examined, thus promoting examination quality."  The USPTO characterized the new rules as part of the Patent Office’s "ongoing effort to ensure patent quality, foster the examination process, and reduce pendency."

    According to the USPTO’s notice in the Federal Register, the Patent Office is seeking to:

    revise the rules of practice pertaining to any claim using alternative language to claim one or more species.  The search and examination of such claims often consume a disproportionate amount of Office resources as compared to other types of claims, because determining the patentability of these claims often requires a separate examination of each of the alternatives within the claims.  The Office expects that requiring applicants who choose to draft claims that read on multiple species using alternative language to maintain a certain degree of relatedness among the alternatives will enable the Office to do a more thorough and more reliable examination of such claims.

    The proposed changes for the examination of "multi-invention alternative" claims appear to have been prompted by rules changes proposed by the USPTO earlier this year which would limit the number of claims the Patent Office will examine.  In particular, the Patent Office notice states that "Applicants should not be permitted to circumvent the proposed claims rules by presenting a single claim that sets forth multiple independent and distinct inventions in the alternative."

    The proposed rules would require that each claim be limited to a single invention.  The USPTO notice indicates that when alternative language is used to define multiple species in a single claim, such claims will be considered to be limited to a single invention when at least one of two conditions is met:

    1.  "All of the species encompassed by the claim share a substantial feature essential for a common utility."
    2.  "[A]ll of the species are prima facie obvious over each other."

    Businessview0
    The notice describes a substantial feature essential for common utility as being "a common structure, material, or act necessary for at least one shared specific, substantial, and credible utility."  The new rules would also require that "the number and presentation of alternatives in [a] claim not make the claim difficult to construe, and requiring that each alternative within a list of alternatives must be substitutable one for another."  In addition, the proposed rules would also prohibit claims from reciting an alternative that would itself be defined as a set of further alternatives.

    Those wishing to comment on the proposed rules or make suggestions for improving the examination of "multi-invention alternative" claims can do so by sending comments or suggestions by e-mail to markush.comments@uspto.gov, by facsimile to 571-273-7754, by regular mail to Mail Stop Comments – Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, or by using the Federal eRulemaking Portal (http:// http://www.regulations.gov).  Comments or suggestions sent by facsimile or regular mail should be marked to the attention of Kathleen Kahler Fonda, Legal Advisor, Office of the Deputy Commissioner for Patent Examination Policy.  Comments or suggestions must be received by the USPTO on or before October 9, 2007.  The USPTO also indicated that no public hearing on the rules changes would be held.

    The USPTO announcement also noted that the final rules pertaining to claims and continuations would be published in the Federal Register by the end of August.

  • USPTO News: Complex Work Unit Pilot Program Announced

        By Christopher P. Singer —

    Uspto_seal_background_2
    Last week, the U.S. Patent and Trademark Office (USPTO) announced that it is seeking participants for a Complex Work Units (CWU) Pilot Program that is scheduled to begin later this year.  CWUs include applications containing chemical structure drawings, mathematical formulae, protein crystal data, and table data, which can add appreciable complexity (time) and cost to the examination and publication of these applications.

    The CWU Pilot Program is designed and operated in an effort to:

    • Investigate filing practice options for CWUs;
    • Gather information about existing CWU formats and their use in the IP community;
    • Evaluate rule changes to allow applicants to submit CWU files; and
    • Determine other acceptable file types.

    The pilot will allow participant applicants to submit original source files for CWUs through EFS-Web or on a CD, as a supplement to the usual application parts.  The CWU source file submissions will not be considered when calculating the application size fee, which will reduce the cost of filing for pilot participants.

    The USPTO is seeking participants in an effort to gather more information about CWUs from the intellectual property community.  If you have any questions about this program or if you are interested in participating in CWU Pilot activities, the USPTO asks that you contact them by e-mail at: cwupilotsupport@uspto.gov.

  • Court Report

        By Sherri Oslick —

    Gavel_20
    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.

    Eli Lilly and Company v. Actavis Elizabeth LLC
    1:07-cv-01023; filed August 8, 2007 in the Southern District of Indiana

    Infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Lilly’s Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder).  View the complaint here.