Patent Law Weblog

recent posts

about

  • Top Stories of 2013: #11 to #14

    By Donald Zuhn —

    FireworksReflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories.  For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Today, we count down stories #14 to #11, and then over the next few days, we will work our way towards the top three stories of 2013.  As with our other lists (2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2013" on January 21, 2014 from 10:00 am to 11:15 am (CT).  Details regarding the webinar can be found here.

    14.  23andMe Patent and Diagnostic Test Create Controversy

    A patent issued to 23andMe, Inc. in September created some controversy for the Mountain View, California biotech company.  The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the plurality of donors based on a phenotype of interest, the genotype of a recipient, and the genotypes of the donors.  In the wake of the '339 patent's issuance, 23andMe was criticized for its efforts to secure patent protection on a method of creating "designer babies," and in response, the company posted an article on its blog, stating that it "never pursued the concepts discussed in the patent beyond our Family Traits Inheritance Calculator, nor do we have any plans to do so."  In an unrelated matter, the FDA issued a Warning Letter to 23andMe in November, demanding that the company stop selling its Personal Genomic Services (PGS) product without obtaining FDA approval.  The FDA's letter was not well received by some healthcare consumers, who posted a petition on the "We the People" portion of the White House website, calling for the Obama Administration to overrule the FDA and permit 23andMe to continue to market the company's PGS product.  Other consumers, however, initiated a class action lawsuit against 23andMe on behalf of "tens or hundreds of thousands of women" who may have used the PGS testing service.

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

    • "23andMe Patent Creates Controversy," October 8, 2013
    • "Bioethicists 'Urge Maximal Transparency' in Response to 23andMe Patent," October 14, 2013
    • "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing," November 25, 2013
    • "Patients Push Back on FDA Threats to 23andMe Genetic Testing Products," November 26, 2013
    • "23andMe Named in Class Action Lawsuit," December 3, 2013


    13.  Supreme Court Hears Oral Argument in Medtronic v. Boston Scientific

    In November, the Supreme Court heard oral argument in the Medtronic Inc. v. Boston Scientific Corp. case, where the sole issue on appeal concerns whether the patent licensee or patent holder/licensor has the burden of proof on the issue of infringement/non-infringement in a declaratory judgment action brought by the licensee under Medlmmune.  The Court is expected to issue its opinion before the end of June 2014.

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

    • "Oral Argument in Medtronic Inc. v. Boston Scientific Corp.," November 7, 2013
    • "Amicus Curiae Briefs in Medtronic v. Boston Scientific – Legal Scholars Support Medtronic; Tessera Supports Vacatur and Remand," November 4, 2013
    • "Amicus Curiae Briefs in Support of Federal Circuit Opinion in Medtronic Inc. v. Boston Scientific Corp.," November 3, 2013
    • "United States Weighs-In on the Medtronic Case," August 15, 2013
    • "Supreme Court Grants Certiorari in Medtronic v. Boston Scientific," May 22, 2013


    12.  Debate Continues on 12-Year Data Exclusivity Period and Biosimilar Substitution

    More than three years after President Obama signed the Patient Protection and Affordable Care Act (PPACA) into law, thereby establishing a biosimilar regulatory pathway in the U.S. via the Biologics Price Competition and Innovation Act (BPCIA), the Administration has continued to press for a reduction of the data exclusivity period from 12 years to 7 years.  The debate over the data exclusivity period continued this year, but in the context of negotiations on the Trans-Pacific Partnership Agreement (TPP), a multilateral free trade agreement involving Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam.  In March, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, urged the Acting U.S. Trade Representative in a letter "to seek commitments from our trading partners that reflect the level of protection under U.S. law, for example 12 years of regulatory data protection for biologic pharmaceuticals."  While the Biotechnology Industry Organization (BIO) expressed its support for the 12-year data exclusivity period, the AARP asked the U.S. Trade Representative not to sign onto the TPP if the trade agreement includes the 12-year data exclusivity period.  While the data exclusivity period of the BPCIA was being debated in the context of the TPP, several states were debating legislation on biosimilar substitution under the BPCIA.  In October, California Governor Jerry Brown vetoed a bill in that state that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the prescriber did not personally indicate "Do not substitute."  In a letter to the California Senate, Governor Brown noted that he vetoed the bill because the FDA had not yet determined the standards required for biosimilars to meet the higher threshold for interchangeability, and therefore, requiring physician notification would have been "premature."

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

    • "AARP Seeks Reduced Data Exclusivity Period in TPP," October 31, 2013
    • "Governor Brown Vetoes California Biosimilar Bill," October 16, 2013
    • "California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution," October 3, 2013
    • "GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars," October 2, 2013
    • "White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics," August 26, 2013
    • "BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics," August 20, 2013
    • "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not," May 9, 2013
    • "WLF Submits Comments on Abbott's Citizen Petition on Biosimilars," March 6, 2013


    11.  EU Council Signs Unified Patent Court Agreement, Taking Step Towards Unitary Patent System

    In February, the Council of the European Union announced that twenty-four member states had signed the international agreement that would establish a Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents.  The signing initiated the process of ratification by national parliaments, with ratification requiring at least thirteen member states (including France, Germany and the United Kingdom).  Ratification of the UPC agreement will result in implementation of two EU regulations on the unitary patent.  According to some reports, ratification may not take place until at least 2015 or 2016, or perhaps even 2017 or 2018.  Spain, which did not sign the agreement, continued to challenge the regulations underpinning the Unitary Patent System in 2013.

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

    • "News from Abroad: Spain's Further Challenges to the Unitary Patent Regulations," June 6, 2013
    • "Member States Sign Agreement to Establish Unified Patent Court," February 21, 2013

  • AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)

    By Kevin E. Noonan —

    AstraZeneca_smallA classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug, Nexium® (particularly, the S-omeprazole enantiomer) as "the little purple pill."  One reason this strategy deserves admiration is that it is not the type of evergreening that some commentators and politicians have objected to (such as using formulation or other types of patents to continue protection after the composition patent has expired; for the record, there is nothing improper about that type of evergreening, either).  But no strategy is perfect, as AstraZeneca found when the Federal Circuit affirmed a District Court judgment of non-infringement in AstraZeneca v. Hanmi.

    HanmiThe claimed invention was directed to the magnesium salts of the esomeprazole isomer sold as Nexium®.  AstraZeneca filed suit under 35 U.S.C. § 271(e)(2) after receiving notice that Hanmi had submitted an ANDA for a generic version of the drug comprising the strontium salt of esomeprazole.  The claims of the Orange Book listed patents in suit (U.S. Patent Nos. 5,714,504 and 5,877,192) as filed and the specification recited six specific cations as components of the enantiomeric salts of the invention:  Na+, Mg2+, Li+, K+, Ca2+, or N+(R)4, where R is an alkyl with one to four carbons (the latter cation is also called generically an ammonium ion).  However, the issued claims recited the esomeprazole isomer more generically as an "alkaline" salt, as in Claim 1 of the '504 patent:

    A pharmaceutical formulation for oral administration comprising a pure solid state alkaline salt of the (-)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole and a pharmaceutically acceptable carrier.

    The District Court construed this and all the claims at issue to be limited to esomeprazole salts of the six specific cations recited in the specification, and the parties conceded that under this construction Hanmi's strontium salt formulation did not infringe.  AstraZeneca appealed, on the basis that these cations were exemplary and that the skilled worker would recognize that the patents were entitled to the broader scope of "alkaline salts" that would encompass Hanmi's strontium salt of esomeprazole.

    The Federal Circuit disagreed with AstraZeneca's arguments, in an opinion by Judge Taranto joined by Judges Dyk and Moore.  The Court found that while the plain meaning of the term "alkaline salt" would encompass Hanmi's strontium salt, "[b]y conspicuously choosing only certain members of the class, and using the language [in the patent specifications that] it did, AstraZeneca conveyed a clear and definitive meaning that it was disclaiming other members of the class" including Hanmi's strontium salts.  The Court cited portions of the specification in support of this construction, for example, "[t]he first sentence of the Detailed Description":

    The present invention refers to the new Na+, Mg2+, Li+, K+, Ca2+ or N+(R)4 salts of the single enantiomers of omeprazole, where R is an alkyl with 1-4 carbon atoms, i.e. Na+, Mg2+, Li+, K+, Ca2+ or N+(R)4 salts of (+)-[omeprazole] and (-)-[omeprazole], where R is an alkyl with 1-4 carbon atoms.

    This disclosure is specific, not generic according to the Court, and amounts to an express disclaimer of the scope of the claims AstraZeneca sought in litigation against Hanmi.

    The Court further held that this disclaimer was not overcome by more generic language in the specification, when taken in context, because there was no evidence that AstraZeneca used the more generic terms in any sense other than joined by express recitation of the six exemplary cations.  Neither the prosecution history nor the doctrine of claim differentiation was persuasive to the Court; with regard to the latter of AstraZeneca's asserted grounds of error, the Court stated that "the doctrine of claim differentiation does not . . . override clear statements of scope in the specification" citing Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1302 (Fed. Cir. 1999).

    Regarding AstraZeneca's prosecution history arguments, at least a part of the Court's reasoning for its decision is that it perceived from the prosecution history that the focus of what AstraZeneca was trying to protect changed during prosecution.  Specifically, the Court noted that AstraZeneca "conducted experiments that led it to conclude that one of the two enantiomers gave particularly good results," i.e., that which of the separated enantiomers (if either) was preferable was only known after the patent application was filed.  As a result, AstraZeneca "filed amended claims to focus on that enantiomer" in response to a rejection:

    When AstraZeneca filed the application that issued as the '504 patent, the language of the claims aligned perfectly with the written description's clear language about the scope of the "present invention":  the broadest of the claims were limited in terms to salts using the six identified cations, combined with either one of the two omeprazole enantiomers.  . . .  After the Examiner rejected those claims for anticipation and obviousness, . . . AstraZeneca shifted the focus to unexpected benefits achieved by using the (-)-enantiomer rather than the (+)-enantiomer.  Whereas the original claims and written description treated the two enantiomers with parity, AstraZeneca now distinguished the prior art by amending the claims to cover only esomeprazole, which it argued "unexpectedly exhibits a different and more advantageous pharmacokinetic profile than the racemic mixture or the (+)-enantiomer of omeprazole.  To support that assertion, AstraZeneca submitted clinical studies that, it explained to the Examiner, "involved both the monovalent sodium salt and the divalent magnesium salt of the (-)-enantiomer of omeprazole, thus supporting the full scope of the genus of alkaline salts disclosed in the application and as claimed herein."

    (record citations omitted, emphasis in opinion).

    The Court did not find the italicized language in the patents' prosecution history to be sufficient to overcome the intrinsic limitations in the language of the specification and broaden the scope to alkaline salts to be greater than the six expressly recited cations (the Court characterizing this as a "substantial expansion" of claim scope).

    AstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)
    Nonprecedential disposition
    Panel: Circuit Judges Dyk, Moore, and Taranto
    Opinion by Circuit Judge Taranto

  • Court Report

            By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited
    1:13-cv-09227; filed December 26, 2013 in the Northern District of Illinois

    • Plaintiffs:  Janssen Pharmaceuticals Inc.; Grünenthal GmbH
    • Defendant:  Alkem Laboratories Ltd.

    Janssen Pharmaceuticals, Inc. et al. v. Alkem Laboratories Ltd.
    2:13-cv-07803; filed December 23, 2013 in the District Court of New Jersey

    • Plaintiffs:  Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
    • Defendant:  Alkem Laboratories Ltd.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,536,130 (""Use of 1 Phenyl-3-Dimethylamino-Propane Compounds for Treating Neuropathic Pain," issued September 17, 2013), licensed to Janssen, following a Paragraph IV certification as part of Alkem's filing of an ANDA to manufacture a generic version of Janssen's Nucynta® ER (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults).  View the New Jersey complaint here.

    Merck Sharp & Dohme B.V. v. Warner Chilcott Co. LLC et al.
    1:13-cv-02088; filed December 24, 2013 in the District Court of Delaware

    • Plaintiff:  Merck Sharp & Dohme B.V.
    • Defendants:  Warner Chilcott Co. LLC; Warner Chilcott (US) LLC

    Infringement of U.S. Patent No. 5,989,581 ("Drug Delivery System for Two or More Active Substances," issued November 23, 1999) following a Paragraph IV certification as part of Warner Chilcott's filing of an ANDA to manufacture a generic version of MSD's NuvaRing® drug product (ethinyl estradiol and etonogestrel vaginal ring, used for contraception).  View the complaint here.

    Teijin Ltd. et al. v. Zydus Pharmaceuticals USA Inc. et al.
    1:13-cv-02086; filed December 23, 2013 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals U.S.A., Inc.
    • Defendants:  Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.

    Infringement of U.S. Patent No. 7,361,676 ("Solid Preparation Containing Single Crystal Form," issued April 22, 2008) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the complaint here.

    Genetic Veterinary Sciences Inc. v. Canine EIC Genetics LLC
    2:13-cv-00422; filed December 20, 2013 in the Eastern District of Washington

    Declaratory judgment of non-infringement of U.S Patent No. 8,178,297 ("Method of Detecting Canine Exercise-Induced Collapse," issued May 15, 2012) based on PPG's genetic screening service for Exercise-Induced Collapse ("EIC") in dogs.  Also, various claims sounding in state law, including unfair competition, etc.  View the complaint here.

    Cephalon Inc. v. Agila Specialties Inc. et al.
    1:13-cv-02080; filed December 20, 2013 in the District Court of Delaware

    • Plaintiff:  Cephalon Inc.
    • Defendants:  Agila Specialties Inc.; Onco Therapies Ltd.

    Cephalon Inc. v. InnoPharma Inc.
    1:13-cv-02081; filed December 20, 2013 in the District Court of Delaware

    Cephalon Inc. v. Dr. Reddy's Laboratories Ltd. et al.
    1:13-cv-02082; filed December 20, 2013 in the District Court of Delaware

    • Plaintiff:  Cephalon Inc.
    • Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the Agila complaint here.

    Cephalon Inc. v. Hetero Labs Ltd. et al.
    1:13-cv-02046; filed December 19, 2013 in the District Court of Delaware

    • Plaintiff:  Cephalon Inc.
    • Defendants:  Hetero Labs Ltd.; Hetero USA Inc.

    Infringement of U.S. Patent No. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.

    IGI Laboratories Inc. v. Mallinckrodt LLC et al.
    1:13-cv-02044; filed December 19, 2013 in the District Court of Delaware

    • Plaintiff:  IGI Laboratories Inc.
    • Defendants:  Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.

    Declaratory judgment of non-infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012) and 8,546,450 ("Treatment of Pain with Topical Diclofenac Compounds," issued October 1, 2013) based on IGI's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  View the complaint here.

  • Conference & CLE Calendar

    CalendarJanuary 8-12, 2014 – National CLE Conference (Law Education Institute, Inc.) – Vail, CO

    January 16, 2014 – "Provisional Patent Applications: Preserving IP Rights in First-to-File System — Assessing Whether to Use — and Strategies for Leveraging — Provisional Applications Under the New Patent Regime" (Strafford) – 1:00 to 2:30 pm (EST)

    January 21, 2014 – "Top Patent Law Stories of 2013" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    January 22, 2014 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (EST)

    January 22-23, 2014 – Patent Reform*** (American Conference Institute) – New York, NY

    January 23, 2014 – "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" (Strafford) – 1:00 to 2:30 pm (EST)

    January 30, 2014 -"Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Litigation and Post-Grant Proceedings — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" (Strafford) – 1:00 to 2:30 pm (EST)

    March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

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

  • Webinar on Maximizing Patent Prosecution Opportunities in Europe

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" on January 23, 2014 from 1:00 to 2:30 pm (EST).  Rebecca M. McNeill of VIVICAR Law and Jens Viktor Nørgaard of HØIBERG will provide guidance for patent counsel in drafting U.S.-origin patent applications to maximize prosecution opportunities in both the U.S. and Europe, and offer best practices for U.S. patent application drafters to protect inventions in Europe without sacrificing U.S. strategy.  The webinar will review the following questions:

    • What are the key considerations for patent counsel drafting U.S. applications when global patent protection is anticipated or desired?
    • What are the significant differences between the U.S. and European approaches to patent applications?
    • What steps should counsel take when drafting U.S. patent applications to maximize protection in Europe?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • European Biotech Patent Law Webinar

    D Young & CoD Young & Co will be offering its next European biotech patent law update on January 22, 2014.  The 45-minute webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (EST).  D Young & Co European Patent Attorneys Simon O'Brien and Robert Dempster will provide an essential update and live Q&A on EPO biotechnology case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • Webinar on Use of Provisional Applications under First-to-File Regime

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Provisional Patent Applications: Preserving IP Rights in First-to-File System — Assessing Whether to Use — and Strategies for Leveraging — Provisional Applications Under the New Patent Regime" on January 16, 2014 from 1:00 to 2:30 pm (EST).  Dale S. Lazar and Timothy W. Lohse of DLA Piper, and Craig Opperman, Chief Intellectual Property Officer of Naspers will discuss provisional patent applications, their benefits and limitations, and best practices for leveraging such applications.  The panel will also examine when and why provisional applications should be used and the issue of tying non-provisional patent applications to provisional applications.  The webinar will review the following questions:

    • Under what circumstances will a patent claimant get the most out of a provisional patent application?
    • What are the benefits and limitations of using a provisional patent application?
    • What are the important considerations when determining whether and when to use a provisional application?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • Webinar on Combatting Patent Trolls

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Combating Patent Trolls: Third-Party Solutions and Defense Strategies in Litigation and Post-Grant Proceedings — Leveraging Counterclaim, Summary Judgment and Other Tactics; Utilizing Legislative, Insurance and Third-Party Tools" on January 30, 2014 from 1:00 to 2:30 pm (EST).  Michael L. Kiklis of Oblon Spivak McClelland Maier & Neustadt and Kevin Jakel, CEO of Unified Patents will provide patent counsel with a broad-based view of defending against patent trolls, and discuss third-party solutions and provide a deep dive into specific troll strategies.  The webinar will review the following questions:

    • What third-party solutions are available?
    • What factors should be considered when determining if and when to use a third-party solution?
    • What defenses are available to companies facing patent troll claims?
    • What strategies can companies implement to minimize the impact of patent assertions?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by January 10, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • USPTO Issues Memo on Changes Pertaining to Patent Law Treaty

    By Donald Zuhn —

    USPTO SealLast week, we reported on changes to the rules of practice made pursuant to title II of the Patent Law Treaties Implementation Act of 2012 (PLTIA), which was enacted on December 18, 2012, and which amended U.S. Patent Law to implement the provisions of the Patent Law Treaty (PLT), which the Senate ratified on December 7, 2007.  The changes, which took effect on December 18, 2013 (one year after the PLTIA was enacted), were outlined in a final rule issued by the U.S. Patent and Trademark Office on October 21 (78 Fed. Reg. 62368).

    In a memorandum distributed to all patent employees on December 13, 2013, the Deputy Commissioner for Patent Operations, Andrew Faile; Deputy Commissioner for Patent Examination Policy, Andrew Hirshfeld; and Deputy Commissioner for Patent Administration, Bruce Kisliuk, discussed notable changes to the U.S. patent laws and practice resulting from the PLT and pertaining to the examination of patent applications.  The memo divides the changes into three categories:

    1.  Procedures for filing patent applications,

    2.  Restoration of the right of priority to a foreign application or a provisional application, and

    3.  Time for reply to Office actions and other notices.

    With respect to the first category of changes, the memo notes that under the PLT and PLTIA, a nonprovisional application may be filed without claims and/or drawings or may be filed by reference to a previously filed application.  The changes to the procedures for filing patent applications only apply to applications filed under 35 U.S.C. § 111 on or after December 18, 2013 (and therefore, do not apply to design patent applications).  As a result of the changes, the filing date of a provisional or nonprovisional application will be the date on which the USPTO receives a specification, with or without claims.  For nonprovisional applications filed without any claims, the Office of Patent Application Processing (OPAP) will issue a notice giving the applicant a time period within which to submit at least one claim in order to avoid abandonment.  The memo also notes that "[a]n application will not be placed on an examiner's docket unless and until the application includes at least one claim."

    With respect to the omission of drawings, the memo notes that "[i]f the subject matter of the application admits of illustration by a drawing to facilitate understanding of the invention, including where a drawing is necessary for the understanding of the invention, the USPTO will continue the practice of requiring a drawing."  However, the memo also notes that the practice of requiring a drawing prior to examination "should continue to be extremely rare and limited to the situation in which no examination can be performed due to the lack of an illustration of the invention."  In addition, the memo reminds USPTO employees that the above changes have not impacted the prohibition on submitting claims or drawings after the filing date that contain new matter.

    The memo points out that applicants may also file a new application by reference to a previously filed foreign, international, provisional, or nonprovisional application, with such reference being made in the application data sheet (ADS) or PLT Model International Request Form.  For applications filed by reference, the memo notes that the OPAP will issue a notice giving applicants a time period within which to submit an English language copy of the specification and drawings from the previously filed application in order to avoid abandonment.

    With respect to the second category of changes to patent practice, the memo notes that under the PLT and PLTIA, an application may claim priority to a foreign or provisional application filed up to fourteen months earlier if the application includes a petition to restore the right of priority that has been granted by the Office of Petitions.  The memo points out that pursuant to the PLT, the delay in filing the application between twelve and fourteen months after the earlier application was filed must have been unintentional (for design patent applications, the restoration of priority rights only applies to the period within six to eight months after an earlier application is filed).

    With respect to the final category of changes to patent practice, the memo notes that under the PLT and PLTIA, most (but not all) Office actions and other Office notices must set a time period for reply of at least two months.  The memo indicates that this final change primarily impacts Office actions containing only a requirement for restriction or an election of species, Office notices treating a reply by the applicant as non-responsive or noncompliant, and Office notices requiring compliance with the sequence regulations.  The memo also indicates that these changes only impact actions and notices mailed on or after December 18, 2013, and that reply time periods in the pre-appeal brief conference program and pre-first Office action on the merits interview program will not be impacted.  A table included in the memo outlines the impact of the PLT on actions that had one-month response times prior to December 18, 2013 (click on table to enlarge).

    PLT Impact on One Month Response Times
    As part of the Office's implementation of the PLT, the Office also informed applicants and their representatives last week via a Patents Alert e-mail that updated versions of several forms have been posted on the USPTO forms webpage.  In particular, the Office noted that revised versions of the following forms were now available:  Application Data Sheet (PTO/AIA/14), Petition for Revival of an Application for Patent Abandoned Unintentionally under 37 CFR 1.137(a) (PTO/SB/64), Petition for Revival of an Application for Patent Abandoned for Failure to Notify the Office of a Foreign or International Filing (37 CFR 1.137(f)) (PTO/SB/64a), and Petition to Accept Unintentionally Delayed Payment of Maintenance Fee in an Expired Patent (37 CFR 1.378(b)) (both PTO/SB/66 and SB/66-EFS-Web).

  • Season’s Greetings from Patent Docs

    Holiday StarsThe authors and contributors of Patent Docs wish their readers and families a Happy Holidays.  Publication of Patent Docs will resume on December 26th.