• By Andrew Williams —

    Supreme Court Building #2As we have reported over the past couple of weeks, the Supreme Court will hear arguments in two cases involving the attorney fees provision of 35 U.S.C. § 285 on Wednesday, February 26.  That statute provides that a "court in exceptional cases may award reasonable attorney fees to the prevailing party."  These cases will be heard shortly after the Court convenes at 10:00 A.M. Eastern.  The first of the cases listed on the Hearing List, Highmark Inc. v. Allcare Management Sys., Inc., relates to whether the lower court's determination regarding attorney fees is entitled to deference.  Specifically, the question presented was: whether a district court's exceptional-case finding under 35 U.S.C. § 285, based on its judgment that a suit is objectively baseless, is entitled to deference.  The second listed case, Octane Fitness v. Icon Health and Fitness, involves how a court is to determine when a case is exceptional.  The specific question presented was:

    [W]hether the Federal Circuit's promulgation of a rigid and exclusive two-part test for determining whether a case is 'exceptional' under 35 U.S.C. § 285 improperly appropriates a district court's discretionary authority to award attorney fees to prevailing accused infringers in contravention of statutory intent and this Court's precedent, thereby raising the standard for accused infringers (but not patentees) to recoup fees and encouraging patent plaintiffs to bring spurious patent cases to cause competitive harm or coerce unwarranted settlement from defendants.

    We have already explained the factual and procedural history of both cases, and highlighted the arguments presented in the briefs submitted by the Petitioners and Respondents in both cases (see "Supreme Court Preview — Octane Fitness, LLC v. ICON Health & Fitness, Inc." and "Supreme Court Preview — Highmark Inc. v. Allcare Health Mgmt. Sys., Inc.").  The amicus curiae briefs in the Octane Fitness case unanimously supported a change in the standard for an exceptional-case determination (even though some of them filed briefs in support of neither party).  They also almost all supported a standard that applies equally to plaintiff patent holders and defendant accused infringers.  In addition, almost all recognized the incentives that the current Federal Circuit standard provides for patent holders to assert their patents abusively (although they portrayed very different pictures of the state of the problem).  What was interesting, however, was the different approaches and alternatives suggested for what the standard should be.  For example, should the district court only look to whether the position of the non-prevailing party was "objectively baseless," or can the subjective intent of the party ever be considered.  Because it is very possible that the Court will adopt one of these new standards, it is worthwhile to review some of the suggestion and arguments presented in these briefs.  This post addresses a selection of the amicus curiae briefs.

    United States Amicus Curiae Brief

    It is generally advisable when reviewing various amicus curiae briefs for a given case to begin with the brief for the United States.  This is because not only is the Solicitor General provided special attention by the Court, but in this case, Roman Martinez, Assistant to the Solicitor General, is scheduled to argue for the United States.  In this case, the United States is advocating a totality of the circumstances test.  Specifically, according to the United States, the lower court should be able to consider whether the losing party had inflicted "gross injustice" on the prevailing party before or during the case.

    To support its position, the United States looked to the history of 35 U.S.C. § 285, including its adoption in 1952.  This statute was based on one that was introduced in 1946, but did not include the "exceptional case" limitation.  Nevertheless, the legislative history suggested that the new provision was not intended to change the substantive standards for granting fee awards.  Therefore, according to the United States, the standard should be the same as that used between 1946 and 1952.  During this time, "grossly unjust" conduct could support a fee award, and such conduct included fraud on the Patent Office, willful infringement, harassing tactics during litigation by either party, or untenable legal or factual theories.  This standard did not have to rise to the level of objective baselessness, because fee awards were made when the theories were "unjustified," "wholly unjustified," "unwarranted," "unreasonable," or "groundless."  Also, "subjective bad faith" was not required, although the United States argued that it could be highly relevant to the Section 285 analysis.  Finally, the United States urged that "clear and convincing" evidence should not be required for an accused infringer to be awarded fees.  The United States did not take a position on whether the present case was an exceptional case under the proffered standard, but instead requested that the case be vacated and remanded.

    Amicus Curiae Briefs From Participants in the Patent System

    Several different companies that own and assert patents filed amicus curiae briefs, either alone or as part of a collection.  In general, they pointed out that as owners of intellectual property and as frequent targets of abusive litigation tactics, they have a balanced perspective and unique insights into the issue.  For example, a collection of seven intellectual property owners, Yahoo!, the New York Times, NetApp, Medtronic, General Mills, EMC, and Boston Scientific, filed a brief in support of petitioners in both cases.  This collection of companies is somewhat interesting, because it includes two (Medtronic and Boston Scientific) that were on opposing sides of a recently decided Supreme Court case.  In an articulated standard much like the one proffered by the United States, this collection urged the adoption of a test that would "afford[] a district court discretion to enter a fee award in favor of a plaintiff or defendant whenever it would be grossly unjust or inequitable for the prevailing party to bear its own costs."  Brief at 5.  And, just like the United States, this collection pointed to the period just before the enactment of 35 U.S.C. § 285 for support.  However, they also pointed to the statute itself as giving three "guideposts" for a district court to follow.  These are that "exceptional" cases are meant to be those that are "uncommon" or "extraordinary," that prevailing plaintiffs and defendants are to be treated equally, and the trial court should have discretion to make the grant determination, as well as the amount.

    Another collection of intellectual property owners, 3M Co., General Electric Co., The Procter & Gamble Company, and Johnson & Johnson, also filed a brief advocating a flexible standard.  Specifically, they urged the "adoption of a flexible standard that permits 'district courts in patent cases to consider traditional equitable factors, guided by the purposes of patent law, in granting fee awards' under Section 285."  Brief and 4.  This collection also acknowledged that there is a problem of abusive patent litigation, but they went out of their way to defend patent assertion entities, explaining that they serve a valuable purpose in the patent system.  For example, they pointed out that the U.S. patent system has always been based on a disclosure system, and that patent holders have never been requirement to practice the invention.  In fact, this collection stressed that greater than 60% of the inventors of the Industrial Revolution sold or licensed at least some of their patents, including Thomas Edison and Charles Goodyear.

    Another collection of "leading providers of high-technology products and services" filed anamicus curiae brief supporting a flexible standard.  This collection included Google, Cisco Systems, Facebook, HTC, Intel, LinkedIn, Motorola Mobility, Netflix, Newegg, Rackspace, salesforce.com, T-Mobile, Verizon, and Vizio.  Specifically, they asserted that there should be no exclusive list of factors that can make a case exceptional under § 285, but that these factors should all be considered together.  Importantly, they requested a disjunctive approach in which subjective bad faith and objective reasonableness can either be used as an independent bases for fee-shifting.  Therefore, bad faith alone can support an award of attorney fees.  Another collection, this one entitled BSA | The Software Alliance, disagreed, and instead asserted that "objectively unreasonable" should be the standard.  The standard was summarized as "[a] losing litigant that persists in advocating a claim or defense lacking an objective basis in law or fact should pay the winning party's fees."  Brief at 2.  BSA | The Software Alliance did not think that a subjective component should be included because common law already allows for fee-shifting when the lower litigates in bad faith.

    The final participant in the patent system to file an amicus curiae brief (not including the Intellectual Property Owners Association), and the only one to do it on its own, was Apple.  Apple's brief was in support of the patent system, but it came out strong against so-called "patent trolls."  It advocated a flexible standard that would look to a host of factors relevant to the particular litigation.  Specifically, Apple advocated for the inclusion of such factors as "the nature of the parties, the motivations underlying the parties' positions, the objective merit of both parties' claims and the particular arguments advanced in court, and the parties' conduct."  Brief at 9.  Only then, according to Apple, will the fee-shifting provision of § 285 function properly to deal with "patent assertion entities that thrive on strike suits, nuisance suits, and in terrorem demands."  Brief at 7.

    Amicus Curiae Briefs From "Anti-Troll" Representatives

    There were several briefs that were filed for organizations and individuals that focused more on the so-called "patent troll" problem then on what the appropriate standard should be for what an exceptional case should be.  For example, the Electronic Frontier Foundation, et al., ("EFF") spent almost its entire brief explaining how the current standard was allowing patent trolls to thrive, and therefore harming small businesses, start-ups, and American innovation.  Only near the end of its brief did the EFF advocate for a flexible test that considers the totality of the circumstances.  The EFF would look to whether the "Plaintiff brings an objectively weak case or uses the cost of defense as a weapon."  Brief at 17.  Not surprisingly, the EFF focused almost exclusively on when the non-prevailing party is the patent holder.  Therefore, it did not address the sort of factors one would look when the accused infringer was the non-prevailing party, if they would even be entitled to an award under the EFF's scheme in the first place.

    To their credit, however, the EFF did provide a somewhat workable test, even if it was one-sided.  Professor Robin Feldman and the U.C. Hastings Institute for Innovation Law filed an amicus brief urging the Court to adopt a standard which would "empower courts to remedy schemes that exploit the patent system."  Instead of articulating a standard, Prof. Feldman railed against the Federal Circuit's standard and the abuses that have stemmed from it.  One of the "abuses" that she cites is that of reverse payments in Hatch-Waxman litigations.  However, she does not explain how section 285 could be used to stop such "abusive schemes."

    As a final example of the "anti-troll" amicus briefs, a collection of thirty (30) states, including Vermont and Nebraska (but not Illinois), filed a brief advocating overturning the Federal Circuit's precedent.  Like the other "anti-troll" parties, these states urge a standard that does not provide for a shift of fees when the accused infringer is the non-prevailing party.  Instead, the states submit that the district courts should "have discretion to award fees where the patentee's claim had an objectively low likelihood of success and a fee award is otherwise appropriate."  Brief at 27.  They also urged the Court to consider the broader context – and unfortunately they asserted that this broader context was that the patent system is broken.  For example, in addition to addressing the "attorney fee" problem, the collective states extoll the other problems of the patent system, including the Federal Circuit's test for personal jurisdiction, the lenient pleading standards allowed by Form 18, and the cost of litigating vague and ambiguous patent claims caused by the Federal Circuits "insolubly ambiguous" test for 35 U.S.C. § 112, ¶ 2.  Of course, the Supreme Court is taking up this last issue in the Biosig Instruments, Inc. v. Nautilus, Inc. case, but it is unclear how the Court is supposed to "take into account" these other problems to address how an "exceptional case" is determined.

  • By Donald Zuhn —

    Washington - White House #2Last week, the Obama Administration announced "major progress on a series of initiatives designed to combat patent trolls and further strengthen our patent system and foster innovation" (see "The White House Releases Update on 'Protecting American Inventors and Innovators'").  In addition to a number of executive actions discussed in our earlier report, the White House also announced delivery on its commitment of "Promoting Transparency" concerning patent ownership.  In particular, a White House Fact Sheet states that:

    • Promoting Transparency — The United States Patent and Trademark Office (USPTO) recently published a draft rule to ensure patent owners accurately record and regularly update ownership information when they are involved in proceedings before the USPTO.  This effort is aimed at improving the quality of patents issued, enhancing competition, facilitating technology transfer, and making it harder to hide abusive litigation tactics behind shell companies.  After receiving input from the public, the USPTO aims to issue a final rule in the coming months.

    The White House Fact Sheet can also be accessed from the USPTO homepage by clicking on the heading "Driving Innovation, Not Litigation"

    USPTO SealThe draft rule discussed in the Administration's Fact Sheet, which was published as a notice of proposed rulemaking in the Federal Register (79 Fed. Reg. 4105) on January 24, would change the rules of practice to require that the "attributable owner" be identified at the time an application is filed (or shortly thereafter), during the pendency of an application when there is a change in the attributable owner (within three months of such change), at the time the issue fee is paid, when maintenance fee payments are made, and if a patent becomes involved in supplemental examination, ex parte reexamination, or a trial proceeding before the Patent Trial and Appeal Board (see "USPTO Proposes Rules Changes to Require Identification in Applications and Patents of Attributable Owners" for more infoirmation regarding the proposed rules changes).  The Office indicated that comments on the notice of proposed rulemaking could be sent by e-mail to AC90.comments@uspto.gov, by regular mail addressed to:  Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of James Engel, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy, or via the Federal eRulemaking Portal, with the deadline for submitting comments initially set for March 25, 2014.

    The link embedded in the White House Fact Sheet's paragraph on "Promoting Transparency" takes readers to a webpage on "Attributable Ownership" at the USPTO website (which as new USPTO webpages goes is far less controversial than the Office's "Beta" webpage entitled "Been Sued or Gotten a Demand Letter?  Answers To Common Questions About Abusive Patent Litigation," and in particular, certain links that can be found in the "Resources and Glossary" page; for more information, see our report on the Office's new "on-line toolkit").  The Attributable Ownership webpage provides a few interesting announcements.  First, the page indicates that the March 25 comment deadline has been extended to April 24, 2014.  The page also indicates that the two public meetings described in the notice of proposed rulemaking will be held on March 13 from 1:00 to 4:00 pm (ET) at the USPTO Madison Auditorium North in the Madison Building, 600 Dulany Street, Alexandria, VA 22314, and on March 26 from 9:00 am to 12:00 pm (PT) at the U.C. Hastings College of the Law, Louis B. Mayer Lounge, 198 McAllister Street, San Francisco, CA 94102.  Both meetings will be accessible via WebEx, with access information to be provided closer to the meeting dates.

    WegnerWith respect to the White House's efforts to promote transparency concerning patent ownership, Hal Wegner (at right) stated in his e-mail newsletter on February 18 that while "attempts to minimize comment have involved suppression of existing comments as if this will perhaps lead to the public falling asleep at the comment switch," "the leadership of the Patent Office has been sheltered from questioning by the public, while the Administration’s lobbyist group, 'Business Forward', continues to have access to PTO leadership" (emphasis in original).  With respect to the Office's attempts to minimize comments on the proposed Attributable Ownership rules, Mr. Wegner noted that as of his e-mail above, no comments had been posted on the USPTO comments webpage.  As of this post, four comments have been posted in response to the notice of proposed rulemaking on Attributable Ownership, with one comment coming from a law firm and three comments coming from individuals.  With regard to the Office's meetings with the group Business Forward, Mr. Wegner noted that a closed door luncheon for selected members of the group and USPTO Deputy Director Michelle Lee had to be postponed as it was set to take place on the same day that the White House announced progress on its patent initiatives.  According to the Business Forward website:

    Members include Aetna, American Airlines, AT&T, CIT, Citi, Comcast, Dow, Duke Energy, Fidelity, Ford, Hilton Worldwide, Intuit, Lockheed Martin, McDonald's, Microsoft, Qualcomm, Time Warner, Time Warner Cable, Verizon, Visa, and Walmart.

    These corporations work with Business Forward to identify, recruit and brief small business owners, venture capitalists and entrepreneurs of all kinds who are looking for a meaningful way to participate in policy debates.

  •         By Sherri Oslick —

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

    AbbVie Inc. et al. v. Aurobindo Pharma Ltd. et al.
    1:14-cv-00215; filed February 19, 2014 in the District Court of Delaware

    • Plaintiffs:  AbbVie Inc.; Wisconsin Alumni Research Foundation
    • Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

    Infringement of U.S. Patent Nos. 5,597,815 ("Prevention of Hyperphosphatemia in Kidney Disorder Patients," issued January 28, 1997) 6,136,799 ("Cosolvent Formulations," issued October 24, 2000), and 6,361,758 (same title, issued March 26, 2002), following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AbbVie's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.

    AbbVie Inc. v. Gilead Sciences Inc. et al.
    1:14-cv-00209; filed February 18, 2014 in the District Court of Delaware

    • Plaintiff:  AbbVie Inc.
    • Defendants:  Gilead Sciences Inc.; Gilead Pharmasset LLC; Gilead Sciences Ltd.

    Infringement of U.S. Patent Nos. 8,466,159 ("Methods for Treating HCV," issued June 18, 2013) and 8,492,386 (same title, issued July 23, 2013) based on Gilead's anticipated manufacture and sale of its combination therapy for the treatment of HCV using sofosbuvir and ledipasvir.  View the (redacted) complaint here (original filed under seal).

    Salix Pharmaceuticals Inc. et al. v. Novel Laboratories Inc.
    1:14-cv-00213; filed February 18, 2014 in the District Court of Delaware

    • Plaintiffs:  Salix Pharmaceuticals Inc.; Dr. Falk Pharma GmbH
    • Defendant:  Novel Laboratories Inc.

    Infringement of U.S. Patent Nos. 6,551,620 ("Pellet Formulation for the Treatment of the Intestinal Tract," issued April 22, 2003), 8,337,886 (same title, issued December 25, 2012), and 8,496,965 (same title, issued July 30, 2013) following a paragraph IV certification as part of Novel's filing of an ANDA to manufacture a generic version of Salix's Apriso® (mesalamine, used for the maintenance of remission of ulcerative colitis in adults).  View the Delaware complaint here.

    Otsuka Pharmaceutical Co., Ltd. v. Torrent Pharmaceuticals Ltd. et al.
    1:14-cv-01078; filed February 18, 2014 in the District Court of New Jersey

    • Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
    • Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

    Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011) and 8,580,796 (same title, issued November 12, 2013) following a Paragraph IV certification as part of Torrent's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

    Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals ApS
    3:14-cv-00124; filed February 18, 2014 in the Western District of Wisconsin

    Merck Sharp & Dohme Corp. v. Xellia Pharmaceuticals ApS
    1:14-cv-00199; filed February 14, 2014 in the District Court of Delaware

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,952,300 ("Antifungal Compositions," issued September 14, 1999) following a Paragraph IV certification as part of Xellia's filing of an ANDA to manufacture a generic version of Merck's Cancidas® (caspofungin acetate, used to treat presumed fungal infections in febrile, neutropenic patients, candidemia and certain Candida infections, esophageal candidiasis, and invasive aspergillosis in patients who are refractory to or intolerant of other therapies).  View the Delaware complaint here.

    Forest Laboratories Inc. et al. v. Apotex Corp. et al.
    1:14-cv-00200; filed February 14, 2014 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
    • Defendants:  Apotex Corp.; Apotex Inc.; Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd. d/b/a/ Zydus Cadila; Par Pharmaceutical Inc.; Anchen Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida

    Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

    Teijin Ltd. et al. v. Roxane Laboratories Inc.
    1:14-cv-00189; filed February 12, 2014 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
    • Defendant:  Roxane Laboratories Inc.

    Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of Roxane's 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.

  • CalendarFebruary 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

    February 27, 2014 – "Patent Inventorship: Best Practices for Determination and Correction — Drawing the Line Between Inventor and Contributor, Leveraging Lessons From Year One of the AIA" (Strafford) – 1:00 to 2:30 pm (EST)

    February 27-28, 2014 – Ninth Annual Symposium (Northwestern Journal of Technology & Intellectual Property and The Searle Center on Law, Regulation, and Economic Growth) – Chicago, IL

    February 28, 2014 – 58th Annual Intellectual Property Law Conference (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

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

    March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 13, 2014 – "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

    March 20, 2014 – "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" (Strafford) – 1:00 to 2:30 pm (EST)

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    March 26, 2014 – "Trade Secret vs. Patent Protection After AIA: Making the Choice — Understanding AIA's Impact on Trade Secrets, Evaluating the Protection Options, Weighing the Benefits and Risks" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

    March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

    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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Trade Secret vs. Patent Protection After AIA: Making the Choice — Understanding AIA's Impact on Trade Secrets, Evaluating the Protection Options, Weighing the Benefits and Risks" on March 26, 2014 from 1:00 to 2:30 pm (EDT).  R. Mark Halligan of Nixon Peabody will provide guidance for IP counsel in determining trade secrets or patents as the mode of protection for inventions and technologies, and examine the AIA's impact on trade secrets and offer best practices for determining which form of protection works best for the subject matter.  The webinar will review the following questions:

    • What impact does the AIA have on trade secrets?
    • Which subject matter is more suitable for trade secrets?
    • Which is more suitable for patents?
    • What factors should counsel consider when choosing between trade secrets and patents as the mode of IP protection?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by February 28, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • By Andrew Williams —

    Washington - White House #1Earlier today, the White House provided an update on the five executive actions that it announced in June of 2013.  At the time, we reported on the President's legislative recommendations and executive initiatives, as well as the Patent Assertion and U.S. Innovation report that accompanied them (see "'When the Patent System is Attacked!' — The White House Task Force on High-Tech Patent Issues").  In addition to "announcing major progress" today on these initiatives to combat so-called "patent trolls" ("FACT SHEET — Executive Actions: Answering the President’s Call to Strengthen Our Patent System and Foster Innovation"), the White House hosted a live webcast entitled "Building a Better Patent System."  President Obama did not participate, but instead PTO Deputy Director Michelle Lee, Secretary of Commerce Penny Pritzker, U.S. Chief Technology Officer Todd Park, and Gene Sperling, Director of the National Economic Council collectively spoke for about 30 minutes on how the executive actions were "building a better patent system" ("Building a Better Patent System").

    With regard to the progress of the patent litigation reform legislation, Mr. Sperling acknowledged that the White House did not agree with everything that ended up in the Innovation Act.  There was some suggestion that the fee-shifting provision found in the final House bill was not what the White House was expecting.  Instead, the President had originally suggested modifying the patent attorney fee provision to have it mirror the equivalent provision in the copyright statute.  This, presumably, meant removing the "exceptional case" requirement, while maintaining the default "American Rule," in which generally both sides pay their own costs.  Of course, the provision in the Innovation Act adopted the so-called "British Rule," with the default being that the losing (i.e., non-prevailing) party pays.  Mr. Sperling indicated that the White House was open to comprise on the issue.  Nevertheless, he said the President is hopeful that he will be able to sign the new legislation into law sometime in 2014.

    As for the executive initiatives, the most immediate was the launching of a new "on-line toolkit" "[t]o help level the playing field and ensure individuals and businesses know their rights and are aware of available resources before entering into costly litigation or settlements . . . ."  On this site, there are icons for various resources directed to victims of abusive patent practices.  The first link provides information for what to do if "I've been sued," which provides information about the patent litigation process.  Also within this link are resources to help find a lawyer (with links to the Office's list of registered patent agents and attorneys, as well as state bar attorney lists), determine if anyone else has been sued over the same patent, and provide information about challenging the patent at the Office.  Another link is directed to individuals that have received demand letters.  The resources on this site include identifying options for the demand-letter recipient, providing guidance if the recipient is an end-user customer (with convenient links to the states attorney general's offices and the FTC), and providing links to find out more information about the asserted patent and who might be behind the demand letter.  The PTO toolkit also includes links to help identify related cases, to provide information about the patent infringement process, and to more generally provide information about patents.

    Perhaps the most interesting link on this new "online toolkit" website is the "Resources and Glossary."  In this section, the Patent Office provides links to several other sites, at least one of which has stated quite plainly that "the patent system is broken," and that the "US Patent Office . . . issues questionable patents every day."  One of the "resources" is to a crowd-sourcing website, Ask Patents, which can assist accused infringers in identifying invalidating prior art.  This is the same website that the Electronic Frontier Foundation ("EFF") used to help find the art that was cited in its petition for Inter Partes Review of Personal Audio's podcasting patent (see "When NPR Podcasters Hit the Patent System – An Update").  In addition, one of the "resources" is a link to the "Trolling Effects" website, which "is a project of the Electronic Frontier Foundation . . ." ("About Trolling Effects").  This site also starts from the premise that the patent system is broken, and offers a "crowd-sourced" demand-letter database.  Of course, submission of demand letters is purely voluntary, and is, for obvious reasons, only done by recipients.  Currently the database holds about 45 letters.  And, not surprisingly, another one of the "resources" is the EFF website itself, ostensibly for the purpose of providing "legal services and referrals, through a 'Cooperating Attorney' list."

    On the subject of "crowdsourcing," the White House also announced three new executive actions aimed at "encouraging innovation and further strengthen[ing] the quality and accessibility of the patent system."  The first of these, "Crowdsourcing Prior Art," is a new initiative to expand ways in which the general public can help patent examiners and applicants find prior art.  No details were provided, however, about how such a system would work.  Second, the White House indicated that it was introducing more robust technical training for its patent examiners.  The Administration is requesting that "innovators . . . volunteer their time and expertise" to provide such training.  Finally, the White House indicated that it will dedicate resources to assist inventors without legal representation.

    Patent Docs will continue to report on any updates from the White House related to these executive actions and initiatives.

  • The Decision of the Court of Appeal in Hospira UK Generics Ltd. v. Novartis AG, [2013] EWCA Civ. 1663 was issued on 19 December 2013.

    Background

    NovartisThe case was initially heard in the High Court and raised the issue of entitlement of a patented invention to priority.  The patent in question was European Patent (UK) 1 296 689, owned by Novartis AG, which related to the use of a particular member of the bisphosphonate class of drugs for the treatment of osteoporosis, amongst other things.

    The particular claim in question was Claim 7 which can be expressed as the combination of the following features:

    (i) the use of a zoledronate medicine
    (ii) for the treatment of osteoporosis
    (iii) where the medicine is adapted for intravenous administration in a unit dosage form
    (iv) comprising from about 2 up to about 10 mg of zoledronate
    (v) wherein the period between administrations is about one year

    Claim 7 claimed priority from two priority documents.  The case, in part, related to whether the second of these priority documents, namely United States patent application number 267689 (hereinafter referred to as 'the priority document'), disclosed the subject matter of Claim 7.  It was agreed that Claim 7 would be invalid if it was not entitled to priority since an intervening publication would become available for an attack on validity.

    In the High Court, Mr Justice Arnold held that the Claim 7 was not entitled to priority since there was no disclosure in the priority document linking all of the features of Claim 7.  Thus, the claim was rendered invalid.

    Novartis appealed the Decision of the High Court.

    Appeal

    Novartis argued that the judge in the court of first instance was led into error by failing to read the priority document as a whole.  Novartis added that had the priority document been read as a whole, the judge would have appreciated the clear link between zoledronate, osteoporosis and intravenous administration which ran through the entire document.

    In addressing Novartis' argument, Lord Justice Floyd outlined the law on the approach to priority, noting that although the language of Section 5 of the UK Patents Act and Article 87 EPC (which relate to priority) is different, the two formulations must be taken to mean the same thing (see Jacob LJ in Unilin Beheer BV v Berry Floor NV [2004] EWCA (Civ) 1021; [2005] FSR 6 at [39]).  More specifically, Article 87 EPC states that for a valid priority claim, the later patent application must be in respect of the same invention.  The Enlarged Board of Appeal in G2/98 held that the requirement for claiming priority of the same invention was met if the skilled person could derive the subject matter of the claim directly and unambiguously, using the common general knowledge, from the priority application as a whole.

    Following this, Lord Justice Floyd asserted that the problem for Novartis in seeking to establish that Claim 7 was entitled to priority was that the disclosure of the priority document was either too general or too specific.

    In particular, the passage relating to zoledronate in an amount of from about 2 up to about 10 mg once a year told the skilled person nothing about the dosage range for any particular method of administration.  Further to this, it did not tell the skilled person about the dosage range for any particular condition, for example osteoporosis, i.e., the passage was too general.

    Contrary to Novartis' assertion that the passage relating to zoledronate in an amount of from about 2 up to about 10 mg once a year was applicable to all modes of administration and all conditions, Lord Justice Floyd held that the passage would be read by the skilled person as meaning that depending on the method of administration and the condition being treated, some doses within the range may be suitable.

    Example 5, on the other hand, disclosed 4 mg of zoledronate taken once a year, administered intravenously to patients with post-menopausal osteoporosis as being effective.  However, it was held that Example 5 did not disclose any other doses that could be used at that dosage interval, i.e., the passage was too narrow.

    Since there was no disclosure in the priority document linking all of the features of Claim 7, Lord Justice Floyd concluded the claim was not entitled to priority from United States patent application number 267689 and thus, it followed that the patent was invalid.

    Conclusions

    Even though each of the features of Claim 7 was disclosed in the priority document, without the explicit linking of these features, the subject matter was not considered clearly and unambiguously disclosed to the skilled person (in accordance with G2/98).  In view of this Decision, it is advisable to take extra care when drafting priority documents to ensure that there are clear linking statements for all the claimed subject matter.

    This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.

  • By Andrew Williams —

    Supreme Court Building #3As we indicated last week, the Supreme Court will hear arguments next week in two cases involving the Attorney Fees provision at 35 U.S.C. § 285.  That section provides that a district court may award reasonable attorney fees to a prevailing party "in exceptional cases."  The Octane Fitness case, which we previewed last week, will address what the standard is for determining when a particular case is "exceptional."  Specifically, the Court will be reviewing the standard articulated by the Federal Circuit, which provided that a case is only exceptional when "both (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless," absent misconduct in litigation or in securing the patent.  See Brooks Furniture Mfg. v. Dutailier, Inc., 393 F.3d 1378 (Fed. Cir. 2005).  The second case, Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., will address the level of deference that the lower court's determination is entitled to on appeal.  The question presented in that case is: whether a district court's exceptional-case finding under 35 U.S.C. § 285, based on its judgment that a suit is objectively baseless, is entitled to deference.

    To be clear, even though it is only the standard of review of the objective prong of an "exception-case" determination that is at issue, it result could also impact the level of deference for subjective-prong determinations as well.  According to the reasoning found in the Federal Circuit's Highmark opinion, there are three standards of review for an award of attorney fees in a patent case.  First, the objective prong is entitled to de novo review because it is purely an issue of law.  Second, the subjective "bad-faith" prong is mainly factual, and therefore entitled to review for clear error.  Finally, if the case is exceptional, the awarding of fees is reviewed under an abuse-of-discretion standard.  Therefore, in the Highmark case, because the Federal Circuit was reviewing the "objectively baseless" prong, it reviewed the lower court's determination de novo.  But, Highmark is seeking a unitary abuse-of-discretion standard for § 285 fee awards, even though there are both questions of law and fact that the lower court must decide.

    Highmark's primary argument is that two Supreme Court cases, Pierce v. Underwood, 487 U.S. 552 (1988) and Cooter & Gell v. Hartmarx, 496 U.S. 384 (1990), dictate the higher standard in patent cases.  In response, Allcare mainly points to the Supreme Court case of Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (1993) ("PRE") as controlling, which is the same case the Federal Circuit relied upon in devising the two-part test in Brooks Furniture.  It is also the same case the Federal Circuit cited in support of the decision rendered below.

    With regard to the facts of this case, Allcare is the owner of U.S. Patent No. 5,301,105 ("the '105 patent"), which is directed to "managed health care systems" used by insurance companies to interact with providers.  The patent discloses two embodiments of the invention, a "diagnostic" system and a "utilization-review" system.  The former involves inputting a patient's symptoms, and the system prepares a list of possible medical conditions.  The latter involves inputting both symptoms and the proposed treatment into the system, and if the treatment is considered to be potentially inappropriate for the symptoms, it is flagged for "utilization review."  This review allows the insurance company to determine if a payment should be made.  Highmark used a system that incorporates "utilization review," so the determinative issue at the district court was whether the claims of the '105 patent covered this embodiment.  After a special master assisted the court in construing the claims and in determining that Highmark should be granted summary judgment of non-infringement, the court adopted the reports without substantial change, thereby disposing of the case.  When the merit case was on appeal, Highmark moved for an exceptional case finding pursuant to § 285, which the court granted on the papers and awarded fees.

    The Federal Circuit affirmed the merit appeal.  However, in response to Allcare's appeal of the exceptional-case determination, the court reversed the lower court's determination as to all claims except the assertion of claim 102 (the determination as to this single claim was remanded to the district court).  The judges on the panel, and indeed the entire court, were almost evenly split on the issue of deference.  The majority opinion, authored by Judge Dyk, relied heavily on the PRE case to hold that the objective-baselessness standard is an issue of law to be reviewed de novo.  However, Judge Mayer dissented, citing to cases like Pierce and Cooter and articulating arguments echoed later in Highmark's merit brief.  Highmark petitioned for a panel rehearing and for a rehearing en banc, both of which were denied.  The denial indicated that the poll for en banc review was "requested, taken, and failed," but five of the twelve judges either wrote or joined dissents, expressing disagreement with the panel's determination.  Judge Mayer did not participate in the decision, but if he had, the court would have been evenly split.  Needless to say, this is not a clear-cut case.

    In its merit brief to the Supreme Court, Highmark relied heavily on the Pierce and Cooter cases.  Pierce involved the proper standard of review for fee awards under the Equal Access to Justice Act ("EAJA").  This statute provides an award of fees upon a finding that the United States' position was not "substantially justified."  This was defined as the position having no "reasonable basis in both law and fact," which was equated to the § 285 "objectively baseless" prong.  The Court in Pierce reasoned that "sound judicial administration" dictated a standard for the "substantial-justification" finding of abuse of discretion.  Cooter involved the determination of the standard of review for the imposition of Rule 11 sanctions.  The Court in that case concluded that all aspects of the decision, even the legal conclusions, should be reviewed under a unitary, abuse-of-discretion standard.

    Highmark applied the reasoning used by the Supreme Court in those two cases to explain why the same result is required here.  First, the statutory text suggests discretion, because it uses the word "may," and "exceptional" cases denote case-by-case judgments best left for the decision of the district court judge.  This argument appears to the miss the mark, however, because no one denied that the actual award of fees is properly reviewed for abuse of discretion.  Rather, the "question presented" related only to the objectively baseless prong.  Next, Highmark pointed out that the district court judge is the best-positioned decision maker.  It is somewhat curious that it would highlight this factor, because the lower court judge appeared to relegate a significant portion of the case to the special master.  Highmark also pointed to the efficiencies associated with deference to the lower court, because the objective-baselessness inquiry "requires appellate courts to have intimate familiarity with the entire progression of a case."  However, the Federal Circuit addressed this concern below, pointing out that review of a case for an award of attorney fees is usually the second time the facts of the case are in front of them, the first being during the merit review.  Therefore, this concern might be overblown.  Highmark continued, explaining that the fact-intensive nature of these decisions would result in very little law-clarifying value, as it would be difficult to formulate a rule for the various case-by-case determinations.  Highmark concluded that the Federal Circuit's holding would distort the appellate process and would not discourage collateral appeals.  In sum, Highmark's position was that the factors as articulated in Pierce and Cooter require that a unitary abuse-of-discretion standard is necessary in the review of § 285 decisions.

    On the other hand, Allcare focused extensively on the PRE decision, explaining why it was more appropriately analogous.  First, Allcare pointed out that "[t]he 'objective-reasonableness' standard derives from the concept of 'probable cause.'"  As PRE explained, "'[p]robable cause to institute civil proceedings requires no more than a 'reasonabl[e] belie[f] that there is a chance that [a] claim may be held valid upon adjudication.'"  Brief for Respondent, at 23 (citing PRE, 508 U.S. at 62-63).  And, "the question of whether a given set of facts justified bringing suit is ultimately a legal question."  Id.  Allcare relied on the fact that there are no facts in dispute in this case, which then reduces the question to a pure issue of law.  However, Allcare did point out that in all such cases, there will never be facts in dispute, because the relevant facts make up the record of the case.  The parties' positions in filing and maintaining patent infringement lawsuit, therefore, will not be in dispute (so the argument goes).

    In the end, this case appears to come down to whether the Supreme Court will find that the Pierce and Cooter cases are more in line with § 285 determinations, or whether the Court will look to the reasoning articulated in PRE.  The Court's decision in Octane Fitness could also be a factor, because a change in the standard for determining exceptional cases could affect the standard of review.  Of course, both sides pointed out why their position would still survive regardless of the outcome of Octane Fitness.

    Finally, as with any case dealing with the shifting of attorney fees, Highmark and some of the amicus curiae brought up the public policy argument against so-called "patent trolls." (Interestingly, the amicus briefs were fairly evenly split between supporting Highmark, supporting Allcare, and supporting neither party).  However, Allcare criticized this attempt at appealing to public sentiment as having no substance, because Highmark could not support its assertion that a change in the standard of review for decisions on attorney fees would reduce the incentive for non-practicing patent assertion entities to file infringement lawsuits.  In its reply brief, Highmark concedes that "a deferential review standard will not solve these problems."  Reply Brief for Petitioner, at 23.  But, Highmark did point out that the de novo standard gives so-called "trolls" "a second bite at the apple," giving them the incentive to fight on.  In the end, Highmark's appeal to anti-troll sentiment seems misplaced, because a causal connection between the problem and the requested deferential standard of review appears to be lacking.

  • By Michael Greenfield —

    SIPOWord comes to us from attorneys at the CCPIT Patent and Trademark Law Office that the Patent Affairs Administration Department of the State Intellectual Property Office of the PRC (SIPO) "clarified" examination procedures for pharmaceutical patent applications with respect to sufficiency of disclosure and supplemental evidence.  A copy of their report can be found at the AIPLA web site this link.  Clarification was apparently necessary because examiners were deviating from SIPO standards.  The effective date for application of the "clarified" standards was October 17, 2013, and apply only to Office Actions issued after that date and not retroactively.

    Those who practice in Asian countries, including, most notably, China and Japan, know that the support requirements ("sufficiency of disclosure") for claims to products intended for pharmaceutical use are quite stringent.  And although some leeway is given with respect to generalizing specific examples, claims are much more strictly limited in China (and Japan) than, for example, the U.S. and Europe.  For chemical compounds, Chinese examiners generally require claim scope to closely conform to embodiments actually reduced to practice.  And the standard for data to support claims to pharmaceutical compositions comprising the compounds is quite high.

    Perhaps because sufficiency of disclosure must be considered at the time of application filing, as a practical matter Chinese examiners have generally refused to consider supplemental post-filing data.  But now it appears that such blanket refusal is considered inconsistent with SIPO examination standards, and examiners have been instructed that supplemental data should be considered under appropriate circumstances.  But as a practical matter, exactly what those circumstances are and for what purpose post-filing data can be considered remains somewhat unclear.

    As noted, the sufficiency requirement must be met at the date of filing.  So supplemental, post-filing data cannot be used to rectify a deficient disclosure by establishing the technical solution of the claims.  Rather, post-filing experimental data can be used to confirm that the technical solution has the use or effect alleged by the applicant and to confirm statements and facts presented in the specification.

    This is all very well and good.  But it's an abstraction.  It remains unclear and yet to be seen as to how Chinese patent examiners will implement the standard.  How will they differentiate between (a) post-filing data that merely confirms a technical solution, statement, or fact in a patent application from (b) post-filing data that itself is considered as the technical solution?

    The CCPIT report gives the example of a new use of a known compound that is contrary to prior art teachings.  Under such circumstances experimental evidence in the application would be necessary to establish the use (or technical solution).  So, post-filing data would not be accepted to demonstrate the use if the application itself was devoid of data.  This is not unlike the case in the U.S., as manifest in In re '318 Patent Infringement Litigation, where the court held a claimed method of treating Alzheimer's Disease invalid as lacking an enabling disclosure because the application contained no experimental data, even though post-filing experimental evidence supported the claim.

    So it would seem that not all statements in a patent application would be amenable to proof with post-filing data.  Statements of therapeutic activity may need to be supported by data present in the application as filed.  But one wonders whether it could be otherwise.

    What if the application provides some data?  Under traditional practice pharmaceutical composition and use claims would have to conform to the scope of the compounds tested for therapeutic activity.  Could post-filing data for additional compounds be used to affirm their utility and permit a broader scope of claims more commensurate in scope with the post-filing data?  The answer may have to be determined on a case-by-case basis and turn on a number of factors, such as how much data is presented in the application as filed compared to the scope of claims sought, the extent to which a structure-activity relationship is provided, and the structural similarity of the claims.

    It will be interesting to see how this plays out and whether appeal of examiners' decisions with respect to post-filing data will be necessary to further elucidate the practice.

  • By Josh Bosman —

    Van Andel Research InstituteThe U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods."  The '983 patent, which is assigned to the Van Andel Research Institute and the University of Pittsburgh, contains claims to a method for differentiating pancreatic cancer from a benign pancreatic disease.

    The invention provides a method for diagnosing pancreatic cancer; more specifically, a method for differentiating pancreatic cancer from a benign pancreatic disease in a patient having or suspected of having a pancreatic disease.  The invention could be particularly helpful in the early diagnosis of pancreatic cancer.  Pancreatic cancer is typically diagnosed at a more advanced stage, and treatment options are limited, leading to five year survival rates of less than 5%.  The inventors indicate that a blood-based diagnostic test for pancreatic cancer would be especially valuable, potentially increasing survival rates and saving resources.

    University of PittsburghThe inventors used antibody arrays to measure the levels of a carbohydrate antigen, CA 19-9, on multiple proteins in 420 individual biological samples from patients with pancreatic adenocarcinoma or pancreatitis.  It is known that the CA 19-9 antigen is elevated in serum from the majority of pancreatic cancer patients, but using CA19-9 in diagnostic tests is discouraged in the guidelines from the American Society of Clinical Oncology due to both false positive and false negative readings.  Surprisingly, the inventors discovered that a subset of cancer patients showed elevations of the CA 19-9 antigen on the mucin proteins MUC1, MUC5AC, or MUC16.  By combining measurements of total CA 19-9 with CA 19-9 on the MUC1, MUC5AC, or MUC16 proteins, the inventors determined that they could differentiate, with sensitivity and specificity, whether the sample was from a patient with pancreatic cancer or a patient with a benign pancreatic disease.

    The '983 patent has one independent claim which recites:

    1.  A method for differentiating pancreatic cancer from a benign pancreatic disease, comprising the steps:
        obtaining a patient biological sample from a patient having or suspected of having a pancreatic disease;
        assaying the patient biological sample (a) to detect a total level of CA 19-9 antigen in the patient biological sample and (b) to detect a glycan level in MUC16 in the patient biological sample;
        comparing the total level of CA 19-9 antigen in the patient biological sample to a statistically validated threshold for total CA 19-9 antigen, which statistically validated threshold for total CA 19-9 antigen is based on a total level of CA 19-9 antigen in comparable control biological samples from patients having a benign pancreatic disease; and
        comparing the glycan level in the MUC16 in the patient biological sample to a statistically validated threshold for the MUC16, which statistically validated threshold for the MUC16 is based on a glycan level in the MUC16 in comparable control biological samples from patients having a benign pancreatic disease;
        wherein (a) a different level of total CA 19-9 antigen in the patient biological sample as compared to the statistically validated threshold for total CA 19-9 antigen and (b) a different level of glycan level in the MUC16 in the patient biological sample as compared to the statistically validated threshold for the MUC16 indicate that the patient has pancreatic cancer rather than a benign pancreatic disease.

    A review of the file history of the '983 patent indicated that a rejection under 35 U.S.C. § 101 was not issued.