•         By Sherri Oslick

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

    Amgen Inc. et al. v. Apotex Inc. et al.
    0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida

    • Plaintiffs:  Amgen Inc.; Amgen Manufacturing Ltd.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 8,952,138 ("Refolding Proteins Using a Chemically Controlled Redox State," issued February 10, 2015) and 5,824,784 ("N-Terminally Chemically Modified Protein Compositions and Methods," issued October 20, 1998) based on Apotex's filing of a BLA to market a biosimilar version of Amgen's Neulasta® (pegfilgrastim, used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs).  View the complaint here.


    Purdue Pharma, L.P. et al. v. Collegium Pharmaceutical, Inc.
    1:15-cv-13099; filed August 6, 2015 in the District Court of Massachusetts

    • Plaintiffs:  Purdue Pharma, L.P.; The P.F. Laboratories Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
    • Defendant:  Collegium Pharmaceutical, Inc.

    Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).   Also, infringement of U.S. Patent No. 8,652,497 ("Pharmaceutical Formulation Containing Irritant," issued February 18, 2014) based on Collegium's filing of its Xtampza ER NDA.  View the complaint here.


    Purdue Pharmaceuticals Products L.P. et al. v. Lannett Holdings, Inc. et al.
    2:15-cv-06036; filed August 6, 2015 in the District Court of New Jersey

    • Plaintiffs:  Purdue Pharmaceuticals Products L.P.; Purdue Pharma L.P.; Purdue Pharma Technologies Inc.
    • Defendants:  Lannett Holdings, Inc.; Lannett Co., Inc.

    Infringement of U.S. Patent No. 6,589,960 ("Hydromorphone And Hydrocodone Compositions And Methods For Their Synthesis," issued July 8, 2003) following a Paragraph IV certification as part of Lannett's filing of an ANDA to manufacture a generic version of Purdue Pharma's Dilaudid® (hydromorphone hydrochloride for injection, used to treat moderate to severe pain).  View the complaint here.


    AstraZeneca Pharmaceuticals LP et al. v. Agila Specialties, Inc et al.
    1:15-cv-06039; filed August 6, 2015 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
    • Defendants:  Agila Specialties, Inc; Onco Therapies Ltd.; Mylan Laboratories Ltd.; Mylan Inc.; Mylan Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Agila's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy).  View the complaint here.


    Merck Sharp & Dohme Corp. v. Actavis Laboratories FL, Inc. et al.
    3:15-cv-06075; filed August 6, 2015 in the District Court of New Jersey

    • Plaintiff:  Merck Sharp & Dohme Corp.
    • Defendants:  Actavis Laboratories FL, Inc.; Andrx Corp.; Andrx Corp.; Actavis, Inc.

    Infringement of U.S. Patent No. 5,661,151 ("Tetrahydrofuran Antifungals," issued August 26, 1997), following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Merck's Noxafil® (posaconazole, used in the prophylaxis of fungal infections in immunocompromised patients, and in the treatment of oropharyngeal candidiasis).  View the complaint here.


    Collegium Pharmaceutical Inc. v. Purdue Pharma L.P. et al.
    1:15-cv-06179; filed August 6, 2015 in the Southern District of New York

    • Plaintiff:  Collegium Pharmaceutical Inc.
    • Defendants:  Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies

    Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Xtampza ER product (oxycodone myristate).  View the complaint here.  [NB: The complaint was later voluntarily dismissed.]

  • CalendarNovember 10, 2015 - Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

    November 12, 2015 - Patent Quality Roadshow (U.S. Patent and Trademark Office) – North Carolina Central University School of Law, Durham, NC

    November 12, 2015 – "Leveraging Experts for USPTO Prosecution and PTAB — Developing Strong Patentability Records to Strengthen Claims Against IPR and PGR Challenges" (Strafford) – 1:00 to 2:30 pm (EST)

    November 12, 2015 – "Protecting Privilege: Patent Agents within the Bar and Attorneys Beyond the Border" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    November 13, 2015 - IP Law Symposium (Intellectual Property Law Association of Chicago) – Chicago, IL

    November 16-17, 2015 – Patent Litigation 2015 (Practising Law Institute) – New York, NY

    November 19, 2015 – "Demonstrating Jurisdiction in Hatch-Waxman Litigation After Daimler — Navigating the New Standard and Leveraging Lessons From Recent Court Treatment" (Strafford) – 1:00 to 2:30 pm (EST)

    November 20, 2015 - 2015 Friedman Memorial Lecture on Excellence in Appellate Advocacy (Federal Circuit Bar Association) – Washington, DC

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

  • IPLACThe Intellectual Property Law Association of Chicago (IPLAC) will be holding its annual IP Law Symposium on November 13, 2015 at the Standard Club in Chicago, IL.  The Symposium will offer presentations on the following topics:

    • What's Happening at the USPTO? — Drew Hirshfeld, Commissioner for Patents, U.S. Patent and Trademark Office

    • Post Alice — Wonderland or Rabbit Hole?

    • Staying Out of Hot Water: Preventing Ethical Infractions in an IP Practice

    • Judges' Panel — Judge Bauer, Seventh Circuit; Judge Kennelly, Northern District of Illinois; Judge Mills, Central District of Illinois; and Judge Bernthal, Central District of Illinois

    The registration fee for the Symposium is $125 (IPLAC members), $175 (non-members), or $25 (students).  Those interested in registering can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Demonstrating Jurisdiction in Hatch-Waxman Litigation After Daimler — Navigating the New Standard and Leveraging Lessons From Recent Court Treatment" on November 19, 2015 from 1:00 to 2:30 pm (EST).  Brian D. Coggio of Fish & Richardson, Brian O’Reilly of O'Reilly IP, and Shashank Upadhye of Amin Talati & Upadhye will provide guidance to patent counsel on establishing personal jurisdiction in Hatch-Waxman litigation, examine the impact of the Supreme Court's decision in Daimler AG v. Bauman (2014) and how it changed the jurisdiction landscape, and review court treatment of the jurisdiction issue since Daimler and explain lessons for counsel that can be drawn from those decisions.  The webinar will review the following questions:

    • How has the Supreme Court's decision in Daimler changed the landscape in establishing jurisdiction in Hatch-Waxman litigation?
    • What lessons can be learned from how the courts had handled jurisdictional issues in post-Daimler cases?
    • What strategies can patent counsel use when asserting or challenging jurisdiction in ANDA litigation?

    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.

  • The Federal Circuit Bar Association's Friedman Memorial Committee will be holding the 2015 Friedman Memorial Lecture on Excellence in Appellate Advocacy on November 20, 2015 at 2:00 pm (ET) at The National Courts Building, 717 Madison Place NW, Washington, DC.  The 2015 lecturer is Circuit Judge Richard G. Taranto of the United States Court of Appeals for the Federal Circuit.  The panel will explore whether Octane obviates the need for fee-shifting patent reform legislation.  Information about registering for this event can be found here.

  • By Michael Borella

    BSAOn July 30, 2015, the U.S. Patent and Trademark Office updated its subject matter eligibility guidance ("July Update").  In the July Update, the Office provided recommendations and resources for examiners in addition to those in the Office's 2014 Interim Guidance on Subject Matter Eligibility.  In particular, the Office provided procedural and substantive guidelines regarding the examination of inventions that may include subject matter that does not meet the requirements of 35 U.S.C. § 101.  For a more detailed overview of the July Update, see our review thereof.

    The Office requested public comments on the July Update, the comment period of which ended on October 28, 2015.  The Office recently published the comments it received from a number of organizations, law firms, companies, and individuals.  This is the second in a series of articles regarding the comments, and covers those provided by BSA – The Software Alliance.

    BSA is a software industry advocacy group, counting Apple, Dell, IBM, Microsoft, Oracle, Salesforce, and Symantec among its members.  The companies represented by BSA collectively hold more than 100,000 U.S. patents, and invest billions of dollars into technology research and development.  The vast majority of these patents and R&D activities are directed to software; thus, BSA has a vested interest in the Office's interpretation and application of the Alice v. CLS Bank test.

    BSA begins by making an observation made by many others — that the Office has been applying the Alice test in an inconsistent fashion, "with dramatic differences between examiners' interpretation of Alice and the PTO Subject Matter Eligibility guidelines."  The resulting uncertainty "creates apprehension in the software field, which, in turn, discourages investment in important technologies."  But BSA members also would like to rely on Alice and its progeny to help in "weeding out truly abstract patents and patent applications that can be asserted in an abusive manner."  Overall, BSA wants a "consistent and predictable intellectual property framework" that provides a foundation for member investment in new technologies.

    To achieve these goals, BSA made two specific recommendations:  that examiners provide a clear rationale for patent-eligibility rejections, and the Office publish more examples of patent-eligible claims involving methods of organizing human activity.

    Regarding the first recommendation, the July Update does state that examiners have the burden to provide a prima facie case of patent-ineligibility.  BSA advocates that for the prima facie case to be made out, examiners must "clearly articulate their reasons for a subject matter eligibility rejection."  BSA notes that its members have recently received "many types of boiler plate rejections" that are insufficient in this regard.  Particularly, these rejections have included "characterizations of the abstract idea akin to a field of the invention rather than tied to the specific invention embodied in the claims."  Such rejections, according to the BSA, fail to "provide the applicant with any guidance as to how to address the examiner's concerns."  BSA would prefer the rejections to "include the underlying reasoning in support of a conclusion that individual elements (or the ordered combination of elements) of a claim fail to provide an inventive concept," and that this reasoning is tailored to the language of the claims.

    Indeed, this point hits at the core of the many practical difficulties with implementing the Alice test.  Unless the examiner provides a detailed rationale for rejecting claims under § 101, the applicant is left with little with which to work.  All too often, examiners reject claims in a terse and conclusory fashion, without fully applying both prongs of Alice.  Consequently, it is difficult or impossible to determine whether the examiner has proper grounds for the rejection, or if the applicant should rebut the examiner.  And such rejections are unnecessarily difficult to rebut when the examiner has not taken a clear position.

    BSA recommends that § 101 rejections should be made using a similar level of detail as § 103 rejections.  From the Supreme Court's KSR v. Teleflex decision, it is now well understood that "rejections on obviousness cannot be sustained with mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness."  BSA suggests that the Office instruct examiners to provide specific evidence in patent-eligibility rejections, and that the Office's quality assurance procedures identify when such rejections lack clear articulation.

    Regarding the second recommendation, in the July Update the Office stated that abstract methods of organizing human activity include (i) managing relationships or transactions between people, (ii) satisfying or avoiding a legal obligation, (iii) advertising, marketing and sales activities or behaviors, and (iv) certain types of mental processes and planning.  BSA is concerned that "some examiners may improperly look to extend the scope of abstract ideas to any software invention which has an end effect of improving organization of human activities."  This would be improper because not all inventions that improve the organization of human activities are fatally abstract.  As examples, BSA states that "a process by which Global Positioning Satellites use data to redirect traffic patterns, a system that automatically reorders a task list of a user based on context, or a new type of board game" are methods of organizing human activity that could be claimed in a fashion that meets the Alice requirements.  Consequently, BSA recommends that the Office provide more patent-eligible examples of this nature.

    To put this another way, a claim directed to a disembodied process for managing a task list might be patent-ineligible under Alice, but this might not be the case for another claim directed to a software invention for automatically updating, re-prioritizing, and displaying a task list.  The Office has already provided useful examples of patent-eligible methods for distribution of stock quote and graphical user interface features in the July Update.  More of these examples for methods of organizing human activity would be welcome.

  •         By Sherri Oslick

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

    Purdue Pharma L.P. et al. v. Actavis Laboratories FL, Inc.
    1:15-cv-00686; filed August 5, 2015 in the District Court of Delaware

    • Plaintiffs:  Purdue Pharma L.P.; Purdue Pharmaceuticals L.P.; The P.F. Laboratories Inc.; Grunenthal GmbH
    • Defendant:  Actavis Laboratories FL, Inc.

    Purdue Pharma L.P. et al. v. Alvogen Pine Brook, Inc.
    1:15-cv-00687; filed August 5, 2015 in the District Court of Delaware

    • Plaintiffs:  Purdue Pharma L.P.; Purdue Pharmaceuticals L.P.; The P.F. Laboratories Inc.; Grunenthal GmbH
    • Defendant:  Alvogen Pine Brook Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,733,783 ("Controlled Release Hydrocodone Formulations," issued May 11, 2004), 8,361,499 (same title, issued January 29, 2013), 8,551,520 (same title, issued October 8, 2013), 8,647,667 (same title, issued February 11, 2014), 9,023,401 (same title, issued May 5, 2015), 8,529,948 ("Pharmaceutical Formulation Containing Gelling Agent," issued September 10, 2013), 8,808,740 ("Encased Tamper Resistant Controlled Release Dosage Forms," issued August 19, 2014), and 8,309,060 ("Abuse-Proofed Dosage Form," issued November 13, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Purdue's Hysingla® ER (hydrocodone bitartrate, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate).  View the Actavis complaint here.


    Eli Lilly and Company v. Uropep Biotech GBR
    1:15-cv-01222; filed August 5, 2015 in the Southern District of Indiana

    Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 8,791,124 ("Use of Phosphodiesterase Inhibitors in the Treatment of Prostatic Diseases," issued July 29, 2014) based on Lilly's manufacture and sale of its Cialis® product (tadalafil) for the treatment of benign prostatic hyperplasia (BPH).  View the complaint here.  [NB: The complaint was voluntarily dismissed.]


    AstraZeneca AB et al. v. HEC Pharm Co., Ltd. et al.
    3:15-cv-06025; filed August 5, 2015 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
    • Defendants:  HEC Pharm Co., Ltd.; HEC Pharm Group; HEC Pharm USA Inc.

    Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 7,411,070 (same title, issued August 12, 2008), and 8,466,175 (same title, issued June 18, 2013) following a Paragraph IV certification as part of HEC's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.


    Boehringer Ingelheim Pharmaceuticals Inc. et al. v. HEC Pharm Co., Ltd. et al.
    3:15-cv-05982; filed August 4, 2015 in the District Court of New Jersey

    • Plaintiffs:  Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; Boehringer Ingelheim Pharma GmbH & Co. KG
    • Defendants:  HEC Pharm Group; HEC Pharm Co., Ltd.; HEC Pharm USA; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Ltd.; Intas Pharmaceuticals Ltd.; Accord Healthcare, Inc.; Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Dr. Reddys Laboratories, Ltd.; Dr. Reddys Laboratories, Inc.; Zydus Pharmaceuticals USA, Inc.; Cadila Healthcare Ltd.; MSN Laboratories Private Ltd.; MSN Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC; Huahai US Inc.; Zhejiang Huahai Pharmaceutical Co., Ltd.; Invagen Pharmaceuticals Inc.; Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE; Sun Pharmaceutical Industries, Inc.

    Infringement of U.S. Patent Nos. 7,407,955 ("8-[3-Aminopeperidin-1-yl-]xanthines, The Preparation Thereof And Their Use As Pharmaceutical Compositions," issued August 5, 2008), 8,119,648 (same title, issued February 21, 2012), 8,178,541 (same title, issued May 15, 2012), 8,673,927 ("Uses of DPP-IV Inhibitors," issued March 18, 2014), 8,846,695 ("Treatment For Diabetes In Patients With Inadequate Glycemic Control Despite Metformin Therapy Comprising A DPP-IV Inhibitor," issued September 30, 2014), and 8,853,156 ("Treatment For Diabetes In Patients Inappropriate For Metformin Therapy," issued October 7, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Boehringer's Tradjenta® (linagliptin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products.  View the complaint here.


    Janssen Biotech, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
    1:15-cv-00130; filed August 4, 2015 in the Northern District of West Virginia

    • Plaintiffs:  Janssen Biotech, Inc.; Janssen Oncology, Inc.; Janssen Research & Development, LLC
    • Defendants:  Mylan Pharmaceuticals Inc.; Mylan, Inc.

    Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer).  View the complaint here.

  • By Andrew Williams

    Last week, we analyzed the Federal Circuit's Dynamic Drinkware, LLC v. National Graphics, Inc. case from early September.  In that case, the Federal Circuit held that an IPR petitioner did not adequately demonstrate that an invalidating reference under 35 U.S.C. § 102(e)(2) was entitled to its provisional filing date because it failed to compare the provisional application to the claims of the reference patent (as opposed to the patent attempting to be invalidated).  The opinion focused on the claims of the reference patent, and was silent as to whether the provisional disclosure would also need to be invalidating.  Therefore, it is clear that comparing the claims of the reference patent to the provisional is necessary, but is such a comparison sufficient to allow the reference patent to claim priority back to the provisional filing date for the entirety of its disclosure.

    In analyzing the case, we highlighted the most important take away — if you are attempting to invalidate a pre-AIA patent claim with a prior art under 102(e)(2), whether in an IPR proceeding or in district court, and you need to rely on the filing date of a provisional application, you must show where support for that prior art patent's claims can be found within the provisional filing.  This is contrary to the common-place practice of merely identifying in the provisional application where the invalidating disclosure can be found (similar to identifying in the 102(e) patent where the invalidating disclosure can be found).  However, even though we suggested that it would still be advisable to make such a showing in addition to where support for the claims can be found, we also provided a scenario demonstrating what problems can ensue if Dynamic Drinkware stood for the proposition that identifying support for the claims of the reference patent was necessary and sufficient for the entirety of the non-provisional disclosure to be entitled to the provisional filing date.

    After the post published, we were accused by several commenters of misreading the case.  If their opinions had no merit, it would not warrant a response.  However, there were some valid points expressed that are worth noting, so we decided to prepare this follow-up post to air this controversy (if it can even be considered that).  For the record, we do not believe that we are misreading the Dynamic Drinkware case.  Instead, we are reading it for precisely what it says.  We do not disagree, however, that there might be an alternative reading that would address these problems.  However, for the alternative reading to be correct, the case needs to be read as incorporating information implicitly.  Nevertheless, this alternative reading is satisfying because it would do away with the problematic scenario that we identified, and it would eliminate the inherent unfairness of our reading of the case.

    As commenter Kip explained:

    The decision says that for provisional X to anticipate under 102e, it must result in a publication or patent that:

    1. has at least one claim supported by X;
    2. contains disclosure (in the spec or claims) that anticipates the patent under review

    In other words, according to this reading, there are two requirements — you need to show support for the claims of the reference patent, and you need to identify where the disclosure in the provisional can be found for the patent being challenged.  This interpretation was echoed by commenter EG, long-time friend of the blog.

    But unfortunately, there is no support in the Dynamic Drinkware case itself that supports this interpretation.  This could be due to a lack of clarity on the part of the Court, as commenter Dan Williams put it (no relation).  Dynamic didn't show that the claims had support, so no further analysis was necessary.  Or, as Mr. Williams put it, "[w]hat they really were saying in my opinion was '(you need both 1 and 2, and even though Dynamic proved 2), Dynamic didn't show 1, so they lose.'"  Nevertheless, there is no support anywhere else in this case for that interpretation, and despite requests, no one was able to provide any.

    The best support, as provided by commenter Kip, was the citation in the opinion to In re Werthein, 646 F.2d 527 (CCPA 1981).  That case was authored by Judge Rich, and stood for the proposition that if you are citing a patent as invalidating art and claiming priority to a continuation-in-part application, you need to find support in that CIP.  The reasoning was the same as that for providing the invaliding effect of patents at the filing date, not the publication date or issue date — that the ability to use a patent as prior art should not depend on the speed and/or efficiency of the Patent Office.  Correspondingly, the theory in this case holds that if the prior patent does not support the claims of the issued patent, than it itself never would have resulted in a patent (regardless of the speed of the Office).  Thus, if the provisional does not support the relevant disclosure, then priority to it is unavailable.

    The problem is Wertheim came out in 1981, prior to the advent of provisional applications.  Therefore, how that case is applied to provisionals needs to be ascertained.  Moreover, rather than applying Wertheim as determinative of the present case, Dynamic Drinkware actually tells us how Wertheim applies to provisionals:  "A reference patent is only entitled to claim the benefit of the filing date of its provisional application if the disclosure of the provisional application provides support for the claims in the reference patent in compliance with § 112, ¶ 1."  It says nothing about the disclosure of the reference patent, much less the claims of the patent that is being challenged.

    At this point, it should be noted that both interpretations have merits and flaws.  It will be interesting to see if these issues come up soon, or even at all.  What is clear is that if you are trying to invalidate the claims of a patent, and you need support to the provisional, you better include support related to the claims of the reference patent.    

  • By Michael Borella

    On July 30, 2015, the U.S. Patent and Trademark Office updated its subject matter eligibility guidance ("July Update").  The update provided recommendations and resources for examiners in addition to those in the Office's 2014 Interim Guidance on Subject Matter Eligibility.  In particular, the Office provided procedural and substantive guidelines regarding the examination of inventions that may include subject matter that does not meet the requirements of 35 U.S.C. § 101.  For a more detailed overview of the July Update, see our review thereof.

    ABAThe Office requested public comments on the July Update, the comment period of which ended on October 28, 2015.  The Office recently published the comments it received from a number of organizations, law firms, companies, and individuals.  This is the first in a series of articles regarding the comments, and covers those provided by the American Bar Association Section of Intellectual Property Law (the Section).

    The Section begins by commending the Office for providing extensive examples of patent-eligible and patent-ineligible claims, as "[t]hese examples help both examiners and stakeholders to reach a common understanding and advance prosecution."  But, the Section is quick to point out that uncertainty regarding the examination of patents under § 101 remains.

    Importantly, the Section took the position that there are three distinct tests for patent-eligibility, the "machine or transformation test," the "law of nature" and "natural phenomenon" test used prior to Mayo v. Prometheus, and the two-prong Alice v. CLS Bank test.  The Section views the first two tests as incompatible because "it would have been unthinkable to observe that one part of a claim was performed in the human mind, and another part operated by natural principles."  (It would not be surprising if there is a DNA analysis claim out there somewhere that is a counterexample to this notion.)  The Section further views the Alice test as being limited to review of long-standing concepts (it isn't).  As a result, the Section recommended that "[w]here the three tests diverge, the Eligibility Update should be separated into three separate sections to make the distinctions clear."

    In Alice, the Court clearly stated that the two-prong Mayo test was universal, in that it applied to all judicial exceptions to patent-eligibility, as well as all statutory classes of claim.  The Court wrote that:

    [W]e set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts . . . first, we determine whether the claims at issue are directed to one of those patent-ineligible concepts [then] we consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application.

    To the extent that they are still applicable, the pre-Alice tests serve to further inform this analysis.  Moreover, whether a claim is novel has little bearing on the eligibility thereof.  This is reflected by the Court's position in Assoc. for Molecular Pathology v. Myriad Genetics ("[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry"), as well as that of the Federal Circuit in Ultramercial Inc. v. Hulu ("[t]hat some of the [claimed] steps were not previously employed in this art is not enough — standing alone — to confer patent eligibility").  Unfortunately, the Section's misunderstanding of the law here detracts from the credibility of its positions as a whole.

    Nonetheless, the Section went on to make an astute observation about how examiners are applying the Office's § 101 framework.  Responding to the Office's statement that the July Update will "ensure that a claimed concept is not identified as an abstract idea unless it is similar to at least one concept that the courts have identified as an abstract idea," the Section wrote that "[i]t is not clear that examiners are following this instruction, but appear to use their creativity in an attempt to identify an abstract idea from the claim, which is a guilty until proven innocent mindset."  Indeed, many patent-eligibility rejections seem to be based on knee-jerk, conclusory reactions, rather than actual analyses of claims.  Some examiners have stated that they are under pressure from their supervisors to reject claims under § 101 unless those claims are clearly eligible.

    The Section also raised the issue that "[u]sing broad, categorizing words to describe a claim, e.g., an advertising method or system . . . will only lead the examiner to label a claim as directed to an abstract idea, since it can be reduced to a few generic words."  Many others have complained about such over-generalization of claimed inventions by the Office.  As the Section noted, "labeling a claimed concept in as few words as possible is certainly not the test."

    The Section further took issue with the Office's statement about official notice.  Namely, in the July Update, the Office stated that "[c]ourts have not identified a situation in which evidence was required to support a finding that the additional [claim] elements were well-understood, routine or conventional, but rather treat the issue as a matter appropriate for judicial notice."  In the Section's view, the Administrative Procedure Act (APA) "requires agencies to support any adverse decision by substantial evidence."  The Section reminded the Office that it is not an Article III court, and noted that the Supreme Court did provide evidence for its reasoning that some claim elements were well known in Alice and Bilski v. Kappos.  Ultimately, the Section recommended that the Office's reference to official notice be completely removed.

    Another Section recommendation is that examiners help applicants draft patent-eligible claims.  For example, applications that "describe and claim specific hardware to accomplish a particular task should be patent eligible, and examiners should help applicants to amend claims to be patent eligible."  This is a commendable notion.  Although many examiners will work actively with applicants to find pathways to allowance, others take an "it's not my problem" approach, which is not productive for either the applicant or the Office.

    And finally, the Section expressed concern that the Office may be in violation of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement due to the Office's "practically excluding certain subject matter as per se patent ineligible."  The Section pointed to application rejection rates of nearly 100% in many art units of Technical Center 3600 as an example.

  • By Kevin E. Noonan

    National GeographicProgress, and faith in progress to improve human lives, has been a cornerstone belief in American civilization (and, indeed, Western civilization generally, at least since St Augustine argued that Christ's death put an arrow on history).  It was so important to the Founding Fathers that they enshrined promoting progress as one of the powers of Congress in the Patent Clause.

    But there has always been a countervailing meme:  that technological progress threatens our humanity and that we run the risk of having our humanity devalued by overreliance on technology.  This idea has fueled countless science fiction plots, from Frankenstein to The Matrix.  In many ways, the urge for "natural" products is a reflection of that idea, and while it provides a useful and (general) healthy counterpoint to overly processed foods, the philosophy has its limits.  As Covert Bailey used to say, syphilis is natural.

    And in the biotechnology era, that is the point:  most of what biotechnology addresses involves the breakdown of the natural machine, at the cellular level.  It has provided and continues to provide drugs that have addressed chronic disease and provided insights into the mechanisms for other diseases of ancient provenance.  Most of the fears that have arisen regarding biotechnology — Asilomar, test-tube-babies — have not come to pass.  And in their stead have been elucidation of the basis of diseases like muscular dystrophy and Huntington's chorea, as well as personalized medicine and treatments for cancer, AIDS, and Alzheimer's disease.

    Indeed, the disruptions that technology can cause are social ones, and these need to be addressed.  Apocryphally, medieval shoemakers threw sabots into prototype machines for mass production to disable them, and this sentiment persists today in resistance to technological change.  What is needed is not resistance to technology but the political will to help workers adapt to such change, and these days political will is one thing most recognize is sorely lacking.

    The National Geographic Channel is airing a new special "Breakthrough: More than Human," hosted by Paul Giamatti and premiering Sunday, November 8 at 9 p.m ET/8 p.m. CT, which addresses some of these questions.  It is serious and informative, and is a welcome addition to the conversation we need to have about technological change.

    But the truth is that the only thing to fear is fear of the new and unknown.  And it would be a shame if collectively we are too afraid to take advantage of the ever-increasing pace of technological change, because we are too afraid of an unlikely dystopian future to accept the benefits we are more likely to get in return.