Patent Docs

MacroPoint, LLC v. FourKites, Inc. (N.D. Ohio 2015)

November 10, 2015

By Michael Borella —

In a previous article on the USPTO's publication of its 2014 Interim Guidance on Patent Subject Matter Eligibility, we wrote:

Despite the Interim Guidance offering a reasonably fair and thorough overview of the current law of patent-eligibility, applicants must remain cautious. The Interim Guidance is for examination of patents only. Courts may give little or no weight to its reasoning. As a result, claims that are allowable by the USPTO under a particular rationale may be invalidated by a reviewing court, even in the presence of this rationale.

Last week, the U.S. District Court for the Northern District of Ohio found five patents owned by MacroPoint to be invalid under 35 U.S.C. § 101, despite the USPTO allowing four of these patents after the Supreme Court's June 2014 Alice v. CLS Bank Int'l decision.

MacroPoint brought an infringement action against FourKites, claiming infringement of U.S. Patents 8,604,943, 9,070,295, 9,082,097, 9,082,098, and 9,087,313. Of these, the '943 patent issued in December, 2013, while the others issued on June 30, 2015, July 14, 2015, July 14, 2015, and July 21, 2015, respectively. Notably, none of these patents was allowed after the USPTO published its July Update to the Interim Guidance, which provides detailed examples of patent-eligible and patent-ineligible claims for examiners. Further, none of these patents was subject to a § 101 rejection during prosecution.

MacroPoint did not dispute that claim 1 of the '943 patent is a representative claim of all 94 claims at issue. This claim recites:

A computer implemented method for indicating location of freight carried by a vehicle, the method comprising:
    [a] correlating the freight to a communications device;
    [b] receiving a first signal including data representing a request for information regarding the location of the freight;
    [c] transmitting to the communications device a second signal including data that prompts an automated message to be communicated to a user of the communications device, the automated message representing a notice communicating to the user of the communications device that the location information of the communication device will be obtained;
    [d] receiving from the communications device a third signal including data indicative of consent from the user to the obtaining of the location information of the communications device;
    [e] transmitting a fourth signal to a location information provider, the fourth signal including data representing a request for location information of the communications device, wherein the location information provider corresponds to a party or device other than the communications device and the location information provider corresponds to at least one of:
    [e][i] a wireless service provider providing wireless service to the communications device,
    [e][ii] a third party that obtains the location information of the communications device from the wireless service provider providing wireless service to the communications device, and
    [e][iii] a party that has access to the location information of the communications device but is other than the wireless service provider or the third party that obtains the location information of the communications device from the wireless service provider;
    [f] receiving a fifth signal from the location information provider, the fifth signal including data representing the location information of the communications device;
    [g] correlating the location information of the communications device to the location of the freight based at least in part on the correlation between the freight and the communications device; and
    [h] transmitting a sixth electronic signal including data representing the location of the freight.

The Court characterized the invention as being directed to "a system for providing location information of a vehicle that includes a communications interface and a correlation logic that correlates location information of a communications device to location of the vehicle."

FourKites filed a motion to dismiss the case for failure to state a claim upon which relief can be granted, contending that the patents in suit were invalid under Alice. Addressing this motion, the Court noted that "it is procedurally proper to address defendant's arguments concerning invalidity based on patent-eligibility at the 12(b)(6) stage" especially because "plaintiff does not argue that claim construction is necessary for a resolution of the instant dispute." The Court went on to state that it would "presume that the patents are valid and grant the motion only if defendant is able to show invalidity by clear and convincing evidence." The fact that four of the patents were granted post-Alice influenced the Court's decision in this regard.

In Alice, the Supreme Court provided a two-prong test for patent-eligibility under 35 U.S.C. § 101, requiring that one first determine whether the claim at issue is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further determine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to something more than the judicial exclusion. Notably, generic computer implementation of an otherwise abstract process does not qualify as "something more."

Applying the test to claim 1, FourKites opined that the claim "discloses nothing more than a process for tracking freight, including monitoring, locating, and communicating regarding the location of the freight . . . [t]hese ideas are all abstract in and of themselves." The Court cited a somewhat analogous invention in Wireless Media Innovations, LLC v. Maher Terminals, LLC, in which the U.S. District Court for the District of New Jersey found the claimed process for tracking freight to be abstract. MacroPoint argued that its patents were distinguishable because they were granted after the Alice decision, while those of Wireless Media Innovations were not. The Court, however, held that "the fact that the PTO may have considered Alice-based guidelines before issuing the patents-in-suit does not mandate a finding that the patents are valid."

With respect to the first prong of the test, MacroPoint invoked DDR Holdings, LLC v. Hotels.com L.P., the only post-Alice Federal Circuit case to find claims patent-eligible, as evidence that claim 1 is not abstract. But the Court found that this case is essentially silent on the first prong, as its conclusion is based on the second prong instead. Ultimately, the Court held that claim 1 was "directed at a method for tracking freight, which is an abstract concept."

Turning to the second prong of Alice, MacroPoint argued that there were three inventive concepts in the claim that would render the claim patent-eligible. These include (i) "correlating the location information of a communications device with the location of freight or a vehicle," (ii) "obtain[ing] location information through an intermediary and not directly from the communication device itself," and (iii) signals that "prompt . . . an automated message to be communicated to a use of the communications device" and "include[e] data indicative of consent from the user." MacroPoint noted that these concepts had the advantage of facilitating the tracking of freight without a GPS receiver.

The Court rejected MacroPoint's contentions. Particularly, the Court wrote that "[c]orrelating simply connotes the ascertaining of a relationship between two pieces of information [and] involves only the conventional use of a computer." With respect to the second and third purported inventive concepts, the Court found that the claim language did not recite any advantages over a GPS-based system, and only included "the ordinary use of a computer that transmits and receives data from a communication device."

The Court also rejected MacroPoint's application of DDR Holdings to the second prong of Alice, stating that "the problem identified by plaintiff [does not] specifically arise in the realm of computer networks" because it is analogous to humans inquiring by telephone as to another individual's location. Finally, the Court addressed preemption by stating that even if the claim does not entirely foreclose all ways that freight can be tracked, the steps therein are only "well-understood, routine, conventional activity [and] upholding the patents would risk disproportionately tying up the use of the underlying conventional steps."

So, as expected, one cannot rely on courts to apply the same § 101 analysis as the USPTO. But this case exhibits a number of factors that may have helped the Court come to its decision: the claims were not allowed over an Alice rejection, there is no evidence that the examiner considered the patent-eligibility of the claims, and the examiner did not apply the USPTO's guidance as reflected in the July Update. As a result, four of these patents were allowed very quickly, and MacroPoint was not forced to make narrowing amendments that might have changed the outcome herein. Also, MacroPoint made a few moves that did not help, such as implicitly conceding that all 94 claims stood or fell together, not arguing that claim construction was necessary prior to patent-eligibility evaluation, and relying on arguments that go beyond the language of the claim.

Also, despite claiming to conduct its analysis under the presumption of validity, the Court appeared to give little or no deference to the USPTO's allowance of the patents. Perhaps this is due to a lack of § 101 examination details in the file wrappers, but it implies that the "clear and convincing" bar is set low for patent-eligibility challenges.
What Are the IP Provisions of the TPP?

November 9, 2015

By Kevin E. Noonan —

The Obama Administration released the approved text of the Trans Pacific Partnership (TPP) agreement last week, and it is substantially (and perhaps entirely; there has not been sufficient time to compare) the same as the Wikileaks' version released weeks ago, at least with regard to the intellectual property provisions (see "TPP Treaty: Intellectual Property Rights Chapter").

As noted previously, there has been vociferous opposition to the agreement, despite Congress having granted the President so-called "fast-track authority" for the TPP. As a consequence, there is an "all-or-nothing" aspect to the treaty, wherein Congress can ratify the agreement but cannot amend the agreement or filibuster Senate consideration. Given the level of political opposition, in addition to the antipathy of the Republican Party to anything the President proposes, and the lame-duck nature of Mr. Obama's Presidency, it is likely that the agreement will not be ratified, if it ever is, until the new Administration takes power in January 2017.

The text of the provisions relating to pharmaceutical products and biologics are set forth below.

Article 18.50: Protection of Undisclosed Test or Other Data⁵⁰
1. (a) If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product,⁵¹ that Party shall not permit third persons, without the consent of the person that previously submitted such information, to market the same or a similar⁵² product on the basis of:
        (i) that information; or
        (ii) the marketing approval granted to the person that submitted such information, for at least five years⁵³ from the date of marketing approval of the new pharmaceutical product in the territory of the Party.
    (b) If a Party permits, as a condition of granting marketing approval for a new pharmaceutical product, the submission of evidence of prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of a person that previously submitted such information concerning the safety and efficacy of the product, to market a same or a similar product based on evidence relating to prior marketing approval in the other territory for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of that Party.⁵⁴

2. Each Party shall:⁵⁵(a) apply paragraph 1, mutatis mutandis, for a period of at least three years with respect to new clinical information submitted as required in support of a marketing approval of a previously approved pharmaceutical product covering a new indication, new formulation or new method of administration; or, alternatively,
    (b) apply paragraph 1, mutatis mutandis, for a period of at least five years to new pharmaceutical products that contain a chemical entity that has not been previously approved in that Party.⁵⁶

3. Notwithstanding paragraphs 1 and 2 and Article 18.52 (Biologics), a Party may take measures to protect public health in accordance with:
    (a) the Declaration on TRIPS and Public Health;
    (b) any waiver of any provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration on TRIPS and Public Health and that is in force between the Parties; or
    (c) any amendment of the TRIPS Agreement to implement the Declaration on TRIPS and Public Health that enters into force with respect to the Parties.

Article 18.51: Measures Relating to the Marketing of Certain Pharmaceutical Products

1. If a Party permits, as a condition of approving the marketing of a pharmaceutical product, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by the Party or in another territory, that Party shall provide:
    (a) a system to provide notice to a patent holder⁵⁷ or to allow for a patent holder to be notified prior to the marketing of such a pharmaceutical product, that such other person is seeking to market that product during the term of an applicable patent claiming the approved product or its approved method of use;
    (b) adequate time and opportunity for such a patent holder to seek, prior to the marketing⁵⁸ of an allegedly infringing product, available remedies in subparagraph (c); and
    (c) procedures, such as judicial or administrative proceedings, and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent.

2. As an alternative to paragraph 1, a Party shall instead adopt or maintain a system other than judicial proceedings that precludes, based upon patent-related information submitted to the marketing approval authority by a patent holder or the applicant for marketing approval, or based on direct coordination between the marketing approval authority and the patent office, the issuance of marketing approval to any third person seeking to market a pharmaceutical product subject to a patent claiming that product, unless by consent or acquiescence of the patent holder.

Article 18.52: Biologics⁵⁹

1. With regard to protecting new biologics, a Party shall either:
    (a) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic,^60,61 provide effective market protection through the implementation of Article 18.50.1 (Protection of Undisclosed Test or Other Data) and Article 18.50.3, mutatis mutandis, for a period of at least eight years from the date of first marketing approval of that product in that Party; or, alternatively,
    (b) with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:
        (i) through the implementation of Article 18.50.1 (Protection of Undisclosed Test or Other Data) and Article 18.50.3, mutatis mutandis, for a period of at least five years from the date of first marketing approval of that product in that Party,
        (ii) through other measures, and
        (iii) recognising that market circumstances also contribute to effective market protection.

2. For the purposes of this Section, each Party shall apply this Article to, at a minimum, a product that is, or, alternatively, contains, a protein produced using biotechnology processes, for use in human beings for the prevention, treatment, or cure of a disease or condition.

3. Recognising that international and domestic regulation of new pharmaceutical products that are or contain a biologic is in a formative stage and that market circumstances may evolve over time, the Parties shall consult after 10 years from the date of entry into force of this Agreement, or as otherwise decided by the Commission, to review the period of exclusivity provided in paragraph 1 and the scope of application provided in paragraph 2, with a view to providing effective incentives for the development of new pharmaceutical products that are or contain a biologic, as well as with a view to facilitating the timely availability of follow-on biosimilars, and to ensuring that the scope of application remains consistent with international developments regarding approval of additional categories of new pharmaceutical products that are or contain a biologic.

Article 18.53: Definition of New Pharmaceutical Product

For the purposes of Article 18.50.1 (Protection of Undisclosed Test or Other Data), a new pharmaceutical product means a pharmaceutical product that does not contain⁶² a chemical entity that has been previously approved in that Party.

Article 18.54: Alteration of Period of Protection

Subject to Article 18.50.3 (Protection of Undisclosed Test or Other Data), if a product is subject to a system of marketing approval in the territory of a Party pursuant to Article 18.47 (Protection of Undisclosed Test or Other Data for Agricultural Chemical Products), Article 18.50 or Article 18.52 (Biologics) and is also covered by a patent in the territory of that Party, the Party shall not alter the period of protection that it provides pursuant to Article 18.47, Article 18.50 or Article 18.52 in the event that the patent protection terminates on a date earlier than the end of the period of protection specified in Article 18.47, Article 18.50 or Article 18.52.

Footnotes:

⁵⁰ Annex 18-B and Annex 18-C apply to paragraphs 1 and 2 of this Article.

⁵¹ Each Party confirms that the obligations of this Article, and Article 18.52 (Biologics) apply to cases in which the Party requires the submission of undisclosed test or other data concerning: (a) only the safety of the product, (b) only the efficacy of the product or (c) both.

⁵² For greater certainty, for the purposes of this Section, a pharmaceutical product is "similar" to a previously approved pharmaceutical product if the marketing approval, or, in the alternative, the applicant's request for such approval, of that similar pharmaceutical product is based upon the

undisclosed test or other data concerning the safety and efficacy of the previously approved pharmaceutical product, or the prior approval of that previously approved product.

⁵³ For greater certainty, a Party may limit the period of protection under paragraph 1 to five years, and the period of protection under Article 18.52.1(a) (Biologics) to eight years.

⁵⁴ Annex 18-D applies to this subparagraph.

⁵⁵ A Party that provides a period of at least eight years of protection pursuant to paragraph 1 is not required to apply paragraph 2.

⁵⁶ For the purposes of Article 18.50.2(b) (Protection of Undisclosed Test or Other Data), a Party may choose to protect only the undisclosed test or other data concerning the safety and efficacy relating to the chemical entity that has not been previously approved.

⁵⁷ For greater certainty, for the purposes of this Article, a Party may provide that a "patent holder" includes a patent licensee or the authorised holder of marketing approval.

⁵⁸For the purposes of paragraph 1(b), a Party may treat "marketing" as commencing at the time of listing for purposes of the reimbursement of pharmaceutical products pursuant to a national healthcare programme operated by a Party and inscribed in the Schedule to Annex 26-A (Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices).

⁵⁹ Annex 18-B, Annex 18-C and Annex 18-D apply to this Article.

⁶⁰ Nothing requires a Party to extend the protection of this paragraph to:

(a) any second or subsequent marketing approval of such a pharmaceutical product; or

(b) a pharmaceutical product that is or contains a previously approved biologic.

⁶¹ Each Party may provide that an applicant may request approval of a pharmaceutical product that is orcontains a biologic under the procedures set forth in Article 18.50.1(a) and Article 18.50.1(b) (Protection of Undisclosed Test or Other Data) within five years of the date of entry into force of this Agreement for that Party, provided that other pharmaceutical products in the same class of productshave been approved by that Party under the procedures set forth in Article 18.50.1(a) and Article 18.50.1(b) before the date of entry into force of this Agreement for that Party.

⁶² For the purposes of this Article, a Party may treat "contain" as meaning utilize.
Court Report

November 8, 2015

By Sherri Oslick —

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.]
Conference & CLE Calendar

November 8, 2015

November 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
IPLAC IP Law Symposium

November 7, 2015

The 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.
Webinar on Jurisdiction in Hatch-Waxman Litigation

November 7, 2015

Strafford 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.
FCBA Friedman Memorial Lecture on Excellence in Appellate Advocacy

November 7, 2015

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.
Comments on the USPTO’s Subject Matter Eligibility Guidance — BSA

November 5, 2015

By Michael Borella —

On 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.
Court Report

November 5, 2015

By Sherri Oslick —

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.
A Closer Look at Dynamic Drinkware, LLC v. National Graphics, Inc.

November 4, 2015

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.

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