• Fitch EvenFitch Even will be offering a webinar entitled "Linking an Invention to the Evidence: Strategic Considerations from Prosecution to Litigation" on March 19, 2020 from 12:00 to 1:00 pm (EDT).  Mark A. Borsos and Evan Kline-Wedeen of Fitch Even will discuss the following:

    • Establishing a nexus between evidence of commercial success of real-world products and the patented invention
    • Demonstrating a connection between patented features and lost profits
    • Proving there is a causal nexus between irreparable harm and the patented invention that justifies an injunction
    • Drafting claims with forethought to future evidentiary requirements

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  •     By Bryan Helwig

    Gavel_2About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation.


    Pfizer Inc. v. Viwit Pharmaceutical Co.

    1-20-cv-000160; filed January 31, 2020 in the District Court of Delaware

    • Plaintiffs: CP Pharmaceuticals International CV, PF Prism CV, Pfizer Inc., amd Pfizer Products Inc.
    • Defendant: Viwit Pharmaceutical Co., Ltd.

    Claim: Infringement of U.S. Patent Nos.:

    6,410,550: Aryl fused azapolycyclic compounds
    6,890,927: Tartrate salts of 5,8, 14-triazateracyclo[10.3.1.02,11 04.9]-hexadeca-2(11),3,5,7,9-pentaene and pharmaceutical compositions thereof
    7,265,119 Tartrate salts of 5,8,14-triazatetracyclo[10.3.1.0.sup.2,11.0.sup.4.9]-hexadeca-2(11),3,5,7-,9-pentaene and pharmaceutical compositions thereof

    Synoposis:  Pfizer asserts infringement of the '550, '927, and '119 patents.  PF PRISM is the holder of approved NDA No. 021928 for varenicline tartrate tablets, (Chantix®) a nicotinic receptor partial agonist for use in smoking cessation.  Viwit submitted ANDA No. 212879 seeking approval to commercially manufacture, use, and sell generic versions of Chantix®.  Pfizer asserts that the method of manufacture, and/or the use of Chantix® are covered by one or more claims of the Patents-in Suit.

    View the complaint here.


    Silvergate Pharmaceuticals, Inc. v. CMP Development LLC
    1-20-cv-000161; filed January 17, 2020 in the District Court of Delaware

    • Plaintiff: Silvergate Pharmaceuticals, Inc.
    • Defendant: CMP Development LLC

    Claim: Infringement of U.S. Patent Nos.:

    10,039,800: Lisinopril formulations
    10,265,370: Lisinopril formulations
    10,406,199: Lisinopril formulations
    9,463,183: Lisinopril formulations
    9,616,096: Lisinopril formulations
    9,814,751: Lisinopril formulations

    Synopsis:  Silvergate asserts infringement of the '800, '370, '199, '183, '096, and '751 patents.  Silvergate is the holder of approved NDA No. 208401 for lisinopril formulations of the angiotensin converting enzyme (ACE) inhibitor QBRELIS® for the treatment of hypertension in adults and pediatric patients.  CMP Development submitted ANDA No. 213935, seeking FDA approval to engage in commercial manufacturing, sale, and use of a generic version of Silvergate's QBRELIS® product.

    View the complaint here.

    Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.
    1-20-cv-00019; filed February 5, 2020 in the Northern District Court of West Virginia

    • Plaintiffs: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc.
    • Defendants: Mylan Inc., Mylan Laboratories Ltd., Mylan Pharmaceuticals Inc.

    Claim: Infringement of U.S. Patent No.:

    9,286,526: Treatment for diabetes in patients inappropriate for metformin therapy

    Synopsis:  Boehringer asserts infringement of the '526 patent.  Boehringer is the holder of NDA No. 201280 for TRADJENTA® for oral use for the treatment of type 2 diabetes via increasing incretin levels.  Mylan submitted ANDA No. 208431 seeking approval to engage in the commercial manufacture and sale of generic copies of TRADJENTA®.

    View the complaint here.


    Boehringer Ingelheim Pharmaceuticals, Inc. v. Aurobindo Pharma Ltd.
    5-20-cv-00023; filed February 5, 2020 in the District Court of Delaware

    • Plaintiffs: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc.
    • Defendant: Aurobindo Pharma Ltd.

    Claim: Infringement of U.S. Patent No.:

    9,286,526: Treatment diabetes in patients inappropriate for metformin therapy rs

    Synoposis:  Boehringer asserts infringement of the '526 patent.  Boehringer is the holder of NDA No. 201280 for TRADJENTA® for oral use for the treatment of type 2 diabetes via increasing incretin levels.  Aurobindo submitted ANDA No. 208415 seeking approval to engage in the commercial manufacture and sale of generic copies of TRADJENTA®.

    View the complaint here.

    Gilead Sciences, Inc. v. Apotex, Inc.
    1-20-cv-00189; filed February 7, 2020 in the District Court of New Jersey

    • Plaintiff: Gilead Sciences, Inc.
    • Defendants: Apotex Inc., Cipla Ltd., Hetero Labs Ltd. Unit-V, Hetero Labs Ltd., Hetero USA Inc., Laurus Labs Ltd., Lupin Ltd., Macleods Pharmaceuticals Ltd., Natco Pharma Ltd., Shilpa Medicare Ltd., and Sunshine Lake Pharma Co., Ltd.

    Claim: Infringement of U.S. Patent Nos.:

    7,390,791: Prodrugs of phosphonate nucleotide analogues
    7,803,788: Prodrugs of phosphonate nucoleotide analogues
    8,754,065: Tenofovir alafenamide hemifumarate
    9,296,769: Tenofovir alafenamide hemifumarate

    Synoposis:  Gilead asserts infringement of the '791, '788, '065, and '769 patents.  Gilead is the holder of NDA No. 208464 for VEMLIDY® (tenofovir alafenamide; 25 mg tablets) for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.  Gilead also holds NDA No. 208215 for DESCOVY® (emtricitabine 200 mg, tenofovir alafenamide 25 mg, and anti-viral agents) for treatment of HIV-1 infection in adults and pediatric patients, and for at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infectionGilead also holds NDA  No. 208351 for ODEFSEY® (200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide) for the treatment of HIV-1 infection in adults and pediatric patients either as an initial therapy in those with no antiretroviral treatment history or to replace a stable antiretroviral regimen in those who are virologically-suppressed.  Defendants, each independently, submitted one or more ANDA applications to engage in the commercial manufacture, use, importation, offer for sale, and/or sale of VEMLIDY®, DESCOVY®, and/or ODEFSEY®.

    View the complaint here.


    Allergan Sales, LLC  v. Breckenridge Pharmaceutical, Inc.
    1-20-cv-00199; filed February 10, 2020 in the District Court of Delaware

    • Plaintiffs: Allergan Sales, LLC, Allergan Pharmaceuticals International Ltd., Allergan USA, Inc.
    • Defendant: Breckenridge Pharmaceutical, Inc.

    Claim: Infringement of U.S. Patent No.:

    5,763,476: Sublingual or buccal pharmaceutical composition

    Synopsis:  Allergen asserts infringement of the '476 patent.  Allergen is the holder of NDA No. 22117 for the use of SAPHRIS® (asenapine maleate) for the treatment of schizophrenia and bipolar disorder.  The FDA granted pediatric exclusivity on March 3, 2015, thereby awarding an additional 6-months of market exclusivity after expiration of the patents listed in the Orange Book for SAPHRIS®.  Breckenridge submitted ANDA No. 205960 seeking to obtain approval for the commercial manufacture, use, and sale of asenapine maleate tablets.

    View the complaint here.

    American Regent, Inc. f/k/a Luitpold Pharmaceuticals, Inc. v. Pharmacosmos A/S
    3-20-cv-01350; filed February 7, 2020 in the District Court of New Jersey

    • Plaintiff: American Reagent, Inc.
    • Defendants: Pharmacosmos Therapeutics Inc. and Pharmacosmos A/S

    Claim: Infringement of U.S. Patent Nos.:

    10,478,450: Methods and compositions for administration of iron
    8,431,549: Methods and compositions for administration of iron

    Synoposis:  American Reagent asserts infringement of the '549 and '450 patents.  Pharmacosmos A/S submitted NDA No. 208171 to market Monoferric® for the treatment of iron deficiency.  Plaintiff contends that Pharmacosmos A/S is working with Pharmacosmos Therapeutics, the latter founded in 2019 "to commercialize Monoferric® in the rapidly growing US high-dose IV iron market."  American Reagent contends that Pharmacosmos A/S, in active concert with Pharmacosmos Therapeutics Inc., will import, manufacture, market, offer for sell, and/or sell Monoferric® immediately and imminently.

    Previously, in 2015, Pharmacosmos filed an IPR seeking to invalidate claims 7, 17, and 21 of the '549 patent.  Pharmacosmos was denied in its validity challenge as to the non-instituted claims (IPR2015-01493).  In 2019, Pharmacosmos filed a second IPR petition against claims 7 and 21 of the '549 patent.  The petition was denied in its entirety (IPR2019-01142).  In January 2020, Pharmacosmos filed a post-grant review, seeking to invalidate all claims of the '450 patent (PGR2020-00009).

    View the complaint here.


    Amgen Inc. v. Hospira, Inc.
    1-20-cv-00201; filed February 11, 2020 in the District Court of Delaware

    • Plaintiffs: Amgen Inc. and Amgen Manufacturing Ltd.
    • Defendants: Hospira Inc. and Pfizer Inc.

    Claim: Infringement of U.S. Patent No.:

    8,273,707: Process for purifying proteins

    Synopsis:  Amgen asserts infringement of the '707 patent.  Amgen is the reference product sponsor (RPS), of Neulasta® (human granulocyte-colony stimulating factor conjugated to a monomethoxypolyethylene glycol), which is approved for use to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs, by stimulating neutrophil production.  Amgen asserts that Hospira, acting in concert with Pfizer, submitted an abbreviated Biologics License Application for a proposed biosimilar to Amgen's Neulasta® product.  In August 2019, Amgen and Hospira began exchanging information as required by the BPCIA.  However, Amgen asserts that Hospira failed to provide Amgen with a true copy of the FDA application as required under 42 U.S.C. § 262(l)(2)(A).  Amgen also asserts that the submission of the Hospira Biologics License Application constitutes one or more acts of infringement of one or more claims of the '707 patent under 35 U.S.C. § 271(e)(2)(C).

    View the complaint here.

  • By Kevin E. Noonan

    USPTO SealTwo papers were filed with the PTAB in Interference No. 106,155 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology, and Junior Party the University of California, Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC").

    On February 13, 2020, the parties filed a Joint Stipulation to Extend Time for time periods 4-6; the deadlines for the responses due during those time periods now are as follows:

    TIME PERIOD 1 — October 4, 2019
    File motions — October 14, 2019
    File priority statements
    (but serve one business day later)

    TIME PERIOD 2 — October 25, 2019
    File responsive motions to motions filed in TIME PERIOD 1 — November 7, 2019

    TIME PERIOD 3 — December 6, 2019
    File oppositions to all motions — January 9, 2020

    TIME PERIOD 4 — January 17, 2020
    File all replies — March 5, 2020
                              March 16, 2020

    TIME PERIOD 5 — February 28, 2020
    File request for oral argument — March 16, 2020
    File motions to exclude evidence — March 23, 2020
    File observations

    TIME PERIOD 6 — March 20, 2020
    File oppositions to motions to exclude — March 26, 2020
    File response to observations — March 30, 2020

    TIME PERIOD 7 — April 3, 2020
    File replies to oppositions to motions to exclude

    DEFAULT ORAL ARGUMENT DATE — TBD

    And on February 25th, CVC provided an updated Notice of Related Proceedings, informing the Board and the Broad of the following newly granted patents (as well as additional pending applications), none of which are involved in this interference:

    10,301,651 (USSN 14/685,504); 10,227,611 (USSN 14/042,782); 10,407,697 (USSN 15/435,233); 10,385,360 (USSN 15/925,544); 10,421,980 (USSN 16/033,002); 10,415,061 (USSN 16/033,005); 10,308,961 (USSN 16/033,016); 10,358,658 (USSN 16/201,836); 10,337,029 (USSN 16/201,848); 10,351,878 (USSN 16/201,855); 10,400,253 (USSN 16/276,343); 10,428,352 (USSN 16/276,348); 10,443,076 (USSN 16/276,356); 10,487,341 (USSN 16/277,090); 10,519,467 (USSN 15/803,424); 10,526,619 (USSN 16/380,758); and 10,513,712 (USSN 16/382,093); 10,533,190 (USSN 16/380,781); 10,550,407 (USSN 16/382,096); 10,563,227 (USSN 16/382,097); 10,570,419 (USSN 16/382,100); 10,577,631 (to be granted March 3rd; USSN 16/383,422); allowance of USSN 16/383,412; allowance of USSN 16/383,443.

  • By Michael Borella

    In 2014's Alice Corp. v. CLS Bank Int'l case, Justice Thomas famously wrote, "we need not labor to delimit the precise contours of the 'abstract ideas' category in this case."  Instead, he found the claims of patentee Alice to have "no meaningful distinction" under 35 U.S.C. § 101 from those the Court previously found ineligible in Bilski v. Kappos.

    Since then, the abstract idea inquiry has been applied by the Federal Circuit over 100 times in various ways.  Initially, there was some hope that this category may be limited to financial transactions or certain types of computer-implemented business methods.  Not so.  Recently, network-controlled electric car charging stations and garage door openers were found to be abstract in ChargePoint, Inc. v. SemaConnect, Inc. and The Chamberlain Group, Inc. v. Techtronic Industries Co., respectively.  These inventions join a long list of those found too abstract for patenting, including claims for displaying advertisements in before content in a video distribution service, dynamic tabs on a user interface, administration of digital images, monitoring of an electrical power grid, and computer virus screening just to name a few.

    Even with all of these appellate opinions, the legal definition of "abstract idea" remains remarkably elusive.  Notably, in Interval Licensing LLC v. AOL, Inc., Judge Plager of the Federal Circuit wrote, "a search for a definition of 'abstract ideas' in the cases on § 101 from the Supreme Court, as well as from this court, reveals that there is no single, succinct, usable definition anywhere available."  Last year, the U.S. Patent and Trademark Office (USPTO) published patent eligibility examination guidance that defined three classes of abstract idea (mental processes, mathematical concepts, and methods of organizing human activity).  This demonstrates that the USPTO is struggling to have its examining corps of thousands apply Alice consistently.  But the courts have not adopted the USPTO's view of the world, and the Federal Circuit has explicitly stated that it is not bound by the guidance.

    Denying one a property right or taking one's granted property right away based on such ill-defined criteria seems suspicious if not straight from the mind of a genetically-engineering offspring of George Orwell, Franz Kafka, and Terry Gilliam.  And yet, here we are.

    The Google dictionary definition of "abstract" is "existing in thought or as an idea but not having a physical or concrete existence."  But one cannot square such a definition with the case law.  Some of the claims in Alice were found abstract despite reciting physical, tangible computer hardware.  Indeed, pure software written in code is stored on a physical tangible medium, such as a disk drive, flash memory, CDROM, etc.  While thinking about software is abstract, the code and equipment that makes your computer display this article — or do anything else for that matter –– is not.  The dictionary definition does not help us decode how the courts are applying § 101.

    Instead, the abstract idea is an elaborate legal fiction that has little to do with the layperson's understanding of what might or might not be abstract.  Without being grounded in statute or plain meaning, it is not hard to see why patentees, patent attorneys, the USPTO, and federal judges remain unable to agree on whether certain types of inventions are eligible for patenting.  And this gray area covers many types of inventions that are not only at the bleeding edge of research, but also crucial to the U.S. economy and competitiveness.  Artificial intelligence, machine learning, data science, and quantum computing innovations are more difficult to patent due to Alice and its progeny.[1]

    A Concise Definition

    Can one synthesize the aforementioned 100-plus Federal Circuit decisions applying the abstract idea test and come to a more clear understanding of what this category entails?  A daunting task no doubt, but one that I will attempt to address (with a handful of caveats, of course).

    Particularly, in view of post-Alice Federal Circuit case law:

    a claim is not directed to an abstract idea if it includes at least one element that is a specific, technical improvement that is not found in the prior art.

    Let's break this down by stating the converse — a claim is directed to an abstract idea if all of its elements are non-specific, address a non-technical problem, or are known in the art.  Thus, in order for a claim to be successful under § 101, it should have three qualities:  specificity, a technical problem that it solves, and some degree of novelty.  I will address each of these notions in turn.

    Specificity

    In ruling the invention in McRO, Inc. v. Bandai Namco Games America Inc. eligible, the Federal Circuit used the word "specific" or "specifically" at least 15 times when referring to the claims.  Similar usage of "specific" as a root word can be found in Enfish LLC v. Microsoft Corp., Trading Techs Int'l v. CQG, Inc., and SRI Int'l Inc. v. Cisco Systems Inc. — in each of these cases, claims were ruled eligible.  In contrast, the Court in Chamberlain lamented the lack of specificity of the claims under review, which — as noted above — were found ineligible.

    An aspect of specificity is whether the claims recite an outcome or how to achieve that outcome.  Purely outcome-oriented claims often appear functional, indicating what the invention provides rather than how the invention provides it.  In Electric Power Group, LLC v. Alstom S.A., the Court found the claims therein ineligible due to their "defining a desirable information-based result and not [being] limited to inventive means of achieving the result."  Likewise, in Two-Way Media Ltd. v. Comcast Cable Communications, LLC, the Court criticized one of the claim's "result-based functional language."  Particularly, "[t]he claim requires the functional results of converting, routing, controlling, monitoring, and accumulating records, but does not sufficiently describe how to achieve these results in a non-abstract way."  It is not hard to find more examples of claims that have fallen due to lacking specificity regarding the steps needed to carry out the invention.

    Indeed, there are five types of specificities that can appear in a claim.[2]  Ideally for § 101 purposes, a claim recites a specific function of a specific element that does something in a specific way to obtain a specific result and thus solve a specific problem.  Not all five specificities need be present in each claim, but the more of these specificities there are, the more likely the claim will survive an eligibility challenge.  Conversely, the fewer specificities in the claim, the more likely it will be found abstract.

    If you are thinking that specificity of claim language should be handled by the definiteness, enablement, and written description requirements of § 112 you would not be wrong.  But one of the odd aspects of post-Alice case law is how the § 101 test has evolved to take on characteristics from the § 112 tests.  This evolution has not gone unnoticed at the Federal Circuit.  In American Axle & Mfg. v. Neapco Holdings LLC, Judge Moore wrote in dissent that the majority had applied an enablement test in the guise of eligibility.[3]

    Addressing a Technical Problem

    But claims require more than just specificity to be eligible.  There are numerous examples of narrow, specific claims that fell to a § 101 challenge, including those of Trading Techs. Int'l, Inc. v. IBG LLC ("[t]he claims are focused on providing information to traders in a way that helps them process information more quickly, not on improving computers or technology"),[4] Versata Development Group, Inc. v. SAP America, Inc. (a claim "akin to creating organizational management charts" fails to "solve a technical problem using a technical solution"), Shortridge v. Foundation Construction Payroll Service, LLC ("generating certified payroll records is an abstract business practice"), and SAP America, Inc. v. InvestPic, LLC ("Under the principles developed in interpreting § 101, patent law does not protect [an advance in mathematical techniques in finance], without more, no matter how groundbreaking the advance").  Thus, specificity will only get you so far and is not the complete answer to the § 101 riddle.

    But Trading Techs, Versata, Shortridge, and SAP America all exhibit an unfavorable characteristic — they are more directed to solving business problems rather than technical problems.  While there is no statutory notion in the U.S. that patents only protect solutions to technical problems, the America Invents Act did introduce the Covered Business Method Review process.  This, along with Alice, may have resulted in the Federal Circuit feeling like it has license to look askance at business methods, with the district courts and USPTO following.

    What exactly is a difference between solving a technical problem versus a business problem?  For guidance, we can look to Europe and other jurisdictions where such a concept has been in place for years.  Along these lines of thinking, inventions exist on a spectrum from those addressing technical problems by improving the operation of machines (e.g., engine control, error correction coding of signals, multiprocessing), to those addressing the operation of a business (e.g., derivative trading, hedging risk analysis, ecommerce, and retail schemes).  The former is much more likely to be patentable than the latter.  In the middle, we have a gray area of inventions that improve human performance or life in general (e.g., film animation, desktop communication applications, video game avatar controls).  These inventions could go either way.

    Indeed, the Federal Circuit has even found inventions that are claimed rather broadly to be eligible due to their technical nature.  In SRI, claims addressing a hierarchical network monitoring system were found rooted in computer technology in order to solve a specific problem arising in the realm of network computing.  Likewise, claims in Koninklijke KPN N.V. v. Gemalto M2M GmbH were also found eligible "because they are directed to a non-abstract improvement in an existing technological process."

    Thales Visionix Inc. v. U.S. is a notable case in this category, where remarkably broad claims were found to be eligible because the accompanying specification explained in detail the technical improvement they provided.  But one should not conclude that specificity can be replaced by a technical improvement.  Claims with both fare better, and Thales may be an outlier.  A lengthy explanation of an invention's technical character in the specification (when argued properly) probably cannot hurt claims, but it will not guarantee success if the claims are outcome-oriented.

    The USPTO's Patent Trial and Appeal Board (PTAB) seems to be taking the European approach.  Recently, the PTAB published a number of informational decisions applying the USPTO's latest examination guidance.  The outcomes of these cases break along the technical problem to a technical solution line.  An invention directed to optimizing the signal to noise ratio from reception coils of an magnetic resonance tomograph was found to meet the § 101 requirements, as was an invention focused on transforming the coordinate system of catheter navigation to the coordinate system of an external model or external image data.  On the other hand, software for selecting a golf club with a suitable loft angle and software for creating a life-cycle workflow for a project were found ineligible due to their addressing non-technical problems.

    Nonetheless, the contours of the business method are somewhat malleable and in the eyes of the beholder.  There are instances of the Federal Circuit finding claims to be eligible where those claims are ostensibly business-oriented.  In Trading Techs Int'l v. CQG, Inc., the Court concluded that claims directed to a securities trading user interface was sufficiently technical because it solved existing problems in such interfaces.  In DDR Holdings, LLC v. Hotels.com L.P., the Court found that the claimed solution of "generating a composite web page that combines certain visual elements of a host website with content of a third-party merchant" to be technical and "necessarily rooted in computer technology," despite arguably addressing the business-oriented problem of retaining or increasing web site traffic.

    Not in the Prior Art

    Patent eligibility under § 101 was not intended to be a prior art test, but it has become one.  Despite Judge Moore's criticism of the Court's combining § 112 considerations into § 101, her opinion in Berkheimer v. HP Inc. introduces factual considerations of prior art under §§ 102 and 103 into part two of the Alice test (the search for an inventive concept where one must consider whether claim elements are well-understood, routine, and conventional).  But the cross-contamination of eligibility and prior art began before Berkheimer.  Indeed, comparisons between claimed inventions and prior art are found in a vast number of § 101 decisions including the aforementioned KPN, Chamberlain, Enfish, and McRO cases, as well as Cellspin Soft, Inc. v. Fitbit, Inc., Data Engine Technologies LLC v. Google LLC, Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc., and Internet Patents Corp. v. Active Network, Inc., just to name a few.

    The exact nature of this de facto prior art analysis under § 101 is unclear.  Not only does it impact the second part of the test but also the first part.  For example, in Chamberlain, the Court found the claims abstract after noting that the "only described difference between the prior art movable barrier operator systems and the claimed movable barrier operator system is that the status information about the system is communicated wirelessly" and that wireless communication is an abstract concept.  Rather than analyzing claims as a whole under part one as was set forth in Enfish and McRO, recent Federal Circuit cases appear to be dividing claims into elements within the prior art and those that are not.  The Court then only considers whether the non-prior-art elements are specific and technical enough to be more than an abstract idea.

    But what if all of your claim elements are in the prior art, but your claims recite a combination that is not?  As noted, even though claims are supposed to be analyzed as a whole under part one of Alice and as an ordered combination under part two, these analyses get short shrift in practice.  In cases like Chamberlain and InvestPic, the Federal Circuit provided conclusory reasoning by using variations of the phrase "when considered as an ordered combination, the components of each claim add nothing that is not already present when the steps are considered separately."  This language is derived from Mayo, and similar wording regarding ordered combinations can be found in numerous district court and PTAB decisions.  Bottom line — relying on claims being viewed as a whole or as an ordered combination is risky.

    Analysis

    To be clear, the definition I propose is not perfect, and is merely an attempt to fit a line through a messy set of data points.  Still, following this approach can provide a sense of how likely it is for your invention to avoid § 101 issues, or whether drafted claims should be edited or amended to become more clearly eligible.  While some of these factors might be able to be downplayed in certain situations, the more specific, technically-oriented, and novel your claimed invention, the higher the probability of a desirable outcome.

    Notably, this definition is not the two-part Alice test.  There is no "directed to" or "inventive concept" inquiries.  In practice, the Alice test often effectively has only one part — whether the claim is directed to a judicial exception.  In conducting this inquiry for the abstract idea category, one considers the claim's specificity, technical character, and whether it recites elements in the prior art.  Therefore, I posit that the definition proposed is a more coherent representation of the process actually carried out than the disparate articulations of Alice in the last five-and-a-half years of Federal Circuit case law.

    [1] Medical diagnostics and genetic engineering are other high-value fields that suffer from the Supreme Court's rulings, though inventions in these areas are generally subject to the natural phenomenon or law of nature exceptions to eligibility, and are thus controlled by Mayo Collaborative Services v. Prometheus Labs., Inc. and Association for Molecular Pathology v. Myriad Genetics rather than just Alice.

    [2] These five specificities are different but in the same spirit as those introduced by Judge Lourie in Vanda Pharmaceuticals v. West-Ward Pharmaceuticals.  In that case, he wrote "[a]t bottom, the claims here are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome."

    [3] Admittedly, the judicial exception in American Axle was a law of nature, but Judge Moore's general reasoning holds.

    [4] There are multiple Federal Circuit cases with this heading, and the one decided April 30, 2019 is referred to here.

  • By Donald Zuhn

    Federal Circuit SealOn Tuesday, the Federal Circuit issued a per curiam Order in NZNP Finance Ltd. v. Actavis Laboratories UT, Inc., denying a petition for rehearing en banc filed by Plaintiffs-Appellants HZNP Finance Ltd. and Horizon Therapeutics USA, Inc.  The Court also denied Plaintiffs-Appellants a panel rehearing.

    Circuit Judge Lourie, joined by Circuit Judges Newman, O'Malley, and Stoll, dissented from the denial of the petition for rehearing en banc, arguing that the panel majority had "erroneously misconstrued the 'consisting essentially of' language in evaluating the definiteness requirement of 35 U.S.C. § 112."  At issue was claim 49 of U.S. Patent No. 8,252,838, which reads:

    49.  A topical formulation consisting essentially of:
        1–2% w/w diclofenac sodium;
        40–50% w/w DMSO;
        23–29% w/w ethanol;
        10–12% w/w propylene glycol;
        hydroxypropyl cellulose; and
        water to make 100% w/w,
        wherein the topical formulation has a viscosity of 500–5000 centipoise.

    The panel majority had affirmed the determination by the District Court for the District of New Jersey that claim 49 was indefinite because of inconsistencies in the meaning of "better drying time."  The '838 patent specification discloses that the claimed formulation can be used as an anti-inflammatory, or analgesic.  The specification also discloses that the advantages of the claimed formulation are better drying time, higher viscosity, increased transdermal flux, greater pharmacokinetic absorption, and favorable stability.

    The dissent begins by noting that "[i]t is not disputed that 'consisting essentially of' generally means that the composition not contain, in addition to its enumerated components, materials that materially affect the basic and novel properties of the invention."  The dissent points out that the term "better drying time" is not recited in the claim, adding that "it is the claims that the statute requires be definite."

    With respect to claim 49, the dissent notes that "[t]he utility of the claimed invention, recited in the specification, is as an anti-inflammatory, or analgesic, because those are the principal properties of diclofenac, the main ingredient of the composition."  As for the advantage of better drying time, the dissent contends that "it is the language of the claims that must not be indefinite, not the understanding or clarity of an advantage of the invention," pointing out that "[t]he advantages of the invention, its utility and its basic and novel properties, are not in the claims."

    Noting that it is not necessary to recite the utility of a claimed compound (e.g., as an anti-inflammatory) in the claims, nor is it necessary to recite in the claims how that utility is measured, the dissent concludes that "aspects of the utility or its measurement are not relevant to indefiniteness of the claims."  The dissent then asks "since how one measures anti-inflammatory activity does not create an indefiniteness issue, why should measuring better drying time?"  The dissent also wonders "whether, if this patent did not recite the methods by which better drying time was measured, any indefiniteness of the 'consisting essentially of' language would have arisen at all."  Because "under the rule this opinion purports to adopt, any uncertainty concerning advantages, utility, or methods of determining such could . . . be translated into indefiniteness of claims," Judge Lourie dissented from the Federal Circuit's decision not to rehear the case en banc.

    NZNP Finance Ltd. v. Actavis Laboratories UT, Inc. (Fed. Cir. 2020)
    Per curiam
    Circuit Judge Lourie dissenting from the denial of the petition for rehearing en banc, joined by Circuit Judges Newman, O'Malley, and Stoll

  • By Kevin E. Noonan

    Federal Circuit SealThe patent marking statute, codified at 35 U.S.C. § 287(a) appears straightforward:

    Patentees, and persons making, offering for sale, or selling within the United States any patented article for or under them, or importing any patented article into the United States, may give notice to the public that the same is patented, either by fixing thereon the word "patent" or the abbreviation "pat.", together with the number of the patent, or by fixing thereon the word "patent" or the abbreviation "pat." together with an address of a posting on the Internet, accessible to the public without charge for accessing the address, that associates the patented article with the number of the patent, or when, from the character of the article, this can not be done, by fixing to it, or to the package wherein one or more of them is contained, a label containing a like notice.  In the event of failure so to mark, no damages shall be recovered by the patentee in any action for infringement, except on proof that the infringer was notified of the infringement and continued to infringe thereafter, in which event damages may be recovered only for infringement occurring after such notice.  Filing of an action for infringement shall constitute such notice.

    Applying the statute to circumstances can be more complicated when the patented invention is a component of an article in commerce, which was the case in Arctic Cat Inc. v. Bombardier Recreational Products Inc., decided last week by the Federal Circuit, limiting the amount of damages due from an infringer based on this section of the Patent statute.

    The case arose over infringement of Arctic Cat's U.S. Patent Nos. 6,793,545 and 6,568,969 by Bombardier, the patents directed to steering systems in personal watercraft (PWC) such as jet skis.  Arctic Cat ceased selling PWC in favor of a licensing agreement with Honda.  This licensing agreement had contained a provision requiring Honda to mark all licensed products sold with appropriate patent numbers, but this provision was not included in the final agreement between the parties.  It was undisputed that Arctic Cat failed to monitor whether Honda was properly marking but not when Honda stopped neglecting this responsibility and began to mark; Arctic Cat asserted September 6, 2013 as the latest date when Honda sold unmarked items while Bombardier alleged Honda sold unmarked PWCs as late as 2018.

    A jury found the asserted patents to be infringed and not invalid, and awarded damages calculated from October 16, 2008 (a date 6 years before Arctic Cat filed suit and a little less than five years before Arctic Cat agreed Honda stopped selling unmarked items).  The jury also found that Bombardier's infringement was willful.  In an earlier appeal, Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350 (Fed. Cir. 2017), the Federal Circuit affirmed the jury's willfulness determination by vacating and remanding on the marking issue for putting the burden on Bombardier to show that unmarked articles did not practice the claimed invention.  Rather, according to that panel, "once an alleged infringer identifies products that it believes are unmarked patented articles subject to the notice requirements of § 287, the patentee bears the burden of proving that the identified products do not practice the claimed invention."  On remand (the subject of this appeal), Arctic Cat moved for summary judgment that it was entitled to "pre-complaint" damages, and that § 287 "did not apply after the time that it alleges Honda stopped selling unmarked products." "More ambitiously," as characterized by the panel opinion, Arctic Cat asserted that the jury's willfulness determination constituted notice and hence it was entitled to the entire period when Bombardier was selling PWCs that infringed the patents in suit under § 286, which constituted a time period when Honda was undisputedly selling unmarked items.  The District Court disagreed and limited the damages awarded not to include damages for pre-complaint sales.

    The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Moore and Stoll.  The opinion set forth the principles behind the restriction of damages embodied in § 287, that while a patentee who does not make or sell a patented article can obtain damages for any infringing article, even without notice, when a patentee makes or sells and fails to mark, she cannot collect damages until she either provides actual notice or sues the accused infringer.  This amounted to cure of the neglect of not marking, but it also provides definitive boundaries on when damages can be obtained for infringing activity and when the statute provides that damages cannot be so obtained — all based on patent marking.  The circumstances in this case were somewhat of an anomaly ("a discontinuous situation") because "unmarked products were sold, such that Arctic Cat could not receive damages before providing notice, but the sales of unmarked products allegedly stopped for a period of time prior to the filing of Arctic Cat's complaint."  As a consequence, the question the Court perceived was presented is "whether the cessation of sales of unmarked products excuses noncompliance with the notice requirement of § 287 such that a patentee may recover damages for the period after sales of unmarked products ceased but before the filing of a suit for infringement," a question having an answer for this panel of "no."

    The panel rejected Arctic Cat's statutory interpretation dependent on the statute being written in the present tense, so that ceasing sales of unmarked product would be sufficient to cure.  This comes from the language of the statute according to the opinion, which while casting a patentee's conduct in the present tense, the consequences of failing to mark are not limited in time.  The statutory language "prohibits a patentee from receiving any damages in a subsequent action for infringement after a failure to mark, rather than merely a reduced amount of damages in proportion to the amount of time the patentee was actually practicing the asserted patent" according to the opinion (emphasis added).  The statute imposes an obligation to mark when the patentee (or in this case, its licensee) begins to sell the patented article.  Succinctly, the opinion captures the equities of these responsibilities saying:

    The notice requirement to which a patentee is subjected cannot be switched on and off as the patentee or licensee starts and stops making or selling its product.  After all, even after a patentee ceases sales of unmarked products, nothing precludes the patentee from resuming sales or authorizing a licensee to do so.  In the meantime, unmarked products remain on the market, incorrectly indicating to the public that there is no patent, while no corrective action has been taken by the patentee.  Confusion and uncertainty may result.  Thus, once a patentee begins making or selling a patented article, the notice requirement attaches, and the obligation imposed by § 287 is discharged only by providing actual or constructive notice.

    The panel also found this interpretation to be consistent with the purpose of the statute:  "(1) helping to avoid innocent infringement; (2) encouraging patentees to give public notice that the article is patented; and (3) aiding the public to identify whether an article is patented," citing Nike, Inc. v. Wal-Mart Stores, Inc., 138 F.3d 1437, 1443 (Fed. Cir. 1998), whereas Arctic Cat's interpretation "would undermine those objectives" because it would allow a patentee "to allow a patentee to mislead others that they are free to make and sell an article that is actually patented, but nonetheless allow the patentee to recover damages without undertaking any corrective action."

    The Court also rejected Arctic Cat's argument that a finding of willfulness was enough to establish actual notice, not least because "Arctic Cat acknowledges, as it must, that this argument is foreclosed by our precedent" citing Amsted Indus. Inc. v. Buckeye Steel Castings Co., 24 F.3d 178, 187 (Fed. Cir. 1994), and relying on Am. Med. Sys., Inc. v. Med. Eng'g Corp., 6 F.3d 1523, 1537 n.18 (Fed. Cir. 1993).  The distinction drawn by the panel is that "willfulness turns on the knowledge of an infringer, [while] § 287 is directed to the conduct of the patentee" and "[k]nowledge by the infringer is not enough.  Actual notice under § 287 requires performance by the patentee."  Accordingly, the opinion affirmed the District Court's denial of pre-complaint damages.

    Arctic Cat Inc. v. Bombardier Recreational Products Inc. (Fed. Cir. 2020)
    Panel: Circuit Judges Lourie, Moore, and Stoll
    Opinion by Circuit Judge Lourie

  • By Bryan Helwig

    USPTO SealAbout the PTAB Life Sciences Report:  We will periodically report on developments at the PTAB involving life sciences patents.

    Abbott Laboratories v. Edwards Lifesciences Corp.

    PTAB Petition:  IPR2020-00480; filed January 28, 2020.  View Petition here.

    Patent at Issue:  U.S. Patent No. 6,719,767, ″Device and a method for treatment of atrioventricular regurgitation," describes a less invasive based mitral-valve clip method for treating "mitral insufficiency" instead of traditional open-heart surgery.  Petitioner requests institution of IPR, seeking cancellation of claims 1-3, 5, and 14 of the ′767 patent as unpatentable under 35 U.S.C. §§ 102 and 103.

    Background:  Petitioner alleges that the challenged claims recite a clip that can be delivered with a catheter passing through a patient's blood vessels and used to repair the mitral valve in the heart, rather than via open-heart surgery.  Petitioner notes that Abbott's subsidiary, Evalve, had already developed and patented several such clips.  Specifically, Abbott's prior art U.S. Patent No. 6,629,534 describes clips for catheter-based mitral valve repair.  Petitioner alleges that the clips in the prior art and the '767 patent are nearly identical, other than the position of the crossbars.


    Glaxosmithkline Consumer Healthcare Holdings (US) LLC v. Cipla Ltd.

    PTAB Petition:  IPR2018-0368; filed January 31, 2020.  View Petition here.

    Patent at Issue:  U.S. Patent No. 8,163,723, "Combination of azelastine and steroids," is directed at a pharmaceutical product comprising azelastine and a steroid, in a form suitable for nasal or ocular administration.  The '723 patent provides a method of prophylaxis or treatment in a mammal where anti-histamines and/or one or more steroids is indicated.  Petitioner challenges claims 1-218 of the ′723 patent as unpatentable under 35 U.S.C. § 103.

    Background:  The claims are directed to methods of using formulations comprising azelastine and fluticasone.  Petitioner alleges that nasal sprays comprising each of these ingredients were known in the prior art and approved by the FDA as safe and effective for allergic rhinitis.  Petitioner also alleges that co-formulation of the two ingredients into a single formulation, and the benefits of such co-formulations, were also known in the prior art, and that combining the teachings of the prior art to arrive at the claimed invention would have been obvious to one of skill in the art.


    Mylan Laboratories Ltd. v. Janssen Pharmaceutica NV

    PTAB Petition:  IPR2020-00440; filed February 7, 2020.  View Petition here.

    Patent at Issue:  U.S. Patent No. 9,439,906, "Dosing regimen associated with long acting injectable paliperidone esters," is directed at a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations.  Petitioner challenges claims 1-21 of the '906 patent as unpatentable under 35 U.S.C. § 103.

    Background:  The ′906 patent claims a dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder.  Petitioner alleges that the claims of the '906 patent are the result of routine optimization of dosing amounts of paliperidone palmitate reported in the prior art.  More specifically, Petitioner alleges that dosing regimens and dosages can be found in the prior art.  Petitioner also alleges that the dosage on each day would have been guided by well-known principle involving injectable depot formulations.


    NanoCellect Biomedical, Inc. v. Cytonome/ST, LLC

    PTAB Petition:  IPR2020-00549; filed February 11, 2020.  View Petition here.

    Patent at Issue:  U.S. Patent No. 10,029,263, "Method and apparatus for sorting particles," is directed at a method and apparatus for the sorting of particles in a suspension, where the input flow path of a sorting module can be split into several output channels.  The claims are further directed at a particle sorting system in which a plurality of sorting modules are interconnected to increase particle throughput.  NanoCellect challenges claims 1, 5-6, 8, 15, and 16 as obvious under 35 U.S.C. § 103.

    Background:  The '263 patent claims a microfludic system for sorting particles.  Petitioner alleges that the claimed combination of elements was already disclosed in a prior art reference.  Further, Petitioner alleges that by the priority date cytometers, including sorters using heater electrodes and piezoelectric actuators for cell sorting, were widely available, and functioning microfluidic devices were also known.

  • CalendarFebruary 26, 2020 – "Blocking Patents in Prosecution Strategy and Corporate IP Strategy after Acorda" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    March 5, 2020 – "Enhancing Diversity & Inclusion in IP Law and Beyond" (Federal Circuit Bar Association) – 3:00 pm to 5:30 pm (ET), Washington, DC

    March 11, 2020 – Patent Litigation Seminar (New Jersey Intellectual Property Law Association) – 12:00 to 5:30 pm, Iselin, NJ

    March 11, 2020 – "Navigating USPTO Pilot Programs" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    March 12, 2020 – "Opposition Practice at the EPO" (J A Kemp) – 15:30 to 16:30 pm GMT (Greenwich Mean Time)

    March 13, 2020 – "Digital Platforms: Innovation, Antitrust, Privacy & the Internet of Things" (The UIC John Marshall Law School) – 8:45 am to 4:30 pm, Chicago, IL

    April 27-28, 2020 – Paragraph IV Disputes Master Symposium (American Conference Institute) – New York, NY

    May 20-21, 2020 – Advanced Summit on Life Sciences Patents (American Conference Institute) – New York, NY

  • NJIPLAThe New Jersey Intellectual Property Law Association (NJIPLA) will be holding a Patent Litigation Seminar from 12:00 to 5:30 pm on March 11, 2020 in Iselin, NJ.  The seminar will offer presentations on the following topics:

    • Patent Cases at the Supreme Court: From Petitions to CVSGs to Arguments, and Everything in Between
    • Written Description and Enablement Issues in Pharma/Bio Patents — Latest Developments
    • Willful Infringement: Acts of Piracy
    • A Behind the Scenes Look at a Supreme Court Argument and a Biotech Jury Trial: A Conversation with Morgan Chu, Irell & Manella LLP
    • Diagnosing what Ails Patent Eligibility: Can this Problem be Solved? – to be presented by Patent Docs author Donald Zuhn of McDonnell Boehnen Hulbert & Berghoff LLP
    • Recent Developments in Inducement and Divided Infringement

    Additional information regarding the seminar, including a complete agenda and list of speakers, can be found here.  The registration fee for the seminar is $185 (member), $230 (non-member), $105 (in-house counsel/government employee member) $130 (in-house counsel/government employee non-member), or $45 (students).  Those interested in registering for the seminar can do so here.

  • J A KempJ A Kemp will be offering a webinar entitled "Opposition Practice at the EPO" on March 12, 2020 from 15:30 to 16:30 pm GMT (Greenwich Mean Time).  Sarah Roques and Ravi Srinivasan of J A Kemp will consider opposition practice, including how to set up an attacking opposition, and also highlight strategies for defence, including setting up the case in prosecution and formulating a strategy for amendment during opposition.  The webinar will also address the following topics:

    • Grounds of opposition and approaches to setting up an opposition statement
    • Good defence starts in prosecution
    • Claim amendments — auxiliary requests in opposition
    • Overall strategies for attack and defence, to maintain flexibility on appeal
    • The role of experiments: what supporting data can usefully be filed, and when should it be provided
    • Oral proceedings at the EPO

    Those wishing to register can do so here.