• CalendarMay 18, 2017 – "Navigating the Chinese Patent System: What U.S. Patent Counsel Need to Know — Protecting IP Rights in China, Leveraging New Amendments, Understanding Current Litigation Trends and More" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 24, 2017 – "Antitrust Issues in ANDA Patent Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    May 25, 2017 – "Evolving PTAB Trial Practice: Navigating Complex Procedural Rules — Strategically Using Routine and Additional Discovery, Requests for Joinder, and Motions to Amend" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 25, 2017 – "Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers" (Strafford) – 1:00 to 2:30 pm (EDT)

    June 12-14, 2017 – Summit on Biosimilars*** (American Conference Institute) – New York, NY

    June 13, 2017 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (ET)

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

  • MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Antitrust Issues in ANDA Patent Litigation" on May 24, 2017 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorney and Patent Docs author Kevin E. Noonan will discuss the following topics:

    • ANDA litigation
    • Reverse payment settlements
    • Actavis decision by US Supreme Court
    • Payments other than money: avoided litigation costs, authorized generics, supply agreements
    • District and Appellate Court decisions post-Actavis
    • Potential for antitrust issues in biosimilars litigation

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Evolving PTAB Trial Practice: Navigating Complex Procedural Rules — Strategically Using Routine and Additional Discovery, Requests for Joinder, and Motions to Amend" on May 25, 2017 from 1:00 to 2:30 pm (EDT).  Kevin B. Laurence of Laurence & Phillips and Scott A. McKeown of Oblon McClelland Maier & Neustadt will provide guidance to counsel on trends in Patent Trial and Appeal Board (PTAB) trial practice, focusing on motion opportunities, amendment, concurrent reissue/reexamination, evidentiary opportunities, and petition missteps.  The webinar will review the following topics:

    • Estoppel
    • Redundancy
    • Joinder
    • Motions to exclude
    • Supplemental evidence vs. supplemental information
    • Rehearing/appeal

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Double Patenting: Defeating Double Patenting Rejections and Avoiding Terminal Disclaimers" on May 25, 2017 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving and Leslie A. McDonell of Finnegan Henderson Farabow Garrett & Dunner, and Margaret J. Sampson of Baker Botts will provide guidance to IP counsel for understanding Patent Term Adjustment (PTA) B-delay possibilities and double patenting, particularly in view of a desire not to lose PTA in an earlier issued patent.  The panel will analyze recent court treatment and offer best practices to defeat double patenting rejections and avoid terminal disclaimers, and if a terminal disclaimer must be filed, some specific language to consider.  The webinar will review the following issues:

    • What is the scope of double patenting?
    • What is the examiner's duty for presenting double patenting rejections?
    • What steps can be taken to defeat double patenting rejections?
    • What best practices can be employed to avoid terminal disclaimers?
    • How can practitioners craft terminal disclaimers with an eye towards patent litigation?

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • D Young & CoD Young & Co will be offering its next European biotech patent law update on June 13, 2017.  The webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (ET).  D Young & Co European Patent Attorneys Simon O'Brien and Matthew Caines will provide an essential update and live Q&A on EPO biotechnology case law.

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Navigating the Chinese Patent System: What U.S. Patent Counsel Need to Know — Protecting IP Rights in China, Leveraging New Amendments, Understanding Current Litigation Trends and More" on May 18, 2017 from 1:00 to 2:30 pm (EDT).  Elizabeth Chien-Hale of Brinks Gilson & Lione and E. Robert Yoches of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to U.S. patent counsel and companies on Chinese patent law and what they need to know about the Chinese system; address changes to the Guidelines for Examination, current litigation trends, and the Anti-Unfair Competition Law (AUCL); and offer U.S. companies and counsel best practices for increasing IP protection under the Chinese system.  The webinar will review the following issues:

    • How the amendments to the Guidelines for Examination change patentability in China
    • The role of the AUCL in IP enforcement in China
    • Litigation trends in China and advantages of using the Chinese system

    The registration fee for the webinar is $297.  Those interested in registering for the webinar, can do so here.

  • Method for Processing Images from 3D Camera System Found Invalid under 35 U.S.C. § 101

    By Joseph Herndon

    District Court for the Northern District of CaliforniaIt is well-known law today that under 35 U.S.C. § 101, a patent claim that recites a solution to a problem but not the means of achieving it is likely not drawn to patent-eligible subject matter.  Courts have found that such claims, rather than disclosing a concrete solution, seek to monopolize the very idea of a solution itself.

    In the present case, Sungkyunkwan University sued LMI Technologies in the U.S. District Court for the Northern District of California for infringement of its U.S. Patent No. 7,957,639.

    The '639 patent is directed to determining an optimal exposure of a structured-light based 3D camera.  The 3D camera of the '639 patent includes a camera and a projecting unit such as a beam projector that illuminates a predetermined pattern on an object, captures an image of the object with the pattern illuminated thereon, and obtains 3D information by analyzing the obtained pattern.  The '639 patent describes that the precision of the calculated 3D data depends on how accurately the pattern is discriminated from the captured image.  To obtain optimal exposure for pattern discrimination, an image captured from a projected pattern without spread phenomenon (saturation) is compared with an image captured from a non-projected reference scene, and a pattern may be optimally discriminated when the intensity difference therebetween becomes the maximum.  As a scale for the intensity difference, SNR and difference in brightness are used.  The '639 patent describes that to determine an optimal exposure level of a camera according to dynamically changing environmental factors, the structured light based camera system employs a method for automatically determining an optimal exposure level by analyzing an image captured at a predetermined exposure level.

    Claim 1 is representative and is reproduced below:

    1.  A method for determining an optimal exposure of a structured light based three dimensional (3D) camera system including a projecting means for illuminating a predetermined pattern on a target object, an image capturing means for capturing an image of the target object with the pattern projected, and a processing means for reconstructing 3D data based on the captured image, wherein the method comprises the steps of:
        obtaining an image of a target object with a predetermined pattern projected thereon, which is illuminated from a projecting means, and an image of the target object without a predetermined pattern projected thereon; and
        determining automatically an optimal exposure level of the structured light based 3D camera system using said two kinds of images.

    LMI filed a motion to dismiss the case based on claim 1 being directed to an abstract idea.  The District Court agreed, and found that claim 1 of the '639 patent is directed to an abstract idea.

    To begin, the District Court noted that the claim's preamble recites the technological context of the invention and its end goal; the first element restates the technological context; and the second element restates the end goal.  Following, the District Court found that the method of optimizing exposure on a structured-light 3D camera — the "how" that's nominally the subject of the claimed invention — is absent.

    The closest claim 1 comes to disclosing how the invention intends to optimize exposure is its reference to two images generated by a structured-light camera (e.g., "determining automatically an optimal exposure level of the structured light based 3D camera system using said two kinds of images").  But as the patent specification makes clear, the images aren't the subject of the invention — "patterned" images are an inherent part of the prior-art cameras, and "unpatterned" images are just ordinary images.  The District Court found that the claim's repeated reference to the steps involved in using a structured-light camera adds nothing of substance to the method that's actually being claimed here.

    By describing the function of the prior-art cameras, the University situated the claimed invention in the technological environment in which it operates, but it did not explain the invention itself.

    The overall result is to place the full weight of patent-eligibility on the claim's use of the word "using" (e.g., "determining automatically an optimal exposure level . . . using said two kinds of images").  But whatever method might be encompassed by the idea of "using" patterned and unpatterned images, claim 1 doesn't disclose it.

    The District Court found that the only effect of the word "using" is to disclose the starting point of a method that the claim doesn't explain:  "using" two images, you get an optimal exposure, or rather "using" certain inputs, you get a certain result.  The District Court found that this is not enough to make claim 1 concrete because a claim cannot recite inputs and end result and attempt to claim every way of arriving at the end result.

    The District Court noted that the patent specification in fact teaches the steps involved in optimizing exposure on a structured-light camera.  But claim 1 does not recite such steps.

    Finally, the District Court noted that at oral argument, counsel for the University made vague reference to the fact that the '639 patent is translated from a Korean patent, as if to suggest that some concrete aspect of claim 1 was lost in translation.  But the District Court was quick to note that it's difficult to understand how this helps the University, because it's the U.S. patent that the University is asserting.

    Thus, the District Court granted the motion to dismiss.

    The end result here is not too surprising given that the claim lacks details of how the method is performed to achieve the recited result.  A claim that recites to obtain two types of images, and then to automatically determine an exposure level using the two kinds of images simply lacks enough detail to satisfy 35 U.S.C. § 101 under today's standards.  Although not discussed by the District Court, the term "automatically" also tends to offer no help in these instances since the claim fails to describe how the function is automatically performed as well.

    Sungkyunkwan University v. LMI Technologies (USA) Inc. (N.D. Cal. 2017)
    Order Granting Motion to Dismiss by District Judge Vince Chhabria

  • By Paul Cole* —

    Study of the background to Recognicorp, LLC v. Nintendo Co. (Fed. Cir. 2017), the subject of Michael Borella's earlier posting, reveals basis for his concerns about lack of analysis of the detailed disclosure of the specification and inattention to the detailed subject matter which was actually claimed.

    A reader of Judge Reyna's opinion is prompted to question why a panel including Judges Lourie and Stoll, both experienced in patent matters, treated the invention dismissively.  Recognicorp LLC which is the assignee of the '303 patent is an entity set up to undertake patent enforcement.  A web search reveals nothing relevant about that company or its activities.  The panel may therefore have been misled into believing that Recognicorp was a mere troll, and that there was therefore nothing significant that could be said in favour of the patent and the entity owning it.

    Further investigation reveals that this is an incomplete picture.  The earlier owner of the '303 patent is IQ Biometrix, Inc. of Kingwood, Texas whose president Greg J. Micek has said that the inspiration for setting up the company was the 9/11 events, and has explained that the company retains at least a contractual interest in the '303 patent.  It provides law enforcement and security technology solutions for government and private industry and its product FACES allows a user to create and re-create billions of human faces.  Facial features selected from a database are automatically blended together to produce a photo-quality composite facial image as is apparent from the images, see their website.  The technology helps law enforcement agencies identify, track and apprehend suspects, but also has wider uses, e.g., in education and theatre.

    It is instructive to consider, as the Court omitted to do, whether the claimed subject matter falls positively within the "process" category of § 101.

    The representative claim concerns a method for creating a composite image although it expressly recites only a single facial feature.  It starts with the steps of displaying facial feature images on a first area of a first display, the facial feature images being associated with facial feature element codes.  A facial feature image from the first area of the first display is selected via a user interface of the first device.  These steps are illustrated by the accompanying image downloaded from the website.  The user is offered a range of relatively small hairline images each one of which has an associated element code.  A selected hairline image is transferred from the first (right hand) area of the display to the second (left hand) area where a larger image is formed, a multiplication step being performed to show the selected hairline on an enlarged scale and to derive a facial image code.

    Image_1
    However, as explained, e.g., with reference to Fig. 4 of the patent, to complete the composite image further classes of feature image are added to provide a complete facial image code which is then displayed on a second display, these further steps being illustrated by the following further images from the website.

    Image_2
    The criteria for eligibility under the "process" category of § 101 are set out in Gottschalk v. Benson (1972), quoting Justice Bradley in Cochrane v Deener (1876):

    A process is a mode of treatment of certain materials to produce a given result.  It is an act, or a series of acts, performed upon the subject matter to be transformed and reduced to a different state or thing.  If new and useful, it is just as patentable as is a piece of machinery.  In the language of the patent law, it is an art.  The machinery pointed out as suitable to perform the process may or may not be new or patentable; whilst the process itself may be altogether new, and produce an entirely new result. The process requires that certain things should be done with certain substances, and in a certain order; but the tools to be used in doing this may be of secondary consequence.

    Novelty was not in question and utility is supported by the fact that FACES has received a number of awards including the President's Award, Crime Stoppers International, 1999 as an outstanding contribution to law enforcement in the field of crime solving and is an official training tool for FBI agents.  The website includes quotes from serving police officers, of which the following is representative:

    "I have been a law enforcement officer for over 30 years, having worked a variety of assignments which required composite drawings of suspects.  For those drawings I utilized a system utilizing individual foils to construct the desired image.  A complex, time-consuming process under the best conditions.  After becoming familiar with your system, I was so impressed that I showed several officers how to develop a composite drawing using your FACES software.  I know that this valuable gift will enhance our efforts in bringing to justice those who are intent on violating the law at the expense of society."  Byron C. Nelson, Chief of Police, Sequim Police Dept., Sequim, Washington.

    The subject matter to be transformed is the various facial feature images, and their conversion to a composite image and reproduction on a second display are plainly transformational within the test set out in Gottsschalk.  The new result is set out in the '303 patent in problem/solution terms familiar to European practitioners and was acknowledged in the panel opinion.

    Prior to the invention disclosed in the '303 patent, composite facial images typically were stored in file formats such as "bitmap," "gif," or "jpeg."  But these file formats required significant memory, and compressing the images often resulted in decreased image quality.  Digital transmission of these images could be difficult.  The '303 patent sought to solve this problem by encoding the image at one end through a variety of image classes that required less memory and bandwidth, and at the other end decoding the images.

    The commercial success and police and other acclaim for FACES provides substantial evidence to support the inventive merit of the subject matter claimed in the '303 patent, and is strikingly reminiscent of the commercial success and industry praise in the en banc decision of the Federal Circuit in Apple Inc. v. Samsumg Electronics (October 2016), where a video showed Steve Jobs unveiling the slide to unlock feature of an iPhone at an Apple event and that when he swiped to unlock the phone, "the audience burst into cheers."  It was held that the jury had been presented with substantial evidence of praise in the industry that specifically related to features of the claimed invention, thereby linking that industry praise with the patented invention.

    It therefore appears almost beyond argument that the claimed subject matter indeed falls positively within the process category, and that this should have been a conclusive holding avoiding the need for any consideration of the ineligible "abstract idea" category.  It is questionable whether that category can be invoked to "nibble away" at the full scope of the "process" category without raising issues of separation of powers.  Shortly before his appointment to the Supreme Court, Judge Neil Gorsuch (as he then was) explained in Gutierrez-Brizuela v. Lynch (2016):

    Conversely, what would happen if politically unresponsive and life-tenured judges were permitted to decide policy questions for the future or try to execute those policies?  The very idea of self-government would soon be at risk of withering to the point of pointlessness.  It was to avoid dangers like these, dangers the founders had studied and seen realized in their own time, that they pursued the separation of powers.  A government of diffused powers, they knew, is a government less capable of invading the liberties of the people.  See  The Federalist No. 47 (James Madison) ("No political truth is . . . stamped with the authority of more enlightened patrons of liberty" than the separation of powers).

    Scalia and Garner in their classic book Reading Law, The Interpretation of Legal Texts, Thomson/West, 2012 devote an entire chapter to the so-called Omitted-Case Canon, supporting the view that supplying omissions in statute law transcends the judicial function, and quoting William Blackstone in the introduction:  "[L]aw, without equity, though hard and disagreeable, is much more desirable for the public good than equity without law: which would make every judge a legislator, and introduce most infinite confusion."  In the context of eligibility under § 101 the classic statement in United States v. Dubilier Condenser Corp that the Court should not read into the patent laws limitations and conditions that the legislature has not expressed has been cited with approval in Diamond v Chakrabarty and Diamond v Diehr and has never subsequently been questioned.

    It is strongly arguable that the Alice test for excluded subject-matter was employed in Regniocorp with disregard for the statute and producing a result contrary to what statute intended.  It is submitted that decisions such as Prometheus, Alice, and Myriad should be interpreted in accordance with standards rules of interpretation and should not be gold-plated, especially given the clearly expressed and almost universally ignored caution with which those decisions were expressed.  In Alice, Justice Thomas indeed said that:  "We must first determine whether the claims at issue are directed to a patent-ineligible concept."  However, that remark is most plausibly interpreted as a pragmatic response to the facts and arguments with which the Court was presented and not as a general instruction as to the approach to be followed in all future cases.  It should not be interpreted as a decision by a side wind that the judicial exclusions should enjoy priority over the categories of eligibility created by Congress in § 101.

    In the panel's Alice step one analysis, it was held that the claim was directed to the abstract idea of encoding and decoding image data and reflected standard encoding and decoding.  No references were quoted in support of that proposition, and the opinion does not record any evidence about what was standard practice immediately prior to the invention in the technical field of encoding and decoding image data.  The examples given are in different fields and for different purposes:  Morse code for the transmission of alphanumeric characters and Paul Revere's signalling system for the transmission of pre-arranged instructions, neither of which have relevance to the transmission of image data.  The panel fastened onto a reference in the Background section of the patent to paper strips containing exemplary features, without acknowledging the inconvenient truth that they were in hard-copy format and that there was no evidence that the idea of encoding those strips had ever occurred to users.  While acknowledging the warning in Enfish that an improperly high level of abstraction should be avoided and recited features should not be ignored, the panel concluded that "[the] patent claims a method whereby a user starts with data . . . and ends with a new form of data."  As clearly recited in the claim the user starts with facial feature images on a display, selects particular features to form a composite image, and ends with a composite image reproduced on a second display.  The allegation that the user starts with and ends with data is therefore wrong not merely as a matter of opinion but as a matter of plain fact, and accordingly, the holding that the claim is directed to subject-matter that is no more than an abstract idea is untenable.

    In Alice step two, the panel held that "[h]ere, RecogniCorp has not alleged a particularized application of encoding and decoding image data.  Indeed, claim 1 does not even require a computer; the invention can be practiced verbally or with a telephone.  J.A. 28 (col. 4 ll. 59–63); J.A. 32 (col. 11 ll. 53–59)."  Although the claimed method reduces facial features to simple codes and magnifications that can be transmitted verbally by telephone (although this seems not to be the normal use in practice) the panel has picked on the verbal transmission blindly and without reference to its overall significance and context, and has magnified that reference out of all proportion.  In reality, the patent deals with displays (which as a matter of common general knowledge and context form parts of computers) and with images on those displays which as is the common experience of all of us who send images as e-mail attachments involve tens or hundreds of kilobytes of data.  The suggestion that "the invention can be practiced verbally" properly belongs in the fictional Wonderland of Lewis Carrol's Alice rather than the real world in which we are all compelled to live.  Moreover, the significance of "multiplication" has been arbitrarily disregarded whereas it is apparent in context that it relates to necessary scaling and image production and is a technical feature of the process.

    It is understood that an application for en banc reconsideration is likely to be filed.  Not only is it difficult to identify a more deserving case for such reconsideration, but as a matter of public interest the opportunity should be taken to re-focus on statutory compliance (which as relevant cast-law shows already contains non-trivial tests) and to relegate the judicial exceptions to the exceptional cross-checking role that they correctly deserve.

    * Mr. Cole is a European Patent Attorney and Partner with Lucas & Co. in Warlingham, Surrey, UK and Visiting Professor at the Centre for Intellectual Property Policy & Management at Bournemouth University.

  • District Court Awards Attorney Fees for Plaintiff's Use of Discovery to Police Defendants' Future Conduct

    By Donald Zuhn

    District Court for the District of New JerseyLast month, in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Senior District Judge William H. Walls of the U.S. District Court for the District of New Jersey issued an amended opinion granting the motion for attorney fees of Defendants Luitpold Pharmaceuticals, Inc., Daiichi Sankyo, Inc., and Daiichi Sankyo Co., Ltd. ("Luitpold").  The District Court also awarded Luitpold $207,482.50 in fees and $4,580.93 in costs.

    The decision arose out of a patent dispute between Plaintiffs Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC ("Par") and Luitpold.  Par is the assignee of patents for Adrenalin®, a product containing epinephrine for use in treating allergic reactions.  Luitpold filed an ANDA seeking approval to market a generic version of Par's Adrenalin® product, and Par responded by filing suit against Luitpold.

    In Luitpold's Answer to Par's Complaint, Defendants sought declaratory relief that, inter alia, it had not infringed Par's Adrenalin® patents and that the case was exceptional under 35 U.S.C. § 285.  The District Court granted Luitpold's counterclaim of non-infringement, finding that Luitpold's ANDA formulations did not infringe Par's Adrenalin® patents.  Luitpold then moved for attorney fees, contending, in part, that the Court should award fees because Par's theory of infringement was "objectively baseless" and Par had abused discovery to attempt to monitor Luitpold's competitive activities.  Par argued that the case was not exceptional because, inter alia, Par had reason to believe Luitpold would change its drug formulation and Plaintiffs did not abuse discovery and received almost no substantive discovery in the case.

    The District Court noted that to satisfy 35 U.S.C. § 285, Luitpold had to establish that Defendants were the prevailing party, the case was exceptional, and the requested fees were reasonable.  With regard to the first inquiry, the Court noted that it had granted Luitpold's motion for judgment on the pleadings, resulting in the dismissal of Counts I-IV of Par's Complaint, and issued a declaration that Luitpold had not infringed Par's Adrenalin® patents.  The Court noted that "[b]ecause Defendants 'receive[d] at least some relief on the merits, which alter[ed] the legal relationship of the parties,' they are prevailing parties under 35 U.S.C. § 285."

    With regard to the second inquiry, the Court noted that Luitpold's argument was based on the contention that Par's legal theory was baseless, and that Par abused discovery in an attempt to monitor Luitpold's competitive activities.  Par countered that it had good reason to bring the lawsuit because it believed Luitpold would change its formulation, and that it had not abused discovery because it received virtually no substantive discovery.  With regard to Par's first contention, the Court indicated that:

    Even if Par's intention was limited to anticipated patent infringement by a possible future formulation of Luitpold's product, Par's claims were meritless because Par provided no basis for its allegations that absent declaratory relief, Par faced irreparable harm from Defendants' infringing activities.  Par's claims for declaratory relief rested only on its own experience of the FDA approval process and speculation that the FDA would require Defendants to change their drug formulation in a manner that would infringe Par's patents.  . . .  Par failed to allege that Defendants were engaged in any specific activities to alter their drug formulation to infringe the patents-in-suit and even acknowledged in briefing that the focus of the case was to determine through discovery how Par intended to proceed through the FDA approval process.

    With regard to Par's second contention, the Court noted that "upon filing of the Complaint, Par vigorously attempted to engage in overbroad discovery of highly confidential, competition information," requesting, inter alia, "all documents and information relating to Defendants' injectable epinephrine compositions, including past, current, and 'contemplated' formulations whether or not they contained ingredients that would infringe Par's patents."  The Court also noted that Par had pursued "this overbroad information" despite Luitpold's testimony that it had not changed its drug formulation.  According to the Court, "Par's conduct is not mitigated by Par's argument that it pursued this discovery mostly unsuccessfully."  The Court therefore found the case to exceptional, stating that "Plaintiffs' unjustified maintenance of this suit and attempts to use discovery to police Defendants' future conduct makes an award of fees appropriate to the extent Defendants' fee request is reasonable."

    The remainder of the opinion concerns the Court's calculation of fees, which were reduced for the reasons outlined in the opinion, and award of costs, which were awarded as requested.

    Amended Opinion by Senior District Judge Walls

  • By Kevin E. Noonan

    Federal Circuit SealThe Federal Circuit's decision on Friday, in Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., illustrates the risks a litigant can take when agreeing to a stipulation in an effort at least to reduce litigation costs and issues presented at trial.

    The case involved ANDA litigation over ANDA defendant Breckenridge Labs' generic version of Braintree's bowel preparation kit (SUPREP), sold to purge a patient's colon prior to inter alia colonoscopy.  The formulation as sold by Braintree comprises "two six-ounce bottles of an aqueous hypertonic solution of potassium sulfate, magnesium sulfate, and sodium sulfate," which according to the FDA-approved label are filled to 16 ounces prior to consumption (which occurs once in the evening before the procedure and once the morning of a colonoscopy).  Claim 15 of Braintree's patent in suit (U.S. Patent No. 6,946,149) is representative:

    A composition for inducing purgation of the colon of a patient, the composition comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

    At issue was construction of the terms "purgation" and "from about 100 ml to about 500 ml."  The former limitation was earlier construed in an unrelated litigation — Braintree Laboratories, Inc. v. Novel Laboratories, Inc. — where the Federal Circuit held that the term means "an evacuation of a copious amount of stool from the bowels after oral administration of the solution."  This is relevant here because under this construction the two claim terms at issue are not contradictory (insofar as complete purging of the bowels is not achieved by ingesting only one bottle of the formulation, and both bottles together have a greater volume (946 mL) than the volumetric limitation permits).

    Here, ANDA defendant Breckenridge stipulated that the construction of "purgation" in the Novel case would apply in this case (representing acquiescence to the reality that the Federal Circuit's construction in the Novel appeal would apply in any case).  But Breckenridge's stipulation went further, wherein defendant agreed to be bound by any parts of the Novel opinion bearing on invalidity or non-infringement.  As it turned out, the Novel decision did not address the volumetric limitations, and the District Court granted summary judgment that Breckenridge did not directly infringe nor induce infringement of the claims of the '149 patent, on two grounds.  The first was that the term "from about 100 ml to about 500 ml" meant the entire volume ingested, which was incontestably greater (946 mL) than the recited 500 mL limit.  Second, the District Court held that Breckenridge's label could not induce infringement under 35 U.S.C. § 271(e) because anything less than "full" colonic purging was not an approved use of the formulation.  Braintree appealed.

    The Federal Circuit reversed and remanded, in an opinion by Judge Moore, joined by Judges Newman and Wallach.  The opinion rejects Breckenridge's view that the Novel opinion was not preclusive with regard to the volumetric limitation.  In the panel's view, "[t]he meaning of the term 'from about 100 ml to about 500 ml' was necessarily connected to our construction of 'purgation.'"  Novel had "intertwined" the two claim limitations in its noninfringement arguments, and the panel read the Court's earlier opinion to hold that "cleansing" (i.e., complete purgation), while recited as a goal expressly disclosed in the specification was not a claim limitation.  The panel also read the Novel opinion to mean that "from about 100mL to about 500mL" was sufficient to induce purgation under the claims of the '149 patent.  Citing the Novel opinion, this panel reminds the parties that:

    Each of those half-dose sixteen ounce solutions has a total volume of 473 mL, which is within the range found in the asserted claims of the '149 patent, but Braintree concedes that neither dose accomplishes a full cleansing.  Thus, Braintree's "one bottle" infringement theory asserts that one (half-dose) bottle of SUPREP, diluted with water to become a sixteen ounce solution, falls within the asserted claims.  This infringement theory can prevail if purgation means the "evacuation of a copious amount of stool from the bowels after oral administration of the solution," which is something less than a full cleansing.

    The Court also asserts that it is cognizant of the due process requirements, recited in Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 329 (1971), that a party not be estopped by a claim construction decision where it is neither a party nor in privity with one.  But Breckenridge stipulated that it would be bound by the Court's earlier decision.  This stipulation foreclosed the District Court from construing the "from about 100mL to about 500mL" limitation otherwise.

    With regard to the § 271(e) argument, the opinion also disagrees with the District Court's distinction between "purgation" and full colonic cleaning, based on the lower court's reading of the Novel decision.  The panel says this case is unlike its earlier decisions, holding that an ANDA defendant's label could not induce infringement, based on the factual differences between those cases and this one.  (The panel cited Warner-Lambert Co v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003); Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003); and Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1321 (Fed. Cir. 2012) in this regard.)  In contrast with those cases, the Court states that "inducing purgation" is not a distinct use of the claimed formulation, because inducing purgation is just a means for achieving the desired result (inducing purgation of the colon of a patient) recited in the preamble of the '149 patent claims.  And Breckenridge conceded that this is what its formulation was intended to do.  Accordingly, the Court held that Breckenridge's generic formulation "recommends or suggests to physicians that the drug is safe and effective for administration to patients for the purposes of inducing [purgation]."  This being the only FDA-approved use for Braintree's SUPREP, the Court held that a physician would understand that the generic label is also "safe and effective" for this use.  Indeed, "[t]o hold otherwise would lead to the absurd result that a physician would understand Breckenridge's proposed product to be safe and effective for fully cleansing the colon, but not safe and effective at accomplishing a partial colon cleansing" according to the Court.

    Due to Breckenridge's stipulations, that its proposed generic product would infringe the asserted claims of the '149 patent absent summary judgment, and that it would not raise defenses or counterclaims other than its noninfringement defense, the Court reversed and remanded with instructions that the District Court enter judgment in favor of Braintree.  And the Court awarded Braintree its costs.

    Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc. (Fed. Cir. 2017)
    Nonprecedential disposition
    Panel: Circuit Judges Newman, Moore, and Wallach
    Opinion by Circuit Judge Moore