• Two Upcoming Webinars on Patent Damages

    1. On Tuesday, July 24, from 1-2 p.m. Eastern Time the Practicing Law Institute (PLI) will be hosting a one-hour webcast titled WesternGeco and Lost Profits: Fair Compensation for Domestic Infringement or Extraterritorial Extension of Patent Rights?  Here is a link, and here is the description:
    On June 22, 2018 the Supreme Court handed down a 7-2 decision in WesternGeco v. ION Geophysical upholding a patent owner’s right to recover lost profits damages for infringement under 35 USC 271(f)(2). While the Court was careful to limit its holding, the reasoning applied by the Court may have implications beyond the narrow statutory provision at issue.
    Please join Douglas R. Nemec of Skadden, Arps, Slate, Meagher & Flom LLP for a presentation that will:

    • Provide a detailed analysis of the WesternGeco decision;
    • Explore the potential ramifications of the WesternGeco decision for patent damages more generally; and
    • Examine how WesternGeco fits into the broader scheme of recent Supreme Court patent decisions, as practitioners seek signs of how the Court may handle upcoming patent cases.

    2. The IP Chat Channel will be hosting a webinar next Thursday, July 26, from 2-3 p.m. Eastern Time titled What’s Next for Design Patent Damages?  The DOJ Test on Trial.  Here is a link, and here is the description: 

    For all its eye-popping size, the $533 million award that Apple won against Samsung in a design patent infringement case was seen by few as legally significant.  Now that the case has settled, it is an interesting time for our expert panel — an attorney who specializes in design patents, a damages expert, and in-house counsel at an automaker — to assess the current state of damages law for design patents.

    The Supreme Court in 2016 held that the relevant “article of manufacture” could be either all or part of the infringing product.  One possible standard for determining the relevant “article of manufacture” for Section 289 purposes was proposed by the United States Department of Justice in an amicus brief it submitted to the Supreme Court.  And that test is taking on a vigorous life of its own.

    This summer, Seirus will file a brief in its appeal at the Federal Circuit after it was required by a jury last year to pay $3 million in design patent damages to Columbia.  Columbia v. Seirus was the first case after Samsung v. Apple to charge a jury to use the DOJ’s test.  The outcome of this case is thus eagerly anticipated.

    Our panelists will discuss the Federal Circuit’s options in addressing the DOJ standard.  They will also discuss:

    • Other legal uncertainties left by the Supreme court, including who bears the burden of proof in the DOJ test, and whether the identity of the article of manufacture is a matter of fact to be decided by the jury
    • Strategies for patent prosecution and litigation in light of uncertainty
    • Certain areas, such as graphical user interfaces, where both innovators and implementers must take special care

    Speakers:  

    • Rick Bero, The Bero Group 
    • James Dottavio, Ford Global Technologies LLC
    • Elizabeth Ferrill, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
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  • CAFC says District Court Erred in Claim Construction in Blackbird Patent Case

    On Monday, July 16th, the Court of Appeals for the Federal Circuit issued a precedential decision in Blackbird Tech v. ELB Electronics, which vacated an earlier judgment of non-infringement of a patent asserted by Blackbird in the District of Delaware. The Federal Circuit majority panel of Chief Judge Sharon Prost and Circuit Judge Kimberly Moore determined that the district court had erred at construing the claim term “attachment surface” in finding non-infringement of the asserted claims….

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  • 構成する

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    構成する

    (CONSTITUTE)
    $$ In this case the discrete electro-active elements constitute the electro-active portions which extend around and bend around the minor axis. / この場合、個別電気活性素子は、短軸の回りに延び短軸の回りで曲がる電気活性部分を構成する。(USP6833656)

    $$ This constitutes overshoot of a pole; / これが極のオーバシュートを構成する。(USP6611142)

    $$ Tr1 and Tr2 constitute a high side switch which enables the voltage regulator to be selectively connected to the B.sup.+ supply. / Tr1およびTr2は、電圧調整器をB+供給に選択的に接続させることができる高サイドスイッチを構成する。(USP6331767)

    $$ The filler material conveniently constitutes between 5% and 85% of the total weight of the composition before polymerisation. / 充填剤材料は好都合に、重合前の組成の全重量の5%から85%を構成する。(USP6313192)

    $$ As an example the shift register SR4 contains binary values 0100010000 and these (together with the appended address bits) constitute the input address to the look-up table 30. 一例として、シフトレジスタSR4が2進値0100010000を有し、これらが(追加されたアドレスビットと共に)ルックアップテーブル30への入力アドレスを構成する。(USP5428643)

    $$ This information constitutes the topology information of the network.(USP5831975)

    $$ As will be understood, the elements of FIG. 3 represent the elements that constitute the data conference shared by nodes of data conferencing system 100 of FIG. 1.(USP5748618)

    $$ The transmission of such information constitutes secured, relatively low-speed, low bandwidth requirements which is suited to the modem-to-modem link over the PSTN.(USP5512935)

    (CONFIGURE)
    $$ Additionally, the touch-screen area can be configured as a general purpose scribing area to allow entry of data and written commands. / さらに、タッチスクリーン領域は、データおよび手書き命令の入力を可能にする汎用の書込み領域として構成することができる。(USP6812954)

    $$ The second alternative is to configure a set of nodes 2" so that all time slots 23 are used on one link. / 第2の代替策は、すべてのタイムスロット23が1つのリンク上で使用されるように、ノード2“のセットを構成することである。(USP6553020)

    $$ Procedures identified at step 910 in FIG. 9 for configuring the database to include specified indexes are detailed in FIG. 18. / 指定されたインデックスを含むようにデータベースを構成するための図9のステップ910 において識別された方法の詳細が図18に示されている。(USP6182079)

    (FORM)
    $$ The drive belt 26 is also carried by a driven pulley 32 forming part of the clutch mechanism 200 (to be described more fully later). / 駆動ベルト26は、クラッチ機構200(詳細は追って説明する)の一部を構成する被駆動プーリー32にも掛けられている。(USP6691849)

    $$ It may alternatively form a sleeve which is adapted to be secured around the circumference of the laminated core section. / あるいは又、マトリックスは、積層コア部の円周の周りに固定することができるようになされたスリーブを構成するもとしてもよい。(USP6815848)

    $$ A novel PSK decoder forming part of the high frequency modem comprises a simple integrator circuit (low pass filter), followed for example by a comparator. / 高周波モデムの一部を構成する新たなPSKデコーダは、簡単な統合回路(低域フィルタ)とそれに続く例えば比較器とによって構成される。(USP6473469)

    $$ The tray 28 together with its insert 30, lid 32 and extension portion 34 form a housing 12 of the assembly 10. / トレイインサート30、トレイ蓋32、延長部分34と共にトレイ28は、集合体10のハウジング12を構成する。(USP6418264)

    $$ After the ion implantation step the gate lines are isolated from each other by etching away areas of these interconnections which form the discharge path. / イオン注入行程後放電経路を構成するこれら相互接続の区域をエッチング除去することによってゲートラインを相互に分離する。(USP5384266)

    $$ This thyristor structure disclosed in the prior art (FIG. 1) forms the basis of the thyristor device forming the transient suppressor. / この従来技術によるサイリスタ構造(図1)は過渡サプレッサを構成するサイリスタデバイスの基本構造をなしている。(USP5429953)

    (IMPLEMENT)
    $$ FIG. 1 is a schematic diagram of a processing system suitable for implementing the present invention; / 【図1】本発明を構成するのに適した処理システムの概略図。(USP6772122)

    $$ Preferably, the JASPER product is used to implement the functionality of the profiling agent 115 in the IMS. / JASPERプロダクトを使用して、IMS内にプロファイリングエージェント115の機能を構成する。(USP6424968)

    $$ The OCS/ACS may be implemented on a cluster of UNIX microprocessors. / OCS/ACSはUNIXマイクロプロセッサのクラスタ上で構成することができる。(USP6330313)

    (MAKE UP)
    $$ The total number of lines identified as suspect is thirteen and make up a total of five clusters. / 疑わしいものとして識別される回線の総数は13であり、合計5つのクラスタを構成する。(USP7573824)

    $$ All the colours which make up a colour image are generated and may be represented by a corresponding mixture of the red, green and blue components. / カラー画像を構成する全ての色は、赤、緑、青の成分の混合により生成され、表示される。(USP6614489)

    $$ Each of the samples represents one of the red, green and blue components of one of the pixels which make up the image. / 各サンプルは、画像を構成する複数の画素のうちの1画素の赤、緑、青のいずれか1色の色成分を表す。(USP6614489)

    (PROVIDE)
    $$ These tracks provide the gate lines for transistors of the device. / これら細条によって電子装置のトランジスタに対するゲートラインを構成する。(USP5384266)

    $$ The recesses are formed so as to provide a continuous grid-like trench. / これら凹部は連続的な格子状トレンチ(溝)を構成するように形成する。(USP5387528)

    (SET UP)
    $$ These switch type probes having the R.C. filtering circuit described above can be set up to exclude contact bounces which occur briefly. / 上記RCフィルタ回路を有するこれらスイッチ型プローブは、瞬間的に生じたチャタリングを除去するように、構成することができる。(USP6941671)

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  • Ex Parte Bhogal and Ex Parte Galloway

    You probably already read the excellent article “Berkheimer, the Administrative Procedure Act, and PTO Motions to Vacate PTAB § 101 Decisions”  by Doerre and Boundy. The article references two recent decisions by the PTAB applying Berkheimer.  Copies of those PTAB opinions are available below: Ex parte Bhogal, appeal no. 2016-008742, (PTAB Mar. 19, 2018) Ex […]

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  • Ariosa Diagnostics v. Illumina: Prior Art Date of a Provisional Patent Application

    by Dennis Crouch

    The new petition for writ of certiorari in Ariosa raises the questions of what “counts” as prior art — what is disclosed or what is claimed?  The petition asks:

    If a patent discloses but does not claim an invention, does that disclosure qualify as prior art as of the date of the application in which it was first made, such that no one else may patent the same invention based on a later-filed application?

    [Ariosa Diagnostics Inc. v. Illumina Inc. – cert. petition].  Here, the prior art statute at issue is pre-AIA 102(e), whose equivalent is in the post-AIA 102(a)(2).  The statute seems to squarely answer the question above — a disclosure in an issued US patent will count as prior art as of its filing date regardless of whether the all features of the disclosure were actually claimed in the patent.

    102 A person shall be entitled to a patent unless (e) the invention was described in . . . (2) a patent granted on an application for patent by another filed in the United States before before the invention by the applicant for patent.

    In the simple case outlined above, the courts all agree that the disclosures found in an issued patent or published application  count as prior art as of the patent’s filing date. 

    Continue reading Ariosa Diagnostics v. Illumina: Prior Art Date of a Provisional Patent Application at Patently-O.

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  • Trump Administration FDA Moves to Speed Up Biosimilar Process in United States

    The high cost of health care in the United States is a significant issue.  Some research points to two causes of the high cost in the United States: 1) high pharmaceutical cost; and 2) high wages for health care workers.

    Notably, two pharmaceutical companies, Novartis and Pfizer, recently announced that they would not implement pharmaceutical price increases on certain drugs.  This is apparently from pressure from the Trump Administration.  
    The Commissioner of Trump’s Food and Drug Administration, Scott Gottlieb, MD, recently released comments concerning pricing reform for a Brookings Institution discussion on pharmaceuticals.  His comments define the problem with rising drug costs by placing a focus on biologics and the very slow movement in the United States for biosimilars to reach the marketplace.  His comments further explain how improving competition can lead to decreased prices and savings for the United States.  He details some solutions to the problems, including increased cooperation with regulators outside the United States to speed up biosimilar approval.  He further points to how intellectual property tactics taken by biologic owners are slowing down the process for biosimilars to reach consumers and how the FDA plans to work with the Federal Trade Commission to address these tactics.  Here is an excerpt of his comments:

    While less than 2 percent of Americans use biologics, they represent 40 percent of total spending on prescription drugs.

    So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.

    By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest in further research that’ll lead to the discovery of even better drugs that deliver additional benefits for patients.

    At the FDA, we’re focused on advancing policies that make the process for developing biosimilars more efficient.

    To achieve these goals, I’m pleased to announce today that we’re releasing our Biosimilars Action Plan. This plan is an important piece of the Administration’s bold Blueprint to Lower Drug Prices and demonstrates the progress being made against the deliverables the President laid out.

    Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products. Before I focus on some of the details, I’d like to talk about some of the broader goals we’re focused on.

    . . .

    Biologics represent 70 percent of the growth in drug spending from 2010 to 2015. And they’re forecasted to be the fastest growing segment of drug spending in the coming years.

    To make sure that the next generation of breakthroughs remains affordable, it requires vibrant competition from biosimilars. But it also means that we must consider new payment approaches. Models that allow us to take advantage of the competition that biosimilars offer.

    Our current payment system, which reimburses drugs based on their average sales price, was designed in a single-source world. It was a market of biologics where there was typically only one drug in a category. And there wasn’t a lot of therapeutic variety or competition.

    At the time, there was only one EGFR inhibitor on the market, and just one VEG-F inhibitor. I was there when this system was designed and implemented. And I can tell you many of us didn’t envision a world where there’d be so much competition in these therapeutic categories.

    So a system was designed that accepted the fact that government programs, like Medicare, would be price takers.

    We didn’t have the advantage of drug competition to enable the development of formularies, bidding and market-based negotiations like we have under Part D prescription drug plans.

    So the system we designed—using the average sales price as a benchmark for reimbursement—was designed to help make sure that drug makers wouldn’t be able to take big price increases once the drugs reached the market. But it wasn’t a system designed to take advantage of price competition. Because we didn’t foresee that there would be multiple drugs in these different categories.

                    . . .

    While the FDA has approved 11 biosimilars through 2018, only three are now marketed in the U.S.

    Competition is, for the most part, anemic.

    It’s anemic because consolidation across the supply chain has made it more attractive for manufacturers, Pharmacy Benefit Managers, Group Purchasing Organizations and distributors to split monopoly profits through lucrative volume-based rebates on reference biologics—or on bundles of biologics and other products—rather than embrace biosimilar competition and lower prices.

    It’s anemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the U.S. several years before they’ll be available to patients here. These delays can come with enormous costs for patients and payors.

    Let me give you one measure of those costs.

    At the FDA, we did an analysis of biosimilar competition across all Organisation for Economic Co-operation and Development (OECD) markets. We looked at what would have happened if all the biosimilars that the FDA approved in the U.S. were successfully marketed here in a timely fashion.

    We’ll release the full details on this analysis soon. But I want to give you a sense today of what we found.

    To measure the potential impact of this biosimilar competition, we assumed that the savings achieved in the U.S., in terms of price discounts, would have been on par with the experience enjoyed in the other OECD nations.

    Based on these assumptions, our analysis showed that if Americans had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than $4.5 billion in 2017.

    These are large savings. They’re about half of the nearly $9 billion in total savings in 2017 from all of the 2017 generic drug approvals, according to earlier FDA work.

    This analysis assumes that all of the biosimilars that the FDA approved were successfully marketed.

    But we know that’s not the case. We know that litigation blocked a lot of these launches. Yet our study found that entry of a single biosimilar product in non-U.S. OECD markets lowers prices relative to the reference product by 30 percent; markets with three to four biosimilar entrants have prices 35 to 43 percent lower than their reference biologics.

    Our savings estimate doesn’t include additional potential savings from biosimilars approved in 2018. Estimated savings would therefore be significantly greater than $4.5 billion if these additional FDA-approved biosimilars were also marketed at or near the time of their approval.

    Biologic manufacturers have a right to defend their legitimate intellectual property interests. And we want them to continue to offer the benefits of improved versions of originator biologics. These benefits might include biologics that target disease in new ways, such as delivering a toxic payload directly to cancer cells, or biologics that target multiple targets of disease at the same time.

    . . .

    But rebating schemes or patent thickets that are purely designed to deter the entry of approved biosimilars are spoiling this sort of competition. Long-dated contracts are another toxin. The branded drug makers thwart competition by dangling big rebates to lock up payors in multi-year contracts right on the eve of biosimilar entry.

    We’re also concerned that volume-based rebates may encourage dysfunctional clinical treatment pathways. We’ve heard from multiple sources that some payors are requiring step-therapy or prior authorization on the reference biologic before patients can access a biosimilar. We see no clinical rationale for these practices, since a biosimilar must demonstrate, among other things, that it has no clinically meaningful differences from the reference product as a part of demonstrating biosimilarity.

    The branded drug industry didn’t build its success by being business naïve. They are smart competitors.

    But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate.

    Some of these tactics should be unacceptable to every member of the drug supply chain.

    Biosimilars may be relatively new, but manufacturers’ tactics to delay and frustrate Congress’ legislative intent to promote competition in drug pricing date back decades.

    These tactics were first honed in battles between branded companies and manufacturers of small molecule generics after the passage of the Hatch Waxman Act in 1984.

    And these battles played out for a time. But ultimately competition prevailed, and so did the benefits of generics.

    In 1983, generic drugs accounted for only 13 percent of U.S. prescriptions. Today, in 2018, it’s 90 percent. And generics can cost 75 to 90 percent less than their branded competitors.

    Robust competition has led to generic drug prices that are often less expensive here in the U.S. than in other developed markets in Europe and Asia. The Association for Accessible Medicines, a trade group that represents generic drug makers, estimates that generic medicines have saved the U.S. well over $1 trillion over the last decade.

    The generics market that we see today, while not perfect, is robust in most respects. But it took about two decades to develop. It took a long time for providers to grow comfortable prescribing generics and patients to be confident in taking them. It took a long time to work through legal tactics that were put in the way of competition. It took a long time for the coverage systems to be changed to take brisk advantage of generic entry.

    Sometimes it feels as if we’re seeing the biosimilars version of “Groundhog Day,” with brand drug makers replaying many of the same tactics, and all of us being too susceptible to many of the same misconceptions about biosimilars’ safety and efficacy relative to originator biologics.

    We’re falling into some of the same doubts and policy constraints that were used to deter competition from generics in the years after the Hatch Waxman Act.

    But we’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We’re not going to wait a decade or more for robust biosimilar competition to emerge.

    Expanding access to affordable biosimilars, and slowing the rise of health care inflation, is an even more critical issue today than it was in 1984. The higher costs, and longer timelines, required to develop biosimilars relative to generics means that these delaying tactics can make it uneconomical for biosimilar sponsors to postpone entry for extended periods of time. I’m worried that the biosimilar manufacturers may pull out of these endeavors altogether if the brand drug makers are able to lock up markets even in cases where there’s a fully interchangeable competitor.

    Ultimately, this behavior is also putting innovative drug development at risk by eroding public confidence in market-based pricing mechanisms. Too many people now are shooting at the branded drug makers. And the shrapnel isn’t just going to tear apart the gaming tactics that we might agree are gratuitous and ill conceived.

    I’m worried that the shrapnel could also fray the fragile market-based rewards that support new innovation.

    Our Biosimilars Action Plan applies many of the lessons learned from our experience with generic drugs to accelerate biosimilar competition with four key strategies.

    First, improving the efficiency of the biosimilar and interchangeable product development and approval process.

    Second, maximizing scientific and regulatory clarity for the biosimilar product development community.

    Third, developing effective communications to improve understanding of biosimilars among patients, providers and payors.

    And fourth, supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.

    I don’t want to get into the details of the entire plan in my remarks today. We’ve issued a plan that lays out all of the discrete elements of our approach.

    But I want to highlight a few key actions that we’re taking.

    I believe some of these actions can be transformative for sponsors’ ability to bring high quality biosimilars to market.

    As part of this effort, the FDA is seeking to strengthen its partnerships with regulatory authorities in Europe, Japan and Canada. Such partnerships can enable greater efficiency in developing safe and effective biosimilars.

    For example, we’re actively exploring whether data sharing agreements could give us better insights into biosimilars’ real-world safety and efficacy and, in some circumstances, facilitate the increased use of non-U.S.-licensed comparator products in certain studies to support an application under Section 351(k).

    We know that when those developing biosimilars use biologics sourced ex-U.S. as their comparator product, it can lower the cost of clinical studies since many of these products can be procured more easily, and cheaply, in European and Asian markets.

    We’ll also be updating the Purple Book and evaluate how we can incorporate additional information into that resource to give product developers more transparency.

    And we’re also taking new steps to make the biosimilar development process more efficient.

    . . .

    Today, the FDA issued its final guidance on biosimilar labeling. The FDA wants to make sure that biosimilar products have labeling that allows health care practitioners to make informed prescribing decisions for their patients. Our guidance gives recommendations to applicants on how to prepare this labeling for review by the FDA.

    We’re also going to be updating guidance to provide additional clarity on how biosimilar manufacturers can carve out indications from their labels where a branded drug maker might still maintain some IP. And we’re going to describe how these indications can be efficiently added into a biosimilar label once that IP on the branded alternative has lapsed.

    We are also currently developing and implementing new FDA review tools, such as standardized review templates, that are tailored to applications for biosimilar and interchangeable products. We’ve already adopted similar approaches when it comes to generic drugs. These templates will improve the efficiency of the FDA’s review.

    We’re also developing an index of biosimilars’ critical quality attributes relative to their reference products.

    Such an index can allow sponsors to better understand how the FDA evaluates data from comparative analytical studies performed to support a demonstration of biosimilarity, and how to use suitable analytical methods.

    And we’re going to be taking new steps to challenge some of the gaming tactics I talked about earlier. This includes new efforts to coordinate with the Federal Trade Commission (FTC) to address anti-competitive behavior.

    A video of the Brookings Institution talk along with panelist responses can be found, here. 

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  • 6 Years Later: The Effects of the Mayo Decision on Diagnostic Methods

    2018 celebrates the six-year anniversary of one of the most important Supreme Court decisions of the modern era. On March 20, 2012, the Court handed down its ruling in Mayo v. Prometheus Laboratories. The decision was understood immediately to be a break from the immediate past, a product of the Court’s intention to clarify patent eligibility for a new era of biotech, pharma, and life science technologies. The Court hoped it would help clarify eligibility issues raised by new technologies that…

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