• By Sherri Oslick

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

    Pozen Inc. v. Sun Pharma Global FZE
    6:11-cv-00272; filed May 26, 2011 in the Eastern District of Texas

    Infringement of U.S. Patent Nos. 6,060,499 ("Anti-migraine Methods and Compositions Using 5-HT Agonists with Long-Acting NSAIDS," issued May 9, 2000) and 6,586,458 ("Methods of Treating Headaches Using 5-HT Agonists in Combination with Long-Acting NSAIDS," issued July 1, 2003), licensed to GlaxoSmithKline, following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of GSK's Treximet® (sumatriptan and naproxen sodium, used to treat migrane attacks).  View the complaint here.


    Genetic Technologies Ltd. v. Agilent Technologies, Inc. et al.

    1:11-cv-01389; filed May 25, 2011 in the District Court of Colorado

    • Plaintiff:  Genetic Technologies Ltd.
    • Defendants:  Agilent Technologies, Inc.; Bristol-Myers Squibb Co.; Eurofins STA Laboratories, Inc.; GlaxoSmithKline, PLC; Hologic, Inc.; Merial L.L.C.; Navigenics, Inc.; Neogen Corp.; Pfizer, Inc.; 454 Life Sciences Corp.

    Infringement of U.S. Patent No. 5,612,179 ("Intron Sequence Analysis Method for Detection of Adjacent Locus Alleles as Haplotypes," issued March 18, 1997) based on defendants' manufacture and sale of various instruments and/or assays for the analysis of non-coding DNA markers.  View the complaint here.


    AstraZeneca Pharmaceuticals LP et al. v. Intellipharmceutics Corp.

    3:11-cv-02973; filed May 23, 2011 in the District Court of New Jersey

    • Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.
    • Defendant:  Intellipharmceutics Corp.

    Infringement of U.S. Patent No. 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Intellipharmceutics' filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder).  View the complaint here.


    Biota Scientific Management Pty Ltd. v. Kappos

    1:11-cv-00944; filed May 20, 2011 in the District Court of the District of Columbia

    Reversal of the decision of the Board of Patent Appeals and Interferences affirming the final rejection of U.S. Patent Application No. 08/737,141 ("Compounds and Compositions for Administration Via Oral Inhalation or Insufflation," filed November 19, 1997).  View the complaint here.


    Genentech, Inc. et al. v. Apotex Inc.

    0:11-cv-61169; filed May 19, 2011 in the Southern District of Florida

    • Plaintiffs:  Genentech, Inc.; Roche Palo Alto LLC
    • Defendant:  Apotex Inc.

    Genentech, Inc. et al. v. Apotex, Inc.
    4:11-cv-02410; filed May 17, 2011 in the Northern District of California

    • Plaintiffs:  Genentech, Inc.; Roche Palo Alto LLC
    • Defendant:  Apotex, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,083,953 ("2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol Derivative," issued July 4, 2000) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Roche's Valcyte® (valganciclovir hydrochloride, used to treat cytomegalovirus retinitis and cytomegalovirus disease).  View the N.D. California complaint here.


    Senju Pharmaceutical Co. et al. v. Lupin Ltd. et al.

    1:11-cv-00439; filed May 18, 2011 in the District Court of Delaware

    • Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
    • Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

    Infringement of U.S. Patent Nos. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued on December 25, 2001) and 5,880,283 ("8-Alkoxyquinolonecarboxylic Acid Hydrate With Excellent Stability And Process For Producing The Same," issued March 9, 1999.) following a paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of plaintiff's Zymar® (gatifloxacin ophthalmic solution, used for the treatment of bacterial conjunctivitis).  View the complaint here.

  • Calendar

    June 7-8, 2011 – Biosimilars*** (American Conference Institute) – New York, NY

    June 8, 2011 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 10:00 am – 4:00 pm (EDT)

    June 19-20, 2011 – IP Business Congress (Intellectual Asset Management magazine) – San Francisco, CA

    June 21-22, 2011 – 10th Annual Forum on Pharma Patent Lifecycles (C5) – London, England

    June 23, 2011 – Chemical Patent Practice Road Show: Prosecution and Litigation Strategies (American Intellectual Property Law Association) – Chicago, IL

    June 27-30, 2011 – BIO International Convention (Biotechnology Industry Organization) – Washington, DC

    June 29-30, 2011 – Pharmaceutical Portfolio & Product Life Cycle Management (SMi Group) – London, UK

    July 16-19, 2011 – 2011 Annual Meeting; The Nuts & Bolts of Patent Prosecution Practice; and 2011 Patent Practice Update (National Association of Patent Practitioners) – Las Vegas, NV

    July 18-19, 2011 – Hatch-Waxman Boot Camp*** (American Conference Institute) – San Diego, CA

    July 20-21, 2011 – Advanced Forum on Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – San Francisco, CA

    July 25-27, 2011 – Intensive Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa (South African Department of Science and Technology) – Cape Town, South Africa

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

  • London The SMi Group will be holding a conference on Pharmaceutical Portfolio & Product Life Cycle Management from June 29-30, 2011 in London, UK.  The conference will offer presentations on the following topics:

    • Linking portfolio management with business strategy;
    • Portfolio management: Integrated approaches to R&D;
    • Tailoring R&D portfolio management to the needs of your company;
    • Project and portfolio risk analysis;
    • Where is the strategy in the strategy?
    • Holistic portfolio management at Bayer Healthcare Pharmaceuticals;
    • Portfolio Management — It’s not about the numbers;
    • Managing a mixed portfolio: Making key decisions at the science, project, resource, and governance level;
    • Partnerships, alliances and collaborations: Achieving successful portfolio management;
    • In-house portfolio vs. in-licensing/out-licensing strategies (panel discussion);
    • New approaches towards managing a portfolio of innovation projects;
    • Creating and challenging LCM brand plans;
    • Life-cycle management — Applied case study;
    • Life cycle management — The academic spin-out contribution;
    • Early stage strategies and intellectual property; and
    • An update on data protection developments.

    SMi Group The programme for the Pharmaceutical Portfolio & Product Life Cycle Management conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    The registration fee for the conference is £1,399.00.  Those interested in registering for the conference can do so here.

    Patent Docs is a media partner of the Pharmaceutical Portfolio & Product Life Cycle Management conference.

  • By Kevin E. Noonan

    The seeming legislative juggernaut that is the America Invents Act (S. 23 and H.R. 1249) is reportedly going to come to a floor vote in the House of Representatives this month.  If it passes, there is a real chance that the bill will be passed "as is" by the Senate, despite any differences between S. 23 and H.R. 1249 and be on the President's desk for signature before fall.  Since the administration's position is known (see "Commerce Secretary Provides Administration's Views on America Invents Act"), the time is for applying political pressure on Congress to address those portions of the bill that may hinder, not help, innovation.

    Gulbrandsen, Carl One example of an attempt to encourage the "grass roots" effort that will be necessary to defeat (or amend, however unlikely that option may be) the bill is a letter from Carl Gulbrandsen (at right), the Managing Director of the Wisconsin Alumni Research Foundation (WARF).  WARF has long been a leader in technology transfer, beginning almost a generation before passage of the Bayh-Dole Act due to Vitamin D technology developed at the University of Wisconsin.  Dr. Gulbrandsen himself is a veteran advocate for increased intellectual property protection for university inventors; for example, he was one of the creators and leading proponents of the CREATE Act, which was intended to facilitate university-industry joint research.  Under his stewardship, WARF received the National Medal of Technology in 2003.

    AUTM In short, Dr. Gulbrandsen has a lifetime of experience with technology transfer, innovation, and the patent system.  Thus, when he airs his views on issues like patent reform, it seems only prudent that Congress (and the rest of us) pay attention to what he has to say.  What follows is a letter from Dr. Gulbrandsen to his colleagues and the members of the Association of University Technology Managers (AUTM), regarding that group's support for the latest "patent reform" bill:

    Dear fellow AUTM members and colleagues:

    I am writing in response to the letter sent out by the AUTM board on May 17, 2011 (the "AUTM Letter") encouraging the membership to support H.R. 1249, the House of Representatives patent reform bill.  As director of an office that has been extensively involved in working with Congress and a number of stakeholders in the patent reform effort, I was very disappointed to read the AUTM Letter.  The letter does not fairly represent the impact the proposed legislation will have on universities, start-up companies, small businesses and independent inventors (hereafter, collectively, "innovators") if it becomes law.  The bill does represent a compromise as indicated by the AUTM Letter, as do all bills; and compared to the legislation as originally proposed, it is an improvement.  But compared to the present patent law, it is anything but an improvement.  Rather than benefit universities and strengthen patents as claimed in the AUTM Letter, H.R. 1249 promises to increase the cost of obtaining, maintaining and enforcing patents.  Directly and indirectly this proposed legislation would weaken patents and greatly reduce the incentive for licensing, changes that will frustrate innovation by favoring big business over innovators.  It conflicts with the statutory objectives and spirit of the Bayh-Dole Act and is of dubious constitutionality.

    The reform proposed in this legislation includes the most significant changes to the U.S. patent law in over a century — and they are not good changes.  There are five major changes proposed which individually and in concert weaken patents and make it more difficult and expensive for universities to obtain, maintain, license and enforce patents.

    First, the proposed legislation moves the U.S. patent system from a first to invent system to a first inventor to file system.  The AUTM Letter states that this enables "U.S. inventors to compete more effectively and efficiently in the global marketplace."  How does moving from a first to invent, which has been part of the U.S. patent system from its beginning, to a race to the patent office make U.S. inventors more competitive?  It doesn't; moving to a first to file system favors large businesses and in particular, well-financed, large foreign businesses over innovators.  Operating effectively in a first to file system requires financial and staffing resources that are generally not available to universities or other small entities.  Most universities today need a licensee willing and able to pay the patent cost before an application is filed.  Under a first to file system, that will often mean the university loses the race.

    Second, the proposed legislation weakens the grace period that has been such an important and valuable right for U.S. inventors.  For universities the grace period has been particularly important. Under present law, the inventor need not do anything affirmative other than having made the invention to be entitled to the grace period.  The inventor is entitled to swear behind any prior art created during the grace period and still be entitled to obtain a patent.  Under the proposed law, the inventor must affirmatively disclose the invention to be entitled to a grace period.  Thus under the proposed law, a disclosure of the invention not made by the inventor or another acting on information from the inventor will act as a bar even if within a year of filing the application.  Moreover, if the purpose of the proposed legislation is harmonization with the rest of the world, then the disclosure grace period is effectively non-existent.  A disclosure before filing acts as an absolute bar in most jurisdictions outside the United States so the grace period only becomes useful if one does not intend to file globally.

    Third, the proposed legislation effectively shifts the constitutional balance between trade secrets and patents to favor trade secrets.  Under present law, a person needs to choose between protecting an invention through trade secret and filing a patent application.  If the inventor chooses trade secret, the law today holds that the inventor abandons his right to obtain a patent.  Under section 35 U.S.C. section 102(c), a person is barred from receiving a patent if that person has abandoned the invention.  The proposed legislation does away with section 102(c), so if this proposed legislation becomes law, a person can keep the invention a trade secret until it becomes clear that it would be better to have a patent and then file a patent application effectively extending that person's competitive advantage 20 years.

    Fourth, the proposed legislation further shifts the constitutional balance in favor of trade secrets by expanding prior user rights.  Under present law, a patent owner holding a patent covering a trade secret that is not a business method can sue the trade secret user, and if successful, receive just compensation including in some circumstances an injunction.  Under the proposed legislation, the trade secret owner could assert the prior user defense and if successful receive a free, paid-up license under the patent for the patented invention and any products made using the patented invention.  In essence, the trade secret holder receives a free ride on the rights of the patent owner and what was thought by the patent owner to be exclusive rights as required by the Constitution becomes non-exclusive.  Of course, if the trade secret owner is a large company able to control the market, the patent rights may become commercially worthless to the patent owner.  As open environments, universities ordinarily do not deal in trade secrets, which is one of the reasons why WARF has consistently opposed expansion of prior user rights.  AUTM, until the letter of May 17, was a partner in opposing expansion of prior user rights, but now has shifted sides for reasons stated in the AUTM letter — reasons we believe are largely political and not in the best interests of universities.

    Fifth, the proposed legislation adds more opportunities to challenge the validity of patents.  Today, patent validity can be challenged through reexamination (ex parte and inter partes) and through infringement litigation.  Currently, it is more difficult to challenge a U.S. patent than a foreign patent, which we believe is good for U.S. universities and for U.S. innovation because it means that U.S. patents are considerably stronger than foreign patents.  Strong patents are critical to start-up companies trying to raise venture dollars.  Strong patents are also good for licensing.  The proposed legislation, however, adds both a post grant review procedure where patents during the 12 months following issuance can be challenged on any grounds and an enhanced inter partes reexamination procedure.  The net result is valuable patents will be more subject to challenge which increases costs for the patent owner, weakens the value of the patent, and makes it more difficult to license or raise capital funds necessary to starting a company and creating jobs.

    As stated above, each of these changes acts to weaken our patent system to the disadvantage of innovators and especially university innovators.  Taken together, these changes strike a terrible blow to innovation in the United States.  Times are hard enough as is to start a company.  The last thing investors want is uncertainty, which is exactly what will happen if this proposed legislation becomes law.

    This uncertainty is enhanced by legitimate questions of the constitutionality of this law.  In shifting the constitutional balance, the expansion of prior user rights runs counter to the constitutional purpose of our patent law which is to promote the progress of the useful arts by securing for a limited time exclusive rights to the inventor in return for disclosure of the invention.  It also fails to respect the express limitations in Article 1, Section 8, clause 8 of the U.S. Constitution.  The movement to a first inventor to file from the present first to invent system may also be constitutionally prohibited (referencing an article by Jonathan Massey).  Any patent reform that runs counter to the constitutional text and underlying purpose will face legal challenges that will call into question the validity of any patents granted under that legislation.  These concerns decrease the value of patents, make it more difficult to license and increase the cost of enforcement, which impacts innovators disproportionately more than large companies.

    We encourage you to take a hard look at the legislation in light of what you and your offices are trying to do to commercialize university inventions.  I believe this proposed legislation strikes at the heart of what we are all trying to do and I am convinced it will make our jobs significantly more difficult.  We have attached materials that add additional information to the comments made above.  If you share our concerns, now is the time to act.  The Chairman of the House Judiciary Committee has stated publicly that he expects H.R. 1249 will be scheduled for consideration by the full House of Representatives during the middle of June.  Please ask your congressional representatives to oppose the bill or if you cannot do that directly, ask your governmental affairs people to do so for you.  Feel free to provide a copy of this letter to anyone you believe will be interested and helpful.  For example, provide a copy of this letter to the start-up companies you are working with, other local entrepreneurs and venture capitalists and ask that they oppose this legislation for the reasons stated in this letter.  Any assistance at all that you can provide will be very much appreciated.   Thank you for taking the time to read and carefully consider this letter.

    Sincerely,

    Carl E. Gulbrandsen
    Managing Director
    Wisconsin Alumni Research Foundation
    614 Walnut Street
    Madison, Wisconsin 53726

    The rush to enact patent reform in this Congress stems from a variety of factors — the perception at the turn of the last century that the patent system was "broken"; the many attempts to enact patent reform over the past four Congresses; the differing economic incentives between technology sectors (with the computer/high tech sector being generally in favor of limited patent rights and the biotech/pharma sector being in favor of strong patent rights) are examples.  This time, however, patent reform has been packaged by its supporters as a way to stimulate the economy and provide jobs; the lure of improving the economy is a veritable siren song to politicians who need to appear to be doing "something" to improve the economy in view of the economic meltdown in 2008.  And patent reform is a good sound bite for that political pitch, since few understand the relationship between patents, innovation, and economic growth and fewer still are immediately harmed by reform (although the negative effects will eventually be felt, it will be hard for most to assess blame on the cause and effect or those responsible).

    While the political impetus and motivations may be understandable, they are not enough to justify passage of a bill as flawed as S. 23/H.R. 1249 (for all the reasons mentioned in Dr. Gulbrandsen's letter and more).  There is some hint of the beginnings of a bipartisan effort to address some of these issues before the bill is brought to a vote in the House; unfortunately, it will take more than that to make this a true "reform" bill.  Politics being the art of the possible, it is only by ramping up their political efforts that opponents have a chance of preventing the bill as currently constituted from passing.  Time is growing short.

  • By James DeGiulio

    H.R. 2015 Introduced in House to Improve System of Federally Funded Research

    Fattah, Chaka On May 26, Rep. Chaka Fattah (D-PA) (at right) introduced The American Discoveries – American Jobs Commission Act of 2011 (H.R. 2015), which is designed to stimulate American job growth, advance federal research and development efforts, and support the training of future scientists.  The federal government spends nearly $130 billion annually on research and development.  This federal funding often leads to marketable innovations, but the government does not have a mechanism to benefit financially from these successes.  Rep. Fattah contends the federal government should be given the same opportunities as the academic and the private sectors, which derive royalties from intellectual property rights and can reinvest these generated funds for additional research.

    The bill will establish a commission to study and recommend improvements to the existing system of federally funded research.  The new commission will weigh the benefits of collecting royalties from government subsidized research that leads to the commercialization of products.  The collected royalties would be reinvested in federal agencies in order to fund future research projects.  In addition to evaluating a new system of royalties, the commission will also confirm that products developed with federal research funds are manufactured in the United States.  This would not only produce jobs but guarantee broader benefits from initial investments.

    H.R. 2015 has been referred to the House Committee on Science, Space, and Technology.


    House Forms Affordable Medicines Caucus to Promote Use of Generic Drugs and Biosimilars

    Emerson, Jo Ann On May 12, Reps. Jo Ann Emerson (R-MO) (at right) and Peter Welch (D-VT) (below) founded the Congressional Affordable Medicines Caucus, with the goal of facilitating future legislation that leads to the wider use of generic drugs, including follow-on biologics.  The lawmakers have started recruiting additional members and will craft a caucus agenda when the initial member drive is finished.

    Welch, Peter The primary goals of the new caucus are slowing the expansion in health care spending and promoting the need to work across party lines to solve problems.  The caucus intends to lobby the Food and Drug Administration for an expansion in funding for the Office of Generic Drugs.  Congress' recent focus on federal deficit reduction could provide a window of opportunity for drug importation to gain more traction.  The caucus may decide to support importing less expensive drugs from outside the U.S. to reduce health care costs, noting the substantial premium that Americans pay for pharmaceuticals compared with the rest of the world.  The caucus founders are hopeful that the new group can generate support for its proposed generic drug policies, which have faced stiff opposition from strong lobbying by brand pharmaceutical companies, which oppose importation on patient safety grounds.

    Generic  Pharmaceutical Association (GPhA) The Generic Pharmaceutical Association (GPhA) applauded the creation of the new caucus, according to a press release issued by the industry group last month.  In particular, the GPhA supports the caucus' stated goals of increasing the utilization of generic drugs for Medicare and Medicaid, programs which currently fail to effectively take advantage of the savings offered by generic drugs.  The Centers for Medicare and Medicaid Services has estimated that as little as a 2% increase in generic utilization by Medicaid would save the program more than $1.3 billion.  A 5% increase could save nearly $3.3 billion.

  • By Donald Zuhn

    Biotechnology Industry Organization (BIO) Last month, the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) sent a letter (and accompanying Appendix) to Commerce Secretary Gary Locke, expressing their appreciation and support for Secretary Locke's "continued leadership in promoting robust intellectual property standards and policies."  BIO and PhRMA also commended the Department of Commerce and U.S. Patent and Trademark Office for their efforts in resisting proposals for new patent disclosure requirements concerning genetic resources and traditional knowledge that were advanced during meetings held at the World Intellectual Property Organization (WIPO) earlier this year.

    CBD The proposals made in WIPO stem from the Convention on Biological Diversity (CBD) and the Nagoya Protocol.  The CBD is an international treaty that entered into force on December 29, 1993, and which has three main objectives:  the conservation of biological diversity, the sustainable use of the components of biological diversity, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.  The Nagoya Protocol — more properly the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity — is a supplementary agreement to the CBD, which has not yet entered into force (the agreement is open for signature by Parties to the CBD until February 1, 2012), and which has as its objective the fair and equitable sharing of benefits arising from the utilization of genetic resources, thereby contributing to the conservation and sustainable use of biodiversity.

    PhRMA #2 In the BIO-PhRMA letter, the industry groups praised the Department of Commerce and USPTO for "effectively resist[ing] demands from certain countries to commence negotiations on ill-advised and harmful changes to the global patent system relating to 'genetic resources' and 'traditional knowledge'" at the WIPO meetings.  The groups contended that "[s]uch changes would undermine the ability of U.S.-based innovative companies to protect their inventions and their ability to thrive, create jobs and compete fairly in global markets."  The proposed disclosure requirements would require patent applicants to disclose the source or origin of any genetic resources or traditional knowledge upon which an invention is based.

    WIPO Although BIO and PhRMA indicated that they supported the principles embodied in the CBD and Nagoya Protocol, their letter states that "the proposals for new patent disclosure requirements concerning genetic resources and traditional knowledge being advanced in WIPO ignore these principles," and "have many practical and conceptual flaws."  According to the letter, the proposals would "introduce uncertainties in the patent system that would undermine entire patent portfolios for companies that use natural materials, particularly for those in the life sciences."  In addition, the letter argues that it will not be possible for applicants to knowingly comply with the proposed disclosure requirements.  In the Appendix to the letter, the industry groups explain that "exhaustively determining the source or origin of a genetic resource — which may include cell lines or other genetic resources that have been available on the open market for decades — is a complex, costly, time consuming and ultimately uncertain exercise."  The letter also notes that "no attempt has been made to show how the proposed disclosure requirements could actually remedy the concerns that motivate these proposals — i.e., the unauthorized collection and use of genetic resources."  The Appendix offers additional criticism of the proposed disclosure requirements, stating that "[n]o attempt is made to limit obligations to genetic resources actually governed by the CBD (i.e., samples of non-human materials that are collected by the patent applicant after the CBD entered into force and after its provisions are implemented in national law)," and adding that "the sanction demanded [under the proposal] — denial or revocation of the patent — is plainly excessive and inappropriate."  Moreover, the groups note that the proposed disclosure requirements would not further the objectives of the CBD because "a disclosure requirement could cover only a tiny fraction of the activities that advocates say are occurring" (i.e., such a requirement would not address uses of genetic resources that do not lead to patents).

    Instead of implementing the proposed disclosure requirements, the BIO-PhRMA letter encourages the international community to "identify mechanisms that would provide for meaningful monitoring of the collection and use of genetic resources as well as safeguards against illegal uses of such genetic resources," and points to examples of "constructive proposals" under consideration by WIPO, which include "a 'one-stop-shop' database to improve the quality of patent examination, model material transfer agreements that contain enforceable cross-border provisions and stating that guidelines for contractual practices relating to managing intellectual property in ABS agreements."

  • Supreme Court Renders Opinion on Induced Infringement

    By Kevin E. Noonan

    Supreme Court Building #2 The Supreme Court issued its opinion today in Global-Tech Appliances, Inc. v. SEB S.A., affirming the Federal Circuit decision upholding a jury verdict that defendants were liable for inducing infringement.  As was the case in Bilski v Kappos, the opinion today spends little time discussing why the Federal Circuit decision was correct.  Instead, it concerns itself with construing the inducement statute and criticizing the appellate court for applying the wrong standard to arrive at the right result.  In doing so, the High Court evinces again its penchant for reaching far afield (here, criminal law) for principles that permit it to criticize the Federal Circuit in the exercise of its role in defining the contours of U.S. patent law, its recognized area of expertise.

    Here, the Federal Circuit was confronted with the following factual situation.  The District Court had upheld (by denying defendants' motion for judgment as a matter of law) a jury verdict that defendants were liable for inducing infringement of the patent-in-suit.  The facts supporting this decision were these:

    • Defendants had copied "all but the cosmetics" of one of patentee's commercially available deep fryers;

    • The copied article was purchased (and copied) outside the country, where no U.S. patent markings were placed on the article;

    • Defendants obtained an opinion of counsel regarding freedom to operate, but did not inform the patent attorney performing the patent search that the article had been copied;

    • Defendant's president was "well versed" in U.S. patents (holding several himself) and was aware that the patentee was also "cognizant of patent rights" from prior dealings; and

    • There was no exculpatory evidence that defendants had any actual belief that the copied article was not protected by a patent.

    The Federal Circuit, in an opinion by (then) Circuit Judge Rader joined by Circuit Judges Bryson and Linn, recognized that there was no direct evidence that defendants were aware of a patent, and yet this pattern of behavior is certainly suggestive that the defendants had done everything they could to remain ignorant of the existence of any patent covering the copied product.  In this absence of evidence of actual knowledge the panel turned to Supreme Court precedent, applying the "deliberate indifference" standard.  This standard, adopted from "a different civil context" was "not necessarily a 'should have known' standard," since "[t]he latter [i.e., the "should have known" standard] implies a solely objective test, whereas the former may require a subjective determination that the defendant knew of and disregarded the overt risk that an element of the offense existed," citing Farmer v. Brennan, 511 U.S. 825, 840 (1994).  Expanding on how the panel applied this test, the opinion stated that "an accused infringer may defeat a showing of subjective deliberate indifference to the existence of a patent where it shows that it was genuinely 'unaware even of an obvious risk'" and that "the standard of deliberate indifference of a known risk is not different from actual knowledge, but is a form of actual knowledge," citing examples from its sister circuits.  Thus, contrary to its traditional tendency to establish objective, bright-line tests that can be clearly understood by patentees and accused infringers alike (and after a decade of Supreme Court reversals of their efforts), the Federal Circuit applied a subjective test for inducing infringement that defendants clearly satisfied.  The panel was even careful to eschew any interpretation that the opinion was intended to be definitive:

    This opinion does not purport to establish the outer limits of the type of knowledge needed for inducement.  For instance, a patentee may perhaps only need to show, as Insituform []Techs., Inc. v. CAT Contracting, Inc., 161 F.3d 688, 695 (Fed. Cir. 1998) suggests, constructive knowledge with persuasive evidence of disregard for clear patent markings, similar to the constructive notice requirement in § 287(a) . . . .  This court does not set those boundaries now, just as it did not set them in DSU Med. [Corp. v. JMS Co., 471 F.3d 1293, 1304 (Fed. Cir. 2006) (en banc)].

    These efforts did not satisfy the Supreme Court.  Writing for an 8-1 majority (with dissenting Justice Kennedy espousing an even more stringent "actual knowledge" standard), Justice Alito first parsed 35 U.S.C. § 271(b) for exactly what knowledge the accused infringer needed to possess:  whether it is just that "the inducer lead another to engage in conduct that happens to amount to infringement" or whether the inducer knows that the induced conduct is infringing.  The statute is unclear, or at least ambiguous, according to the Court, since it can be sensibly read either way.  The Court found the case law to be equally unavailing, since cases prior to enactment of § 271 as part of the 1952 Patent Act included under "inducing infringement" conduct now codified as inducing infringement (§ 271(b)) and contributory infringement (§ 271(c)).  Reviewing those cases, the opinion finds that what is now called contributory infringement was "more common" but that the cases contain "conflicting signals" as to the nature and extent of the required knowledge.

    The Court finds precedential its decision in Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U. S. 476 (1964), where the Court found that contributory infringement under § 271(c) required that an infringer "must know 'that the combination for which his component was especially designed was both patented and infringing," despite the Court's characterization that Aro was "a badly fractured decision"; indeed, the principle relied upon by the Court was contained in Justice Black's dissent (because he disagreed with the judgment; however, he was in the majority with respect to the interpretation of § 271(c), and his opinion sets out the reasoning of the majority on this point).  This decision had stare decisis effect, because "[t]he 'holding in Aro II has become a fixture in the law of contributory infringement under [section] 271(c),'" citing 5 R. Moy, Walker on Patents § 15:20, p. 15–131 (4th ed. 2009).  Further, the opinion noted that respondent SEB "has not asked us to overrule it" and that "Congress has not seen fit to alter §271(c)'s intent requirement in the nearly half a century since Aro II was decided."  The Court thus assessed the meaning of § 271(b) "on the premise that §271(c) required actual knowledge of the patent that is infringed."  Using this premise, the Court finds that "the same knowledge is needed for induced infringement under §271(b)," in view of the "common origins" of the two statutory provisions and their similar language.  "It would thus be strange to hold that knowledge of the relevant patent is needed under §271(c) but not under §271(b)," Justice Alito concludes.

    Having determined that some knowledge regarding infringement was required, the majority then turned to the quality and quantity of that knowledge.  Without extensive comment on their reasoning, the majority states baldly that, in the absence of evidence of actual knowledge (which would satisfy the statutory requirement), "we agree [with defendant-petitioner] that deliberate indifference to a known risk that a patent exists is not the appropriate standard under §271(b)."  Instead, the opinion adopts the "willful blindness" doctrine from criminal law as the appropriate standard.  This standard requires "(1) the defendant must subjectively believe that there is a high probability that a fact exists [here, presumably, the existence of a patent] and (2) the defendant must take deliberate actions to avoid learning of that fact."  As applied in the criminal law, "defendants cannot escape the reach of these statutes [that require knowing or willful acts] by deliberately shielding themselves from clear evidence of critical facts that are strongly suggested by the circumstances" and thereby are as culpable as defendants who have "actual knowledge."  Citing the ALI Model Penal Code, § 2.02(7), the standard includes "a situation in which 'a person is aware of a high probability of [the fact's] existence, unless he actually believes that it does not exist.'"  The Court further defines how the concept of willful blindness is to be applied by stating that it "surpasses recklessness and negligence," because "a willfully blind defendant is one who takes deliberate actions to avoid confirming a high probability of wrongdoing and who can almost be said to have actually known of the critical facts," citing G. Williams, Criminal Law § 57, p. 159 (2d ed. 1961).  The opinion contrasts this level of culpability with recklessness, where the defendant "merely knows of a substantial and unjustified risk of such wrongdoing," citing ALI Model Penal Code § 2.02(2)(c) (1985), and with negligence, where the defendant "should have known of a similar risk but, in fact, did not," citing ALI Model Penal Code § 2.02(2)(d).

    The Court's opinion states that the Federal Circuit test departs from the proper willful blindness standard in two important respects:

    First, it permits a finding of knowledge when there is merely a "known risk" that the induced acts are infringing.  Second, in demanding only "deliberate indifference" to that risk, the Federal Circuit's test does not require active efforts by an inducer to avoid knowing about the infringing nature of the activities.

    Despite these criticisms, the majority upheld the Federal Circuit's decision affirming the District Court judgment below that defendants were liable for inducing infringement.

    Reviewing the two opinions, the Supreme Court clearly believes that the difference in their approach and the standard applied by the Federal Circuit is that willful blindness requires not only the existence of a known risk but a high probability of that risk that is appreciated by the defendant, coupled with active efforts by the defendant to avoid knowing that the induced activities are infringing.  The latter is subject to objective evidentiary support, being based on conduct that can be interpreted regarding its intent.  The former requirement, however, is expressly subjective and perhaps not as amenable to competent proofs sufficient to establish infringement.  In this sense, the Court's opinion has increased the burden on patentees to enforce their patent rights.

    In a biotech/pharma context, the effects of the opinion may be less negative.  For pharmaceutical products regulated by the FDA, the Orange Book provides not only actual notice but would be expected to vitiate any claim that an accused defendant did not appreciate the existence of the risk of patent infringement; the complex patent infringement portions of the recently enacted "follow-on biologics" approval pathway similarly make lack of appreciation of the known risk an unlikely defense.  In other aspects, particularly regarding method claims, the Court's decision may indeed make inducing infringement a less likely source of protection against infringement.

    A careful consideration of the Court's opinion reveals parallels between the types of factual situations that arise in the inducing infringement context with another aspect of patent law where an accused malefactor's subjective knowledge and intent are at issue — inequitable conduct.  While perhaps resulting in a different outcome, the application of the willful blindness standard to inducing infringement has obvious analogies with the question of the intent required to show a patentee's intent to deceive by failing to disclose information or references material to patentability.  There are certainly distinctions, in view of the "special relationship" traditionally recognized between the PTO and patent applicants and the duty of candor imposed upon applicants by Rule 56 and Supreme Court precedent, compared with a third-party infringer and the question of whether the existence of a patent and induced infringement thereof can be established by a patentee.  However, in both instances the accused's behavior and the intent of that behavior is at issue; it may be profitable to assess, in each instance, whether the principles enunciated today regarding the standard for inducing infringement may be adopted to defeat a charge of inequitable conduct.

    Global-Tech Appliances, Inc. v. SEB S.A. (2011)
    Opinion of the Court by Justice Alito, joined by Chief Justice Roberts and Justices Scalia, Thomas, Ginsburg, Breyer, Sotomayor, and Kagan;
    Dissenting opinion by Justice Kennedy.

  • By Donald Zuhn

    Locke, Gary In similar letters sent earlier today to the Chairman and Ranking Member of the House Judiciary Committee, Secretary of Commerce Gary Locke (at right) outlined the Department of Commerce's position on the House version of the America Invents Act (H.R. 1249), which was reported out of Committee almost seven weeks ago (see "House Judiciary Committee Approves H.R. 1249").  Secretary Locke began each letter by noting that "passage of needed reforms to our patent laws has been a high priority for me during my time as Secretary of Commerce because of its importance to America's competitiveness and our economic growth."

    With the Republican-controlled House focused on cost cutting and deficit reduction, the Secretary reminded the letters' recipients, Chairman Lamar Smith (R-TX) and Rep. John Conyers, Jr. (D-MI), that "[e]nactment of a balanced bill is an important part of the Administration's goal of 'out-innovating' our economic competitors and winning the future — and it can be done with no cost to taxpayers and no addition to the deficit."  While acknowledging that the Senate (S. 23) and House versions of the bills are not identical, Secretary Locke stated that the Administration was "confident that the variations between the two can be resolved and that enactment of a bipartisan consensus bill is within reach."  The Secretary spent the remainder of each letter outlining the Administration's views on five "key provisions" of the House bill, which he said were "important to our goals of an appropriately funded and well-functioning USPTO and successful passage of a balanced bill."

    Commerce Department Seal Secretary Locke started by tackling the first-inventor-to-file provision, declaring that the Administration "strongly support[s] the proposed transition of the United States to a first-inventor-to[-]file system."  Arguing that this transition is "an essential feature of any final bill that will simplify the process of acquiring rights while protecting innovators," the Secretary pointed out that "[t]he first-inventor-to-file provision is consistent with the practices of our economic competitors, and would benefit U.S. businesses by providing a more transparent and cost-effective process that puts them on a level playing field with the rest of the world."  With regard to the grace period provided by the House bill — which has been a topic of debate in patent circles since the bill was reported out of Committee — Secretary Locke contended that H.R. 1249 "provides a more transparent and certain grace period (a key feature of U.S. law) and a definite filing date that enables inventors to promote, fund and market their technology while making them less vulnerable to costly patent challenges, which disadvantage small entity inventors."  According to the Secretary, these changes "will benefit all stakeholders, both small and large, regardless of the field of innovation."

    Moving to the USPTO fee setting and funding provisions, Secretary Locke stated that the fee-setting authority provided in the bill would allow the USPTO to "ensure full cost recovery at no expense to America's taxpayers," as well as "process applications more quickly and produce higher-quality patents that are less likely to be subject to a court challenge."  Pointing to the "deliberative and transparent [fee] review process" set forth in the bill, the Secretary suggested that the bill contained "a comprehensive and appropriate set of mechanisms to ensure all fee changes are well-considered and well-calibrated."

    Addressing the bill's post-grant review provisions, the Secretary stated that the Administration "supports establishing a new post-grant review proceeding and retooling the existing post-grant inter partes reexamination procedure," arguing that "[t]hese proceedings will serve to minimize costs and increase certainty by offering efficient and timely alternatives to litigation as a means of reviewing questions of patent validity," and "provide a check on patent examination, ultimately resulting in higher quality patents."  As for the Office's ability to handle the burden of these proceedings, Secretary Locke indicated that "[v]arious safeguards and flexibilities are included in the proposed proceedings to enable USPTO to effectively implement and manage them."

    With regard to pre-issuance submissions, the Secretary contended that "the opportunity for third parties to submit potentially relevant prior art to the USPTO after publication of an application and before examination" will "increase the quality of patents."

    The Secretary closed his letter by discussing the expansion in H.R. 1249 of the prior user defense to all areas of technology, stating that "[a]s a matter of fairness, we believe that innovators who independently create and commercialize technology should not be penalized for, or deprived of, their investment."  Taking note of the concerns raised by "some in the university community," Secretary Locke offered "to work with the Committee on any proposed revisions" to the provision.

    USPTO Seal In a press release concerning Secretary Locke's letter to House leadership, the U.S. Patent and Trademark Office indicated that the America Invents Act "enhances the U.S. patent system by increasing certainty of patent rights through implementation of a first-inventor-to-file standard for patent approval while also reducing the need for cost-prohibitive litigation, which all too often ties up new ideas in court, stifling innovation and holding back job creation," adding that "[u]ltimately, the proposed legislation will provide the most meaningful reforms to the U.S. patent system in 60 years."  The release also stated that the legislation will create an "updated patent infrastructure [that] will level the playing field for small enterprises seeking to participate in the global marketplace — reducing expensive and time-consuming litigation, simplifying the process of acquiring rights and creating a system that mirrors others around the world, all while enhancing American competitiveness and spurring economic growth."

    For additional information regarding this and other related topics, please see:

    • "Patent Reform News Briefs," May 11, 2011
    • "Boundy Issues Call to Arms on America Invents Act," April 21, 2011
    • "More Reaction to H.R. 1249," April 18, 2011
    • "House Judiciary Committee Approves H.R. 1249," April 14, 2011
    • "Reaction to Manager's Amendment to House Patent Reform Bill," April 13, 2011
    • "House Judiciary Chairman Releases Manager's Amendment to H.R. 1249," April 12, 2011
    • "Reaction to House Patent Reform Bill," March 31, 2011
    • "House Introduces Its Version of 'America Invents Act,'" March 30, 2011
    • "Patent Reform Discussion Moves to House," March 29, 2011
    • "The Disappearance of Deceptive Intent in S. 23," March 23, 2011
    • "'Reform' at the U.S. Patent and Trademark Office," March 22, 2011
    • "Few 'Reform' Provisions Remain in S. 23 Relating to the Judiciary," Marech 21, 2011
    • "Additional Opportunities for Pre- and Post-grant Review, and Brand New Patent Trial and Appeal Board in S. 23," March 17, 2011
    • "Post-grant Review Provisions of S. 23," March 16, 2011
    • "Inventor's Interests, If Not Rights, Limited by S. 23," March 15, 2011
    • "What Are the Provisions of the Proposed "First-Inventor-to-File" System in S. 23?" March 14, 2011
    • "Obama Administration Supports S. 23," March 9, 2011
    • "Reaction to Senate Passage of S. 23," March 8, 2011
    • "Senate Passes S. 23," March 8, 2011

  •     By Kevin E. Noonan

    Federal Circuit Seal The Federal Circuit delivered its en banc opinion on inequitable conduct last week in Therasense, Inc. v. Becton, Dickinson & Co.  Judge O'Malley wrote separately, concurring in part with the majority while also dissenting in part, in an idiosyncratic opinion that reflects, in part, her experience.  While a relative newcomer to the Federal Circuit, Judge O'Malley brings a distinguished career as a district court judge to the appellate bench, making hers a unique voice among her colleagues.

    Judge O'Malley Judge O'Malley's (at left) focus is on what she terms "clear guidelines," for patent practitioners as well as the courts.  However, Judge O'Malley recognizes that absolute precision or the kind of "defining rules [that can exist] in the scientific world" are not only impracticable in the law, but in fact that under equitable principles, law is actually "imprecise by design."  This idea provides the basis for her disagreement with the majority, specifically with the Court's adoption of the "but-for" test for the materiality prong of their inequitable conduct analysis, as well as the parts of the decision that vacated and remanded the question of materiality to the District Court (while concurring with the decision to send the inequitable conduct question back to the lower court for reconsideration).  She writes that the majority opinion's guidance and direction with regard to the intent question mandate this remand, since the District Court's decision "understandably referred to standards governing its intent determination drawn from our prior case law" and the Federal Circuit clearly set forth the standard that "a district court must find that the conduct at issue is of 'sufficient culpability to require a finding of intent to deceive,'" citing Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 (Fed. Cir. 1988).  And like the other dissenters, she rejects any application of a "sliding scale" that would conflate or diminish the requirement that "intent to deceive and materiality must be found separately" (although like the dissent, albeit less broadly, in a footnote Judge O'Malley enunciates the type of "guidance" that has led to the conundrums and difficulties that the majority has tried to reduce in its opinion:

    While I join this portion of the majority opinion (Part V), I do so with the understanding that the majority does not hold that it is impermissible for a court to consider the level of materiality as circumstantial evidence in its intent analysis.  As in all other legal inquiries involving multiple elements, the district court may rely on the same items of evidence in both its materiality and intent inquiries.  A district court must, however, reach separate conclusions of intent and materiality and may not base a finding of specific intent to deceive on materiality alone, regardless of the level of materiality.

    Judge O'Malley's disagreement with both the majority and the dissent is that both, in her view, attempt to impose strict guidelines (or "hard and fast rules") on the inequitable conduct question that she finds incompatible with the equitable principles underlying the doctrine.  She cites Supreme Court cases for the propositions that the Chancellor in equity is given the power to "do equity" and to "mould each decree to the necessities of the particular case," citing Weinberger v. Romero-Barcelo, 456 U.S. 305, 312 (1982) (quoting Hecht Co. v. Bowles, 321 U.S. 321, 329 (1944)) and have the power to be flexible in "moulding" such decrees, citing Holmberg v. Armbrecht, 327 U.S. 392, 396 (1946).  And she notes that the Supreme Court has not found patent law to be an exception to these general rules of equitable jurisprudence, citing eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 393-94 (2006), as an example.

    Both the majority opinion and the dissent err when they "eschew flexibility in favor of rigidity," suggesting "tests for materiality [that] apply in all cases."  Judge O'Malley sees both opinions as being inquiries that are "black or white, while equity requires judicial consideration of shades of gray."  Her concern is specifically directed at district courts, particularly in cases where neither of the tests (those proposed by the majority or the dissent) are met, yet equity "demands" that a patent not be enforced (albeit in "an extraordinary case").  She rejects the majority's panacea of using the "unclean hands" principle for "egregious misconduct," both because she objects to the majority's formulation that the inequitable conduct doctrine is distinct from "the unclean hands principles the Supreme Court described and explained in its trilogy of cases" (saying there is no authority to support this dichotomy" and noting that "[i]f 'unclean hands' remains available in cases of PTO misconduct, charges of unclean hands could simply supplant the very allegations of inequitable conduct the majority seeks to curb."  She finds equal fault with the dissent's proposal to define materiality by PTO Rule 56, since this would "not allow, for in- stance, for a finding of inequitable conduct for conduct not encompassed by Rule 56."

    She sets forth her view as follows:

    We should adopt a test that provides as much guidance to district courts and patent applicants as possible, but, in doing so, we may not disregard the equitable nature of the inquiry at hand.  Thus, we must make clear that, while we believe the test we offer encompasses virtually all forms of conduct sufficient to warrant a finding of inequitable conduct, we leave open the possibility that some form of intentional misconduct which we do not currently envision could warrant equitable relief.

    This would be consistent with Supreme Court precedent and with "the flexible nature of equity jurisdiction."

    Such flexibility should also extend to determination of the remedy for a finding of inequitable conduct, she argues, citing Mills v. Elec. Auto-Lite Co., 396 U.S. 375, 386 (1970), for the proposition that "the lower courts should exercise the sound discretion which guides the determinations of courts of equity, keeping in mind the role of equity as the instrument for nice adjustment and reconciliation between the public interest and private needs as well as between competing private claims."  Judge Rader's "atomic bomb" of complete unenforceability is "neither compelled by statute, nor consistent with the equitable nature of the doctrine," and Judge O'Malley would expressly "hold that, in the exercise of its discretion, a district court may choose to render fewer than all claims unenforceable, may simply dismiss the action before it, or may fashion some other reasonable remedy, so long as the remedy imposed by the court is "commensurate with the violation," citing Columbus Bd. of Educ. v. Penick, 443 U.S. 449, 465 (1979).  Judge O'Malley believes that this would "reduce the incentive to use inequitable conduct as a litigation tactic and address many of the concerns that trouble my colleagues and were expressed by Abbott and certain amici in these en banc proceedings"; she also opines that "[c]areful application of the pleadings requirements set forth in Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312 (Fed. Cir. 2009)" can be used by district courts to address this problem.

    The opinion also sets forth the judge's test for materiality:

    (1) but for the conduct (whether it be in the form of an affirmative act or intentional non-disclosure), the patent would not have issued (as Chief Judge Rader explains that concept in the majority opinion);

    (2) the conduct constitutes a false or misleading representation of fact (rendered so either because the statement made is false on its face or information is omitted which, if known, would render the representation false or misleading); or

    (3) the district court finds that the behavior is so offensive that the court is left with a firm conviction that the integrity of the PTO process as to the application at issue was wholly undermined.

    Finally, she joins the majority in rejecting the dissent's view that the proper materiality standard is PTO Rule 56, calling it "both too vague and too broad," particularly insofar as it would encompass acts that are "not sufficiently egregious to fall within the bounds of the Supreme Court trilogy from which the doctrine emerged."  Of course, the judge also rejects the majority's test, saying it is too narrow, since "[g]iven the scope and complexity of PTO proceedings, misconduct can and does occur outside the context of written affidavits."

    Turning to the case at bar, Judge O'Malley would affirm that the EPO arguments not submitted to the PTO during prosecution of the '551 patent were material (saying this information would satisfy her proposed test "or any reasonable test for materiality that comports with Supreme Court precedent" as well as the majority's "but-for" test), so that a remand on the materiality issue "is neither necessary nor appropriate."

    The majority addresses Judge O'Malley's objections by asserting as a "mischaracterization" limiting "affirmative egregious acts" to the example of the case below — filing a false affidavit.  The majority states that its test provides "clear guidance to patent practitioners and the courts [in the general case regarding "but for" materiality], while the egregious misconduct exception gives the test sufficient flexibility to capture extraordinary circumstances."  The majority contends that Judge O'Malley "appears to eschew the use of any test" due to the fact that for any test there may be instances that are not encompassed by the test.  While acknowledging the flexibility required for applying equitable doctrines, the majority notes that "[c]ourts have long applied rules and tests in determining whether a particular factual situation falls within the scope of an equitable doctrine," citing Winter v. Natural Res. Def. Council, Inc., 129 S.Ct. 365, 374 (2008) (preliminary injunctions); eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006) (permanent injunctions); Gutierrez v. Waterman S.S. Corp., 373 U.S. 206, 215 (1963)(laches), and in particular, Lonchar v. Thomas, 517 U.S. 314, 323 (1996) (stating that "[c]ourts of equity must be governed by rules and precedents no less than the courts of law . . . [because] the alternative is to use equity chancellor's conscience as a measure of equity, which alternative would be as arbitrary and uncertain as measuring distance by the length of each chancellor's foot").

    No doubt the differing views of majority, the dissent, and Judge O'Malley's objections to both will be useful for the parties in the expected petition for certiorari and plaintiff's opposition to the petition.  Perhaps the most important party to be heard will be the Solicitor General, and his position is likely to depend on how the USPTO views the Federal Circuit's en banc opinion.  Director Kappos has indicated that guidelines for implementing the Court's opinion will be forthcoming (see "USPTO Studying Therasense Decision, Will Issue Guidance Soon") and that may provide the first inkling of whether the PTO believes that the Court's decision will positively or negatively affect its ability to properly provide effective patent examination.

    Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc)
    Before Chief Judge Rader and Circuit Judges Newman, Lourie, Bryson, Gajarsa, Linn, Dyk, Prost, Moore, O'Malley, and Reyna
    Opinion by Chief Judge Rader, joined in full by Circuit Judges Newman, Lourie, Linn, Moore, and Reyna, and joined in part by Circuit Judge O'Malley
    Concurring-in-part and dissenting-in-part opinion by Circuit Judge O'Malley
    Dissenting opinion by Circuit Judge Bryson, joined by Circuit Judges Gajarsa, Dyk, and Prost

    For additional information regarding this and other related topics, please see:

    • "USPTO Studying Therasense Decision, Will Issue Guidance Soon," May 26, 2011
    • "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc): The Dissenting Opinion," May 26, 2011
    • "Therasense, Inc. v. Becton, Dickinson & Co. (Fed. Cir. 2011) (en banc)," May 25, 2011
    • "Abbott Files Reply Brief in Therasense Case," November 8, 2010
    • "Appellees File Reply Brief in Therasense v. Becton Dickinson," October 27, 2010
    • "Bayer Submits Brief in Therasense v. Becton Dickinson," October 20, 2010
    • "PhRMA Files Amicus Brief in Therasense Case," August 22, 2010
    • "PTO Files Amicus Brief in Therasense Case," August 19, 2010
    • "American Bar Association Files Amicus Brief in Therasense Case," August 17, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. — Briefing Schedule Update," August 8, 2010
    • "BIO Files Amicus Brief in Therasense Case," August 8, 2010
    • "Pharma and Software Companies File Joint Amicus Brief in Therasense Case," August 3, 2010
    • "IPO Files Amicus Brief in Therasense Case," August 2, 2010
    • "Abbott Files Brief in Therasense Case," July 28, 2010
    • "CAFC Sets Date for Oral Argument En Banc in Inequitable Conduct Appeal," June 9, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. — Briefing Schedule Update," May 16, 2010
    • "Therasense, Inc. v. Becton, Dickinson & Co. Briefing," May 13, 2010
    "Federal Circuit Grants En Banc Review in Therasense v. Becton Dickinson," April 28, 2010

  • By Sherri Oslick

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

    Abbott Laboratories et al.v. Sandoz Inc.
    1:11-cv-00424; filed May 13, 2011 in the District Court of Delaware

    • Plaintiffs:  Abbott Laboratories; Wisconsin Alumni Research Foundation
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent No. 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.


    Lupin Atlantis Holdings S.A. v. Mylan Inc. et al.

    2:11-cv-03129; filed May 12, 2011 in the Eastern District of Pennsylvania

    • Plaintiff:  Lupin Atlantis Holdings S.A.
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals, Inc.; Ethypharm S.A.

    Lupin Atlantis Holdings, S.A. v. Mylan Inc. et al.
    2:11-cv-00630; filed May 12, 2011 in the Western District of Pennsylvania

    • Plaintiff:  Lupin Atlantis Holdings, S.A.
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Ethypharm S.A.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,101,574 ("Pharmaceutical Composition Containing Fenofibrate and the Preparation Method," issued September 5, 2006) and 7,863,331 ("Pharmaceutical Composition Containing Fenofibrate and Method for the Preparation Thereof," issued January 4, 2011) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Lupin's Antara® (fenofibrate, used to treat hypercholesterolemia and hypertriglyceridemia).  View the E.D. Penn. complaint here.


    Medicis Pharmaceutical Corp. et al.v. Actavis Mid Atlantic LLC

    1:11-cv-00409; filed May 11, 2011 in the District Court of Delaware

    • Plaintiffs:  Medicis Pharmaceutical Corp.; Dow Pharmaceutical Sciences, Inc.; Alyzan, Inc.
    • Defendant:  Actavis Mid Atlantic LLC

    Infringement of U.S. Patent Nos. 6,387,383 ("Topical Low-Viscosity Gel Composition," issued May 14, 2002) and RE41,134 ("Slow Release Vehicles for Minimizing Skin Irritancy of Topical Compositions," issued February 16, 2010) based on Actavis' filing of an ANDA to manufacture a generic version of Medicis' Ziana® (clindamycin phosphate and tretinoin gel, used to treat acne).  View the complaint here.


    Takeda Pharmaceutical Co. et al.v. Macleods Pharmaceuticals Ltd.

    1:11-cv-03109; filed May 6, 2011 in the Southern District of New York

    • Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals North America, Inc.
    • Defendant:  Macleods Pharmaceuticals Ltd.

    Infringement of U.S. Patent Nos. 5,965,584 ("Pharmaceutical Composition," issued October 12, 1999), 6,329,404 (same title, issued December 11, 2001), 6,166,043 (same title, issued December 26, 2000), 6,172,090 (same title, issued January 9, 2001), 6,211,205 (same title, issued April 3, 2001), 6,271,243 (same title, issued August 7, 2001), and 6,303,640 (same title, issued October 16, 2001) following a Paragraph IV certification as part of Macleods filing of an ANDA to manufacture a generic version of Takeda's Actos® (pioglitazone hydrochloride, used to treat type II diabetes).  View the complaint here.


    Eli Lilly and Company v. Zydus Pharmaceuticals USA, Inc.

    2:11-cv-02582; filed May 5, 2011 in the District Court of New Jersey

    Infringement of U.S. Patent No. 5,658,590 ("Treatment of Attention-Deficit/Hyperactivity Disorder," issued August 19, 1997) following a paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Lilly's Strattera® (atomoxetine hydrochloride, used to treat attention-deficit/hyperactivity disorder).  Also, breach of prior Consent Judgment.  View the complaint here.


    Schering Corp. v. Sandoz, Inc.

    3:11-cv-02589; filed May 4, 2011 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 5,661,151 ("Tetrahydrofuran Antifungals," issued August 26, 1997), 5,703,079 (same title, issued December 30, 1997), and 6,958,337 ("Crystalline Antifungal Polymorph," issued October 25, 2005) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Schering's Noxafil® (posaconazole, used in the prophylaxis of fungal infections in immunocompromised patients, and in the treatment of oropharyngeal candidiasis).  View the complaint here.