• By Kevin E. Noonan —

    An anonymous correspondent writes:

    48 hours ago, it looked like the Patent Reform Act was a done deal.  Today, it's not at all that clear.

    Tuesday afternoon, Harold Rogers (Chairman of the House Appropriations Committee) and Paul Ryan (Chairman of Budget) wrote a letter to Chairman Smith insisting on maintaining the power of these two committees to raid the Patent Office of its user fees.  [See "Patent Reform News Briefs," June 7, 2011.]  What isn't mentioned in the letter is that Chairman Rogers was one of the main architects of fee diversion in the early part of the decade.

    Wednesday, four senior members of the Appropriations Committee reiterated their preference for fee diversion.

    It can be expected that almost all stakeholders will come out in opposition to the bill if the appropriators get their way.

    On Wednesday afternoon, in a debate between Robert Armitage (Eli Lilly) and Steven Miller (Proctor & Gamble) as proponents of the bill, against Pat Choate (an economist) and Jonathan S. Massey of Massey & Gail (a former Supreme Court clerk) in opposition to the bill, reports are that audience members came away with the realization that the bill raises real questions, that it may indeed be harmful to companies outside the Fortune 100, that the opponents of the bill have valid concerns, and that constitutionality of some provisions is certainly sufficiently questionable to create commercial uncertainty.

    In a third letter, Rep. Adam Schiff [D-CA] joined other legislators that have expressed concerns with several provisions of the bill.

    One knowledgeable source (who wished not to be identified) expressed the opinion at the end of the day Wednesday that the bill was no longer a "done deal," that its passage was truly an open question.

    Phone calls that seemed hopeless a week ago could now be decisive — the fate of the bill turns on about 5000 phone calls to representatives.

    Washington - Capitol #1 The letters in question raise legitimate questions.  As noted in an earlier Patent Docs post, Representatives Harold Rogers (R-KY) and Paul Ryan (R-WI) object to provisions of the House "patent reform" bill (H.R. 1249) by citing Constitutional concerns (transferring appropriation authority from Congress to the Executive) and partisanship (characterizing this change as being contrary to "the new Republican majority's commitment to restraining spending, improving accountability and transparency, and reducing the nation's unparalleled deficits and debt" and saying that "it would be both irresponsible and unwise to allow the PTO to operate solely under the authority of bureaucrats and White House political appointees," conveniently forgetting that the Bush White House ended fee diversion from 2004-2008).

    These sentiments were echoed (almost word-for-word) in a second letter from Rep. Rogers, joined by Representatives Frank Wolf (R-VA), Norman Dicks (D-WA), and Chaka Fattah (D-PA).

    Schiff, Adam On the other hand, Rep. Adam Schiff (R-CA) (at left) writes to oppose the "First to File" system set forth in Section 2 of the bill.  Rep. Schiff writes that this change will be "counterproductive" because it will hurt "the most creative inventors in our economy and lead to rushed patent filings."  In support of this proposition, he notes that "[t]he driving force of innovation comes from small, agile firms that marshal creative energies in exciting and productive ways" and that "[i]t is precisely these small firms" that will be hurt by this change, in his opinion.  Rep. Schiff cites the need for such small companies "to do additional market research, talk to venture capitalists or investors, develop their idea further and a myriad of other necessities" that the current system permits and a "first to file" regime will inhibit.  He also ties the need for outside patent counsel to prepare applications that will ultimately be discarded as a misuse of resources that would otherwise be used for "hiring and actual act[s] of invention."

    Artful lobbying and crafty politics (as well as a genuine belief that "patent reform" is necessary to address the backlog and other perceived weaknesses in the patent system) have gotten us to this moment.  Whether sufficient political opposition can be mounted to prevent passage of H.R. 1249 is an open question, one that will only be answered if enough stakeholders who think the bill is fundamentally flawed exercise their franchise and let their Representative know.  The time (once again) is now.

  • By Donald Zuhn —

    House Issues Report on America Invents Act

    House of Representatives Seal On June 1, the House Committee on the Judiciary issued its report on H.R. 1249, the America Invents Act.  The 165-page report indicates that following consideration of the bill, the Committee now "reports favorably thereon with an amendment and recommends that the bill as amended do pass."  The report is divided into sixteen sections, including discussions of the amendment to the bill, the bill's purpose and summary, background and need for the legislation, agency views, dissenting views, and additional views.  Patent Docs intends to provide a more comprehensive analysis of the report in future posts.


    Rep. Manzullo Urges House Leaders to Shelve "Patent Reform" Bill

    Manzullo, Donald On Monday, Rep. Don Manzullo (R-IL) (at left) issued a press release calling on House leadership to "shelve" H.R. 1249, the "controversial 'patent reform' bill" that could make it to the floor for a vote as early as next week.  The impetus for Rep. Manzullo's request was the Supreme Court's decision in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc., which he says "upends the basic premise of the bill."  In particular, Rep. Manzullo points to the opinion's opening statement that "[s]ince 1790, the patent law has operated on the premise that rights in an invention belong to the inventor."  He also points to a subsequent statement by Chief Justice Roberts, the author of the opinion, that "[a]lthough much in intellectual property has changed in the 220 years since the first Patent Act, the basic idea that inventors have the right to patent their inventions has not."  Noting that the "main premise" of H.R. 1249 "is to switch America's patent system from a 'first to invent' system to a 'first to file' system," Rep. Manzullo contends that the "ruling by the Supreme Court affirms 'first to invent' and indicates HR 1249 would not pass constitutional muster."


    52 Representatives Seek Debate on Constitutionality of H.R. 1249

    Washington - Capitol #3 In a letter to Rep. David Dreier (R-CA), the Chairman of the House Committee on Rules, and Rep. Louise Slaughter (D-NY), the Ranking Member of the House Committee on Rules, 52 members of the House have requested that "any resolution reported by the Committee on Rules . . . to provide for consideration of H.R. 1249 include provision for a separate period of at least 20 minutes for debate on constitutionality of H.R. 1249 under clause 8 of Section 8 of Article I."  As most patent practitioners are aware, the clause of the Constitution cited in the legislators' letter confers upon Congress the power "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."

    In addition to Rep. Manzullo (R-IL), the other signatories to the letter include:  Representatives Michele Bachmann (R-MN), Tammy Baldwin (D-WI), Lou Barletta (R-PA), Roscoe Bartlett (R-MD), Dan Benishek (R-MI), Paul Broun (R-GA), Corinne Brown (D-FL), Mike Coffman (R-CO), Tom Cole (R-OK), John Conyers, Jr. (D-MI), Chip Cravaack (R-MN), Danny Davis (D-IL), Lloyd Doggett (D-TX), John Duncan, Jr. (R-TN), Donna Edwards (D-MD), Keith Ellison (D-MN), Marcia Fudge (D-OH), Charles Gonzales (D-TX), Walter Jones (R-NC), Marcy Kaptur (O-OH), Mike Kelly (R-PA), Steve King (R-IA), Dennis Kucinich (D-OH), John Lewis (O-GA), Daniel Lipinski (D-IL), Frank Lucas (R-OK), Jim McDermott (D-WA), Gregory Meeks (D-NY), Richard Neal (D-MA), Ed Pastor (D-AZ), Ron Paul (R-TX), Collin Peterson (D-MN), Thomas Petri (R-WI), Chellie Pingree (D-ME), Bill Posey (R-FL), Nick Rahall II (D-WV), Dana Rohrabacher (R-CA), Mike Ross (D-AR), Lucille Roybal-Allard (D-CA), Jon Runyan (R-NJ), Bobby Rush (D-IL), Robert Schilling (R-IL), Aaron Schock (R-IL), James F. Sensenbrenner, Jr. (R-WI), Brad Sherman (D-CA), Christopher Smith (R-NJ), Bennie Thompson (D-MS), Edolphus Towns (D-NY), Tim Walberg (R-MI), Allen West (R-FL), and Don Young (R-AK).  The letter was a bipartisan effort, with 26 Republicans and 26 Democrats requesting the period of debate.  Interestingly, two of the letter's signatories, Rep. Conyers and Rep. Sensenbrenner, Jr., are members of the House Judiciary Committee.


    House Appropriations and Budget Chairs Seek Changes to USPTO Funding Provision

    Rogers, Harold While some House members have begun to question the constitutionality of H.R. 1249 — or at least have expressed a desire to debate the issue — Rep. Harold Rogers (R-KY) (at right), the Chairman of the House Committee on Appropriations, and Rep. Paul Ryan (R-WI) (below), the Chairman of the House Committee on the Budget, have now raised concerns regarding the USPTO funding provision of the legislation.  In a letter sent on Monday to Rep. Lamar Smith (R-TX), the Chairman of the House Committee on the Judiciary, the two House Republicans state that H.R. 1249, which "is likely to be considered on the House floor in the upcoming weeks," would "permit the PTO to collect and spend authorized fees — all without requiring action or approval from Congress."

    Ryan, Paul Rep. Rogers and Ryan noted that they "strongly oppose this proposed shift of billions in discretionary funding and fee collections to mandatory spending," stating that "[p]utting PTO funding on auto-pilot is a move in exactly the wrong direction, given the new Republican majority's commitment to restraining spending, improving accountability and transparency, and reducing the nation's unparalleled deficits and debt."  The House Republicans add that "H.R. 1249 would also hand the Congressional 'power of the purse' — bestowed in the Constitution — to the Obama White House, and essentially eliminate the ability of Congress to perform substantive oversight of the PTO."  Asserting that "[o]versight of the PTO belongs with the Congress," the two legislators argue that "[i]t would be both irresponsible and unwise to allow the PTO to operate solely under the authority of bureaucrats and White House political appointees — without being held accountable to the American public through their elected Representatives in Congress."  The letter concludes by requesting that section 22 of H.R. 1249, which would create the U.S. Patent and Trademark Office Public Enterprise Fund to cover all USPTO administrative and operating expenses, be deleted or modified prior to floor consideration of the bill.


    Patent Reform Is Part of House Republican Jobs Plan

    Cantor, Eric Last week, House Majority Leader Eric Cantor (R-VA) (at right) announced the House Republican plan for job creation and economic growth.  A one-page summary of the plan indicated that entrepreneurship and growth would be encouraged by "[m]oderniz[ing] our patent system to protect our nation's innovators, discourage frivolous lawsuits, and expedite patent reviews."  The full jobs plan provided a bit more detail regarding this goal, characterizing the patent-related problem and the House Republicans' solution to that problem as follows:

    PROBLEM: PATENT BACKLOGS

    Our patent system protects American ideas and products.  It has historically been the envy of the world, but today it is failing to meet the challenges of the 21st Century.  Under our current patent system there is a backlog of 700,000 patent applications.  The current system of filing, challenging, and litigating patents can also lead to costly and unnecessary delays.

    REPUBLICAN SOLUTION

    We will modernize and improve the patent system to discourage frivolous lawsuits, expedite reviews, and provide better protection for job creating entrepreneurs.  Streamlining the system will make it easier for existing businesses to grow and allow more start-up companies to flourish.  The House Judiciary Committee voted to approve a bipartisan patent reform bill to address these challenges.

  • Supreme Court Sets Limits on the Bayh-Dole Act

        By Kevin E. Noonan —

    Supreme Court Building #1 The Supreme Court today handed down its opinion in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc.  The opinion begins (and could have ended) with a recitation of a fundamental premise of U.S. Patent Law:  "[s]ince 1790, the patent law has operated on the premise that rights in an invention belong to the inventor."  The question here, according to the Court, is whether Congress acted to overrule that principle for federally funded inventions under the Bayh-Dole Act and automatically vest title in the federal contractor.  The Court's opinion is that it does not.

    Stanford University The dispute arose when a research scientist at Stanford, who had signed (as part of his employment agreement) an agreement to assign to Stanford all federally funded inventions, performed research at Cetus and, as a condition for performing that work, signed an agreement to assign any inventions to the company.  This work resulted in methods for detecting HIV virus in patient samples, which are used to assess the effectiveness of AIDS treatments.  Stanford later obtained several patents on these inventions and sued Roche Molecular Systems (who had acquired Cetus) when the company marketed a diagnostic test that incorporated these methods.  The Federal Circuit below made a distinction between an "agreement to assign" to Stanford and the agreement to Cetus, which read that the scientists "will assign and hereby assigns" all inventions to the company.  For the appellate court, the language that the scientist "agreed to assign" to Stanford amounted to a promise to assign inventions not yet made and thus, under contract law, was insufficient to divest Cetus of title under the "will assign and hereby assigns" language of that agreement.

    Supreme Court Seal The Supreme Court affirmed, in an opinion by Chief Justice Roberts joined by all but Justices Breyer and Ginsberg (Justice Sotomayor filed a concurring opinion).  In doing so, the Court did not pass judgment on the Federal Circuit's interpretation of contract law, however, but focused on the preclusive effect, if any, of the Bayh-Dole Act on the inventor's interests in the invention.  The Court recited the several provisions of the Patent Act that require that an inventor is entitled to a patent (subject to the specific provisions of the Act; § 101); that the inventor must sign an oath or declaration attesting to inventorship (§ 115); and that a patent is issued to the inventor or the inventor's assignee (§§ 151, 152, and 261).  The primacy of the inventor as patentee is supported by precedent cited by the Court, including Gayler v. Wilder, 10 How. 477, 493 (1851); Solomons v. United States, 137 U.S. 342, 346 (1890); United States v. Dubilier Condenser Corp., 289 U.S. 178, 188 (1933), and under treaty, according to the Court.  While much of this same precedent supports the right of an inventor to assign rights to an invention to another, the patent right, ultimately, "must trace back to the inventor."  Mere employment is not enough to convey title to an invention from the employee to the employer, "unless there is an agreement to the contrary," and thus the issue before the Court was whether (or which of) the agreements was effective in transferring title.

    The Court characterizes the position taken by Stanford and the U.S. as amicus curiae, to be that Congress altered this traditional relationship regarding title to inventions made using monies from the Federal Government.  The Court rejected this view, saying that when Congress intended to do so in the past it had done so expressly.  The Court cited statutory provisions regarding nuclear energy (42 U.S.C. § 2182), NASA (51 U.S.C. § 20135(b)(1)) and the Department of Energy (42 U.S.C. § 5908) as examples of such express vesting of title of private patents to the U.S.  Such express language is "notably absent" from the Bayh-Dole Act, according to the Court, which stated that:

    Nowhere in the Act is title expressly vested in contractors or anyone else; nowhere in the Act are inventors expressly deprived of their interest in federally funded inventions.  Instead, the Act provides that contractors may "elect to retain title to any subject invention."  35 U. S. C. §202(a).

    The Court noted that, under § 201(e), "[a] 'subject invention' is defined as 'any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement.'"  The Court explicitly rejected Stanford's reading of the phrase "invention of the contractor" to perform the vesting function, saying that to do so would "assume that Congress subtly set aside two centuries of patent law in a statutory definition" and would render the phrase "of the contractor" superfluous.  By this interpretation, the Act is limited to those inventions "owned by or belonging to the contractor," which would require assignment from the inventor to the university in order to be satisfied.  While noting that Stanford's reading of the phrase "the invention of the contractor" to mean "all inventions made by the contractor's employees is 'plausible in the abstract,'" the opinion expressly rejected the analogy with the products of other employees in other contexts (such as automobile manufacturing), saying that "patent law has always been different."  The Court rejected the idea that employment is enough, absent an agreement, to vest ownership of a patented invention.  The language of the Act specifying that the contractor can elect to retain title supports this view, in the Court's opinion, saying that "you cannot retain something unless you already have it," citing as an example Alaska v. United States, 545 U.S. 75, 104 (2005).  In the Court's opinion, "[t]he Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have."

    Roche The opinion contains two other important statements.  First (and in a footnote), the Court rejects the dissent's assertion that Executive Order 10096 acts to vest title in the government, saying that this Executive Order applies to federal employees, and that recipients of federally funded contracts are not federal employees.  Second, the Court rejected the interpretation that § 210 of the statute, which states that "it 'take[s] precedence over any other Act which would require a disposition of rights in subject inventions . . . that is inconsistent with' the Act" displaces the inventor's rights in favor of the university.  This can happen only with regard to "subject inventions," which the Court interprets to mean "inventions of the contractor," i.e., only after an inventor has assigned rights in the invention to the university.  This argument leads to the second statement:  the Court finds that the Act is limited to the "order of priority rights between the Federal Government and a federal contractor in a federally funded invention that already belongs to the contractor.  Nothing more."  The Court says that this interpretation is supported by the absence of any provisions regarding third parties "that have neither sought nor received federal funds" such as Roche.  The absence of such remedies "would be deeply troubling," according to the opinion, "[i]n a world in which there are frequent collaboration between private entities, inventors and federal contractors."  The opinion also states that Stanford's interpretation would vest title in inventions "even if the invention was conceived before the inventor became a University employee, so long as the invention's reduction to practice was supported by federal funding," and that title would vest in the university "even if only one dollar of federal funding was applied towards the invention's conception or reduction to practice."

    Finally, the opinion reviews other portions of the Act, such as § 202(d), which relate to the inventor "retaining" rights to the subject invention if the university declines to retain title.  The use of the word "retention" in the statute "would be odd," says the Court, if the inventor did not have rights in the invention to retain.

    Breyer, Justice Justice Breyer's (at right) dissent is based on his belief that the answer to the question presented to the Court "turns on matters that have not been fully briefed (and are not resolved by the opinion of the Court)."  In an opinion further supporting the Justice's role as this Court's Justice Douglas when it comes to patents (going so far as citing Heller and Eisenberg's discredited (by experience) "tragedy of the anticommons" article published more than a dozen years ago), the dissent sets forth a dichotomy.  On the one hand, the Justice writes, patents "help to elicit useful inventions and research and [] assure public disclosure of technological advances."  On the other hand, patents "sometimes mean unnecessarily high prices or restricted dissemination . . . [that] sometimes discourage further innovation and competition by requiring costly searches for earlier, related patents or by tying up ideas, which, were they free, would more effectively spur research and development."

    The dichotomy is given historical personification, between Jefferson discussing the "embarrassment of an exclusive patent" and Madison favoring a "'patent monopoly'" as "'compensation for' a 'community benefit.'"  Accordingly, the Justice is concerned about situations where the public must "pay twice" for inventions produced using federal funding.  In support of these concepts, he cites statutory provisions form before Bayh-Dole was enacted, which it should be recognized reflect a situation that the Act was intended (in part) to change, because it limited the capacity for publicly supported research to be commercialized.  Justice Breyer recognizes these pubic policy concerns — he states in his opinion that the desire to "encourage those institutions to commercialize inventions that otherwise might not realize their potentially beneficial public use" constitutes "a special public policy reason" expressly recited in the Act (§ 200).

    These concerns inform Justice Breyer's reticence to join the majority in permitting an inventor to assign an invention made using federal funds to a third party, "thereby taking that invention out from under the Bayh-Dole Act's restrictions, conditions, and allocation rules."  To do so would be "inconsistent with the Act's basic purposes" and could "significantly undercut the Act's ability to achieve its objectives."  The detriment to the public would be to permit a situation where an invention for which the public has paid would "avoid the Act's  . . . restrictions and conditions" and (paradoxically) "makes the commercialization and marketing of such an invention more difficult" due to questions about title like the ones raised in this case.

    Justice Breyer's dissent concentrates on the contract law interpretations of the Federal Circuit and, since he disagrees with them, would use that as the basis for reversing the decision below and remanding.  He notes that the Federal Circuit had relied upon an earlier opinion of that Court, FilmTec Corp. v. Allied-Signal, Inc., 939 F. 2d 1568 (1991), for the principle that "'[o]nce the invention is made and [the] application for [a] patent is filed, . . . legal title to the rights accruing thereunder would be in the assignee [i.e., Cetus] . . . , and the assignor-inventor would have nothing remaining to assign.'"  In Justice Breyer's opinion, this makes "too much of too little," since the scientist's agreement with Stanford "conveyed equitable, but not legal, title," and that under the circumstances of this case, equitable title would be all that the scientist could have conveyed to Cetus as well (relating to "present assignment of future inventions").  And "as between these two claims in equity," Justice Breyer would vest title in Stanford, because its equitable interest arose first and Stanford thereafter obtained express assignment of the inventions.

    In Justice Breyer's view, the FilmTec case was decided with "no explanation for what seems a significant change in the law" and its application to this case "undercuts the objectives of the Bayh-Dole Act."  Indeed, the Justice characterized the Federal Circuit's decision as producing "a technical trap for the unwary."

    Justice Breyer is careful to note that his views are 'tentative" because these issues were not briefed and were not the basis for the Court's decision.  However, although he doesn't believe the majority opinion "forecloses" these issues being raised by "similarly situated part[ies]" in a future case, since he believes they are important, he dissents.  Justice Sotomayor writes separately to concur because she, too, believes that these issues need to be considered when again properly raised.

    The real world consequences of the Court's decision today should be minimal, provided the Court is correct regarding the "common practice among parties operating under the Act."  These include policies to obtain assignments from inventor-employees and requirements (or at least expectations) from funding agencies that such assignments will be routinely obtained (the Court cited policy provisions promulgated by the NIH).  While this may be true, for university clients it is important to review such policies, not only to ensure they are in compliance with federal funding agency requirements but that university personnel (professors, students, and researchers) are aware of their obligations.  The Court's decision may not have, in fact, increased the burden on universities to protect these inventions, but it increases the vigilance that technology transfer offices and university officials must exercise in order to prevent loss of rights to third parties.  And it should not escape our notice that the Court's emphasis on the primacy of the inventor as a Constitutional limit on the powers of Congress in the exercise of the patent grant suggests that attempts to change U.S. Patent Law to a "first to file" system may not meet the standard set forth by the Supreme Court today.

    Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (2011)
    Opinion of the Court by Chief Justice Roberts, joined by Justices Scalia, Kennedy, Thomas, Alito, Sotomayor, and Kagan
    Concurring opinion by Justice Sotomayor
    Dissenting opinion by Justice Breyer, joined by Justice Gisburg

  • 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.