• By Kevin E. Noonan

    Leonard Cohen sings:

    Everybody knows that the dice are loaded
    Everybody rolls with their fingers crossed
    Everybody knows that the war is over
    Everybody knows the good guys lost
    Everybody knows the fight was fixed
    The poor stay poor, the rich get rich
    That's how it goes
    Everybody knows

    What everybody doesn't seem to know is how to get Congress to listen to the needs of the innovation community when well-heeled sectors put their lobbying and financial support in favor of legislation purportedly aimed at improving innovation ("It's a jobs bill!") by changing the rules of the patent system in their favor.  But since various stakeholders have made the effort it is well for us at least to listen to what they have to say.

    The Higher Education Community

    Association of American UniversitiesIn a statement released November 8, 2013, the Association of American Universities (AAU), American Council on Education (ACE), American Association of Medical Colleges (AAMC), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and Council on Government Relations (COGR) "communicated the[ir] views" on the provisions of H.R. 3309 (oxymoronically entitled "The Innovation Act").  (As with most of these letters and communiques, the Chairman is extolled for the "open, thoughtful process" and the goals of the bill lauded as being directed to "reduc[ing] abusive patent litigation," which putatively has a "corrosive impact on the U.S. patent system and the capacity of that system to foster innovation and economic competitiveness.  With that as prelude, the authors should have expressly conceded that their aim was merely to rearrange the deck chairs rather than challenge the shaky assumptions behind the legislation; the only hint of disagreement is that the measures proposed in the bill may be "overbroad" and lead to "unintended consequences.  To whom they would be unintended is unclear, but the universities clearly state that any such negative consequences would be suffered by them.)  Nevertheless, this stakeholder missive provides specific commentary on the various provisions of the bill:

    •    The fee-shifting provisions.  The first example of overbreadth is the scope of the statutes where fee-shifting would be mandated, including "the Space Act, the Atomic Energy Act, the Non-Nuclear R&D Act as well as all titles of the omnibus bills in which the Bayh-Dole Act and amendments became law."  These provisions would impact not only "abusive" litigation practices but also ones that fall within the scope of "ordinary enforcement procedures and litigation activities," the authors not recognizing that the supporters of this bill believe that "ordinary enforcement procedures and litigation activities" are themselves abusive (insofar as they are directed at such supporters).  The statement recognizes that fee-shifting will occur in the ordinary course against non-prevailing patentees due to the "burden of proof and substantive standards" imposed upon the nonprevailing party by the bill.  This outcome will have a "chilling effect" on impecunious parties, like universities, small businesses and startups, the statement asserts, and instead the university groups suggest that fee shifting should be limited to cases where the nonprevailing patentee plaintiff "is not the named inventor of or an original assignee to an asserted patent and does not make or sell a product related to the subject matter described in the asserted patent."

    •    Joinder provisions under Sec. 299(d).  Here, it is the definition of the term "interested party" that is purportedly overbroad according to these stakeholders.  The risk, they recognize, is that in combination with the fee-shifting provisions universities will be put at risk in litigation by their licensees, resulting in an "unfunded mandate" against them.  This would result in "a substantial disincentive for universities and startups to enforce patents on new technologies and innovations," which while true would return the situation regarding university inventions to pre-Bayh-Dole status, where companies could simply steal university inventions with impunity.

    •    The pleading requirements under Sec. 281(A).  This objection is merely practical, wherein a patentee plaintiff is charged with making averments in a complaint that may not be known until after discovery, and if not permitted to amend may foreclose relief for certain activities.  (Not mentioned is the practical effect of the requirement, since the scope of discovery is defined in large part by the allegations of the complaint that define relevant evidence.)

    •    The "transparency" of patent ownership under Sec. 4.  Again, the objection is a practical and logistical one, insofar as the breadth of the requirement (which exists for the life of the patent) "may well exceed the capacity of even the best-intentioned plaintiff to acquire and provide."

    •    The discovery limitations under Sec. 299(A).  While clearly viewed as posing the greatest risk in conjunction with the pleadings requirements discussed above, the statement also notes that the judiciary has the ability to limit discovery when necessary and the blanket limitations imposed by the bill "could make it more difficult to provide information called for in other sections of the bill and could militate against cases where allowing broader discovery would be more efficient."

    •    Changes in the provisions of the Leahy-Smith America Invents Act.  These objections are concerned with expanding the scope of post-grant review of covered business method patents, and narrowing the extent of the estoppel that attaches to petitioners who employ the new post-grant review procedures.  The universities are concerned that the former will sweep into the scope of these reviews patents other than "pure" business method patents (few of which are owned by universities) and that removing the "reasonably could have raised" estoppel will promote patentee harassment by "extending, rather than limiting, patent litigation."

    The Biotechnology Industry Organization (BIO)

    Biotechnology Industry Organization (BIO)The letter from BIO, although less obsequious in tone than the university groups' letter, similarly praises at least the intent of the bill.  But the letter (signed by BIO President and CEO, Jim Greenwood, himself a former Congressman) is front-and-center regarding the potential for the legislation to "erect unreasonable barriers to access to justice for innovators, especially small start-ups."  The letter also sounds a caution against legislative solutions to what are essentially problems (insofar as they exist) in judicial administration, better handled by the judiciary in BIO's view (and the view of several members of the Federal Circuit; see below).

    BIO begins with the parts of the bill it can support:  protecting IP licenses in bankruptcy cases; harmonizing claim construction standards applied by the PTO and the courts; and clarifying the judicially created doctrine of obviousness-type double patenting (particularly under the "first-inventor-to-file" provisions of the Leahy-Smith America Invents Act); and the "recognition [in the bill] of the already existing and specific statutory schemes that apply to [ANDA] litigation."  Of concern, however, are the following provisions of the bill:

    •    "Routinely defer[ring] or suspend[ing] discovery and litigation on the merits in patent infringement cases";
    •    "Permit[ting] infringers to add additional parties to the litigation under overly broad criteria and permitting [prevailing] parties to seek reimbursement of [] litigation costs against other parties under a vaguely-defined and potentially very broad set of patent-related cases";
    •    "Requir[ing] unreasonable amounts of pleading specificity and disclosure and public recordation of patent ownership, litigation interests, and other business or confidential information";
    •    "Direct[ing] courts and judges [on] how to handle patent case management in an overly-prescriptive and one-size-fits-all manner that would unduly interfere with the responsibility of judges and courts to craft case-appropriate management orders that reflect the complexity of the matters at issue and the respective positions of the parties"; and
    •    "Singl[ing] out patents on certain technologies for unfavorable treatment in open-ended administrative litigation, contrary to long-standing U.S. policy and international treaty obligations."

    (For many reasons, the last of these points raises particularly acute concerns, both with challenges to U.S. authority, moral or otherwise, before the WTO and with regard to advancing American interests abroad in the face of patent challenges to U.S. patentees under other national patent systems.)

    The letter concludes by noting at least some of the expected consequences of enactment of these provisions:  "systematic delays in patent litigation" due to "piecemeal discovery and adjudication" and the "inclusion of potentially numerous and unnecessary parties," which would increase the "time and expense of patent litigation" (here, BIO notes that such an outcome would be contrary to "the legislations purported goals").  In an effort to address the "abusive litigation practice of the few," BIO warns that the legislation will "impose unjustified burdens on too many legitimate patent owners seeking to enforce and defend their inventions in good faith."

    The Pharmaceutical Research and Manufacturers of America (PhRMA)

    PhRMA #2PhRMA, in a letter to the Judiciary Committee by its Executive Vice President of Advocacy and member Relations, Chester (Chip) Davis, also raises issues similar to other stakeholders albeit with less substantive detail or supporting argument.  PhRMA "commends" Congress for "considering legislation to curb abusive patent litigation" and "applauds [the Committee's] efforts" in this regard, but voices the following concerns:

    • Increasing pleadings requirements, which "raises questions about the balance between having information available in pleadings and providing prompt and effective access to the courts by patent owners";
    • Including fee-shifting provisions for "covenants not to sue";
    • Restricting discovery in a way "that could serve to delay ultimate resolution of patent litigation and increase costs";
    • Lacking "balance" over the requirements for "transparency" regarding patent ownership;
    • Including a "customer suit" exception not "targeted narrowly";
    • Infringing on the province of the Judicial Conference and the Supreme Court regarding case management;
    • Eliminating Section 145 proceedings (providing for an applicant or interference litigant to appeal to the U.S. District Court as an alternative to the Federal Circuit);
    • Expanding the time and scope of the transitional Covered Business Method Patent [Reexamination] Program;
    • Limiting the scope of Patent Term Adjustment (by adopting the PTO's position regarding the availability of so-called "B" delay after filing an RCE).

    Former Chief Judge Paul Michel

    Judge MichelOne of the evident benefits of being a retired, former Chief Judge of the U.S. Court of Appeals for the Federal Circuit is that it must be generally recognized that you know of what you speak, and that (if you have the proper inclination) you can speak authoritatively on proposals like H.R. 3309.  Former Chief Judge Michel does not disappoint, and he recently spoke on the provisions of Chairman Goodlatte's bill.

    As reported in IPLaw 360 by Ryan Davis, the former Chief Judge does not think much of the bill.  In a speech at Fordham Law School's recent IP Summit, Judge Michel is quoted as saying the bill would "do more harm than good" and is "hugely counterproductive."  Of these features of the bill, the Chief Judge notes that the pleadings requirements require such "excruciating detail" that they may more readily be deemed defective, resulting in an increase in motions to dismiss which will at a minimum raise the time and cost of litigating (such motions "will become routine," according to Judge Michel).  Provisions requiring nonprevailing patentee plaintiffs to pay their opponents' litigation costs will "backfire" because prevailing attorneys will always seek them (fearing malpractice liability for not doing so).  Not surprisingly, Judge Michel also asserted that the discovery provisions amounted to Congressional "micromanaging" of the judiciary.

    But the Chief Judge saved his most strident criticism to provisions of the bill that would expand the Covered Business Methods Patent Program, calling this the "worst part" of the bill.  This is because the scope of patents under this proposed expanded program would include almost all software patents and the existence of this option for such patents will lead to stays in patent litigation while the PTO procedures are exhausted.

    Judge Michel predicted that "[t]he value of patents will go down and the value of patent portfolios will go down" if the bill is enacted by Congress, despite the fact that the bill is a "blunderbuss attempt to curb abusive litigation tactics by a small fraction of litigants."

    The former Chief Judge conceded that he was in favor of "smart patent reform" legislation, but only by legislators who "understand how the patent system works, not by congressional staffers and lobbyists."

    H.R. 3309 passed out of the Judiciary Committee last night by a vote of 33-5, and is headed to the House floor.  Senator Leahy introduced a companion (but not identical) bill in the Senate yesterday (see "Yet Another "Patent-Troll" Bill – Senator Leahy Introduces Patent Transparency and Improvements Act").  In one House of Congress or the other, members of the patenting community who "understand how the patent system works" need to make sure their Congressional representatives know it too.

  • By Andrew Williams

    Washington - Capitol #4There has been a flurry activity recently in both the House and Senate aimed at addressing the perceived patent-troll problem.  We have recently reported on the introduction of both the "Innovation Act," from Rep. Bob Goodlatte (R-Va), and the "Patent Litigation Integrity Act," from Sen. Orrin Hatch (R-Utah).  The Goodlatte bill was marked-up today by the House Judiciary Committee in a session that lasted into the early evening (we will provide details on the amendments at a future date).  In addition, on the heels of a hearing by the U.S. House Energy & Commerce subcommittee on "The Impact of Patent Assertion Entities on Innovation and the Economy," Rep. Jared Polis (D-Co.) introduced the "Demand Letter Transparency Act."  According to a statement on Rep. Polis's website, this Act "strikes the right balance in protecting the rights of legitimate patent holders to enforce their patents while protecting consumers and businesses against non-legitimate abusers of the patent system."  Adding to this ever-increasing mass of proposed legislation, Sen. Patrick Leahy (D-Vt.), chair of the Senate Judiciary Committee, introduced S. 1720 (the "Patent Transparency and Improvements Act of 2013") on Monday, November 18, 2013.  Because this Act contains some provisions not found in any of the other pieces of legislation, and because of Sen. Leahy's influential position in Congress with regard to intellectual-property matters, an analysis of the provisions of this Act is warranted.

    Transparency of Patent Ownership

    As the title of the Act would suggest, one of the provisions of the bill is aimed at making the ownership of patents transparent.  Sen. Leahy has a couple of different ways to accomplish this.  First, any patentee that files an action in Federal Court would be required to disclose any and all persons that have a financial interest in the controversy or a party to the proceedings, or that have an interest that could be affected by the outcome of the proceedings.  The complication comes in the definition of "financial interest."  The proposed legislation refers to 28 U.S.C § 455(d), which is the section of the U.S. Code that addresses the disqualification of federal judges.  "Financial interest" is defined as "ownership of a legal or equitable interest, however small, or a relationship as director, advisor, or other active participant in the affairs of a party," providing any of the enumerated exceptions do not apply, such as passive ownership through a mutual or common investment fund.  As a result, a publically traded corporation brining a patent infringement lawsuit would be required to provide a list of every stockholder, no matter how many (or few) shares are actually owned.  Such a requirement would be incredibly onerous, and would serve as a significant barrier to patent litigation for such patent holders.

    Another "solution" provided for in this bill is an assignment disclosure requirement at the U.S. Patent Office.  When "all substantial rights in an issued patent" have been assigned, the name of the assignee and the ultimate parent entity of the assignee would need to be recorded with the Office within three months.  However, the only hint as to what "all" substantial rights means in this context is whether the assignment "results in a change to the ultimate parent entity."  The penalty for not complying would be that a party asserting infringement "may not recover increased damages under section 284 or attorney fees under section 285 with respect to infringing activities taking place during any period of noncompliance," and the party may be responsible for the reasonable attorney fees incurred by an alleged infringer in discovering the "ultimate patent entities in the chain of title."  Nevertheless, in relation to other mandatory assignment recordation provisions that have been discussed, this one does not appear to be overly demanding.  If this provision passes, it would behoove any patent owner to confirm that all assignments had been properly recorded at the first signs of any potential infringing activity.  It would also be necessary to conduct the proper due diligence related to assignment recordation before taking any interest in a patent, because the ability to recover such fees for some period of time may already have been forfeited.

    Customer Stay

    In order to address the concern that "patent trolls" are preying on customers, not manufacturers, Sen. Leahy's bill contains a provision allowing for the stay of litigations where both a customer and manufacturer have been sued for patent infringement.  This section is not dissimilar to other proposed legislation.  The requirement for the grant of a motion for stay would include the consent in writing of both the manufacturer and the customer, that the manufacturer be a party to the action or a separate action involving the same patents and relating to the same product or process, that the customer must agree to be bound by the decision, and that the motion must be filed early in the case.  The Act also provides that the stay can be lifted by a motion showing that a major issue in the customer action will not be resolved by the manufacturer action, or if the stay would unreasonably prejudice the party seeking to lift the stay.  Finally, the estoppel effect of the stay could be waived if the manufacturer seeks or consents to a consent judgment or fails to prosecution to a final, non-appealable judgment at least one common issue that gave rise to the stay.

    Bad-Faith Demand Letters

    There has been a lot of activity in the past week or so directed to the impact of demand letters on the patent system.  This is interesting, because demand letters themselves do not necessarily fall within the scope of the patent statute.  Still, the prototypic activity of a putative "patent troll" is the sending of demand letters, and if the anecdotal evidence is to be believed, all of these letters have little to no information.  However, any attempt to solve this problem through legislation will certainly have unintended consequences, likely to detriment of legitimate patent holders.  Moreover, it is difficult to see how the First Amendment rights of patent holders can be protected in the attempt to curtail this practice.  Finally, it would appear that one potential out for the patent holder would be to pre-emptively file a complaint, which could then be included with, or substituted for, any demand letter.  Of course, Rule 11 would need to be satisfied.  Nevertheless, it would appear that to have the intended effect, "demand letter" legislation will need to go hand-in-hand with some form of heightened pleading standards.  The concern is that such legislation may introduce more problems than it solves, as we have highlighted in previous posts in this forum.

    The Leahy bill addresses the demand letter issue by empowering the Federal Trade Commission to consider such conduct an "unfair or deceptive act or practice."  In order to be classified as such, the patent holder must "engage in the widespread sending of written communications" that "falsely threaten that administrative or judicial relief will be sought if compensation is not paid or the infringement issue is not otherwise resolved."  The demand letter would also be considered to be "unfair or deceptive" if it lacks a reasonable basis in fact or law, or if the content "is likely to materially mislead a reasonable recipient."  Of course, the success of this section will depend on the definitions of several key terms.  For example, just what does it mean to "falsely threaten"?  Will this apply anytime a lawsuit does not result?  Or will it be necessary to demonstrate that the patent holder never had any intention of filing suit (which may be difficult to prove without a "smoking gun").  Still, by giving the power to the FTC to combat this issue, it may solve some of the issues that were highlighted above for any attempt to directly legislate the issue.

    AIA-Related Provisions

    The Leahy bill also includes provisions that expand upon some of the changes brought about by the America Invents Act ("AIA").  For example, the bill provides for the use of claim construction rules in post-grant and inter partes reviews that are consistent with those used in federal court.  Currently, the Patent Trial and Appeals Board ("PTAB") uses the broadest reasonable interpretation standard, similar to that employed by the Office during the patent application examination process.  The problem is that these two different claim construction rules could result in two different oppositely-dispositive constructions based solely on while rule was applied.  There is general agreement that such a provision is necessary.  Another AIA-related provision is the codification of the double-patenting doctrine for first-inventor-to-file patents.  Finally, Leahy's bill includes some technical corrections to the AIA.

    Other Miscellaneous Provisions

    Leahy's Patent Transparency and Improvements Act of 2013 also contains several provisions that do not fall within these various categories.  First, the bill provides for small business education and outreach.  The only issue is that it must be funded from existing sources.  Next, there is a section of the bill that provides for the protection of intellectual-property licenses in bankruptcy.  Finally, the bill calls for several studies to be carried out by the Patent Office or other organizations.  For example, the bill requires the Patent Office Director to undertake a study "to develop legislative recommendations to ensure greater transparency and accountability in patent transactions occurring on the secondary market," "to examine the economic impact that the patent secondary market has on the United States," "to examine licensing and other oversight requirements that may be placed on the patent secondary market," and "to examine the requirements placed on other markets."  The bill would also require the Director to conduct a study on patents owned by the United States Government.  The GAO would be required to study patent examination at the Office and the technologies available to improve patent quality.  Finally, the Director of the Administrative Office of the United States Court would be charged with conducting a study to examine the idea of a patent small claims court.  These studies are clearly an attempt to get at the heart of a lot of the complaints that have been levied at the so-called patent trolls.

    We will continue to monitor the legislative activity in Congress directed to patents and addressing perceived abusive patent litigation, and we will continue to report on any significant activity that occurs.

  • By Donald Zuhn

    Tufts CSDDLast week, the Tufts Center for the Study of Drug Development (CSDD) at Tufts University released a report showing that the pharmaceutical industry has dramatically shifted its focus from a historical concentration on small molecule drugs to include an increasing number of biotechnology drugs.  In a press release announcing the release of the Tufts CSDD Impact Report, the independent, academic, non-profit research group noted that biotech products, which in 2001 accounted for 7% of the revenue top 10 selling biopharm products worldwide, accounted for 71% of the top 10 selling products in 2012.  Tufts CSDD Director Dr. Kenneth Kaitin explained that "[t]he transformation of Big Pharma has been driven as much by new technologies that have enabled development of new products that improve disease outcomes and command high prices, as by the expiring patents on many top-selling small molecule drugs."

    The transformation of the pharma pipeline can be seen in the number of commercially available biotech drugs, which the report indicates rose from only 13 in 1989 to 210 by 2012, with worldwide sales growing by 353% from $36 billion in 2001 to $163 billion in 2012.  The industry's R&D focus also shows evidence of the shift, with clinical trials of biotech products rising 155% from 355 in 2001 to 907 in 2012.  The report indicates that in 2012, the 21 largest pharmaceutical companies had 429 biotech drugs in clinical development, and that 58% of these products were monoclonal antibodies.  The report also notes that Big Pharma was involved in nearly 40% of biotech drug clinical development in 2012.

    Biotech financing also showed a significant increase between 2001 and 2012, increasing from $10.5 billion to $103 billion over this period.  Finally, the report compares biotech company acquisitions by Big Pharma in the 1998-2002 and 2008-2012 time frames, and notes that such acquisitions increased five-fold from 15 in the earlier time frame to 75 in the later time frame.

    In view of the report's findings, Dr. Kaitin concluded that "[t]he notion that large pharmaceutical companies primarily develop small molecule drugs no longer holds."

  • By Andrew Williams

    Last week, the Patent Trial and Appeal Board ("PTAB" or "Board") issued the first inter partes review opinion in case IPR2012-00001, Garmin USA, Inc. (Petitioner) v. Cuozzo Speed Technologies LLC (Patent Owner).  In what is being considered good news for parties wishing to challenge the validity of patents at the Office, the PTAB invalidated claims 10, 14, and 17 of Patent No. 6,778,074 ("Speed limit indicator and method for displaying speed and the relevant speed limit") as obvious in view of two different combinations of prior art.  The Board also denied Cuozzo's motion to amend the claims.  Even though the '074 patent does not deal with the Biotech or Pharmaceutical industry, the reasoning of the Board should be of interest to parties involved in all technologies.

    As suggested by the title, the '074 patent relates to determining local speed limits, and it does so by using a Global Positioning System ("GPS").  Figure 1 from the patent is representative:

    FIG
    The speedometer 12 is mounted on dashboard 26, and has a backplate 14 with speed markings, a color display 18 (described as red in the example), and a plastic needle 20 mounted on the backplate.  The GPS receiver is able to track the location of the vehicle, and the speed limit indicator correlates the vehicle position with a database containing the speed limit for that location.  The colored filter adjusts so that speeds above the legal speed are displayed in red, while legal speeds are displayed in white.  Claim 10 reads as follows:

    10.    A speed limit indicator comprising:
        a global positioning system receiver;
        a display controller connected to said global positioning system receiver, wherein said display controller adjusts a colored display in response to signals from said global positioning system receiver to continuously update the delineation of which speed readings are in violation of the speed limit at a vehicle's present location; and
        a speedometer integrally attached to said colored display.

    Cuozzo had asserted this claim against Garmin and Chrysler in the U.S. District Court for the District of New Jersey, alleging in part that "Garmin components in Chrysler's Uconnect system provide a display and warning indicating when the vehicle speed exceeds the speed limit."  The following picture of the accused device was found in the Amended Complaint at paragraph 26, with the picture being credited to the Dodge website:

    2
    Important in the Board's decision was the construction of the term "integrally attached."  Of course, the PTAB does not use the same standard as a district court to construe issued claims — the Board is required to use the broadest reasonable interpretation.  The Board determined that "integrally attached" required that the speedometer and the colored display be separately identifiable from each other, otherwise "'attached' effectively would be read out of the claim."  Therefore, the claim term was construed to mean "discrete parts physically joined together as a unit without each part losing its own separate identity."  In so doing, it rejected Cuozzo's attempt to construe the term to mean that the two parts be joined or combined to work as a complete unit.  Looking at the above picture, it would appear that Cuozzo was pressing for such a construction because it had its eye on the accused Garmin's product.

    The Board was also required to determine the date of Cuozzo's invention, because two of the prior art references qualified under 35 U.S.C. § 102(e)(2), and therefore Cuozzo could have antedated these references.  The references in question had effective filing dates of October 19, 2000, and March 8, 2001.  Cuozzo, the inventor, explained that he conceived his invention on November 28, 1999, when he was pulled over and ticketed for speeding.  As he stated in his declaration:

    I [Giuseppe A. Cuozzo] came up with the idea of using GPS technology combined with instrumentation for displaying a speed limit and its relation to vehicle speed in a manner that would alert a driver as to whether he or she was speeding without requiring the driver to refer to roadside speed limit signs.

    However, even though he provided the speeding ticket as evidence, the Board did not consider this sufficient corroboration.  Such a story can be invaluable when describing a case to a jury, but the Board was more skeptical.  Part of the reason was that it could not see how the account provided for all of the limitations as found in the claims.  Cuozzo also provided his written disclosure to the "Invention Submission Corporation" ("ISC").  Again, the Board found this document insufficient to corroborate the inventor's alleged date.  The document had the hand-written date of October 30, 2000, which could not itself establish that it was prepared on that date.  Instead, the Board afforded a date of conception of December 8, 2000, the date on which a patent attorney contacted Cuozzo describing the invention record.  Nevertheless, the Board did not find that Cuozzo had acted diligently in reducing his invention to practice.  There were two extended periods of little activity, which the Board found were not adequately explained.  First, Cuozzo took about two months to respond to the attorney about a preliminary patentability report.  In addition, Cuozzo took several months to get the required fee to the ISC.  Cuozzo did not appear to be a sophisticated party with regard to the patent system, so such delays may well be understandable.  However, the Board was not convinced, probably based in part on inconsistencies found in the inventor's testimony.  As a result, the two cited art references were available for consideration in the obviousness determination.

    Without going into a lot of technical detail regarding the obviousness analysis, both grounds involved one or two references that provided a way to display the vehicle speed with the maximum legal speed limit indicated in a single unit (not integrally attached).  The first ground used one reference ("Aumayer"), which provided such an electronic embodiment (such as a liquid crystal display), in which the legal speed was obtained from an on-board GPS.  The second ground used two references ("Tegethoff" and "Awada"), one which described the speedometer display, and the other which provided for reporting the legal speed limit.  Because these references did not contain the "integrally attached" limitation, the Board also cited to "Evans," which provided for a permanent "indicator plate" that would alert the driver when a certain speed was reached (even though the speed could only be changed by manually changing the plate), and "Wendt," which provided a movable pointer that the driver could rotate himself when the speed limit changed.  It was therefore possible to see how one skilled in the art could have derived the claimed invention.  What appeared to be lacking from the decision was an explanation of why or how one skilled in the art would do so.  Instead, the Board cited In re Kahn, 441 F.3d 977 (Fed. Cir. 2006) for the proposition that "[t]here only need be an articulated reasoning with rational underpinnings to support a motivation to combine teachings."  Id. at 988.  However, the Board's "articulated reasoning" was not very satisfying.  The Board appeared to simply conclude that "[o]ne with ordinary skill in the art would have known to apply the same automated approach to the manually-adjusted colored plate suggested by Evans and Wendt."  As further support, the Board noted that Cuozzo did not even argue that one of skill in the art would not have known how to implement this system.  But, is this sufficient to show the requisite motivation to combine?  One clear lesson for patent holders is that they will need to develop a strong case for all of the Graham factors when responding to an obviousness challenge before the Board.

    Finally, the PTAB denied Cuozzo's attempt to amend the claims.  For example, Cuozzo sought to amend claim 10 to add the limitation:  "wherein the speedometer comprises a liquid crystal display, and wherein the colored display is the liquid crystal display."  Cuozzo argued that these limitations simply incorporated limitations found in the dependent claims.  However, the Board pointed out that such a limitation would read "integrally attached" out of the claims.  Because a claim amendment in an inter partes review cannot enlarge the scope of claims or introduce new matter, the Board denied the motion.  It does not appear that such an amendment would have had any impact on the validity ruling.  Cuozzo was again probably seeking such a change because of the concurrent trial court action against Garmin.

    This decision is important because the patent community is getting its first view at how the PTAB will be deciding these inter partes reviews.  This decision should be good news for all of the parties challenging patents, and should be good news for everyone worried about the perceived patent-troll problem.  The cost of an IPR proceeding, while not inexpensive, is likely to be much cheaper than a corresponding action in district court.  Moreover, in case anyone was worried that the Board would rubber-stamp the original decision of the patent examiners, it is clear that patent owners could face significant challenges in defending their issued patents.  It will be interesting to observe the trends as more of these decisions are issued.

  •         By Sherri Oslick

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

    Eli Lilly and Company et al. v. Watson Laboratories Inc et al.
    3:13-cv-00637; filed November 14, 2013 in the District Court of Nevada

    • Plaintiffs:  Eli Lilly and Company; Acrux DDS Pty. Ltd.; Eli Lilly Export S.A.
    • Defendants:  Watson Laboratories Inc; Actavis, Inc.; Actavis Pharma, Inc.

    Eli Lilly and Company et al. v. Watson Laboratories, Inc. et al.
    1:13-cv-01799; filed November 12, 2013 in the Southern District of Indiana

    • Plaintiffs:  Eli Lilly and Company; Eli Lilly Export S.A.; Acrux DDS Pty Ltd.
    • Defendants:  Watson Laboratories, Inc.; Actavis, Inc.; Actavis Pharma, Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,299,900 ("Dermal Penetration Enhancers and Drug Delivery Systems Involving Same," issued October 9, 2001), 6,818,226 (same title, issued November 16, 2004), 6,923,983 ("Transdermal Delivery of Hormones," issued August 2, 2005), 8,071,075 (Dermal Penetration Enhancers and Drug Delivery Systems Involving Same," issued December 6, 2011), 8,419,307 ("Spreading Implement," issued April 16, 2013), and 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone).  View the Nevada complaint here.

    Pfizer Inc. et al. v. Fresenius Kabi USA LLC
    1:13-cv-01893; filed November 13, 2013 in the District Court of Delaware

    • Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC; Wyeth Holdings LLC; Wyeth Holdings Corp.
    • Defendant:  Fresenius Kabi USA LLC

    Infringement of U.S. Patent Nos. RE40,183 ("7-Substituted-9-Substituted Amino-6-Demethyl-6-Deoxytetracyclines," issued March 25, 2008), 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

    Millennium Pharmaceuticals Inc. v. Apotex Corp. et al.
    1:13-cv-01874; filed November 8, 2013 in the District Court of Delaware

    • Plaintiff:  Millennium Pharmaceuticals Inc.
    • Defendants:  Apotex Corp.; Apotex Inc.

    Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Fresenius' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.

    Genzyme Corp. et al. v. Dr. Reddy's Laboratories, Inc. et al.
    1:13-cv-06827; filed November 8, 2013 in the District Court of New Jersey

    • Plaintiffs:  Genzyme Corp.; Southern Research Institute
    • Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

    Infringement of U.S. Patent No. 5,661,136 ("2-Halo-2'-Fluoro ARA Adenosines as Antinoplastic Agents," issued August 26, 1997) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Genzyme's Clolar® (clofarabine injection, used to treat acute lymphoblastic leukemia).  View the complaint here.

    Novartis Pharmaceuticals Corp. v. Akorn, Inc.
    2:13-cv-06835; filed November 8, 2013 in the District Court of New Jersey

    Infringement of U.S. Patent Nos. 7,932,241 ("Pharmaceutical Products Comprising Bisphosphonates," issued April 26, 2011) and 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.

    Teijin Ltd. et al. v. Apotex Inc. et al.
    1:13-cv-01851; filed November 6, 2013 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Teijin Ltd. et al. v. Sun Pharma Global FZE et al.
    1:13-cv-01852; filed November 6, 2013 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
    • Defendants:  Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories Ltd.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the Apotex complaint here.

    Johns Hopkins University v. 454 Life Sciences Corp.
    1:13-cv-01853; filed November 6, 2013 in the District Court of Delaware

    Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to 454 Life Sciences in the interference between U.S. Patent Application No. 12/361,690 ("Method and Compositions for Detection and Enumeration of Genetic Variations," filed January 29, 2009), assigned to Johns Hopkins and U.S. Patent Application No. 13/033,240 ("Bead Emulsion Nucleic Acid Amplification," filed February 23, 2011), assigned to 454 Life Sciences.  View the complaint here.

    Forest Laboratories Inc. et al. v. Sandoz Inc.
    1:13-cv-01830; filed November 4, 2013 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent Nos. 6,602,911 ("Methods of Treating Fibromyalgia," issued August 5, 2003), 7,888,342 ("Methods of Treating Fibromyalgia Syndrome, Chronic Fatigue Syndrome and Pain," issued February 15, 2011), and 7,994,220 ("Milnacipran for the Long-Term Treatment of Fibromyalgia Syndrome," issued August 9, 2011), all licensed to Forest, following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Forest's Savella® (milnacipran hydrochloride, used in the management of fibromyalgia).  View the complaint here.

  • CalendarNovember 17-20, 2013 – Creating and Leveraging Intellectual Property in Developing Countries: A Power Tool for Social and Economic Growth*** (Companies and IP Commission and National IP Management Office of South Africa) – Durban, South Africa

    November 19, 2013 – PTAB or the District Court: Which Is the Better Option When Challenging Patent Validity? (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    November 19, 2013 – Patenting Biotech Inventions (California Healthcare Institute (CHI) and D Young & Co) – San Diego, CA

    November 20, 2013 – Patenting Biotech Inventions (California Healthcare Institute (CHI) and D Young & Co) – San Francisco, CA

    November 21, 2013 – "Leveraging the AIA's Expanded Prior Use Defense for Patent Infringement Claims" (Strafford) – 1:00 to 2:30 pm (EST)

    November 22, 2013 – "Global Utility Requirements For Pharmaceutical and Biological Inventions" (American Bar Association (ABA) Section of Intellectual Property Law, Young Lawyers Action Group, Young Lawyers Division, and Center for Professional Development) – 1:00 to 2:30 pm (Eastern)

    December 3, 2013 – "Post-AIA Preissuance Prior Art Submissions at the USPTO — Best Practices for Third-Party Challenges to Patent Applications and for Monitoring Competition" (Strafford) – 1:00 to 2:30 pm (EST)

    December 4, 2013 – Congress on Biotech & Pharma Patenting*** (C5 (UK)) – London, UK

    December 5, 2013 – Forum on Biosimilars*** (C5 (UK)) – London, UK

    December 9-10, 2013 – Patent Infringement Litigation Summit (Legal iQ (IQPC)) – San Francisco, CA

    December 10-11, 2013 – Advanced Forum on Patent Litigation*** (American Conference Institute) – New York, NY

    December 10-11, 2013 – International Patent Litigation (IBC Legal) – London, UK

    December 12, 2013 – "Using Competitive Technical Intelligence Techniques to Assess University Patents" (Technology Transfer Tactics) – 1:00 – 2:00 pm (Eastern)

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

  • LondonIBC Legal Conferences will be holding its 5th annual International Patent Litigation conference on December 10-11, 2013 in London.  IBC Legal faculty will offer presentations on the following topics:

    • The Unified Patent Court — progress and implications — How patent litigation behaviour may change as the unitary system becomes a reality;
    • Future of UK patent litigation after Virgin Atlantic;
    • Patent litigation, after America Invents Act: Strategy update needed?
    • Current problems with privilege;
    • "Plausibility" in patent law — UK case law and EPO jurisprudence;
    • FRAND after the Huawei v. ZTE;
    • Recent developments in SPC law?
    • Issues around enforcing second medical use patents;
    • Germany and UK — Do the German Courts need English guidance?
    • New developments in granting injunctions;
    • Use of expert witnesses — Comparing current practices in the UK and EU under the UPC;
    • Patent settlements/Pay-for-Delay — Are they so incompatible?
    • Trolls: Positions that each country is taking against NPEs;
    • Competence of EU and member states to interpret patent provisions on TRIPS; and
    • How to obtain real-life damages in patent infringement proceedings?

    Brochure CoverA 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 £1,499.  Those interested in registering for the conference can do so here, by e-mailing professionalcustserv@informa.com, by calling +44 (0)20 7017 5503, or by faxing a registration form to +44 (0)20 7017 4746.

  • Technology Transfer Tactics will be offering a webinar entitled "Using Competitive Technical Intelligence Techniques to Assess University Patents" on December 12, 2013 from 1:00 – 2:00 pm (Eastern).  Alan Porter, Professor Emeritus of Industrial & Systems Engineering, and of Public Policy, Georgia Institute of Technology; Barry Brager, Founder and Managing Partner of Perception Partners®; and Laura A. Schoppe, president of Fuentek, LLC will help attendees adopt the key methods and tools they use to improve their IP assessments and apply high-level market and competition analysis to their early-stage technologies, and also focus on how to systematically use Competitive Technical Intelligence (CTI) for detailed technology assessment and decision-making.  The webinar will cover the following topics:

    • Demystify CTI through a case study approach
    • Understand your IP's value proposition, market share and application potential
    • How to keep your budget in check while maintaining high quality data
    • Identify emerging trends in a technology space for:
        – Research and development
        – Licensing
        – Sales
    • Identify competitive threats and risks when developing IP
    • Visualize how the technology landscape is changing and where your IP fits in
    • Find and leverage information on market players, products, and positioning
    • Use CTI to help set achievable goals
    • Craft useful deliverables that deliver clear messages to the non-technical/rushed/executive mindset

    The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

    Technology Transfer Tactics

  • By Donald Zuhn

    Sanofi-AventisLast week, in Sanofi-Aventis v. Pfizer Inc., the Federal Circuit affirmed an award of priority to Pfizer by the Board of Patent Appeals and Interferences in an interference involving the cDNA for the human interleukin-13 receptor binding chain (IL-13bc).  In particular, the appeal concerned the Board's decision with respect to the following count:

    Count 3.  The isolated protein of 6,268,480 claim 4;

    OR

    The isolated polynucleotide of 5,710,023 claim 1, selection (b) (an isolated polynucleotide comprising a nucleotide sequence of SEQ ID NO:3 from nucleotide 103 to nucleotide 1242).

    PfizerAs the Federal Circuit noted, the parties disagreed as to the dispositive question in the interference, with Pfizer arguing that the question was "who first had in hand the actual isolated DNA of the count and appreciated its IL-13bc function," and Sanofi arguing that the question was "the date each party first knew the complete sequence" of nucleotides 103 to 1242 (i.e., the protein encoding portion of IL-13bc).  In the interference, Sanofi was awarded the benefit of its December 6, 1995 priority date, and Pfizer presented evidence that by October 16, 1995, it had isolated a clone for human IL-13bc from a human cDNA library.  While the sequencing of that human IL-13bc clone was completed by November 15, 1995, eight possible errors were subsequently identified in the 1143-nucleotide sequence, yielding an amino acid sequence that was correct at 379 of 380 residues.  Although the Board concluded that Pfizer did not have a corrected sequence until February 7, 1996, it nevertheless determined that Pfizer had established conception of the subject matter of the count when it selected, isolated, and obtained the desired IL-13bc full-length polynucleotide and verified that it was the desired product, regardless of whether the fully correct sequencing of the polynucleotide was complete.

    On appeal, Sanofi argued that by awarding priority to Pfizer, the Board had erred as a matter of law.  In particular, Sanofi argued that Pfizer cannot be credited with conception before December 6, 1995 (Sanofi's date) because Pfizer's sequence analysis was in error as to eight nucleotides.  In other words, Sanofi contended that until Pfizer had correctly analyzed the polynucleotide, neither conception nor reduction to practice could occur, because Federal Circuit precedent requires the full and correct nucleotide sequence to establish conception and reduction to practice.  In support of its argument, Sanofi pointed to Amgen Inc. v Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991), Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993), and Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994).

    In affirming the Board's award of priority to Pfizer, the Federal Circuit indicated that Amgen did not support Sanofi's argument that Pfizer did not, as a matter of law, have a complete conception until Pfizer had the full correct nucleotide sequence.  Instead, "[t]he court in Amgen held that when 'an inventor is unable to envision the detailed constitution of a gene' there may nonetheless be conception and reduction to practice of the gene when the inventor is in possession of the gene and a method for its preparation, i.e. 'after the gene has been isolated,' accompanied by knowledge of 'other characteristics sufficient to distinguish it from other genes.'"  In this case, "[t]he Pfizer activity meets these criteria."  With respect to Fiers, which Sanofi argued established a per se rule that conception of an isolated DNA requires the full and correct nucleotide sequence, the Federal Circuit noted that "[t]he Board distinguished Fiers and Amgen as holding that conception and reduction to practice did not occur until the gene was isolated, for in those cases neither structure nor definitive properties had been established for the isolated gene," and indicated that "Amgen and Fiers did not hold, as Sanofi asserts, that conception requires the complete and correct sequencing of the isolated DNA; the court instead referred to 'whatever characteristics sufficiently distinguish it.'"  With respect to Sanofi's citation of Burroughs Wellcome, the Court stated that this case "did not change these requirements, in holding that conception requires that the claimed DNA is possessed as a physical embodiment," adding that "[k]nowledge of the specific nucleotide sequence was not required in Burroughs Wellcome."

    The Federal Circuit explained that its "[p]recedent illustrates a variety of circumstances in which this requirement was met although the complete nucleotide sequence was not known," citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) (upholding claims for DNA probes that were made available by deposit in a public depository although the nucleotide sequence had not been determined); University of New Mexico v. Knight, 321 F.3d 1111 (Fed. Cir. 2003) (explaining that "a chemical structure is simply a means of describing a compound; it is not the invention itself"); and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004) (finding that the inventors were in possession of a protein that was described by a partial amino acid sequence in addition to other characteristics sufficient to identify it).  Stating that "[w]hen the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed," the Federal Circuit concluded that "the Board correctly based conception and reduction to practice on the possession of the isolated DNA segment that was shown to have the desired properties."  The Court therefore concluded that the Board had applied the correct law, and affirmed the Board's award of priority to Pfizer.

    Sanofi-Aventis v. Pfizer Inc. (Fed. Cir. 2013)
    Panel: Circuit Judges Newman and Lourie and District Judge Davis, sitting by designation
    Opinion by Circuit Judge Newman

  • By Donald Zuhn

    AstraZeneca_smallIn an appeal decided last month, the Federal Circuit reversed and remanded a decision of noninfringement by the District Court for the District of New Jersey with respect to U.S. Patent No. 7,524,834, and affirmed the District Court's finding of obviousness with respect to U.S. Patent No. 6,598,603.  The panel also affirmed the District Court's dismissal of invalidity counterclaims brought by Defendants-Cross Appellants Apotex, Inc. and Apotex Corp., and the lower court's decisions regarding the bond amount.

    The '834 patent is directed to a sterile, pharmaceutically effective budesonide product, which is used to treat asthma in children.  Claims 1 and 50 of the '834 patent recite (emphasis in opinion):

    1.  A pharmaceutically acceptable micronized powder composition at least 98.5% by weight of which is pure budesonide or an ester, acetal or salt thereof, wherein the composition meets the criteria of sterility according to the US Pharmacopoeia [sic] 23/NF18, 1995, pages 1686-1690 and 1963-1975. ’834 Patent col. 11 ll. 48–52.

    50.  A pharmaceutically acceptable suspension consisting of a micronized powder composition at least 98.5% by weight of which is pure budesonide or an ester, acetal or salt thereof suspended in an aqueous solution, wherein the suspension meets the criteria of sterility according to the US Pharmacopoeia [sic] 23/NFl8, 1995, pages 1686-1690 and 1963-1975.

    The '603 patent is directed to a once-daily treatment of patients with budesonide administered by nebulizer.  Independent claim 1 of the '603 patent recites:

    1.  A method of treating a patient suffering from a respiratory disease, the method comprising administering to the patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day.

    AstraZeneca markets a "once-daily nebulized budesonide suspension used to treat asthma in children" under the name Pulmicort Respules®.

    Seeking approval to market generic versions of AstraZeneca's Pulmicort Respules® drug, Appellees Breath Ltd.; Apotex, Inc. and Apotex Corp.; Sandoz, Inc.; and Watson Laboratories, Inc. filed Abbreviated New Drug Applications (ANDAs) with the FDA.  In response to those ANDA filings, AstraZeneca brought suit against the Appellees for induced infringement of the patents at issue, and the Appellees counterclaimed for declaratory judgments of invalidity and noninfringement.

    Apotex #1With respect to Appellees Apotex, Inc. and Apotex Corp. (Apotex), the District Court granted AstraZeneca's request for a preliminary injunction, preventing Apotex from launching its generic product, subject to AstraZeneca's posting of a bond.  In response to a motion made by Apotex at trial, the District Court increased the bond amount to cover future damages, but refused to increase the bond amount to cover past damages.  Following a bench trial, the District Court found that claims 50 and 51 of the '834 patent were not infringed by Apotex and Sandoz, and that claims 1, 2, 50, and 51 of the '834 patent were not infringed by Breath and Watson.  Although the District Court determined that Appellees' labels induce infringement of claims 1-3, 7, 8, 12-17, and 24-28 of the '603 patent, the lower court also found these claims invalid as anticipated and obvious.  Finally, the District Court declined to exercise jurisdiction over Apotex's invalidity counterclaims directed to certain claims of the '603 patent (the lower court had first dismissed AstraZeneca's assertion of infringement with respect to these same claims).

    The District Court's finding of noninfringement with respect to the '834 patent was based on the lower court's construction of the phrase "micronized powder composition" as meaning "heat sterilized finely divided dry particles."  The District Court also determined that "heat sterilized" refers to "particles that have been sterilized through a process, consistent with heat sterilization, that allows them to essentially maintain the same pharmacological activity, physico-chemical properties, chemical purity, and physical form as the starting material."  AstraZeneca argued that the District Court erred by importing limitations into the claims because the plain meaning of the phrase "micronized powder composition" has nothing to do with heat sterilization.  In reversing and remanding the District Court's finding of noninfringement, the Federal Circuit noted that "[w]ith respect to the ordinary, plain meaning of the term 'micronized powder composition,' none of the three words imposes, or even implies, any form of sterilization."  While acknowledging that "[t]here is no dispute that the patent refers only to dry heat sterilization as the preferred method of achieving the claimed 'micronized powder composition' and criticizes, often sharply, other forms of sterilization," the panel determined that such criticism did not rise to the level of a disavowal of the phrase's otherwise plain meaning.  Noting that the '834 patent describes processes, products, and methods of use, the opinion states that "[a]t most, the specification is confusing with respect to whether it limits only the disclosed process to a specific form of sterilization or both the process and the disclosed product to a specific form of sterilization," adding that this "confusion leaves available an interpretation of the patent that the products, as opposed to the processes, are not limited to any particular form of sterilization."  Because the Court could not conclude that AstraZeneca disclaimed non-heat sterilized micronized powder compositions, the panel determined that the District Court erred by adding the "heat sterilized" limitation into the asserted claims, and that a more accurate construction of the phrase "micronized powder composition" would be "finely divided dry particles."

    As for the District Court's finding of invalidity with respect to the asserted claims of the '603 patent, the lower court determined that the '603 patent disclosed "once-daily dosing of nebulized budesonide" and that a skilled artisan would have been motivated to arrive at this "obvious conclusion."  In particular, the District Court found that the prior art included numerous studies that "taught the safety and efficacy of once-daily inhaled budesonide," including once-daily treatment of children and that practitioners would attempt to titrate a drug dose down to the lowest possible dose, i.e., a once-a-day dose.  The District Court also found that the prior art taught that nebulizers were the "most practical delivery device for certain patients like young children."  In affirming the District Court's finding of obviousness, the panel identified no clear error in the lower court's underlying factual determinations, and determined that those facts established by clear and convincing evidence that the asserted claims of the '603 Patent are obvious.

    With respect to the District Court's decision to decline jurisdiction over Apotex's invalidity claims, the panel declined to say that the lower court abused its discretion in dismissing those counterclaims, as "[t]he decision whether to accept jurisdiction of a Declaratory Judgment counterclaim is quintessentially left to the discretion of the district court."

    Finally, with respect to District Court's decisions regarding the bond amount, the Federal Circuit first noted that a bond amount is a procedural issue that is not unique to patent law, and therefore, that the law of the Third Circuit applied.  Looking to the Third Circuit's decision in Sprint Commc'n Co. v. Cat Commc'n Int'l, 335 F.3d 235 (3d Cir. 2003), the Federal Circuit concluded that "the Third Circuit would consider improper an increase to cover past damages even in the present circumstances."  In affirming the District Court's refusal to increase the bond amount to cover past damages, the opinion explains that:

    AstraZeneca expected that its liability would be limited to the bond amount before Apotex's motion.  AstraZeneca cannot be fairly informed after it obtained the benefit of the injunction that it must later pay more for the benefit it already obtained in order to obtain the benefit of a continued injunction.  The bond would no longer serve to cabin or fix liability, and that would result in an unexpected liability, which Sprint sought to prohibit.  It is immaterial whether the injunction has been dissolved, as in Sprint, or continues, as it does here.  Either way: the party securing the injunction decided to accept the preliminary relief by posting the bond required at the time.  Later requiring that party to post a higher bond for a period that already has passed results in a situation where that bond no longer fixes exposure or caps liability.  The party no longer simply could withdraw its request for an injunction over that period because that period already would have passed.


    AstraZeneca LP v. Breath Ltd.
    (Fed. Cir. 2013)

    Nonprecedential disposition
    Panel: Chief Judge Rader and Circuit Judges Bryson and Linn
    Opinion by Circuit Judge Linn