• Calendar

    November 30 to December 1, 2010 – 12th Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA

    December 6, 2010 – 21st Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, DC

    December 7-8, 2010 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, England

    December 8, 2010 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – Alexandria, VA

    December 8-9, 2010 – Paragraph IV Disputes*** (American Conference Institute) – San Francisco, CA

    January 26-27, 2011 – The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) – New York, NY

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

  • USPTO Seal The U.S. Patent and Trademark Office has announced the agenda for the next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting to be held on December 8, 2010.  The proposed agenda is as follows:

    Morning Session

    • Greetings and Overview (10:00 – 10:15 am EDT):  Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

    • PPH/Workshare (10:15 – 11:00 am):  Bruce Kisliuk, Assistant Deputy Commissioner for Patent Operations for Chemical Disciplines

    • Break (11:00 – 11:15 am)

    • Patents End-to End:  Update and Focus Session (11:15 am – 12:50 pm):  Christian Chace, Project Director, Patent Process Reengineering – this session will cover applicant/Office communication (interviews, etc.), filing applications (including artifacts, etc.), fee payment and processing, maintaining application and patent data, eGrant, double patenting, and color drawings

    • Lunch (12:50 – 2:00 pm)

    Afternoon Session

    Therasense (2:00 – 2:45 pm):  Mercedes K. Meyer, Ph.D., Esq., Drinker Biddle & Reath LLP

    • Break (2:45 – 3:00 pm)

    KSR Update (3:00 – 3:45 pm):  Kathleen Fonda, Office of Patent Legal Administration

    • Closing Remarks/Discussion (3:45 – 4:00 pm):  Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

    The meeting can be attended in person at the USPTO's Auditorium in Madison East, 600 Dulany Street, Alexandria, VA, or viewed online here (select the "enter as guest" option).  Those wishing to attend the meeting in person should contact Cecilia Tsang at 571-272-0562, by fax at 571-273-0562, or by e-mail at Cecilia.Tsang@uspto.gov to confirm attendance by November 29, 2010.  The Patent Office asks that non-USPTO employees login using their e-mail addresses.

  • New York #2 American Conference Institute (ACI) will be holding a conference entitled "The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions" on January 26-27, 2011 in New York, NY.  ACI faculty will help attendees:

    • Understand the unique role of PTE and PTA in patent life cycle management for the life sciences industry;
    • Master the essentials of PTA from questions of eligibility and calculation to the application process to procedures for redress;
    • Decipher the mysteries of A, B and C-delays;
    • Learn to solve the A and B-delay overlap dilemma and B-delay National Stage queries vis-à-vis Wyeth v. Dudas and Japan Tobacco;
    • Avoid applicant delays and circumvent "failure to engage" findings by the PTO;
    • Navigate the complexities of PTE in terms of substance and procedure;
    • Comprehend how the key challenges in Wyeth Holdings, Photcure, Lupin, and The Medicine Company will affect PTE determinations in the future;
    • Appreciate how second generation patents and regulatory exclusivities factor into patent term extensions; and
    • Examine the significance of Supplemental Protection Certificates (SPCs) in patent term restoration in the EU.

    Brochure In particular, ACI's faculty will offer presentations on the following topics:

    • Exploring the role of PTA and PTE in patent life cycle management in the life sciences industry;
    • PTA 101:  Mechanics, essentials and conundrums;
    • Using A-delays, B-delays and C-delays to your advantage;
    Wyeth v. Dudas:  Analyzing and solving the A and B delay overlap dilemma;
    Japan Tobacco:  Remedying B-delay errors in national stage applications under 35 U.S.C. § 371;
    • Strategies for avoiding applicant PTA delays and other pitfalls;
    • PTE:  Laying the groundwork for patent term restoration;|
    • New trends and challenges in PTE litigation:  Key cases to watch;
    • Supplementing PTE through the use of second generation patents;
    • Understanding the interplay of PTE and certain regulatory exclusivities; and
    • Exploring patent extensions and exclusivities in the EU.

    The agenda for the 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.

    ACI - American Conference Institute The registration fee for this conference is $2,195.  Attendees registering by November 23, 2010 will receive a $300 discount and attendees registering by December 21, 2010 will receive a $200 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of ACI's Patent Term Adjustment and Patent Term Extension conference.

  • By James DeGiulio

    Otsuka Abilify Patent Found Valid and Enforceable

    Otsuka Pharmaceuticals Otsuka Pharmaceutical Co. won a key court ruling that upheld its patent covering Abilify, thereby preventing Teva, Apotex, and Sandoz from releasing generic versions of the drug until April 2015.

    Teva #1 In 2007, Otsuka sued several defendants, including Teva, Apotex, and Sandoz, after the defendants filed Abbreviated New Drug Applications (ANDAs) for aripiprazole, which Otsuka claimed infringed U.S. Patent No. 5,006,528.  The cases over individual ANDAs were consolidated in the U.S. District Court for the District of New Jersey.  The defendants did not contest Otsuka's claim of infringement, arguing instead that the '528 patent was invalid due to obviousness and obviousness-type double patenting over Otsuka's U.S. Patent No. 4,734,416.  They also argued that the patent was unenforceable due to inequitable conduct.  In August, Otsuka went to trial with Teva, Barr and Apotex, with the other defendant generics agreeing to be bound by the District Court's decision.

    Apotex #1 On November 15, Judge Mary L. Cooper ruled that the '528 patent is valid and enforceable, and enjoined the defendants from marketing generic Abilify until Otsuka's patent expires on April 20, 2015.  Weighing the obviousness of three chemical substitutions, Judge Cooper first rejected the defendant's notion that a person of ordinary skill must possess all of the attributes of a multi-member chemistry research team.  Several pieces of prior art were considered, and though these references disclosed the structure of the active ingredient in Abilify, the references did not teach its use as an antipsychotic.  Judge Cooper also found that the defendants did not show by clear and convincing evidence that a person of ordinary skill in the art would have selected the particular lead compound.  An extensive analysis of secondary considerations was also included in the opinion.  On the issue of inequitable conduct, the Judge found Sandoz #2 that two declarations that the defendants argued were materially misrepresented to the U.S. Patent and Trademark Office did not rise to the requisite level to render the '528 patent unenforceable.  Judge Cooper's Opinion can be found here.


    Lilly's Alimta Patent Found Valid

    Lilly Eli Lilly enjoyed a victory in its patent dispute over the chemotherapy treatment Alimta following a ruling which upheld the validity of Lilly's U.S. Patent No. 5,344,932.  The decision prevents defendants Teva and APP Pharmaceuticals from producing generic versions of Alimta until July 2016.

    Teva #1 In June 2008, Lilly and Princeton University, which owns the '932 patent, brought suit against Teva and APP for patent infringement, seeking to block them from marketing 500 mg doses of generic Alimta.  In November 2008, Lilly filed another suit against Teva over the 100 mg dose of the drug.  The three suits were consolidated in the U.S. District Court for the District of Delaware for discovery and trial purposes.  The case has been at trial since early November.

    APP Pharmaceuticals On November 15, Judge Gregory M. Sleet issued a bench ruling for the trustees of Princeton University and Lilly, which holds an exclusive license to the '932 patent.  The trial ended with Judge Sleet entering judgment in Lilly's favor, upholding the patent's validity.


    Stryker's Challenge of USPTO Ruling in Bone Screw Interference Struck Down

    Stryker Stryker Spine was unsuccessful in its attempt to force the USPTO to define two allegedly distinct inventions in Stryker's patent for spinal fixation devices.  The decision came in an interference proceeding involving Stryker, Biedermann Motech GmbH, and DePuy Spine.

    Biedermann Motech In December 2005, the USPTO issued U.S. Patent No. 6,974,460, covering spinal fixation devices, to Stryker.  Biedermann had previously filed U.S. Application No. 10/763,431 in January 2004, and filed a request for a declaration of interference in July of that year.  During the course of the interference, Biedermann filed a motion to redefine the interference, arguing that the first count of the interference included two separate inventions that were patentably distinct.  In April 2008, the USPTO rejected this contention, concluding that the two inventions were not distinct.  Following this rejection, Stryker filed suit in the U.S. District Court for the District of Columbia, seeking a declaratory judgment that the separate claims at issue in the interference were directed to two separate and distinct inventions, and thus should be two counts.  In February, the District Court denied Stryker's motion for summary judgment, ruling that the issue of whether the board erred by failing to redefine the interference count must proceed to trial.

    On November 15, Judge Colleen Kollar-Kotelly entered judgment in favor of defendants Biedermann Motech GmbH and DePuy Spine, finding that the BPAI did not err in declaring a single interference count encompassing both claimed inventions.  The Judge heard expert testimony from both sides, and concluded that the inventions were not patentably distinct.  Since all of Stryker's remaining claims in the interference were contingent upon the redefined interference, Judge Kollar-Kotelly endered judgment for the defendants and dismissed the action.  Judge Kollar-Kotelly's opinion can be found here.

  • By Donald Zuhn

    Report On Tuesday, the U.S. Patent and Trademark Office released its Performance and Accountability Report for FY 2010.  With respect to the Office's performance goals, the report indicates that 64% of performance targets were met.  The report identifies three strategic goals, each comprising several objectives:

    1.  Optimize patent quality and timeliness
    2.  Optimize trademark quality and timeliness
    3.  Provide domestic and global leadership to improve intellectual property policy, protection and enforcement worldwide

    With regard to the first strategic goal, the report indicates that the Office met two of that goal's objectives and achieved results that were slightly below target with respect to three other objectives (see table below).

    Goal 1
    In particular, the report states that the Office:

    [M]ade significant progress towards reducing the backlog and patent pendency, despite continued funding and hiring challenges.  The improvements and increased efficiencies are seen in our performance metrics.  Our progress as measured in actions per disposal show a downturn from 2.7 in FY 2009 to 2.42 in FY 2010.  Productivity was up by 3.6 percent over the same time last year.  The year’s total production units were 522,407 versus 504,481 production units in FY 2009.  Allowances have increased from 189,120 last year to 240,438 this year.  Final rejections ended the year with 258,436 final rejections, compared to 238,497 for the same period in FY 2009.  Interviews have increased approximately 37 percent from last year.

    The report notes that patent filings increased 4.7% for 2010, jumping from 486,499 in 2009 to 509,367 in 2010 (according to preliminary data).  This follows a 2.1% decline in patent filings for 2009.

    Filings & Pendencies
    In 2010, the Office accepted more than 500,000 applications for the first time.  Nevertheless, the number of application awaiting action dropped from 735,961 in 2009 to 726,331 in 2010 (the lowest total since 2006), and the total number of pending application dropped from 1,207,794 in 2009 to 1,163,751 in 2010 (the lowest total since 2007).  Utility patent issuances were up substantially in 2010 (according to preliminary data), rising from 165,213 in 2009 to 207,915 in 2010.

    With respect to first action and final action pendency, the report shows that the Office fell short of the target, with average first action pendency 0.3 months higher than the 25.4 month target and final action pendency 0.5 months higher than the 34.8 month target.

    Pendency
    Participation in electronic filing continued to rise, with electronically-filed patent applications rising from 82.4% in 2009 to 89.5% in 2010.

    Electronic Filing
    For biotechnology and organic chemistry applicants, the news was mixed as the average first action pendency of 22.8 months for Technology Center 1600 applications was lower than the overall first action pendency of 25.7 months, and the final action pendency of 36.0 months was higher than the overall final action pendency of 35.3 months.  No other Technology Center posted a better first action pendency than TC 1600, and only TC 2800 (semiconductor, electrical, optical systems & components) and TC 3600 (transportation, construction, agriculture & electronic commerce) posted better final action pendencies.

    For additional information regarding this and other related topics, please see:
    • "USPTO Announces 'Highest Performance Levels in Agency's History' in 2008," November 18, 2008
    • "USPTO Announces 'Record Breaking' 2007 Performance," November 15, 2007
    • "Patent Office Announces Record-Breaking Year," December 27, 2006

  • By Donald Zuhn

    Cancer Research Technology Last week, in Cancer Research Technology Ltd. v. Barr Laboratories, Inc., the Federal Circuit reversed the decision by the District Court for the District of Delaware holding U.S. Patent No. 5,260,291 unenforceable for prosecution laches and inequitable conduct.  Judge Lourie, writing for the Court and joined by Judge Newman, held that the unreasonable and unexplained delay requirement of the prosecution laches defense includes a finding of prejudice, and that an accused infringer must show evidence of intervening rights — i.e., that either the accused infringer or others invested in, worked on, or used the claimed technology during the period of delay — in order to establish such prejudice.  With respect to the District Court's finding of inequitable conduct, the majority determined that the District Court erred because it relied solely on its finding of materiality to infer intent.  Judge Prost dissented from the opinion of the Court.

    Temozolomide Plaintiff-Appellant Cancer Research Technology Ltd. ("Cancer Research") owns the '291 patent, which relates to a genus of tetrazine derivative compounds and methods for treating cancer by administering those compounds.  The '291 patent identifies and characterizes thirteen tetrazine derivative compounds, including temozolomide (structure at left), which is the active ingredient in the cancer drug Temodar®, and mitozolomide, which the '291 patent describes as having "particular importance."  The '291 patent issued following more than eleven years of prosecution during which time eleven continuing applications were filed by the applicants.  With respect to most of the applications in the chain, applicants "responded" to the rejection of original claim 31 for lack of utility by filing a continuation application and abandoning the rejected application.  Cancer Research obtained ownership of the application for the '291 patent after ten of the eleven applications in the chain had been filed, filed one last continuing application, and challenged the utility rejection by arguing that animal data in the original specification sufficed to establish utility in humans.  The '291 patent subsequently issued.  In the eleven years during which the '291 patent was being prosecuted, one of the inventors co-authored several papers reporting animal and human clinical data for the tetrazine derivative compounds of the '291 patent, including data for mitozolmide, which showed the compound to have little activity against many cancers.

    Barr Pharmaceuticals Seeking approval to market a generic version of Temodar®, Defendants-Appellees Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc. ("Barr") filed an Abbreviated New Drug Application (ANDA) with the FDA.  In response to Barr's ANDA filing, Cancer Research brought suit against Barr for infringement of the '291 patent.  The parties stipulated to infringement and validity of claim 13, which is directed to temozolomide, leaving Barr's counterclaims of unenforceability for prosecution laches and inequitable conduct for trial.

    Following a bench trial, the District Court held the '291 patent unenforceable for both prosecution laches and inequitable conduct.  With respect to the first issue, the Court determined that prosecution laches turned on whether Cancer Research's delay in prosecuting the '291 patent was unreasonable and unexplained under the totality of the circumstances, but did not require a showing of intervening rights.  The Court found that the delay caused by eleven continuation applications, ten abandonments, and no substantive prosecution for nearly a decade was unreasonable and a sufficiently egregious misuse of the patent system to bar enforcement of the '291 patent for prosecution laches.  With respect to the second issue, the Court determined that Cancer Research failed to disclose, inter alia, Phase I and II human data indicating that mitozolomide failed to treat numerous cancers to the Patent Office, and that this information was highly material because it directly contradicted statements in the '291 patent and directly contravened the patentability of claim 28.  The Court also determined that there was an intent to deceive because one of the inventors withheld highly material information, knew or should have known that the materiality contradicted the '291 disclosure, and did not provide a credible explanation for withholding the information.

    On appeal, Cancer Research argued that the doctrine of prosecution laches requires both an unreasonable and unexplained delay in prosecution and prejudice based on the intervening rights of the defendant or the public during the period of delay, and that the District Court erred in holding the '291 patent unenforceable for prosecution laches because the Court failed to find any evidence of actual prejudice either to the defendant or the public.  Barr responded by arguing that the District Court correctly recognized that the defense of prosecution laches does not require a specific showing of prejudice.

    Federal Circuit Seal In reversing the District Court's finding of unenforceability for prosecution laches, the majority determined that prosecution laches' requirement of an unreasonable and unexplained delay includes a finding of prejudice, and declared that "[w]e . . . now hold that to establish prejudice an accused infringer must show evidence of intervening rights, i.e., that either the accused infringer or others invested in, worked on, or used the claimed technology during the period of delay."  In support of this holding, the majority cited four Supreme Court cases which the majority stated "all rely on a finding that the applicant's delay in prosecution adversely affected others working in the same field":  Woodbridge v. United States, 263 U.S. 50 (1923); Webster Electric Co. v. Splitdorf Electrical Co., 264 U.S. 463 (1924); Crown Cork & Seal Co. v. Ferdinand Gutmann Co., 304 U.S. 159 (1938); and General Talking Pictures Corp. v. Western Electric Co., 304 U.S. 175 (1938).  The majority also pointed to Symbol Techs., Inc. v. Lemelson Med., 277 F.3d 1361 (Fed. Cir. 2002) ("Symbol Techs. I"), for support, stating that:

    In first recognizing the doctrine, we relied on the above-cited Supreme Court cases and noted their reliance on intervening rights.  Symbol Techs. I, 277 F.3d at 1364-65.  For example, we stated that in Crown Cork, "the [Supreme C]ourt ratified the existence of the prosecution laches defense; it did not apply the defense there in the absence of intervening rights," and we noted that "in General Talking Pictures, the Court rejected the defense of prosecution laches because there was no evidence of intervening public rights."  Id. at 1365.  We then applied the doctrine in a manner that recognized the requirement for intervening rights.  We held that the district court had not abused its discretion in holding certain patents unenforceable for prosecution laches based on the applicant's unreasonable delay and "the existence of 'intervening private and public rights.'"  [Symbol Technologies, Inc. v. Lemelson Medical, 422 F.3d 1378, 1386 (Fed. Cir. 2005)].  We also extended the holding to all the remaining claims based on finding that the subject matter of all the asserted patents had been pending for eighteen to thirty-nine years, an unreasonably long time, and that "prejudice to the public as a whole has been shown here in the long period of time during which parties, including the [declaratory judgment] plaintiffs, have invested in the technology described in the delayed patents."  Id.

    Applying its holding to the instant appeal, the majority stated that:

    Barr . . . while entitled under the law to file an ANDA four years after the NDA approval, in this case in 2003, did not do so until 2007.  Thus, Barr filed its ANDA more than thirteen years after the issuance of Cancer Research's patent and more than seven years after approval of Cancer Research's product.  Barr was thus hardly prejudiced by the delay in the issuance of the '291 patent, in 1993.  Nor was anyone else.  There has been no evidence presented that anyone was deterred from entering the market for temozolomide because Cancer Research's patent issued in 1993 rather than several years earlier.  Thus, the delay had only limited consequences to Barr and the public.

    The majority observed that "Cancer Research's delay in prosecuting and issuing its patent application, whatever the asserted justifications, and we do not appraise them here, caused it to run the risk that some other pharmaceutical company (e.g., Barr) would intervene and claim prejudice from the delay, but that did not happen."  The Court also noted that "the facts of this case are not likely to be frequently repeated, as patent terms are now measured from effective filing date, . . . subject to only limited extensions provided by statute, not by delaying issuance by refilling."

    With respect to inequitable conduct, Cancer Research argued that the District Court erroneously relied solely on its finding of materiality to infer deceptive intent, and therefore, erred in finding that one of the inventors withheld studies on tetrazine derivatives with deceptive intent.  Barr argued in response that that the District Court correctly found that the inventor knew he possessed undisclosed data that contradicted the disclosure in the patent application, and knew he had a duty to disclose such material information to the Patent Office, but did not do so.  According to Barr, the only reasonable inference that could be drawn from this was an intent to deceive.  In reversing the District Court's finding of unenforceability for inequitable conduct, the majority determined that "the district court erred because it relied solely on its finding of materiality to infer intent."  In particular, the majority noted that:

    [M]ateriality and intent are separate requirements, and intent to deceive cannot be found based on materiality alone.  Larson Mfg. Co. of S.D., Inc. v. Aluminart Prods. Ltd., 559 F.3d 1317, 1340 (Fed. Cir. 2009).  A court cannot simply infer that an applicant "should have known" the materiality of withheld information and thus intended to deceive the PTO because the applicant knew of the information and the information is material.  A district court must find some other evidence that indicates that the applicant appreciated the information's materiality.  See, e.g., Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1256 (Fed. Cir. 1997) (finding intent to deceive based in part on handwritten notes of prosecution counsel corroborating that counsel subjectively believed the undisclosed patent was material).  In this case, evidence that [an inventor] co-authored articles that contradict the disclosure of the '291 patent specification does not alone establish that [the inventor] withheld those studies intending to deceive the PTO.

    As for other reasonable inferences that could be drawn from the inventor's publication of contradictory data, the majority surmised that "an equally reasonable inference to draw from the evidence is that [the inventor] viewed publication of all the data as important to his career as a scientist but did not appreciate their potential importance to the patentability of the tetrazine derivatives patent claims."

    In her dissent, Judge Prost declared that "the majority propounds a new and unsupportable legal standard for prosecution laches" and "creates a new evidentiary standard [for inequitable conduct," while] it also ignores virtually unassailable credibility findings made by the district court after a four-day bench trial."  On the issue of prosecution laches, Judge Prost argued that the District Court "got it right" because the Court's precedent does not compel a showing of intervening rights, adding that "even if one could construe the case law as requiring prejudice, there is no basis, in the relevant case law or otherwise, for the majority’s further temporal limitation that the prejudice exists during the period of delay."  The dissent noted that:

    By requiring this particularized prejudice, the majority sidesteps the real harm at issue in this case.  The Supreme Court has explicitly recognized that delaying a patentee's monopoly period harms the public by delaying its free use of the patented invention.  Woodbridge, 263 U.S. at 48-49.  Here, the applicant first filed the patent application disclosing temozolomide in 1982.  By stalling prosecution for its own business purposes for nearly a decade, Cancer Research obtained a patent which does not expire until 2014 — almost thirty-two years after the first application in this chain was filed.  The majority downplays the public prejudice caused by this delay, Maj. Op. at 12-13; however, Cancer Research's conduct has prejudiced the public by extending its patent monopoly over temozolomide.

    On the issue of inequitable conduct, Judge Prost stated that:

    Again, in my view, the district court got it exactly right.  Here, an inventor . . . withheld important data from the U.S. Patent and Trademark Office ("PTO") that contradicted the disclosure in the patent applications.  The majority does not take issue with the district court's conclusion that this data was highly material.  Clearly, it could not, because at a minimum the disclosure would have affected the scope of the patent granted.  Rather, it rejects the district court's credibility determination that [the inventor's] explanation for not submitting this highly material data was belied by the facts that [the inventor] found the data conclusive enough (and sufficiently non-confidential) to publish the data and his conclusions of inactivity or toxicity to the scientific community.

    The dissent concluded by arguing that "[r]equiring separate evidence for each prong [i.e., materiality and intent to deceive,] has no basis in our precedent."

    Cancer Research Technology Ltd. v. Barr Laboratories, Inc. (Fed. Cir. 2010)
    Panel: Circuit Judges Newman, Lourie, and Prost
    Opinion by Circuit Judge Lourie; dissenting opinion by Circuit Judge Prost

  • By Kevin E. Noonan

    Federal Circuit Seal The Supreme Court has spent a decade second-guessing (and in large part overturning) decisions of the Federal Circuit in the exercise of its unique mission to harmonize patent law.  Sometimes this oversight has been occasioned by disputes between different members of the appellate court (e.g., Warner-Jenkinson Co. v. Hilton Davis Chemical Co.).  In other instances, the Court has acted to reverse Federal Circuit jurisprudence specific to patent law, to bring practices more into line with the law of the other circuits (e.g., eBay Inc. v. MercExchange, L.L.C.).  In one specific instance, the Court resolved the standard of review the Federal Circuit must apply (substantial evidence) in reviewing factual determinations made by the U.S. Patent and Trademark Office (Dickinson v. Zurko).  The Court overruled decades of precedent, wherein the Federal Circuit (like the C.C.P.A. before it) gave such factual determinations little deference, holding that the Administrative Procedures Act mandated the substantial evidence standard, wherein PTO factual determinations were given the same degree of deference given to other administrative agencies whose decisions were subject to judicial review.

    The Federal Circuit's decision in Hyatt v. Kappos is poised to give the Supreme Court an opportunity to decide whether a patent-specific statute (35 U.S.C. § 145) or the APA controls in appeals to a district court in cases where the PTO refuses to grant a patent.  The issue is whether and to what extent an applicant can introduce new evidence to the district court:  the PTO argued that the District Court should be limited to reviewing the record as it developed during ex parte prosecution, except when there is some good-faith basis for such evidence not being submitted to the Office.  The plaintiff argued that this interpretation made district court review duplicative of appellate review by the Federal Circuit (which there is no dispute is limited to the PTO record).  The Federal Circuit's en banc decision did not show a great disparity in the members of the Court's views (the decision was 7-2), but the arguments of the majority and the dissenting judges exposed a tension between § 145 and the APA that can only ultimately be decided by the Supreme Court.

    The appeal was originally heard by a panel comprising (now retired) Chief Judge Michel and Judge Dyk in the majority, with a dissent by Judge Moore.  The majority explained the equitable basis for its decision:

    It is clear from the record that under our caselaw Hyatt had an affirmative and specific duty to disclose to the PTO the evidence excluded by the district court, and was so notified by the PTO, but willfully refused to cooperate in the examination process.  On the facts of this case, we uphold the district court's exclusion of Hyatt's evidence.  We therefore hold that the district court correctly granted summary judgment sustaining the Board decision because Hyatt offered no other evidence and the Board's decision was based on findings of fact and factual conclusions, all of which are supported by substantial evidence, and thus we affirm.

    The majority opinion contained a thorough review of how courts had reviewed PTO decisions from the first Patent Act to the current 1952 Act, and used this precedent to support its decision that the District Court properly excluded the new evidence proffered by the applicant:

    In sum, it has been the general practice of federal courts for over eighty years in certain circumstances to exclude evidence which a party could and should have introduced before the Patent Office but did not despite an obligation to do so.  Our own cases likewise have not adopted a de novo standard for trial.  We have said that "[c]learly, the applicant does not start over to prosecute his application before the district court unfettered by what happened in the PTO."  Fregeau, 776 F.2d at 1038.  On the other hand, it is beyond question that in appropriate circumstances new evidence may be submitted to the district court in a § 145 action (subject, at least, to the Federal Rules of Evidence).  See Gould v. Quigg, 822 F.2d 1074, 1079 (Fed. Cir. 1987) ("[A]dditional evidence is permitted in a civil action under section 145, allowing the district court to make de novo fact findings."); Newman v. Quigg, 877 F.2d 1575, 1579 (Fed. Cir. 1989) ("A district court action under 35 U.S.C. § 145 is a de novo determination of patentability. It is not limited to the record before the PTO.")

    The opinion expressly based its decision on its view that deference to PTO factfinding and an affirmative obligation on applicants to submit all evidence to the Office were mandated by the APA, and that the provisions of the APA controlled.

    Judge Moore dissented:

    The majority's decision to affirm the district court's exclusion of the inventor's own declaration in a § 145 civil action severely restricts the rights that Congress action contemplated and enacted by Congress.  Moreover, by concluding that an inventor has an "affirmative duty" to submit his own declaration in response to a rejection by the PTO, lest he be prevented from admitting the material in any subsequent district court proceeding, the majority makes it impossible for inventors to ever testify in a § 145 action unless their testimony had first been proffered to the PTO.  I cannot agree that this was what Congress contemplated when it enacted § 145, and therefore I dissent.

    In the en banc opinion Judge Moore's views prevailed and she is the author of the majority opinion.  The Court begins with the plain language of the statute:

    An applicant dissatisfied with the decision of the Board of Patent Appeals and Interferences in an appeal under section 134(a) of this title may, unless appeal has been taken to the United States Court of Appeals for the Federal Circuit, have remedy by civil action against the Director in the United States District Court for the District of Columbia if commenced within such time after such decision, not less than sixty days, as the Director appoints.  The court may adjudge that such applicant is entitled to receive a patent for his invention, as specified in any of his claims involved in the decision of the Board of Patent Appeals and Interferences, as the facts in the case may appear and such adjudication shall authorize the Director to issue such patent on compliance with the requirements of law.  All the expenses of the proceedings shall be paid by the applicant.  35 U.S.C. § 145 (emphases added).

    The majority's reasoning is set forth plainly:

    On its face, § 145 authorizes a civil action in district court by which an applicant can prove his entitlement to a patent.  The statute provides no indication that this civil action is somehow different from a customary civil action.  In particular, § 145 does not provide that unique rules of evidence, separate from or supplementary to the Federal Rules of Evidence that apply to all civil actions, control to limit an applicant's ability to introduce new evidence before the district court.  Additionally, § 145 makes clear that the civil action is distinct from an appeal, in which the applicant would be limited to the record before the Patent Office.  See 35 U.S.C. § 144.  Pursuant to the plain language of § 145, this civil action does not merely afford judicial review of agency action.  Rather, the statute directs that the district court may "adjudge that such applicant is entitled to receive a patent for his invention . . . as the facts in the case may appear."

    As in the panel opinion (but with citation to the contrary), the en banc majority sets forth extensive precedent "nearly to the creation of the Patent Office" in support of its conclusion that "Congress intended [by passing §145] to provide for a civil action in which an applicant would be free to introduce new evidence."  Much of this evidence takes the form of Congressional committee testimony, both by proponents and opponents of a provision permitting new evidence introduction under § 145, to illustrate that Congress understood the issue, debated it and knowingly passed into law provisions that permitted new evidence to be introduced freely by disgruntled applicants suing in Federal district court to compel the Office to grant them a patent on their invention.  Distinguishing precedent asserted by the Office in support of its position that no new evidence should be admitted, the en banc majority noted that "the correct approach" for evaluating such later-submitted evidence was with regard to the weight given the evidence, not its admissibility, and that "failure to introduce the evidence earlier casts doubt as to its credibility or reliability."  The opinion supports this standard using earlier Supreme Court cases (Butterworth v. Hoe, 112 U.S. 50 (1884); Gandy v. Marble, 122 U.S. 432, 439 (1887); Hoover Co. v. Coe, 325 U.S. 79, 83 (1945)) that permitted applicants to adduce new evidence in support of suits brought at the district court under the legislative parent of § 145 (§ 4915 of the Patent Act of 1927).  The majority even cites to Zurko in support of its position that "[Section 145] permits the disappointed applicant to present to the court evidence that the applicant did not present to the PTO.  The presence of such new or different evidence makes a factfinder of the district judge."  527 U.S. at 164.  And the majority opinion cites Chandler v. Roudebush, 425 U.S. 840, 845-46, 862 (1976), for the proposition that "specific statutory authorization" can permit trial de novo for review of agency action.  Application of the APA's deferential standard of review is appropriate, the majority states, when no new evidence is introduced, citing Mazzari v. Rogan, 323 F.3d 1000, 1005 (Fed. Cir. 2003).  On the other hand, "[w]hen new evidence is introduced, the court acts as a factfinder with respect to that new evidence and would make de novo fact findings if the evidence conflicts with any related Patent Office finding."

    The majority frankly rejects several policy reasons proffered by the Office in support of its position, most importantly that the majority's standards would lead to applicants "withholding evidence form the Patent Office to avoid generating adverse prosecution history."  This tendency is negated by the provisions of the statute requiring the applicant to pay "all expenses of the proceeding regardless of the outcome," as well as the lost time in pursuing the district court rather than the Patent Office route to obtaining a patent.  Finally:

    We hold that new evidence is admissible in a civil action under 35 U.S.C. § 145, subject only to the Federal Rules of Evidence and Federal Rules of Civil Procedure.

    Judge Newman dissented in part, to the extent that the majority applied the deferential standard of review of Patent Office factual findings mandated by the APA be binding on the district court in § 145 proceedings.  "That is not the statutory plan," according to Judge Newman, who would permit the district court judge to consider the evidence de novo.  Her reasoning is that Congress intended § 145 proceedings not to be duplicative of appeals to the Federal Circuit; in her view, mandating a deferential standard of review for factfinding would have just such a duplicative effect.

    The argument over whether "specific statutory authorization" embodied by § 145 or provisions of the APA controls is forcefully set forth in a dissenting opinion by Judge Dyk, joined by Judge Gajarsa.  For these judges, the "majority decision reflects a remarkable departure from settled principles of administrative law."  These judges fear that under the majority's balancing of the competing statutory interpretations, "applicants will deliberately withhold evidence in their possession, in order to spring it on the district court under section 145."  For the dissenting judges, § 706 of the APA controls (5 U.S.C. § 145).  Citing Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 414–20 (1971), the dissent argues that judicial review is limited to the agency record and that all relevant evidence be submitted by an applicant.  While the dissent recognizes that "[PTO] procedures are inadequate only insofar as they do not provide for live testimony," they see this as the sole exception (other than instances where an applicant did not have the evidence during ex parte prosecution).  With regard to the majority's view, the dissent states:

    Allowing a trial de novo in the district court denigrates the important expertise of the PTO, is contrary to established principles of administrative law, finds no support in the language of the statute, and is contrary to decisions of at least five other circuits.  The majority opinion invites applicants to deliberately withhold evidence from the PTO in favor of a more hospitable district court forum.  Today's decision reflects yet another misguided effort to craft special rules for patent cases that the Supreme Court in other cases has held to be impermissible.  See eBay v. MercExchange, LLP, 547 U.S. 388 (2006) (overturning this court's special test for issuing permanent injunctions in patent cases); MedImmune v. Genentech, Inc., 549 U.S. 118 (2007) (rejecting this court's Declaratory Judgment Act test).  The majority decision is all the more remarkable because the Court has previously rejected our efforts to craft a special rule for review of PTO decisions in Dickinson v. Zurko, 527 U.S. 150, 152 (1999), holding that review under section 141 must proceed under the established administrative law substantial evidence standard.

    For these judges, the majority's decision disregards "the important expert role that the PTO plays in patent examination proceedings," the expertise of the examining corps and the "careful structur[ing]" of the examination process to take advantage of examiner expertise.  But the touchstone of the dissent is the provisions of the APA and the application of these provisions to judicial review of PTO decisions, particularly in view of the Supreme Court's Zurko decision, which stands for the proposition that "[t]he Supreme Court has emphasized that in general the PTO should be treated like other administrative agencies; that patent cases are subject to the same general administrative law principles under the APA; and that departure from those principles requires clear statutory language — language that is absent here."  For these judges, only under certain circumstances — where credibility determinations must be made to properly assess evidence — should an applicant be permitted to introduce evidence in a district court proceeding under § 145.  And unlike the majority, their reading of the "plain language" of the statute does not support an interpretation permitting unfettered introduction of new evidence upon judicial review.  Their position is supported with several examples of Supreme Court decisions for other administrative agencies and other statutory schemes (the Packers and Stockyards Act of 1921, the Communications Act of 1934, the Wunderlich Act, Individuals with Disabilities Education Act) that prohibited the introduction of evidence not submitted to the agency in lawsuits intended (as in § 145) to require an agency to rule in the applicant's favor.  The dissent would limit review to those statutes (unlike § 145) that expressly recite de novo review, such as the Food Stamp Act, 7 U.S.C. § 2023(a)(15).  Unlike the majority, the dissent finds no support in the legislative history for permitting free introduction of new evidence in proceedings before the district court under § 145.

    Concluding a review of Supreme Court and circuit courts of appeals cases, the dissent opines that:

    Not a single court of appeals case has interpreted section 145 as permitting the submission of any and all new evidence.  Although the cases suggest varying standards for the admission of new evidence, they all acknowledge the necessity of establishing significant limitations on the admission of new evidence, and recognize that to provide otherwise would undermine the requirement of administrative exhaustion.  Today's decision represents an anomalous and unjustified departure from prevailing circuit authority.

    The dissent ends with the following policy concerns:

    In conclusion, I note the quite arresting policy argument made by the majority for permitting applicants to bypass the PTO — that the applicant would bypass the PTO in favor of a de novo district court proceeding only in cases where the patent is commercially significant and the costs of a separate proceeding can be justified.  See Maj. op. at 30–31.  But those are exactly the cases in which PTO review is most important.  In such cases, contrary to the majority, it is not somehow fantastic to imagine that applicants will elect to bypass the PTO in favor of a second bite at the apple in the district court.  They will do so exactly in those circumstances where an expert agency would reject the evidence but a non-expert district court might be convinced to accept it.  A more pernicious approach is difficult to imagine.

    While not as fractured as in other areas of the Federal Circuit's jurisprudence, the majority and dissenting opinions set forth diametrically opposed answers to the question of which law — patent-specific § 145 or APA provisions that govern all administrative agencies — controls.  Under these circumstances, there is a specific legal question that only the Supreme Court can resolve (as well as a "circuit split" in judicial review of administrative agency actions).  Whether the Court has the occasion to opine will depend on whether the Solicitor General files a certiorari petition (since it is unlikely that the Court will refuse to review this type of question in the face of a certiorari petition from the government).

    Hyatt v. Kappos (Fed. Cir. 2010)
    Panel:  Chief Judge Rader and Circuit Judges Newman, Lourie, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore
    Opinion for the court by Circuit Judge Moore, joined by Chief Judge Rader and Circuit Judges Lourie, Bryson, Linn, and Prost; concurring-in-part and dissenting-in-part opinion by Circuit Judge Newman; dissenting opinion by Circuit Judge Dyk, joined by Circuit Judge Gajarsa

  • By Sherri Oslick

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

    Astrazeneca UK Ltd. et al. v. Watson Pharmaceuticals, Inc. et al.
    2:10-cv-01969; filed November 11, 2010 in the District Court of Nevada

    • Plaintiffs:  Astrazeneca UK Ltd.; IPR Pharmaceuticals, Inc.; Shionogi Seiyaku Kabushiki Kaisha
    • Defendants:  Watson Pharmaceuticals, Inc.; Watson Pharma, Inc.; Watson Laboratories, Inc.

    Infringement of U.S. Patent No. RE37,314 ("Pyrimidine Derivatives," issued August 7, 2001) following a Paragraph IV certification as part of Watson's filing of an NDA to manufacture a generic version of AstraZeneca's Crestor® (rosuvastatin calcium, used to treat high cholesterol).  View the complaint here.


    Bristol-Myers Squibb Co. v. Apotex, Inc. et al.

    3:10-cv-05810; filed November 8, 2010 in the District Court of New Jersey

    • Plaintiffs:  Bristol-Myers Squibb Co.
    • Defendants:  Apotex, Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 6,596,746 ("Cyclic Protein Tyrosine Kinase Inhibitors," issued July 22, 2003), 7,125,875 (same title, issued October 24, 2006), 7,153,856 (same title, issued December 26, 2006), and 7,491,725 ("Process For Preparing 2-Aminothiazole-5-Aromatic Carboxamides As Kinase Inhibitors" duly and legally issued on February 17, 2009) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Bristol-Myers' Sprycel® (dasatinib, used to treat adults chronic myeloid leukemia).  View the complaint here.


    Sanofi-Aventis U.S. LLC et al. v. Aurolife Pharma LLC et al.

    2:10-cv-05801; filed November 5, 2010 in the District Court of New Jersey

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventisub II INC.; Carderm Capital L.P.
    • Defendants:  Aurolife Pharma LLC; Aurobindo Pharma Ltd.

    Infringement of U.S. Patent Nos. 7,135,571 ("Processes for Preparing Anhydrous and Hydrate Forms of Antihistaminic Piperidine Derivatives, Polymorphs and Pseudomorphs Thereof," issued November 14, 2006), 6,399,632 ("Method of Providing an Antihistaminic Effect in a Hepatically Impaired Patient," issued June 4, 2002), 6,187,791 (same title, issued February 13, 2001), and 6,037,353 (same title, issued March 14, 2000) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Aventis' Allegra ® (fexofenadine hydrochloride, used to treat allergies).  View the complaint here.


    Monsanto Co. et al. v. Southfork Farms, LLC et al.

    1:10-cv-01290; filed November 5, 2010 in the Western District of Tennessee

    • Plaintiffs:  Monsanto Co.; Monsanto Technology, LLC
    • Defendants:  Southfork Farms, LLC; Scott Roland; William L. Johnson

    Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' use of soybean and cotton seed produced from earlier planted Roundup Ready® soybean and cotton seed.  View the complaint here.


    Triax Pharmaceuticals LLC et al. v. Glenmark Generics Inc. USA et al.

    1:10-cv-00946; filed November 4, 2010 in the District Court of Delaware

    • Plaintiffs:  Triax Pharmaceuticals LLC; Astellas Pharma Europe B.V.; Astellas Pharma International B.V.
    • Defendants:  Glenmark Generics Inc. USA; Glenmark Pharmaceuticals Ltd.

    Infringement of U.S. Patent No. 5,635,497 ("Topical Application Compositions," issued June 3, 1997), licensed to Triax, following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Triax's Locoid Lipocream® (hydrocortisone butyrate, used to treat eczema).  View the complaint here.


    Astrazeneca LP et al. v. Sandoz Inc.

    1:10-cv-05785; filed November 4, 2010 in the District Court of New Jersey

    • Plaintiffs:  Astrazeneca LP; Astrazeneca AB
    • Defendant:  Sandoz Inc.

    Infringement of U.S. Patent Nos. 6,598,603 ("Method for Treating Respiratory Diseases," issued July 29, 2003) and 7,524,834 ("Sterile Powders, Formulations, and Methods for Producing the Same," issued April 28, 2009) following a Paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Astrazeneca's Pulmicort Respules® (budesonide inhalation suspension, used to treat asthma).  View the complaint here.

  • Calendar

    November 15-16, 2010 – European Pharmaceutical Regulatory Law Boot Camp*** (American Conference Institute) – New York, NY

    November 15-16, 2010 – Patent Litigation 2010 (Practising Law Institute) – New York, NY (Groupcasts to be held in Philadelphia, Pittsburgh, and Mechanicsburg, PA)

    November 18, 2010 – Current Developments in Trilateral Offices (Intellectual Property Owners Association) – Washington, DC

    November 30 to December 1, 2010 – 12th Advanced Forum on Biotech Patents (American Conference Institute) – Boston, MA

    December 6, 2010 – 21st Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, DC

    December 7-8, 2010 – Developing IP Strategies for Crystalline Forms*** (International Quality & Productivity Center) – London, England

    December 8-9, 2010 – Paragraph IV Disputes*** (American Conference Institute) – San Francisco, CA

    January 26-27, 2011 – The Life Sciences Lawyer's Guide to Patent Term Adjustment and Patent Term Extensions*** (American Conference Institute) – New York, NY

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

  • EPO-EPC The Intellectual Property Owners Association (IPO) will offer a two-hour seminar entitled "Current Developments in Trilateral Offices" on Thursday, November 18, 2010 from 12:30 to 2:30 PM (ET) at the Capital Hilton, 1001 16th Street, NW, Washington, DC.  The seminar will bring together the heads of the European Patent Office, Japan Patent Office, and U.S. Patent and Trademark Office:  President Benoît Battistelli, EPO; Commissioner Yoshiyuki Iwai, JPO; and Director David Kappos, USPTO.  The seminar will be preceded by lunch and followed by a question and answer session to be moderated by Director Kappos.

    USPTO Seal The registration fee for the event is $85.  Those interested in registering for the webinar, can do so here.  CLE credit will not be offered for the event.

    Japan Patent Office