• CalendarFebruary 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

    February 27, 2014 – "Patent Inventorship: Best Practices for Determination and Correction — Drawing the Line Between Inventor and Contributor, Leveraging Lessons From Year One of the AIA" (Strafford) – 1:00 to 2:30 pm (EST)

    February 27-28, 2014 – Ninth Annual Symposium (Northwestern Journal of Technology & Intellectual Property and The Searle Center on Law, Regulation, and Economic Growth) – Chicago, IL

    February 28, 2014 – 58th Annual Intellectual Property Law Conference (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

    March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

    March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 13, 2014 – "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

    March 20, 2014 – "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" (Strafford) – 1:00 to 2:30 pm (EST)

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    March 26, 2014 – "Trade Secret vs. Patent Protection After AIA: Making the Choice — Understanding AIA's Impact on Trade Secrets, Evaluating the Protection Options, Weighing the Benefits and Risks" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

    March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

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

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Trade Secret vs. Patent Protection After AIA: Making the Choice — Understanding AIA's Impact on Trade Secrets, Evaluating the Protection Options, Weighing the Benefits and Risks" on March 26, 2014 from 1:00 to 2:30 pm (EDT).  R. Mark Halligan of Nixon Peabody will provide guidance for IP counsel in determining trade secrets or patents as the mode of protection for inventions and technologies, and examine the AIA's impact on trade secrets and offer best practices for determining which form of protection works best for the subject matter.  The webinar will review the following questions:

    • What impact does the AIA have on trade secrets?
    • Which subject matter is more suitable for trade secrets?
    • Which is more suitable for patents?
    • What factors should counsel consider when choosing between trade secrets and patents as the mode of IP protection?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by February 28, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • By Andrew Williams

    Washington - White House #1Earlier today, the White House provided an update on the five executive actions that it announced in June of 2013.  At the time, we reported on the President's legislative recommendations and executive initiatives, as well as the Patent Assertion and U.S. Innovation report that accompanied them (see "'When the Patent System is Attacked!' — The White House Task Force on High-Tech Patent Issues").  In addition to "announcing major progress" today on these initiatives to combat so-called "patent trolls" ("FACT SHEET — Executive Actions: Answering the President’s Call to Strengthen Our Patent System and Foster Innovation"), the White House hosted a live webcast entitled "Building a Better Patent System."  President Obama did not participate, but instead PTO Deputy Director Michelle Lee, Secretary of Commerce Penny Pritzker, U.S. Chief Technology Officer Todd Park, and Gene Sperling, Director of the National Economic Council collectively spoke for about 30 minutes on how the executive actions were "building a better patent system" ("Building a Better Patent System").

    With regard to the progress of the patent litigation reform legislation, Mr. Sperling acknowledged that the White House did not agree with everything that ended up in the Innovation Act.  There was some suggestion that the fee-shifting provision found in the final House bill was not what the White House was expecting.  Instead, the President had originally suggested modifying the patent attorney fee provision to have it mirror the equivalent provision in the copyright statute.  This, presumably, meant removing the "exceptional case" requirement, while maintaining the default "American Rule," in which generally both sides pay their own costs.  Of course, the provision in the Innovation Act adopted the so-called "British Rule," with the default being that the losing (i.e., non-prevailing) party pays.  Mr. Sperling indicated that the White House was open to comprise on the issue.  Nevertheless, he said the President is hopeful that he will be able to sign the new legislation into law sometime in 2014.

    As for the executive initiatives, the most immediate was the launching of a new "on-line toolkit" "[t]o help level the playing field and ensure individuals and businesses know their rights and are aware of available resources before entering into costly litigation or settlements . . . ."  On this site, there are icons for various resources directed to victims of abusive patent practices.  The first link provides information for what to do if "I've been sued," which provides information about the patent litigation process.  Also within this link are resources to help find a lawyer (with links to the Office's list of registered patent agents and attorneys, as well as state bar attorney lists), determine if anyone else has been sued over the same patent, and provide information about challenging the patent at the Office.  Another link is directed to individuals that have received demand letters.  The resources on this site include identifying options for the demand-letter recipient, providing guidance if the recipient is an end-user customer (with convenient links to the states attorney general's offices and the FTC), and providing links to find out more information about the asserted patent and who might be behind the demand letter.  The PTO toolkit also includes links to help identify related cases, to provide information about the patent infringement process, and to more generally provide information about patents.

    Perhaps the most interesting link on this new "online toolkit" website is the "Resources and Glossary."  In this section, the Patent Office provides links to several other sites, at least one of which has stated quite plainly that "the patent system is broken," and that the "US Patent Office . . . issues questionable patents every day."  One of the "resources" is to a crowd-sourcing website, Ask Patents, which can assist accused infringers in identifying invalidating prior art.  This is the same website that the Electronic Frontier Foundation ("EFF") used to help find the art that was cited in its petition for Inter Partes Review of Personal Audio's podcasting patent (see "When NPR Podcasters Hit the Patent System – An Update").  In addition, one of the "resources" is a link to the "Trolling Effects" website, which "is a project of the Electronic Frontier Foundation . . ." ("About Trolling Effects").  This site also starts from the premise that the patent system is broken, and offers a "crowd-sourced" demand-letter database.  Of course, submission of demand letters is purely voluntary, and is, for obvious reasons, only done by recipients.  Currently the database holds about 45 letters.  And, not surprisingly, another one of the "resources" is the EFF website itself, ostensibly for the purpose of providing "legal services and referrals, through a 'Cooperating Attorney' list."

    On the subject of "crowdsourcing," the White House also announced three new executive actions aimed at "encouraging innovation and further strengthen[ing] the quality and accessibility of the patent system."  The first of these, "Crowdsourcing Prior Art," is a new initiative to expand ways in which the general public can help patent examiners and applicants find prior art.  No details were provided, however, about how such a system would work.  Second, the White House indicated that it was introducing more robust technical training for its patent examiners.  The Administration is requesting that "innovators . . . volunteer their time and expertise" to provide such training.  Finally, the White House indicated that it will dedicate resources to assist inventors without legal representation.

    Patent Docs will continue to report on any updates from the White House related to these executive actions and initiatives.

  • The Decision of the Court of Appeal in Hospira UK Generics Ltd. v. Novartis AG, [2013] EWCA Civ. 1663 was issued on 19 December 2013.

    Background

    NovartisThe case was initially heard in the High Court and raised the issue of entitlement of a patented invention to priority.  The patent in question was European Patent (UK) 1 296 689, owned by Novartis AG, which related to the use of a particular member of the bisphosphonate class of drugs for the treatment of osteoporosis, amongst other things.

    The particular claim in question was Claim 7 which can be expressed as the combination of the following features:

    (i) the use of a zoledronate medicine
    (ii) for the treatment of osteoporosis
    (iii) where the medicine is adapted for intravenous administration in a unit dosage form
    (iv) comprising from about 2 up to about 10 mg of zoledronate
    (v) wherein the period between administrations is about one year

    Claim 7 claimed priority from two priority documents.  The case, in part, related to whether the second of these priority documents, namely United States patent application number 267689 (hereinafter referred to as 'the priority document'), disclosed the subject matter of Claim 7.  It was agreed that Claim 7 would be invalid if it was not entitled to priority since an intervening publication would become available for an attack on validity.

    In the High Court, Mr Justice Arnold held that the Claim 7 was not entitled to priority since there was no disclosure in the priority document linking all of the features of Claim 7.  Thus, the claim was rendered invalid.

    Novartis appealed the Decision of the High Court.

    Appeal

    Novartis argued that the judge in the court of first instance was led into error by failing to read the priority document as a whole.  Novartis added that had the priority document been read as a whole, the judge would have appreciated the clear link between zoledronate, osteoporosis and intravenous administration which ran through the entire document.

    In addressing Novartis' argument, Lord Justice Floyd outlined the law on the approach to priority, noting that although the language of Section 5 of the UK Patents Act and Article 87 EPC (which relate to priority) is different, the two formulations must be taken to mean the same thing (see Jacob LJ in Unilin Beheer BV v Berry Floor NV [2004] EWCA (Civ) 1021; [2005] FSR 6 at [39]).  More specifically, Article 87 EPC states that for a valid priority claim, the later patent application must be in respect of the same invention.  The Enlarged Board of Appeal in G2/98 held that the requirement for claiming priority of the same invention was met if the skilled person could derive the subject matter of the claim directly and unambiguously, using the common general knowledge, from the priority application as a whole.

    Following this, Lord Justice Floyd asserted that the problem for Novartis in seeking to establish that Claim 7 was entitled to priority was that the disclosure of the priority document was either too general or too specific.

    In particular, the passage relating to zoledronate in an amount of from about 2 up to about 10 mg once a year told the skilled person nothing about the dosage range for any particular method of administration.  Further to this, it did not tell the skilled person about the dosage range for any particular condition, for example osteoporosis, i.e., the passage was too general.

    Contrary to Novartis' assertion that the passage relating to zoledronate in an amount of from about 2 up to about 10 mg once a year was applicable to all modes of administration and all conditions, Lord Justice Floyd held that the passage would be read by the skilled person as meaning that depending on the method of administration and the condition being treated, some doses within the range may be suitable.

    Example 5, on the other hand, disclosed 4 mg of zoledronate taken once a year, administered intravenously to patients with post-menopausal osteoporosis as being effective.  However, it was held that Example 5 did not disclose any other doses that could be used at that dosage interval, i.e., the passage was too narrow.

    Since there was no disclosure in the priority document linking all of the features of Claim 7, Lord Justice Floyd concluded the claim was not entitled to priority from United States patent application number 267689 and thus, it followed that the patent was invalid.

    Conclusions

    Even though each of the features of Claim 7 was disclosed in the priority document, without the explicit linking of these features, the subject matter was not considered clearly and unambiguously disclosed to the skilled person (in accordance with G2/98).  In view of this Decision, it is advisable to take extra care when drafting priority documents to ensure that there are clear linking statements for all the claimed subject matter.

    This report comes from European Patent Attorneys at WP Thompson & Co., 55 Drury Lane, London UK.  Further details and commentary can be obtained from Gill Smaggasgale, a partner at the firm.

  • By Andrew Williams

    Supreme Court Building #3As we indicated last week, the Supreme Court will hear arguments next week in two cases involving the Attorney Fees provision at 35 U.S.C. § 285.  That section provides that a district court may award reasonable attorney fees to a prevailing party "in exceptional cases."  The Octane Fitness case, which we previewed last week, will address what the standard is for determining when a particular case is "exceptional."  Specifically, the Court will be reviewing the standard articulated by the Federal Circuit, which provided that a case is only exceptional when "both (1) the litigation is brought in subjective bad faith, and (2) the litigation is objectively baseless," absent misconduct in litigation or in securing the patent.  See Brooks Furniture Mfg. v. Dutailier, Inc., 393 F.3d 1378 (Fed. Cir. 2005).  The second case, Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., will address the level of deference that the lower court's determination is entitled to on appeal.  The question presented in that case is: whether a district court's exceptional-case finding under 35 U.S.C. § 285, based on its judgment that a suit is objectively baseless, is entitled to deference.

    To be clear, even though it is only the standard of review of the objective prong of an "exception-case" determination that is at issue, it result could also impact the level of deference for subjective-prong determinations as well.  According to the reasoning found in the Federal Circuit's Highmark opinion, there are three standards of review for an award of attorney fees in a patent case.  First, the objective prong is entitled to de novo review because it is purely an issue of law.  Second, the subjective "bad-faith" prong is mainly factual, and therefore entitled to review for clear error.  Finally, if the case is exceptional, the awarding of fees is reviewed under an abuse-of-discretion standard.  Therefore, in the Highmark case, because the Federal Circuit was reviewing the "objectively baseless" prong, it reviewed the lower court's determination de novo.  But, Highmark is seeking a unitary abuse-of-discretion standard for § 285 fee awards, even though there are both questions of law and fact that the lower court must decide.

    Highmark's primary argument is that two Supreme Court cases, Pierce v. Underwood, 487 U.S. 552 (1988) and Cooter & Gell v. Hartmarx, 496 U.S. 384 (1990), dictate the higher standard in patent cases.  In response, Allcare mainly points to the Supreme Court case of Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (1993) ("PRE") as controlling, which is the same case the Federal Circuit relied upon in devising the two-part test in Brooks Furniture.  It is also the same case the Federal Circuit cited in support of the decision rendered below.

    With regard to the facts of this case, Allcare is the owner of U.S. Patent No. 5,301,105 ("the '105 patent"), which is directed to "managed health care systems" used by insurance companies to interact with providers.  The patent discloses two embodiments of the invention, a "diagnostic" system and a "utilization-review" system.  The former involves inputting a patient's symptoms, and the system prepares a list of possible medical conditions.  The latter involves inputting both symptoms and the proposed treatment into the system, and if the treatment is considered to be potentially inappropriate for the symptoms, it is flagged for "utilization review."  This review allows the insurance company to determine if a payment should be made.  Highmark used a system that incorporates "utilization review," so the determinative issue at the district court was whether the claims of the '105 patent covered this embodiment.  After a special master assisted the court in construing the claims and in determining that Highmark should be granted summary judgment of non-infringement, the court adopted the reports without substantial change, thereby disposing of the case.  When the merit case was on appeal, Highmark moved for an exceptional case finding pursuant to § 285, which the court granted on the papers and awarded fees.

    The Federal Circuit affirmed the merit appeal.  However, in response to Allcare's appeal of the exceptional-case determination, the court reversed the lower court's determination as to all claims except the assertion of claim 102 (the determination as to this single claim was remanded to the district court).  The judges on the panel, and indeed the entire court, were almost evenly split on the issue of deference.  The majority opinion, authored by Judge Dyk, relied heavily on the PRE case to hold that the objective-baselessness standard is an issue of law to be reviewed de novo.  However, Judge Mayer dissented, citing to cases like Pierce and Cooter and articulating arguments echoed later in Highmark's merit brief.  Highmark petitioned for a panel rehearing and for a rehearing en banc, both of which were denied.  The denial indicated that the poll for en banc review was "requested, taken, and failed," but five of the twelve judges either wrote or joined dissents, expressing disagreement with the panel's determination.  Judge Mayer did not participate in the decision, but if he had, the court would have been evenly split.  Needless to say, this is not a clear-cut case.

    In its merit brief to the Supreme Court, Highmark relied heavily on the Pierce and Cooter cases.  Pierce involved the proper standard of review for fee awards under the Equal Access to Justice Act ("EAJA").  This statute provides an award of fees upon a finding that the United States' position was not "substantially justified."  This was defined as the position having no "reasonable basis in both law and fact," which was equated to the § 285 "objectively baseless" prong.  The Court in Pierce reasoned that "sound judicial administration" dictated a standard for the "substantial-justification" finding of abuse of discretion.  Cooter involved the determination of the standard of review for the imposition of Rule 11 sanctions.  The Court in that case concluded that all aspects of the decision, even the legal conclusions, should be reviewed under a unitary, abuse-of-discretion standard.

    Highmark applied the reasoning used by the Supreme Court in those two cases to explain why the same result is required here.  First, the statutory text suggests discretion, because it uses the word "may," and "exceptional" cases denote case-by-case judgments best left for the decision of the district court judge.  This argument appears to the miss the mark, however, because no one denied that the actual award of fees is properly reviewed for abuse of discretion.  Rather, the "question presented" related only to the objectively baseless prong.  Next, Highmark pointed out that the district court judge is the best-positioned decision maker.  It is somewhat curious that it would highlight this factor, because the lower court judge appeared to relegate a significant portion of the case to the special master.  Highmark also pointed to the efficiencies associated with deference to the lower court, because the objective-baselessness inquiry "requires appellate courts to have intimate familiarity with the entire progression of a case."  However, the Federal Circuit addressed this concern below, pointing out that review of a case for an award of attorney fees is usually the second time the facts of the case are in front of them, the first being during the merit review.  Therefore, this concern might be overblown.  Highmark continued, explaining that the fact-intensive nature of these decisions would result in very little law-clarifying value, as it would be difficult to formulate a rule for the various case-by-case determinations.  Highmark concluded that the Federal Circuit's holding would distort the appellate process and would not discourage collateral appeals.  In sum, Highmark's position was that the factors as articulated in Pierce and Cooter require that a unitary abuse-of-discretion standard is necessary in the review of § 285 decisions.

    On the other hand, Allcare focused extensively on the PRE decision, explaining why it was more appropriately analogous.  First, Allcare pointed out that "[t]he 'objective-reasonableness' standard derives from the concept of 'probable cause.'"  As PRE explained, "'[p]robable cause to institute civil proceedings requires no more than a 'reasonabl[e] belie[f] that there is a chance that [a] claim may be held valid upon adjudication.'"  Brief for Respondent, at 23 (citing PRE, 508 U.S. at 62-63).  And, "the question of whether a given set of facts justified bringing suit is ultimately a legal question."  Id.  Allcare relied on the fact that there are no facts in dispute in this case, which then reduces the question to a pure issue of law.  However, Allcare did point out that in all such cases, there will never be facts in dispute, because the relevant facts make up the record of the case.  The parties' positions in filing and maintaining patent infringement lawsuit, therefore, will not be in dispute (so the argument goes).

    In the end, this case appears to come down to whether the Supreme Court will find that the Pierce and Cooter cases are more in line with § 285 determinations, or whether the Court will look to the reasoning articulated in PRE.  The Court's decision in Octane Fitness could also be a factor, because a change in the standard for determining exceptional cases could affect the standard of review.  Of course, both sides pointed out why their position would still survive regardless of the outcome of Octane Fitness.

    Finally, as with any case dealing with the shifting of attorney fees, Highmark and some of the amicus curiae brought up the public policy argument against so-called "patent trolls." (Interestingly, the amicus briefs were fairly evenly split between supporting Highmark, supporting Allcare, and supporting neither party).  However, Allcare criticized this attempt at appealing to public sentiment as having no substance, because Highmark could not support its assertion that a change in the standard of review for decisions on attorney fees would reduce the incentive for non-practicing patent assertion entities to file infringement lawsuits.  In its reply brief, Highmark concedes that "a deferential review standard will not solve these problems."  Reply Brief for Petitioner, at 23.  But, Highmark did point out that the de novo standard gives so-called "trolls" "a second bite at the apple," giving them the incentive to fight on.  In the end, Highmark's appeal to anti-troll sentiment seems misplaced, because a causal connection between the problem and the requested deferential standard of review appears to be lacking.

  • By Michael Greenfield

    SIPOWord comes to us from attorneys at the CCPIT Patent and Trademark Law Office that the Patent Affairs Administration Department of the State Intellectual Property Office of the PRC (SIPO) "clarified" examination procedures for pharmaceutical patent applications with respect to sufficiency of disclosure and supplemental evidence.  A copy of their report can be found at the AIPLA web site this link.  Clarification was apparently necessary because examiners were deviating from SIPO standards.  The effective date for application of the "clarified" standards was October 17, 2013, and apply only to Office Actions issued after that date and not retroactively.

    Those who practice in Asian countries, including, most notably, China and Japan, know that the support requirements ("sufficiency of disclosure") for claims to products intended for pharmaceutical use are quite stringent.  And although some leeway is given with respect to generalizing specific examples, claims are much more strictly limited in China (and Japan) than, for example, the U.S. and Europe.  For chemical compounds, Chinese examiners generally require claim scope to closely conform to embodiments actually reduced to practice.  And the standard for data to support claims to pharmaceutical compositions comprising the compounds is quite high.

    Perhaps because sufficiency of disclosure must be considered at the time of application filing, as a practical matter Chinese examiners have generally refused to consider supplemental post-filing data.  But now it appears that such blanket refusal is considered inconsistent with SIPO examination standards, and examiners have been instructed that supplemental data should be considered under appropriate circumstances.  But as a practical matter, exactly what those circumstances are and for what purpose post-filing data can be considered remains somewhat unclear.

    As noted, the sufficiency requirement must be met at the date of filing.  So supplemental, post-filing data cannot be used to rectify a deficient disclosure by establishing the technical solution of the claims.  Rather, post-filing experimental data can be used to confirm that the technical solution has the use or effect alleged by the applicant and to confirm statements and facts presented in the specification.

    This is all very well and good.  But it's an abstraction.  It remains unclear and yet to be seen as to how Chinese patent examiners will implement the standard.  How will they differentiate between (a) post-filing data that merely confirms a technical solution, statement, or fact in a patent application from (b) post-filing data that itself is considered as the technical solution?

    The CCPIT report gives the example of a new use of a known compound that is contrary to prior art teachings.  Under such circumstances experimental evidence in the application would be necessary to establish the use (or technical solution).  So, post-filing data would not be accepted to demonstrate the use if the application itself was devoid of data.  This is not unlike the case in the U.S., as manifest in In re '318 Patent Infringement Litigation, where the court held a claimed method of treating Alzheimer's Disease invalid as lacking an enabling disclosure because the application contained no experimental data, even though post-filing experimental evidence supported the claim.

    So it would seem that not all statements in a patent application would be amenable to proof with post-filing data.  Statements of therapeutic activity may need to be supported by data present in the application as filed.  But one wonders whether it could be otherwise.

    What if the application provides some data?  Under traditional practice pharmaceutical composition and use claims would have to conform to the scope of the compounds tested for therapeutic activity.  Could post-filing data for additional compounds be used to affirm their utility and permit a broader scope of claims more commensurate in scope with the post-filing data?  The answer may have to be determined on a case-by-case basis and turn on a number of factors, such as how much data is presented in the application as filed compared to the scope of claims sought, the extent to which a structure-activity relationship is provided, and the structural similarity of the claims.

    It will be interesting to see how this plays out and whether appeal of examiners' decisions with respect to post-filing data will be necessary to further elucidate the practice.

  • By Josh Bosman

    Van Andel Research InstituteThe U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods."  The '983 patent, which is assigned to the Van Andel Research Institute and the University of Pittsburgh, contains claims to a method for differentiating pancreatic cancer from a benign pancreatic disease.

    The invention provides a method for diagnosing pancreatic cancer; more specifically, a method for differentiating pancreatic cancer from a benign pancreatic disease in a patient having or suspected of having a pancreatic disease.  The invention could be particularly helpful in the early diagnosis of pancreatic cancer.  Pancreatic cancer is typically diagnosed at a more advanced stage, and treatment options are limited, leading to five year survival rates of less than 5%.  The inventors indicate that a blood-based diagnostic test for pancreatic cancer would be especially valuable, potentially increasing survival rates and saving resources.

    University of PittsburghThe inventors used antibody arrays to measure the levels of a carbohydrate antigen, CA 19-9, on multiple proteins in 420 individual biological samples from patients with pancreatic adenocarcinoma or pancreatitis.  It is known that the CA 19-9 antigen is elevated in serum from the majority of pancreatic cancer patients, but using CA19-9 in diagnostic tests is discouraged in the guidelines from the American Society of Clinical Oncology due to both false positive and false negative readings.  Surprisingly, the inventors discovered that a subset of cancer patients showed elevations of the CA 19-9 antigen on the mucin proteins MUC1, MUC5AC, or MUC16.  By combining measurements of total CA 19-9 with CA 19-9 on the MUC1, MUC5AC, or MUC16 proteins, the inventors determined that they could differentiate, with sensitivity and specificity, whether the sample was from a patient with pancreatic cancer or a patient with a benign pancreatic disease.

    The '983 patent has one independent claim which recites:

    1.  A method for differentiating pancreatic cancer from a benign pancreatic disease, comprising the steps:
        obtaining a patient biological sample from a patient having or suspected of having a pancreatic disease;
        assaying the patient biological sample (a) to detect a total level of CA 19-9 antigen in the patient biological sample and (b) to detect a glycan level in MUC16 in the patient biological sample;
        comparing the total level of CA 19-9 antigen in the patient biological sample to a statistically validated threshold for total CA 19-9 antigen, which statistically validated threshold for total CA 19-9 antigen is based on a total level of CA 19-9 antigen in comparable control biological samples from patients having a benign pancreatic disease; and
        comparing the glycan level in the MUC16 in the patient biological sample to a statistically validated threshold for the MUC16, which statistically validated threshold for the MUC16 is based on a glycan level in the MUC16 in comparable control biological samples from patients having a benign pancreatic disease;
        wherein (a) a different level of total CA 19-9 antigen in the patient biological sample as compared to the statistically validated threshold for total CA 19-9 antigen and (b) a different level of glycan level in the MUC16 in the patient biological sample as compared to the statistically validated threshold for the MUC16 indicate that the patient has pancreatic cancer rather than a benign pancreatic disease.

    A review of the file history of the '983 patent indicated that a rejection under 35 U.S.C. § 101 was not issued.

  •         By Sherri Oslick

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

    Teijin Ltd. et al. v. Lupin Ltd. et al.
    1:14-cv-00184; filed February 12, 2014 in the District Court of Delaware

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

    Teijin Ltd. et al. v. Hetero USA Inc. et al.
    1:14-cv-00166; filed February 7, 2014 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals USA Inc.
    • Defendants:  Hetero USA Inc.; Hetero Labs 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 Hetero complaint here.

    Fresenius Kabi USA LLC v. Dr. Reddy's Laboratories Ltd. et al.
    1:14-cv-00160; filed February 6, 2014 in the District Court of Delaware

    • Plaintiff:  Fresenius Kabi USA LLC
    • Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

    Fresenius Kabi USA LLC v. Watson Laboratories Inc. et al.
    1:14-cv-00161; filed February 6, 2014 in the District Court of Delaware

    • Plaintiff:  Fresenius Kabi USA LLC
    • Defendants:  Watson Laboratories Inc.; Actavis Inc.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,476,010 ("Propofol Formulations with Non-Reactive Container Closures," issued July 2, 2013) following a Paragraph IV certification as part of defendats' filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  View the Dr. Reddy's complaint here.

    Forest Laboratories Inc. et al. v. Glenmark Generics Inc. USA et al.
    1:14-cv-00159; filed February 6, 2014 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Royalty Pharma Collection Trust
    • Defendants:  Glenmark Generics Inc. USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.

    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 Glenmark'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.

    Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
    2:14-cv-00785; filed February 6, 2014 in the District Court of New Jersey

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

    Infringement of U.S. Patent No. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the complaint here.

  • CalendarFebruary 18, 2014 – "Proposed Patent Reform Legislation: How It May Impact You (Especially if You Are Not Considered to be a 'Patent Troll'" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    February 18, 2014 – "When the Dust Settles – What Have We Learned From the First Post-Grant Final Decisions?" (Foley & Lardner) – 1:00 to 2:00 pm (Eastern)

    February 19, 2014 – "Privilege in Patent Disputes: Thorny Issues Involving Patent Agents and Foreign Lawyers" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    February 19-20, 2014 – AIA Post-Grant Patent Practice Conference (International Intellectual Property Institute and Bloomberg BNA) – Arlington, VA

    February 20, 2014 – "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; and Avoiding Unintended Consequences" (Strafford) – 1:00 to 2:30 pm (EST)

    February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

    February 27, 2014 – "Patent Inventorship: Best Practices for Determination and Correction — Drawing the Line Between Inventor and Contributor, Leveraging Lessons From Year One of the AIA" (Strafford) – 1:00 to 2:30 pm (EST)

    February 27-28, 2014 – Ninth Annual Symposium (Northwestern Journal of Technology & Intellectual Property and The Searle Center on Law, Regulation, and Economic Growth) – Chicago, IL

    February 28, 2014 – 58th Annual Intellectual Property Law Conference (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

    March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

    March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 13, 2014 – "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

    March 20, 2014 – "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" (Strafford) – 1:00 to 2:30 pm (EST)

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

    March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

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

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Privilege in Patent Disputes: Thorny Issues Involving Patent Agents and Foreign Lawyers" on February 19, 2014 beginning at 2:00 pm (ET).  A panel consisting of Anthony Tridico of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; Heather Repicky of Nutter McClennen & Fish LLP; and Buckmaster De Wolf, General Counsel of GE Global Research will discuss the case law that governs situations involving patent agents and foreign lawyers, and what internal procedures companies and law firms should rely on to maintain privilege whenever possible.

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.