Patent Docs

USPTO Outlines Changes to Myriad-Mayo Guidance at BIO Symposium

By Donald Zuhn --

Last Friday, at the Biotechnology Industry Organization (BIO) IP & Diagnostics Symposium in Alexandria, VA, the U.S. Patent and Trademark Office provided additional information regarding changes that the Office plans to make to its controversial Myriad-Mayo Guidance.  The Myriad-Mayo Guidance, which was issued on March 4, implemented a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).  In response to public feedback regarding the Guidance, the Office hinted at the BIO International Convention in June that changes to the Guidance might be forthcoming (see "Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance"), and then provided a stronger indication that revised Guidance was imminent at the Office's first Bicoastal BCP (BCBCP) earlier this month (see "USPTO Expected to Issue Revised Myriad-Mayo Guidance in October").

Representing the USPTO once again was June Cohan, Legal Advisor with the USPTO's Office of Patent Legal Administration, who appeared on a panel that also featured Sherry Knowles of Knowles IP Strategies (former Senior Vice President and Chief Patent Counsel at GlaxoSmithKline) and Patent Docs author Kevin Noonan.  Ms. Cohan had previously presented on the Guidance at the biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting in April, a BIO Intellectual Property Counsels Committee (IPCC) workshop that same month, the BIO International Convention in June, and the BCBCP meeting on September 17.  At the BCBCP meeting, Ms. Cohan indicated that the Office intended to release "revised" Guidance in about a month.  She also briefly discussed what the Office had learned from the more than eighty comments the Office had received on the Myriad-Mayo Guidance.

At last week's BIO Symposium, Ms. Cohan began by dispensing the bad news first.  Noting that there are different ways to interpret relevant Supreme Court decisions on subject matter eligibility, she noted that the revised Guidance would not be confined to DNA because the Court's Myriad decision "does not stand alone."

Moving on to the good news, Ms. Cohan listed four expected changes to the Guidance's initial iteration.  First, she conceded that the Office had cast "too broad a net," pointing out that a subject matter eligibility analysis should focus on claims that are "directed" to a judicial exception rather than to claims "involving" or "reciting" a judicial exception.

With respect to showing whether a claim is directed to a product that is markedly different from a naturally occurring product, Ms. Cohan acknowledged that "we were a little narrow before," and that the Office needed to consider functional differences and "other things" (perhaps utility) as opposed to just structural differences.  As Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, first noted at the BIO International Convention, Ms. Cohan reiterated that the Guidance's "significantly different" standard was not a new legal standard, but rather was merely a "teaching tool" for examiners.  In a somewhat surprising announcement, Ms. Cohan pledged that "you won't see this term again," suggesting that the teaching tool would be eliminated in the revised Guidance.

Also slated for elimination in the revised Guidance are the twelve factors that weigh towards or against eligibility.  Ms. Cohan conceded that the twelve-factor test was too complex and needed to be simplified, adding that "you won't be seeing twelve factors again."

Finally, Ms. Cohan noted that a number of comments had provided examples and that the Office was "thinking of using many of them."  She also noted that the Office was planning to clarify many of the inferences that should be drawn from the current examples.

Ms. Cohan concluded her presentation by providing a nice summary of several recent cases on subject matter eligibility, including Alice Corp. v. CLS Bank International (2014); In re Roslin Institute (Fed. Cir. 2014); SmartGene, Inc. v. Advanced Biological Laboratories, SA (Fed. Cir. 2014); Ultramercial, Inc. v. Hulu, LLC (Fed. Cir. 2013); and the return of Myriad to the Federal Circuit (see "Federal Circuit Argument in Myriad Appeal Scheduled").  She also indicated that the timeline for the release of the revised Guidance was "late October" or shortly thereafter.

Patent Docs plans to provide a summary of the presentation Sherry Knowles gave at the IP & Diagnostics Symposium regarding the impact of the Guidance in a subsequent post.

Supreme Court Preview -- Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. -- The End of Cybor Corp.?

By Andrew Williams --

The Supreme Court will begin its 2014-2015 term next Monday.  Last year, the Court heard a record number of patent law cases, at least for recent history.  Nevertheless, it is scheduled to hear another one on October 15.  Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. will address whether appellate courts should afford any deference to a trial court's claim construction determination.  This issue stems from the holding of the Supreme Court's 1996 Markman decision, although the Court did not address the standard of review in that decision.  And even though the Teva case is familiar to readers of this weblog, as it arose under the Hatch-Waxman statute of 35 U.S.C. § 271(e), any pronouncement by the Supreme Court will certainly have implications for nearly all patent cases.  This post will preview the upcoming argument by providing an overview of the Teva decision and the cases leading up to it.

Teva at the District Court and the Federal Circuit

The Teva case arose from Sandoz's ANDA application to market and sell Teva's multiple sclerosis drug Copaxone^®.  However, unlike small molecule drug products, the active ingredient of Copaxone^® is copolymer-1 (or glatiramer acetate) -- a mixture of polypeptides molecules.  Specifically, the copolymer-1 polypeptides contain four different amino acids (alanine, glutamic acid, lysine, and tyrosine), but vary in their arrangement and number.  Because the composition is not uniform, it is often expressed in terms of "average molecular weight."  The District Court was therefore required to construe the term "molecular weight."

Statistically speaking, there are at least three ways to calculate average molecular weight:  peak average molecular weight (M_p), number average molecular weight (M_n), and weight average molecular weight (M_w).  These three values can be determined from the common method for measuring "molecular weight" -- Size Exclusion Chromatography ("SEC").  A simplistic way to think about SEC is as a technique that utilizes a column "sieve" that allows different size (or weight) molecules to leave (elute) the column at different times.  After the column is calibrated, the size or weight of the molecules in question can be determined depending on when they elute from the column.  The patents at issue contained an ambiguity with regard to which of the average molecular weight calculation was intended.  The District Court listened to the testimony of Teva's expert, Dr. Grant, and reviewed the specification and prosecution history, and based on that evidence, construed the term as "peak average molecular weight (M_p)."  M_p is the molecular weight of the most abundant molecule in the sample, which occurs as the highest peak in an elution profile.  Correspondingly, because the Court found that the term was not insolubly ambiguous, it held that the claims containing the term were not invalid as indefinite.

The Federal Circuit did not agree.  Specifically noting the standard of review, the Court held that "[o]n de novo review of the district court's indefiniteness holding, we conclude that Dr. Grant's testimony does not save [a particular subset of claims] from indefiniteness."  Teva Pharmaceuticals USA, Inc. v. Sandoz Inc., 723 F.3d 1363, 1369 (Fed. Cir. 2013).  Instead, the appellate court appeared to give more credibility to the testimony of Appellants' experts.  Moreover, the Federal Circuit also reviewed the specification and prosecution history and found them not to be as clear as did the District Court.  The Federal Circuit, however, gave no indication whether the outcome would have been different under a different standard of appellate review.

The Question Presented at the Supreme Court

The sole issue on appeal to the Supreme Court was encapsulated by the question presented:

Rule 52(a) of the Federal Rules of Civil Procedure provides that in matters tried to district court, the court's "[f]indings of fact ... must not be set aside unless clearly erroneous."

The question presented is as follows:

Whether a district court's factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires.

One wonders if the phrasing of the question presumes the answer.  The grant of certiorari came on the heels of the Federal Circuit's en banc decision in Lighting Ballast Control LLC. v. Philips Electronics N.A. Corp. on February 21, 2014.  That case reconsidered, and affirmed, the holding in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc), which itself established the standard of appellate review for claim construction decisions after the Supreme Court's Markman II decision.  Therefore, to truly appreciate the issues in Teva, it is necessary to understand these cases as well.

Markman v. Westview Instruments (Markman II)

The Supreme Court, in its seminal case Markman II, held "that the construction of a patent, including terms of art within its claim, is exclusively within the province of the court."  Markman v. Westview Instruments, Inc., 517 U.S. 370, 372 (1996).  In so doing, it affirmed the Federal Circuit's determination that claim construction is an issue for the judge, not the jury, but was silent with regard to that court's determination that it should review a district court's construction de novo on appeal.

To resolve who has responsibility for construing claim terms, the Supreme Court analyzed Seventh Amendment jurisprudence to determine if it was proper to remove claim construction from the province of the jury.  In so doing, it repeatedly noted the factual components involved.  See, e.g., id. at 378 ("But the sounder course, when available, is to classify a mongrel practice (like construing a term of art following receipt of evidence) by using the historical method . . . ."); id. at 388 ("when an issue 'falls somewhere between a pristine legal standard and a simple historical fact, the fact/law distinction at times has turned on a determination that . . . one judicial actor is better positioned than another to decide the issue in question.'" (citing Miller v. Fenton, 474 U.S. 104 (1985)).  Nevertheless, the Court found "sufficient reason to treat construction of terms of art like many other responsibilities that we cede to a judge in the normal course of trial, notwithstanding its evidentiary underpinnings."  Id. at 390.  The public policy of uniformity was an important consideration for the Court, because "treating interpretive issues as purely legal will promote (though it will not guarantee) interjurisdictional certainty through the application of stare decisis on those questions not yet subject to interjurisdictional uniformity under the authority of the single appeals court."  Id. at 391.

Cybor Corporation v. FAS Technologies, Inc.

After the Supreme Court's pronouncement in Markman II, the Federal Circuit inconsistently applied different standards of appellate review for claim construction determinations.  Therefore, the Court sua sponte ordered that the issue be decided en banc in the case that issued as Cybor Corporation v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998).  The majority concluded that the proper standard is de novo review, "including any allegedly fact-based questions relating to claim construction."  Id. at 1456.  The Court relied heavily on the fact that the Supreme Court affirmed Markman I, which itself used the de novo standard of review.

Curiously, the outcome in the Cybor case was not affected by the standard of review -- even under de novo review, the majority affirmed the lower court's claim construction determination.  As such, the judges not joining the opinion filed concurrences-in-judgment, but a vocal minority expressed their disagreement with the articulated appellate review standard.  Then-Chief Judge Mayer stressed that the Supreme Court stopped short of requiring de novo review of evidentiary disputes where the lower court did not commit clear error.  Judge Rader pointed to the district court judges as being in a better position to make these evidentiary determinations.  Finally, Judge Newman noted that the Supreme Court's goal of promoting stability in the application of patent law had already been diminished by the Federal Circuit's use of the de novo standard.  She pointed to three areas that have disappointed expectations:  (1) the Federal Circuit's refusal to accept certified questions related to claim construction, (2) the Court's creative claim interpretations in some cases, and (3) the failure of the Court to be bound by stare decisis with regard to the same claims.  This last point was exemplified by the CVI/Beta Ventures, Inc. v. Tura LP, 112 F. 3d 1146 (Fed. Cir. 1997) case, in which the Court concluded that a lower court erred in claim construction, even though it relied on "the Federal Circuit's claim interpretation in a separate infringement action involving the same patent."  Cybor, 138 F.3d at 1477 (Rader, J., dissenting in part, joining in part, and concurring in the judgment).

Lighting Ballast Control LLC v. Philips Electronics N.A. Corp.

Because of the continued criticisms of the Cybor decision, the Federal Circuit recently took up the issue of what standard of review was appropriate for claim construction determinations.  The majority in the Lighting Ballast en banc case, this time authored by Judge Newman, applied the principals of stare decisis in affirming the standard articulated in Cybor.  Otherwise, the majority opinion included very little analysis supporting the Cybor decision itself.  Instead, the Court found that the reasons asserted for departing from fifteen years of the de novo review were not compelling.

The two other possible standards expressed by Lighting Ballast and amici curiae were that either the entire claim construction determination should be reviewed for clear error, or that review should be a hybrid of de novo and deferential review.  With regard to the former, Lighting Ballast had argued that the Supreme Court's Markman decision was only concerned with whether claim construction could be heard by a jury or whether it was solely within the purview of the judge.  In so doing, it made no pronouncement related to the standard of review.  Because construing patent claims often involves expert testimony and documentary evidence, Lighting Ballast asserted that the deferential standard of clear error should apply.  In contrast, several amici curiae advocated a hybrid approach, including most notably the United States.  This approach would maintain the ultimate determination of claim construction as a "purely legal" matter, but would acknowledge that there are factual aspects to any determination.

A vigorous dissent was filed by Judge O'Malley, joined by three other judges including then-Chief Judge Rader.  This dissent stressed the requirements of Federal Rule of Civil Procedure 52(a)(6), which requires that all "findings of fact . . . must not be set aside unless clearly erroneous."  The dissent pointed repeatedly to Supreme Court's analysis in Markman II, in which it highlighted the factual nature of claim construction determinations.  In criticizing the Lighting Ballast holding, the dissent pointed out that stare decisis is not an inexorable command.  Rather, case law can be abrogated in at least three circumstances, when it was originally wrongly decided, when it is at odds with congressional directives, and when it have negative consequences.  Not surprising, the dissent found all three to be present with regard to this issue.  In support of the proposition that Cybor has resulted in negative consequences, the dissent pointed to the high reversal rate with respect to claim interpretation by district courts, coupled with the fact that entire trials are held premised on these constructions.

The Look Ahead

There remain some important questions to consider.  First, in view of the fact that the Federal Circuit has been applying the de novo standard of review to claim construction determinations for over fifteen years, should the Supreme Court give any weight to the patent community's many years of experience with this standard?  In fact, a close reading of Lighting Ballast suggests that the outcome might have been different if the Federal Circuit were considering the issue as one of first impression.  And, of course, the Supreme Court is not limited by the same concerns of stare decisis.  Another question involves the Supreme Court's articulated goal in Markman (II) of "interjurisdictional uniformity."  Should the Supreme Court overlook the factual nature of claim construction determinations in order to further this goal?  Increasingly, the same patent is being asserted against multiple defendants, often in different jurisdictions.  If required to adopt a more deferential standard of appellate review, the Federal Circuit will likely be forced to affirm conflicting constructions of the same claim terms from the same patents.  This, in turn, could lead to heightened forum shopping by patent owners.  Finally, the Supreme Court's articulated "Question Presented" in the Teva appeal would appear to suggest that it will apply Rule 52(a) to the factual findings in support of the construction of patent claim terms.  Should the Supreme Court adopt such a hybrid approach, and if so, what criteria should be used to differentiate issues of fact from issues of law?

Ten amicus briefs were filed in the Teva case.  Only three of these represented the opinions of operating companies, but there were 20 companies represented:  (1) Intel, EMC, Facebook, Red Hat, and Verizon; (2) Google, Dell, Hewlett-Packard, Salesforce.com, Twitter, Yahoo!, Acushnet, Ebay, Kaspersky Lab, Limelight Networks, Newegg, QVC, SAS, and Xilinx; and (3) Fresenius Kabi USA.  Interestingly, each of these briefs advocated for maintaining the de novo standard.  The United States also submitted a brief, and advocated for this hybrid deferential/de novo standard of review.  We will provide some of the highlights of all of the briefing, including these amicus briefs, in the upcoming weeks.

Court Report

        By Sherri Oslick --

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

Cadence Pharmaceuticals Inc. et al. v. InnoPharma Licensing LLC et al.
1:14-cv-01225; filed September 24, 2014 in the District Court of Delaware

• Plaintiffs:  Cadence Pharmaceuticals Inc.; SCR Pharmatop; Mallinckrodt IP
• Defendants:  InnoPharma Licensing LLC; InnoPharma Inc.

Infringement of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions, and Method for Preparing the Same," issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles," issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of InnoPharma's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cadence's Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers).  View the complaint here.

Purdue Pharma L.P. v. Watson Laboratories Inc. et al.
1:14-cv-01227; filed September 24, 2014 in the District Court of Delaware

• Plaintiff:  Purdue Pharma L.P.
• Defendants:  Watson Laboratories Inc.; Actavis Laboratories UT Inc.; Actavis plc

Infringement of U.S. Patent Nos. RE41,408 ("Method of Providing Sustained Analgesia with Buprenorphine," issued June 29, 2010), RE41,489 (same title, issued August 10, 2010), and RE41,571 (same title, issued August 24, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Purdue Pharma's Butrans® (buprenorphine transdermal, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate).  View the complaint here.

Genzyme Corp. et al. v. Emcure Pharmaceuticals USA, Inc. et al.
1:14-cv-05975; filed September 24, 2014 in the District Court of New Jersey

• Plaintiffs:  Genzyme Corp.; Southern Research Institute; Sanofi-Aventis U.S. LLC
• Defendants:  Emcure Pharmaceuticals USA, Inc.; Emcure Pharmaceuticals Ltd.

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

AstraZeneca Pharmaceuticals LP et al. v. Sagent Pharmaceuticals, Inc.
1:14-cv-07358; filed September 22, 2014 in the Northern District of Illinois

• Plaintiffs:  AstraZeneca Pharmaceuticals LP; AstraZeneca UK Ltd.; AstraZeneca AB
• Defendant:  Sagent Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy).  View the complaint here.

Reckitt Benckiser Pharmaceuticals, Inc. et al. v. BioDelivery Sciences International, Inc. et al.
3:14-cv-05892; filed September 22, 2014 in the District Court of New Jersey

• Plaintiffs:  Reckitt Benckiser Pharmaceuticals, Inc.; Monosol Rx, LLC
• Defendants:  Biodelivery Sciences International, Inc.; Quintiles Commercial US, Inc.

Infringement of U.S. Patent No. 8,765,167 ("Uniform Films for Rapid-dissolve Dosage Form Incorporating Anti-tacking Compositions," issued July 1, 2014), licensed to Reckitt Benckiser, based on BDSI's manufacture, use, sale, and offer for sale of its Bunavail® product (buprenorphine hydrochloride and naloxone hydrochloride dehydrate mucoadhesive buccal film).  View the complaint here.

BioDelivery Sciences International, Inc. v. Reckitt Benckiser Pharmaceuticals, Inc. et al.
5:14-cv-00529; filed September 20, 2014 in the Eastern District of North Carolina

• Plaintiff:  BioDelivery Sciences International, Inc.
• Defendants:  Reckitt Benckiser Pharmaceuticals, Inc.; RB Pharmaceuticals Ltd.; MonoSol Rx, LLC

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 8,475,832 ("Sublingual and Buccal Film Compositions," issued July 2, 2013), 7,897,080 ("Polyethylene-Oxide Based Films and Drug Delivery Systems Made Therefrom," issued March 1, 2011), and 8,652,378 ("Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions," issued February 18, 2014) based on BDSI's anticipated launch of its Bunavail® product (buprenorphine hydrochloride and naloxone hydrochloride dehydrate mucoadhesive buccal film).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Ajanta Pharma Ltd. et al.
1:14-cv-05876; filed September 19, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Ajanta Pharma Ltd.; Ajanta Pharma USA Inc.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Ajanta's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Teva Pharmaceuticals USA, Inc. et al.
1:14-cv-05878; filed September 19, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 8,580,796 (same title, issued November 12, 2013) and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:14-cv-05824; filed September 18, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Conference & CLE Calendar

September 30, 2014 - 2014 Intellectual Property Continuing Legal Education Seminar (DuPont and Widener University School of Law) - Wilmington, DE

September 30, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Dallas, TX

September 30 - October 1, 2014 - Paragraph IV Disputes Master Symposium (American Conference Institute) - Chicago, IL

October 2, 2014 - "USPTO Guidance for Determining Subject Matter Eligibility In View of U.S. Supreme Court's Mayo and Myriad Decisions" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

October 2, 2014 - "Conflicts in Patent Prosecution: Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) - 1:00 to 2:30 pm (EDT)

October 2, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Denver, CO (webcast)

October 9, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Atlanta, GA

October 16, 2014 - "Patent Licensing: Advanced Tactics for Licensees Post-AIA -- Structuring Contractual Protections and Responding When Licensed Patents Are Challenged in Post-Grant Proceedings" (Strafford) - 1:00 to 2:30 pm (EDT)

October 21, 2014 - "Recent Judicial Decisions Impacting Technology Licensing" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

October 21, 2014 - "Patent Reissue: Strategic Use for Pre- and Post-AIA -- Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule" (Strafford) - 1:00 to 2:30 pm (EDT)

October 20-22, 2014 - Business of Biosimilars (Institute for International Research) - Boston, MA

October 29-30, 2014 - Congress on PIV Litigation (Momentum) - Philadelphia, PA

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

Federal Circuit Argument in Myriad Appeal Scheduled

By Kevin E. Noonan --

The Federal Circuit has scheduled oral argument in Myriad Genetics' appeal of denial earlier this year by the Utah District Court of its motion for preliminary injunction against Ambry Genetics (see "Utah Judge Denies Myriad's Preliminary Injunction Motion").  Designated case no. 14-1361, University of Utah Research v. Ambry Genetics Corp., argument is scheduled for 10:00 am on Monday, October 6th.  Federal Circuit procedures should make in MP3 audio recording of the argument within about 24-48 hours of the argument.  And, of course, interested members of the patent community can attend the argument in person (subject to space limitations) in Courtroom 402, at the Howard T. Markey Federal Courts Building, 717 Madison Place, N.W.
Washington D.C.

In re Lipitor Antitrust Litigation (D.N.J. 2014)

By Kevin E. Noonan --

In the lastest instance of a plaintiff attempting to extend the Supreme Court's holding in FTC v. Actavis that "reverse payment" settlement agreements in ANDA litigation could be anticompetitive and violate the antitrust laws, the District Court of New Jersey (P. Sheridan, J.) granted defendants' motion to dismiss under Fed. R. Civ. Pro. 12(b)(6) for failure to state a claim (Memorandum).  While acknowledging that the Court's Actavis decision could apply to agreements where consideration other than money was exchanged between a branded drug company and its generic drug challenger, the District Court held that the quanta of alleged facts must be sufficient to support the antitrust allegations.

The lawsuit involved Pfizer's Lipitor® drug (atorvastatin calcium), which was so profitable at the time that Plaintiffs' alleged sales amounted to $ 1 billion per month.  These plaintiffs were placed by the Court into four groups = (1) a proposed class of direct purchaser plaintiffs asserting claims under the Sherman Act ("Direct Purchaser Plaintiffs"); (2) several opt-out groups of direct purchaser plaintiffs asserting nearly identical claims to the direct purchaser class; (3) a proposed class of end-payor plaintiffs asserting claims under various states' laws; and (4) the RP Healthcare plaintiffs, a group of pharmacist plaintiffs, asserting claims under California law.  This case only involved the "Direct Purchaser Plaintiffs," namely:  Stephen L. LaFrance Holdings, Inc.; Stephen L. LaFrance Pharmacy, Inc. d/b/a SAJ Distributors; McKesson Corp., SAJ's assignor; Burlington Drug Co., Inc.; Value Drug Company; Professional Drug Company, Inc.; Rochester Drug Co-Operative, Inc.; American Sales Company LLC; and Cardinal Health, Inc., American Sales Company's assignor.  Defendants were the parties to the ANDA settlement agreement: Pfizer, Inc., Pfizer Manufacturing Ireland (formerly known as Pfizer Ireland Pharmaceuticals and previously Warner Lambert Export, Ltd.), and Warner-Lambert Company, the branded drug companies; and generic drugmakers Ranbaxy Inc., Ranbaxy Pharmaceuticals, Inc., and Ranbaxy Laboratories Ltd.

This settlement agreement was highly complex, encompassing  three separate ANDA litigations as well as more than two dozen other actions in foreign jurisdictions, and involving Pfizer drugs Accupril® and Caduet® as well as Lipitor®.  The Lipitor® ANDA litigation involved seven patents:  U.S. Patent No. 4,681,893 (the "'893 patent") and U.S. Patent No. 5,273,995 (the "'995 patent," reissued later as U.S. Reissue Patent No. 40,667), directed to the active pharmaceutical agent (API); U.S. Patent No. 6,126,971 (the "'971 patent"), U.S. Patent No. 5,686,104 (the "'104 patent"), directed to formulations (the "Formulation Patents"); U.S. Patent No. 6,087,511 (the "'511 patent"), and U.S. Patent No. 6,274,740 (the "'740 patent"), directed to specific processes of making amorphous atorvastatin calcium using crystalline Form I atorvastatin as a starting material (the "Process Patents"); and U.S. Patent No. 5,969,156 (the "'156 patent"), directed to the crystalline form of the API.  The API patents and the Formulation Patents were listed in the Orange Book, while the Process Patents were ineligible for listing.

Ranbaxy was the first ANDA filer, and its Paragraph IV letter with regard to the '893, '995, '156, '971 and '104 patents asserted non-infringement based on its ANDA for sale of amorphous (not crystalline) Lipitor®.  In the underlying ANDA case, Ranbaxy failed on all its validity and unenforceability challenges as to product patents, which the Federal Circuit affirmed as to the '893 patent and reversed as to validity of asserted claim 6 of '995 patent.  Thereafter the District Court entered an injunction that kept Ranbaxy off the market until March 24, 2010, and Pfizer filed for and obtained reissue patent No. RE40,667 based on the '995 patent.  (Pfizer also filed a declaratory judgment action as to the Process Patents which settled outside ANDA context and the settlement agreement at issue here.)

In the first Accupril® litigation (Accupril I), Teva was the first ANDA filer and Ranbaxy the second filer over U.S. Patent No. 4,743,450.  In that action, Pfizer was awarded summary judgment against Teva, with the District Court rejecting all Teva's validity and unenforceability assertions.  The second Accupril litigation (Accupril II) resulted from an exclusive "distribution and supply agreement" between Teva and Ranbaxy, in return for which Teva gave up its rights to the 180 day exclusivity period as first filer.  Ranbaxy launched "at risk" based on structural distinctions between Pfizer's approved drug and its generic drug and the District Court granted Pfizer an injunction keeping Ranbaxy's generic Accupril off the market.  This action was included in the settlement agreement at issue here.

In the Caduet® litigation, the accused generic drug was a combination of atorvastatin and amlodipine (and thus subject to infringement liability for the '893 patent); there was also a related declaratory judgment action involving the Process Patents and both actions were part of the settlement agreement before the Court.

That settlement agreement was a "non-monetary" reverse payment, that contained terms "absolving Ranbaxy of damages accrued from Accupril litigation" and "resolved and terminated patent litigation on the three drugs Lipitor®, Caduet® and Accupril®."  Under the terms of the agreement, "the U.S. actions [falling under the scope of the settlement] were the Accupril II litigation, Lipitor Process litigation, Caduet ANDA litigation, and Caduet Process litigation" as well as all (26) foreign litigations between the companies.  The agreement delayed generic entry into the Lipitor market until November 30, 2011 (a 20 month delay from the earlier District Court injunction) and contained a promise by Ranbaxy not to challenge the Process Patents (the '511 or the '740 patents).  Generic entry of Caduet was also delayed until November 30, 2011 and also contained an agreement not to challenge the relevant patents.  Regarding damages for the "at risk" Accupril® sales, Ranbaxy paid Pfizer $1M.  Finally, Pfizer agreed to be Ranbaxy's API supplier for Lipitor, and Ranbaxy changed its formulation to (putatively infringing) crystalline atorvastatin calcium instead of the amorphous form.

The case was consolidated in the District of New Jersey by the Panel for Multidistrict Litigation, and defendants filed motions to dismiss by defendants under Fed. R. Civ. Proc. 12(b)(6), directed to the class of "Direct Purchaser Plaintiffs."  Prior to these motions, the Court had dismissed "Walker Process" and sham litigation claims, as well as Sherman Act Section 2 allegations.  Thereafter the only claim left against defendants was the reverse payment claim.  The Court allowed limited discovery while this action was stayed awaiting the Actavis decision and permitted Plaintiffs to file an amended complaint after the Supreme Court rendered its decision in the Actavis case.  That amended complaint asserted three causes of action:  Count I alleged violation of Section 1 of the Sherman Act for an "[a]greement in restraint of trade against all defendants."  Count II alleges violation of Section 2 of the Sherman Act for a "[c]onspiracy to monopolize against all defendants."  Count III alleged a violation of "15 U.S.C. §§ 1 and 2," but plaintiffs acknowledged that "the Court dismissed this count" and that it was being "restated here for purposes of appellate rights."  The Court thus addressed only the first two Counts in its decision.

The Court set forth the allegations made by Plaintiffs against defendants:

[T]he Plaintiffs contend that this Settlement Agreement was Pfizer and Ranbaxy's purposeful intent to restrain and monopolize trade by extending the Lipitor patent duration until November 30, 2011, when Ranbaxy's generic amorphous version would not have infringed the Lipitor process patents.  Plaintiff allege that this was accomplished by Pfizer forgiving its claim for infringement damages by settling the Accupril claim for $1 million when the value of the Accupril claim was far higher; and allowing the defendants to market generic Lipitor in foreign markets.  As a result, Ranbaxy agreed to delay entry of its generic until November 30, 2011.

In rendering its decision granting defendants' motions to dismiss, the Court discussed the Supreme Court's Actavis decision, which it said was based on the "atypical" posture of the reverse payment settlement agreement.  The Court considered the Actavis decision to reject the approach taken by both the 3rd Circuit (the "quick look" rule of reason antitrust standard) and the appellate consensus "scope of the patent" standard, in favor of a "rule of reason" approach "in order to strike a balance 'between the lawful restraint on trade of the patent monopoly and the illegal restraint prohibited broadly by the Sherman Act.'"  The Court then set forth the Supreme Court's "factors" for performing the "rule of reason" analysis for reverse payment settlement agreements of ANDA cases:

Sometimes there are types of settlements that do not fall within the Actavis rationale.  The Supreme Court provided two types of 'commonplace forms' of settlement that are not subject to Actavis scrutiny.  The first one is when A sues B for patent infringement and demands $100 million in damages; and then B pays A $40 million as settlement.  Actavis, 133 S. Ct. at 2233.  The "implicit net payment" or reduction in demand of $60 million by A does not trigger antitrust scrutiny.  Id.  The second situation occurs when B has a counterclaim for damages against A, the patentee, and A pays B to settle B's counterclaim.  Id.  Such settlements between a patentee and a generic manufacturer are permissible.

However, the Court also acknowledged that "[t]he Supreme Court left 'to the lower courts the structuring of the present rule-of-reason antitrust litigation.'  Id. at 2238."

Having stated its understanding of the proper analysis of the substantive antitrust issues, the Court then discussed the standard for granting motions to dismiss enunciated by the Supreme Court in Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009).  Simply put, these decisions require that a complaint must assert evidence supporting entitlement to the relief requested, and cannot be merely conclusory statements or bare recitation of the elements of the cause of action.  In the Third Circuit, this precedent has been interpreted as a three part test:

[O]ur inquiry is normally broken into three parts:  (1) identifying the elements of the claim, (2) reviewing the complaint to strike conclusory allegations, and then (3) looking at the well-pleaded components of the complaint and evaluating whether all of the elements identified in part one of the inquiry are sufficiently alleged [citing Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011)].

The Court also noted that Twombly was itself an antitrust case and thus particularly relevant in its exhortation that a court determine whether a complaint has satisfied the requirement for factual pleadings as early in the litigation as possible to avoid wasted time for the court and expense for the parties (noting that it may take fewer facts to plausibly plead an auto accident than an antitrust or RICO claim).

The Court found that the five "backup" patents -- "the '156 patent, the two Formulation Patents (the '971 and '104 patents), and the Process Patents (the '740 and '511 patents)" -- were successfully designed around by Ranbaxy, based on, inter alia, Ranbaxy's Paragraph IV certification to the FDA.  The facts were thus sufficiently plead according to the Court; the question was whether the antitrust allegations were as well.  The Court identified "the heart of the issue" as being "whether there was a settlement agreement between Pfizer and Ranbaxy that constituted a [reverse settlement payment agreement] that warrants antitrust scrutiny."  In considering this question, the Court cited the several pejorative characterizations contained in the complaint, including that the settlement agreement constituted a "'sweetheart' agreement to dismiss damages claims likely worth hundreds of millions of dollars in Accupril II litigation in exchange for a token 'pretextual' payment of $1 million"; and that settlement of the Process Patent infringement was included to "disguise the [Agreement's] true anticompetitive purpose" (the complaint does not make any allegations regarding settlement of the Caduet Process litigation and the Caduet ANDA litigation, or the twenty-three foreign actions pending at the time of the Settlement Agreement).  The complaint also alleged that Ranbaxy did not "relinquish or selectively waive" its 180-day exclusivity term, creating a "bottleneck" having the effect of blocking generic entry by any other generic drugmaker.

The Court gave little weight to these characterizations, based on their lack of relevance to factual allegations.  Rather, the Court invoked the Supreme Court's Actavis decision for the rubric that it must "examine[] whether the factual allegations are sufficient to make plausible that Pfizer made a large and unexplained reverse payment to Ranbaxy in support of antitrust activities."

Turning to the matter of the reverse payment, the Court in a masterful understatement explained that the Actavis decision "does not define payment or provide any clarity" regarding whether a "payment" that raises antitrust scrutiny can be anything other than a monetary payment.  Citing Third Circuit precedent as well as cases from other jurisdictions and even Black's Law Dictionary, the Court concluded that a "payment" could be anything sufficient to discharge a debt or obligation and was not limited to cash payments.  The Court found no consistent or persuasive authority for whether the Actavis decision required a payment of money between the parties.  However, the Court found that there must be a way to "convert" whatever was exchanged between the parties into a monetary equivalent in order to apply the Supreme Court's Actavis precedent.  The Court recognized that the Supreme Court's "general concern" enunciated in Actavis was whether there were "genuine adverse effects on competition" and that this was not limited to merely monetary arrangements.  However, the Court also recognized that the factual requirements needed to satisfy Rule 12(b)(6) are more extensive for non-monetary consideration between the parties.

Citing Twombly and Iqbal, the Court noted that the "flexible standard" contained in those cases could be met if "the pleading [] demonstrate[s a] reliable foundation showing a reliable cash value of the non-monetary payment," but that the Plaintiffs would need more facts than had been plead to meet that standard here.  Specifically, the Court asserted that Plaintiffs would need to establish a value for the non-monetary payments alleged in support of the complaint, consistent with its discussion earlier in the opinion.  The Court made reference to  Aaron Edlin, et al., Activating Actavis, 28 Antitrust 16, 18 (2013)  in setting forth the following factors:

The payment prong involves the following steps:  (a) valuing any consideration flowing from the patentee to the claimed infringer, which may be made over time and may take forms other than cash; (b) deducting from that payment the patent holder's avoided litigation costs; and (c) deducting from that payment the value of goods, services, or other consideration provided by the claimed infringer to the patent holder as part of the same transaction (or linked transactions).

The Court found that a "lack of any reliable foundation pervade[d] the entire Complaint."  The purported nature of value of the settlement was in part contingent, because the court in the Accupril II case had not ruled on whether the patents-in-suit were valid and enforceable.  In addition, the complaint alleged no facts relating to the amount of the damages Ranbaxy was at risk for incurring in the Accupril II case, and merely assumed these damages to be on the order of the $200 million bond Pfizer posted in support of its injunction for Ranbaxy's "at risk" sales or the difference in gross sales ($525 million vs. $70 million).  The Court found neither of these assumptions to be plausible.  Even if Plaintiffs had "relied on a reliable foundation (which Plaintiffs did not)," settlements must also be assessed with regard to the parties' own assessment of their risk, including for example "the branded company's perceived probability of winning the patent litigation; the branded company's monopoly profits and duopoly profits (if the generic were to enter the relevant market); the remaining lifetime of the patent at issue and the proposed market entry date for the generic manufacturer; and the branded company's litigation costs and the amount of payment from the brand to the generic."  In addition, "Plaintiffs must allege a measure of damages accepted within the industry and a discussion of the settlement factors relating to the claim of damages settled at that time."

Turning to other factors, the Court found that there were close to no allegations relating to legal fees between the parties, which the Supreme Court stated should be deducted from any monetary compensation flowing from the branded pharmaceutical company to the generic drugmaker, because such compensation does not raise "the same concern that a patentee is using its monopoly profits to avoid the risk of patent infringement or a finding of noninfringement."  In view of the number of actions settled (foreign and domestic) and the costs to the generic company of these litigations (estimated by the Court to be $117-$260 million), the Court found Plaintiffs' complaint to be implausible without any assertion of the relevance of these savings to Ranbaxy's decision to settle.  The Court also noted that, while the Supreme Court did not define what was a "large" cash payment, "[o]ne way to measure the 'largeness' of a reverse payment is to assess whether the amount is larger than what the generic would gain in profits if it won the Paragraph IV litigation and entered the market," which can be "'strong evidence' of anticompetitive activity."  The Court found no such allegations in Plaintiffs amended complaint.  Finally, statements by Pfizer's former and current Chief Executive Officers did not rise to the level of probative evidence of antitrust intent, the Court said, because inter alia they were cited without context and were merely conclusory.

It is likely that Plaintiffs made the strategic decision not to address all of the aspects of the Settlement Agreement; if so this was a strategic error, because the Court also held that their complaint was not plausible because it did not evaluate the agreement as a whole as is necessary in applying the "rule of reason" to antitrust questions.  Specifically:

In order to analyze whether an alleged RSPA occurred to delay entry of generic Lipitor, as plaintiffs allege, the terms of the entire Settlement Agreement must be analyzed to determine plausibility.  To rely only on certain sections (Accupril) of the Settlement Agreement and disregard other sections (Caduet) is not a reasonable analysis.  The Complaint does not plead the Settlement Agreement as a whole.

Accordingly, the Court granted Defendant's motions to dismiss with prejudice because "Plaintiffs have failed to plead their Amended Complaint with the plausibility required by the Federal Rules of Civil Procedure and the relevant case law" even after being given the opportunity to conform their pleadings to Actavis and other Supreme Court precedent.

The Court sets forth the rule, insofar as their can be one, succinctly as follows:

Pursuant to Twombly and Iqbal, the standard for considering a motion to dismiss a complaint is a based upon a flexible pleading benchmark.  In this case, where Plaintiffs rely on a non-monetary reverse payment of an inchoate claim, they must plead plausible facts including an estimate the monetary value of same so the Actavis rationale can be applied.  The Plaintiffs have failed to delineate any type of methodology to connect the claim to its monetary value.  To meet this standard, Plaintiffs must stand in the shoes of the underlying parties at the time of the settlement, and determine an estimate of the monetary value of the settlement at that time.

This case illustrates the consequence of the Court's jurisprudential decision to permit the contours of its Actavis decision to be "worked out" in district and appellate courts below (much like the PTO and the courts will be working out the differences between the Federal Circuit's "insolubly ambiguous" and the Supreme Court's "reasonable certainty" standards for indefiniteness established in Nautilis v. Biosig).  It also illustrates the consequences of the Supreme Court asserting its authority to be the final arbiter of patent law questions over the Federal Circuit, and changing a specialized court for a generalist one.  While perfectly proper under the Constitution, this change has produced and will continue to produce uncertainties that can be expected to seriously harm competition and innovation, two of the supposed reasons why the Court decided to reenter the patent law arena with such vigor.  Rarely has the Court's decisions had the potential for such harm to the American economy and global competitiveness.

Inovia Releases 2014 Report on Global Patent Trends

By Donald Zuhn --

Patent services provider inovia has released its fifth annual report on global patent and IP trends.  In compiling "The 2014 U.S. Global Patent & IP Trends Indicator," inovia, which produces products for PCT national phase entry, European patent validation, and patent translations, surveyed more than 100 companies and universities in May 2014 to identify the trends having the greatest impact on the foreign filing strategies of U.S. patentees.

The 2014 report notes that 20.4% of survey respondents are involved in the pharmaceuticals or biotech industries.  Other sectors or groups represented in the survey include chemicals/materials (13.6%), electrical/electronics (7.8%), mechanical/engineering (12.6%), IT/software/media (1.9%), and university/association/non-profit (16.5%).  The report also indicates that 24.3% of survey respondents had no in-house patent attorneys or agents, 51.5% had one to four attorneys or agents, 11.7% had five to nine attorneys or agents, 4.9% had ten to 24 attorneys or agents, and 7.8% had 25 or more attorneys or agents.  With respect to the number of in-house patent attorneys or agents, the trend was towards increasing numbers of in-house practitioners (in last year's report, 33% of survey respondents had no in-house patent attorneys or agents and 47% had one to four attorneys or agents, and in the 2012 report 37% of respondents had no in-house patent attorneys or agents and 46% had one to four attorneys or agents).  Also, fewer respondents experienced IP budget cuts in 2013 than in 2012, and fewer respondents brought some prosecution activies in house in 2013 (dropping to 45% of respondents in 2013 from 57% of respondents in 2012).

Not surprisingly, the 2014 report indicates that for U.S. applicants, patent reform was the dominating issue in 2013.  With respect to filing expectations, 79% of respondents said they filed as many patent applications as they expected to file in 2013, 6% filed more than they expected, and 14% filed less than they expected.  In last year's survey, 73% of respondents said they filed as many applications as expected in 2012, 11% filed more, and 16% filed fewer, and in the 2012 survey, 67% of respondents said they filed as many applications as expected in 2011, while 18% filed more and 15% filed fewer.

The 2014 report indicates continued growth for international patent protection, as 52.6% of respondents filed more than half of their patent applications abroad (up from 50% in last year's report and 42% in the 2012 report).  Respondents were also less selective with their filings abroad in 2013, with 12.4% of respondents filing corresponding applications in only 1-3 foreign countries and another 30.9% filed internationally in 4-19 countries.  In last year's survey, 22% of respondents drew the line at 1-3 foreign filings and 32% filed in only 4-19 countries, and in the 2012 survey, 37% filed corresponding applications in only 1-3 foreign countries.

With regard to the countries in which respondents regularly filed, 20% added new countries to their list (down from from 23% in 2012), with China now considered a regular destination for many U.S. applicants.  A smaller percentage of respondents (15%) dropped countries from their lists (down from 19% in 2012), with respondents noting that market opportunity in Japan, Australia, and Canada was dwindling, prosecution was becoming more onerous in Saudi Arabia and too expensive in Japan.  As in last year's survey, respondents who dropped the European Patent Office believed that the high cost of pursuing such protection did not justify the value.  In ranking foreign jurisdictions, respondents placed Europe, China, and Japan first, second, and third, respectively, which was the same ranking respondents provided in the last two reports.  Finally, the report noted that a large majority of respondents (96%) rely on the PCT for foreign filing.  Of these respondents, 71% selected the EPO as an International Searching Authority (down from 75% in 2012), 45% selected the Korean IP Office (KIPO) (down from 50% in 2012), and 11% selected the Japan Patent Office (JPO) (no change from 2012).

USPTO to Hold Roundtable on Patent Law Harmonization

By Donald Zuhn --

In a notice published in the Federal Register last week (79 Fed. Reg. 56070), the U.S. Patent and Trademark Office announced that it would be holding a roundtable to obtain public input on several issues related to the international harmonization of substantive patent law.  In particular, the Office is interested in stakeholder feedback regarding the definition and scope of prior art, the grace period, and standards for assessing novelty and obviousness/inventive step.

In the notice regarding the roundtable, the Office indicates that it has continued to focus on work sharing, which allows one patent office to leverage work done by another patent office on a corresponding application in order to improve quality and reduce duplicative search and examination efforts.  The notice suggests that harmonization can enhance the effectiveness of work sharing by better aligning the patentability standards of the two offices.  According to the Office, the areas of substantive patent law which are most relevant for work sharing purposes are those related to the search and application of prior art.  As a result, the Office is most interested in securing public feedback regarding the definition and scope of prior art and standards for assessing novelty and obviousness/inventive step.  The Office is also interested in obtaining public input regarding the grace period.

While an agenda for the roundtable has yet to be released, the Office indicated that the event will consist of two panel discussions.  The first discussion will address key patent examination-related issues such as the definition of prior art, prior art effect of published applications, prior art not affecting patentability (grace period), and conditions for patentability -- novelty and obviousness/inventive step.  In the second discussion, the Office will focus on how to best advance substantive patent law harmonization.  Those interested in serving as a panelist should submit their name, contact information (telephone number and email address), the name of the organization(s) the person represents, if any, relevant biographical information as it pertains to the topic(s) to be discussed during the session(s), and a few brief comments on the topic(s) to [email protected] before October 24, 2014.  Panelists will be selected approximately two weeks in advance of the roundtable.

The roundtable will take place from 8:30 am to 12:00 pm on November 19, 2014 in the Madison Building on the USPTO's Alexandria campus. An agenda and webcast information for the roundtable will be made available a week prior to the event on the Office's Events webpage.  Those interested in registering for the event can do so here.  Attendees may also register at the door.

Court Report

        By Sherri Oslick --

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

Reckitt Benckiser LLC v. Aurobindo Pharma Ltd. et al.
1:14-cv-01203; filed September 17, 2014 in the District Court of Delaware

• Plaintiff:  Reckitt Benckiser LLC
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002), 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005), and 7,838,032 ("Sustained Release of Guaifenesin," issued November 23, 2010 following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® and Mucinex® DM (guaifenesin, and guaifenesin/dextromethorphan, respectively, used to treat chest congestion).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories, Inc. et al.
2:14-cv-01602; filed September 17, 2014 in the Southern District of Ohio

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc. et al.
1:14-cv-01196; filed September 16, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Roxane Laboratories Inc.; Boehringer Ingelheim Roxane Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,665,772 ("O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants," issued September 9, 1997), 6,004,973 ("Pharmaceutical Compositions Comprising Rafamycin Coprecipitates," issued December 21, 1999), 6,239,124 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection or Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin," issued May 29, 2001), and 6,455,518 ("Pharmaceutical Compositions for the Treatment of Transplant Rejection, Autoimmune or Inflammatory Conditions Comprising Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin," issued September 24, 2002) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Zortress® (everolimus, used for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in adult patients receiving a liver transplant).  View the Delaware complaint here.

Genetic Technologies Ltd. v. Ambry Genetics Corp. et al.
8:14-cv-01475; filed September 12, 2014 in the Central District of California

• Plaintiff:  Genetic Technologies Ltd.
• Defendants:  Ambry Genetics Corp.; DOES

Infringement of U.S. Patent No. 5,612,179 ("Intron Sequence Analysis Method for Detection of Adjacent Locus Alleles as Haplotypes," issued March 18, 1997) based on Ambry's provision of genetic disorder testing, including for cystic fibrosis.  View the complaint here.

Celgene Corp. et al. v. InnoPharma Inc.
1:14-cv-01188; filed September 12, 2014 in the District Court of Delaware

• Plaintiffs:  Celgene Corp.; Astellas Pharma Inc.
• Defendant:  InnoPharma Inc.

Infringement of U.S. Patent Nos. 7,608,280 ("Method of Producing FR901228," issued October 27, 2009) and 7,611,724 (same title, issued November 3, 2009) following a Paragraph IV certification as part of InnoPharma's filing of an ANDA to manufacture a generic version of Celgene's Istodax® (romidepsin for injection, used to treatment of peripheral and cutaneous T-cell lymphoma).  View the complaint here.

Shire LLC v. Corepharma, LLC
2:14-cv-05694; filed September 12, 2014 in the District Court of New Jersey

Infringement of U.S. Patent Nos. RE42,096 ("Oral Pulsed Dose Drug Delivery System," issued February 1, 2011) and RE41,148 (same title, issued February 23, 2010) following a Paragraph IV certification as part of Corepharma's filing of an ANDA to manufacture a generic version of Shire's Adderall XR® (a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Teva Pharmaceuticals USA, Inc. et al. v. Doctor Reddy's Laboratories, Ltd. et al.
3:14-cv-05672; filed September 11, 2014 in the District Court of New Jersey

• Plaintiffs:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd.
• Defendants:  Doctor Reddy's Laboratories, Ltd.; Doctor Reddy's Laboratories, Inc.; Sandoz, Inc.; Momenta Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis).  View the complaint here.

Conference & CLE Calendar

September 23, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Alexandria, VA (webcast)

September 24, 2014 - "Trade Secrets in the Life Sciences" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

September 25, 2014 - "Charting New Territory: Prosecution and Diligence Strategies in the Wake of the AIA" (American Bar Association Center for Professional Development and Section of Intellectual Property Law) - 1:00 to 2:30 pm (ET)

September 26, 2014 - IP & Diagnostics Symposium (Biotechnology Industry Organization) - Alexandria, VA

September 30, 2014 - 2014 Intellectual Property Continuing Legal Education Seminar (DuPont and Widener University School of Law) - Wilmington, DE

September 30, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Dallas, TX

September 30 - October 1, 2014 - Paragraph IV Disputes Master Symposium (American Conference Institute) - Chicago, IL

October 2, 2014 - "USPTO Guidance for Determining Subject Matter Eligibility In View of U.S. Supreme Court's Mayo and Myriad Decisions" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

October 2, 2014 - "Conflicts in Patent Prosecution: Minimizing Risks of Malpractice Liability and Ethics Sanctions" (Strafford) - 1:00 to 2:30 pm (EDT)

October 2, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Denver, CO (webcast)

October 9, 2014 - First Inventor to File America Invents Act Roadshow (U.S. Patent and Trademark Office) - Atlanta, GA

October 16, 2014 - "Patent Licensing: Advanced Tactics for Licensees Post-AIA -- Structuring Contractual Protections and Responding When Licensed Patents Are Challenged in Post-Grant Proceedings" (Strafford) - 1:00 to 2:30 pm (EDT)

October 21, 2014 - "Recent Judicial Decisions Impacting Technology Licensing" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

October 21, 2014 - "Patent Reissue: Strategic Use for Pre- and Post-AIA -- Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule" (Strafford) - 1:00 to 2:30 pm (EDT)

October 20-22, 2014 - Business of Biosimilars (Institute for International Research) - Boston, MA

October 29-30, 2014 - Congress on PIV Litigation (Momentum) - Philadelphia, PA

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

IPO Trade Secrets Webinar

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar on "Trade Secrets in the Life Sciences" on September 24, 2014 beginning at 2:00 pm (ET).  Dianna DeVore of Oblon, Spivak, McClelland, Maier & Neustadt, LLP; Matthew Pugmire of Pfizer, Inc.; and Michael Samardzija of Dentons US LLP examine the alternative of using trade secrets to protect intellectual property in the life sciences.  The webinar will review the following topics:

• What kinds of IP in the life sciences are best suited to protection by trade secrets?
• The potential value of "negative know-how," i.e., what doesn't work;
• The risk of losing trade secrets through disclosure to regulators;
• What kinds of information are amenable to trade secret protection in diagnostic laboratory-developed tests (LDTs)?
• The risks to the makers of biosimilars posed by the disclosure requirements of the Biologics Price Competition and Innovation Act (BPCIA).

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.

Webinar on Patent Reissue

Strafford will be offering a webinar/teleconference entitled "Patent Reissue: Strategic Use for Pre- and Post-AIA -- Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule" on October 21, 2014 from 1:00 to 2:30 pm (EDT).  Erika H. Arner, Thomas L. Irving, and Deborah M. Herzfeld of Finnegan Henderson Farabow Garrett & Dunner; and Donna M. Meuth, Associate General Counsel - Intellectual Property, Eisai will provide patent counsel with an in-depth review of the pros and cons of using reissue to correct patent errors, whether before or after AIA, discuss the rule against recapture and the effect of reissue, and offer their experiences, perspectives and best practices on the strategic use of patent reissue to correct errors.  The webinar will review the following questions:

• What factors should be considered in evaluating the possibility of reissue?
• How have patent reissue implications changed post-AIA?
• What are the risks and limitations of using reissue proceedings to resolve patent errors?
• If you have a pending patent application, how good an idea is reissue?
• When is supplemental examination a better idea than reissue and does reissue basically get the owner to the same place a supplemental examination would in a shorter time?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by September 26, 2014 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

Webinar on Patent Licensing

Strafford will be offering a webinar/teleconference entitled "Patent Licensing: Advanced Tactics for Licensees Post-AIA -- Structuring Contractual Protections and Responding When Licensed Patents Are Challenged in Post-Grant Proceedings" on October 16, 2014 from 1:00 to 2:30 pm (EDT).  William C. Coppola, Senior Patent Counsel, Sanofi-Aventis; and April Weisbruch Goodwin Procter and Eleanor M. Yost of Goodwin Procter will provide guidance to patent counsel on addressing patent licensing issues for licensees post-AIA, and discuss incorporating protections in the license agreement and responding when a licensed patent is the subject of a post-grant proceeding.  The webinar will review the following questions:

• How has the AIA impacted patent licensing?
• What steps can licensee counsel take to effectively build protections into the license itself?
• How should licensees respond when a challenger attempts to invalidate a licensed patent in an AIA post-grant proceeding?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

MBHB Webinar on Judicial Decisions Impacting Licensing

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Recent Judicial Decisions Impacting Technology Licensing " on October 21, 2014 from 10:00 am to 11:15 am (CT).  MBHB attorney Patrick Gattari give participants an overview of the recent judicial decisions and trends in technology licensing agreement through a review of current cases involving a number of important issues:

• Patent Exhaustion
• Definitions of Licensed Technology
• Improvements
• Forum Selection and Venue
• Burden of Proof
• Bankruptcy
• Licensed Parties

While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.