Patent Docs

Biosimilars Forum

December 16, 2011

C5 will be holding its Biosimilars Forum 2012 on January 25-26, 2012 in London, UK. C5 faculty will help attendees:

• Overcome the regulatory hurdles blocking biosimilar approval by increasing knowledge of EMA guidelines;
• Discover how the development of the FDA regulatory approval pathway will affect market access for biosimilars in the United States;
• Hear legal advice on information exchange between applicants and patent holders to establish a framework for clinical development of a biosimilar;
• Refine patent protection strategy by mastering the nuances of intellectual property rights of biosimilar applicants and innovators;
• Learn how to approach risk-benefit analysis more effectively to identify the true commercial and clinical value of a biosimilar;
• Enhance knowledge of data exclusivity and SPC regulation and get advice as an innovator on how to mitigate the threat of biosimilars; and
• Discuss the usage of biosimilars and biobetters as substitutes for original products and evaluate the implications for product liability.

In particular, C5's faculty will offer presentations on the following topics:

• Regulatory approval standards and pharmacovigilance criteria for biosimilars;
• European biosimilar approval guidelines: Interpretation, implementation and evolution;
• EMA vs. FDA: Comparing biosimilar approval pathways in Europe and the United States;
• Navigating the U.S. information and patent exchange process for biosimilars;
• Patent enforcement issues relating to biosimilars;
• Analysing the SPC regulatory landscape for biosimilars;
• Case studies and national perspectives on SPCs and U.S. patent dispute provisions;
• Clinical standards for the approval of biosimilars;
• Biosimilars in merger, licensing and collaboration agreements;
• Biosimilars vs. biobetters;
• Market access and the commercial landscape of biosimilars;
• Interchangeability and substitution of biosimilars and reference products;
• Crushing the bandwagon: Innovator companies doing biosimilars; and
• Standards for inequitable conduct in patent cases.

A pre-conference workshop on "Biosimilar Monoclonal Antibodies," will be offered from 8:30 am to 4:30 pm on January 24, 2012. The workshop will offer presentations on the following topics:

• Assessment of the European draft guidelines for similar biological medicinal products containing monoclonal antibodies;
• Anticipating outcomes of first approvals of monoclonal antibody biosimilars in highly regulated markets;
• The potential role of emerging markets and non-comparable products in driving/undermining biosimilars for the more complex biologics products, such as monoclonal antibodies, even in the highly regulated markets; and
• Interchangeability and substitution issues Will patent expiries govern biosimilar filings?

The agenda for Biosimilars Forum 2012 can be found here (conference) and here (workshop). A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is £1599 (conference alone) or £2098 (conference and workshop). Those registering by January 6, 2012 will receive a £200 discount. Those interested in registering for the conference can do so here, by calling +44 20 7878 6888, or by faxing a registration form to +44 20 7878 6885.
China IP Counsel Forum

December 16, 2011

C5 will be holding its 3rd Advanced China IP Counsel Forum on February 13-14, 2012 in Shanghai, China. C5 faculty will provide insights on:

• Ensuring an employment remuneration policy that can withstand potential employee lawsuits challenges;
• Aligning tax planning with IP investment in China to maximize tax incentives and R&D funding;
• Beijing High People's Court Patent infringement establishment and its impact on multinational patent litigation practice;
• Resolving IP ownership challenges in collaborative research with Chinese universities;
• Effective strategies to prevent trade secret leakage and maximize damage claims;
• Building up evidence for criminal threshold to initiate anti-counterfeiting raids by Police Department;
• Meeting new requirements on filing patent infringement lawsuits between trade fairs;
• Adjusting copyright protection and business strategies to prepare for 3rd China copyright amendment; and
• Impact of proposed amendment to the PRC Trademark Law on registry and enforcement strategies.

In particular, C5's faculty will offer presentations on the following topics:

• Ensuring your employment remuneration policy can withstand potential employee lawsuit challenges;
• How to get R&D funding and tax benefits: Aligning tax planning with intellectual property related investment in China;
• Patent infringement establishment: Beijing High People's Court's guideline, key changes and impact on multinational patent litigation practice;
• Resolving IP ownership challenges in collaborative research with Chinese universities: How to create a win-win working relationship;
• Protecting trade secrets: Effective strategies to prevent leakage and maximize damage claims;
• Effectively working with China government authorities to initiate anti-counterfeiting raids;
• Exclusive panel — Meeting of the China IP minds;
• Enforcing patent rights against infringement at trade fairs in China;
• Preparing for 3rd China copyright amendment: How to adjust copyright protection and business strategies;
• Resolving complex IP licensing challenges in China: Compliance & royalties;
• Secrecy examination: Developing and refining your filing strategy for China;
• Impact of proposed amendment to the PRC trademark law on registry and enforcement strategies;
• Distinguishing "similarity" with "likelihood of confusion" to prevent trademarks infringement; and
• Interactive Q&A session with speakers.

Two pre-conference workshops will be held on February 14, 2012. The first workshop, entitled "How to Bullet Proof your Technology Contracts in China: A Practical Checklist for Intellectual Property Attorneys," will be offered from 9:00 am to 12:00 pm. The second workshop, entitled "A Deep Dive into China Patent Litigation: Litigation Tactics from Both Plaintiff and Defendant Perspectives," will be offered from 1:30 to 5:00 pm.

The agenda for China IP Counsel Forum can be found here (conference) and here (workshops). A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,395 (conference alone), $2,995 (conference and one workshop), or $3,595 (conference and both workshops). Those registering by January 12, 2012 will receive a $200 discount. Those interested in registering for the conference can do so here, by calling +44 20 7878 6888 in Europe or 416-926-8200 in the U.S., or by faxing a registration form to 416-927-1563.
USPTO News Briefs

December 15, 2011

By Donald Zuhn —

USPTO Seeks Comments on Eliciting Assignment Information

In a notice published in the Federal Register (76 Fed. Reg. 72372) last month, the U.S. Patent and Trademark Office announced that it is considering several changes in assignment practice that are "designed to encourage a more complete record at the USPTO of patent assignments." The notice invites comments on the methods the Office can employ to collect more timely and accurate assignment information.

Noting that "[i]t is increasingly clear that applications, patents and the completeness of the patent record play an essential role in the markets of innovation," and further that "[intellectual property right} clearance is often made more difficult and time-consuming, legally risky, and expensive because current assignment information on patents and applications is not available," the Office lists a number of changes that are currently under consideration. Among these changes are several amendments to the regulations:

    (1) Amending 37 CFR to require that any assignee or assignees be disclosed at the time of application filing;
    (2) Amending 37 CFR 3.81 to require that the application issue in the name of the assignee or assignees as of the date of payment of the issue fee [§ 3.81 currently allows, but does not require, an application to issue in the name of the assignee];
    (3) Amending 37 CFR 1.215(b) to require the identification of assignment changes after filing date for inclusion on the patent application publication (PGPub) [§ 1.215(b) currently allows, but does not require, that assignee information be provided];
    (4) Amending 37 CFR 1.27(g) to require timely identification of any new ownership rights that cause the application or issued patent to gain or lose entitlement to small entity status; and
    (5) Amending 37 CFR to provide for discounted maintenance fees in return for verification or update of assignee information either when a maintenance fee is paid or within a limited time period from the date of maintenance fee payment.

In addition to the proposed changes to assignment practice, the notice concludes with a list of nineteen questions for which the Office is seeking comments (see p. 72373).

According to the notice, written comments on eliciting more complete assignment information can be submitted by e-mail to saurabh.vishnubhakat@uspto.gov or by regular mail to Saurabh Vishnubhakat, Attorney Advisor, Office of Chief Economist, United States Patent and Trademark Office, Mail Stop External Affairs, P.O. Box 1450, Alexandria, VA 22313–1450. All comments must be submitted by January 23, 2012.

USPTO Seeks Comments on Satellite Offices

Section 23 of the Leahy-Smith America Invents Act calls for the establishment of three of more satellite offices in the United States by September 16, 2014, subject to available resources. The U.S. Patent and Trademark Office has begun the process of collecting information on potential locations for future satellite offices. As part of that process, the Office published a notice in the Federal Register (76 Fed. Reg. 73601) requesting comments and information on potential cities and regions for future locations of the satellite offices. One satellite office is already planned for Detroit, Michigan (§ 24 of the AIA designates this office as the "Elijah J. McCoy United States Patent and Trademark Office" — Elijah McCoy, the son of fugitive slaves, named inventor on 57 U.S. patents, and source of the saying "the real McCoy"). The USPTO has indicated that, subject to available resources, it will establish at least two more satellite offices. According to the notice, written comments regarding the locations of these two offices can be submitted by e-mail to satelliteoffices@uspto.gov; by regular mail to Azam Khan, Deputy Chief of Staff, United States Patent and Trademark Office, Mail Stop Office of Under Secretary and Director, P.O. Box 1450, Alexandria, VA, 22313–1450; or through the Federal eRulemaking Portal website at http://www.regulations.gov.  All comments must be submitted by January 30, 2012. The notice states that:

    Comments should provide information that supports the USPTO’s purposes of establishing satellite offices, including that the location will:
    (1) Increase outreach activities to better connect patent filers and innovators with the USPTO, including the number of patent filings and grants by the city/region as well as other information that provides insight into the region’s innovation activity;
    (2) Enhance patent examiner retention, including quality of life indicators such as average household income, cost of living factors, and other factors related to employee retention;
    (3) Improve recruitment of patent examiners, including data on employment rates and other economic factors in the area, science and technology professionals, as well as legal professionals in the workforce and other related information;
    (4) Decrease the number of patent applications awaiting examination; and
    (5) Improve the quality of patent examination.

In a press release regarding the Office's request for comments, the USPTO noted that the satellite office in Detroit would open in the second half of 2012.

USPTO Adds eTerminal Disclaimer to EFS-Web

In an eAlert distributed last month, the U.S. Patent and Trademark Office announced the release of a beta version of an eTerminal Disclaimer on the EFS-Web. The Office noted that the eTerminal Disclaimer can be filled out online and that no EFS-Web fillable forms are required. In addition, while approval of paper-filed Terminal Disclaimers is not guaranteed (and frequently seem to be hit or miss), eTerminal Disclaimers are auto-processed and approved immediately upon submission (provided, of course, that the request meets all of the requirements). Although a terminal disclaimer fee must be paid immediately, each eTerminal Disclaimer can include up to 50 "reference applications" and 50 "prior patents." During the beta period, eTerminal Disclaimers will only be accepted for a patent application that has been docketed to an examiner (which can be assessed via the Transaction History Tab on public or private PAIR). The eTerminal Disclaimer webpage on the USPTO website can be found here.
Successful Gene Therapy for Hemophilia B Reported

December 14, 2011

By Kevin E. Noonan —

One of the perennial promises of biotechnology is the possibility that genetic diseases can be cured by replacing a defective gene with a normal copy of it. Gene therapy has been attempted on and off for about thirty years, although initial attempts were sporadic and in some cases of doubtful provenance. And the field suffered a serious setback when a patient died undergoing clinical gene therapy trials. Gene targets for therapeutic intervention have traditionally been related to diseases mediated by hematopoietic cells, since these are most easily manipulated ex vivo and returned to the body, but there have also been attempts to cure diseases of other somatic tissues. One traditional problem has been the choice of vector: since in only rare instances have attempts been made to target the replacement gene to the site of the genetic lesion, vectors for delivering exogenous genes have involved viral sequences. But viruses (particularly efficiently integrating viruses like retroviruses) raise the specter of oncogenic transformation that has retarded their clinical development. Alternatives, most commonly adenovirus or adeno-associated virus (AAV) (see graphic below), while having less oncogenic risk have been associated with immunological responses due to the prevalence of anti-adenovirus antibodies in humans as a result of naturally occurring infections.

All this may explain the excitement that has greeted the report by authors from University College London Cancer Institute, the Royal Free National Health Service Trust, Queen Mary School of Medicine, Basingstoke and North Hampshire NHS Foundation Trust, St. Jude's Research Hospital, the University of Chicago, Children's Hospital of Philadelphia, and the Howard Hughes Medical Institute. The report, published in the New England Journal of Medicine this week, reports the results of clinical trials of gene therapy involving human blood clotting Factor IX (at right). The disease, also called Hemophilia B, is like Hemophilia A an X-linked genetic disorder associated with uncontrolled bleeding, arthopathy and early death. It is only controlled by frequent intravenous injection of Factor IX protein. It suffers not only from expense and being palliative rather than providing a cure, but also because inhibitors can arise that reduce the effectiveness of the treatment. Until now, clinical trials of gene therapy for Factor IX have shown only transient expression of the transgene but also cytotoxic T-cell response against the cells (hepatocytes) transduced with the transgene-encoding vector.

The new study, with a total of six patients, differed from earlier attempts in three ways. First, the authors produced a "codon-optimized" expression cassette in which "complementary dimers" of the construct were packed in each virion. These vectors were found to express the transgene "at substantially higher levels" than the previously used single-stranded AAV vectors. Second, the virus capsids were "pseudotyped" with a capsid of serotype 8, which the authors report have a lower levels of native serum antibodies in the human population due to a lower prevalence of infection with the serotype 8 AAV (AAV8). Finally, the virus was administered through a peripheral vein rather than into liver tissue directly, which provided a safer route for patients having compromised blood-clotting capacity.

The virus was administered in three concentration levels: low (200 billion vector genomes/kg body weight); intermediate (600 billion vector genomes/kg body weight); and high (2 trillion billion vector genomes/kg body weight). Patients were screened for the absence of neutralizing antibodies to AAV8. All patients expressed less than 1% of normal amounts of Factor IX in the blood and all but one of them were receiving Factor IX protein therapy. Only three adverse effects were reported, two of which involved anemia and the third being associated with an unrelated surgery.

All three treatment groups showed positive effects of gene transfer. In the low dose group, one participant showed elevated (~2% of normal) Factor IX levels for 16 months after treatment and while prophylactic Factor IX treatment could be discontinued this patient required additional therapy associated with "accidental injury and elective surgery." The second participant in the low dose trial showed less immediate effects of the transgene (~1% of normal Factor IX levels); these levels rose to about 2% of normal 23 weeks (~6 months) after therapeutic administration of the virus. The intermediate dose group showed variable initial response (one patient showed less than 1% Factor IX while the other showed about 4% of normal Factor IX levels immediately after treatment), but over the course of the study these values stabilized to about 2-3% of normal Factor IX levels. Finally, one member of the high dose group showed an initial large effect (Factor IX levels at about 7% of normal) but these levels dropped suddenly to about 3% in a manner consistent with hepatocyte injury due to an immunological reaction against the viral capsid. The other member of the high-dose cohort showed persistent levels that were 8-12% of normal Factor IX values, although these levels were reduced after periods of intense physical activity.

Importantly, the study reports no humoral (antibody) immunological response to the Factor IX transgene product but did show a primary immune response against the AAV8 capsid. Also significant was that no T-cell mediated immune response against the transgene were detected. There was such a response, however, against the AAV8 viral vector, particularly in the higher dosages cohorts, although this resolved.

Skeptics will note that this report is based on a total of six patients, falling far beneath any success level that would be accepted by any regulatory agency for widespread use. The authors recognize this, but also note that "this gene-therapy approach, even with the associated risk of transient hepatic dysfunction, has the potential to convert the severe bleeding phenotype into a mild form of the disease or to reverse it entirely." That promise has driven gene therapy research for a generation and this success suggests that that promise may soon be fulfilled.

For additional information regarding other related topics, please see:

• "EMA Continues to Defer Approval of First Gene Therapy Application in Europe," July 26, 2011
• "Renova Therapeutics Begins Congestive Heart Failure Gene Therapy Trials," February 8, 2011
• "GSK Forms Alliance for Development of Gene Therapy Techniques for Rare Diseases," October 20, 2010
• "Gene Therapy Experiencing a Revival," May 3, 2010
USPTO Revises PTA Provisions for Submission of Certain IDS’s

December 13, 2011

By Donald Zuhn —

In a Federal Register notice (76 Fed. Reg. 74700) published earlier this month, the U.S. Patent and Trademark Office announced that it was revising the rules of practice pertaining to patent term adjustment (PTA) determinations such that applicants would no longer be docked for delays when citing information from a counterpart U.S. application, where the information was promptly filed with the USPTO. In particular, the notice indicates that the Office will no longer reduce PTA in the following situations:

[W]hen applicant promptly submits a reference in an information disclosure statement after the mailing of a notice of allowance if the reference was cited by the Office in another application, or when applicant promptly submits a copy of an Office communication (e.g., an Office action) in an information disclosure statement after the mailing of a notice of allowance if the Office communication was issued by the Office in another application or by a foreign patent office in a counterpart foreign application.

As with the submission of information cited in a communication from a foreign patent office in a counterpart application under 37 C.F.R. § 1.704(d), the Office will not reduce PTA under the above circumstances if the applicant promptly files the information with the Office. In other words, "[t]he Office is revising 37 CFR 1.704(d) to also embrace information first cited in a communication from the Office, as well as the communication (e.g., Office action) in a counterpart foreign or international application." Under § 1.704(d), prompt submission means within thirty-days of receipt of the information.

According to the notice, the changes in PTA practice were "intended to ensure compliance with AIPA in light of the evolving case law." The notice cites three Federal Circuit decisions as the basis for the change in practice: Dayco Products, Inc. v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir. 2003); McKesson Info. Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007); and Larson Mfg. Co. v. Aluminart Products Ltd., 559 F.3d 1317 (Fed. Cir. 2009).

According to the notice, the change in PTA practice is the first of several changes resulting from the Office's notice of proposed rulemaking and request for comments published in the Federal Register last spring (see "USPTO Proposes Changes to PTA and PTE Provisions"). The Office states that other changes to the rules of practice pertaining to patent term adjustment (PTA) determinations will be announced in forthcoming Federal Register notices.

For additional information on this and other related topics, please see:

• "USPTO Proposes Changes to PTA and PTE Provisions," April 6, 2011
• "USPTO Provides Clarification Regarding Treatment of PTA Letters," July 26, 2010
• "Novartis Challenges USPTO's Interim Procedure for Requesting PTA Recalculations," July 12, 2010
• "USPTO Continues to Modify System for Calculating PTA," May 25, 2010
• "USPTO Announces Interim Procedure for Requesting PTA Recalculations," January 28, 2010
• "Patent Term Adjustment: 37 C.F.R. § 1.704(b)'s Three-Month Provision," November 17, 2009
• "USPTO Says Some Requests for PTA Reconsideration Are Premature," September 7, 2009
• "Fish & Richardson Catches Error in Patent Office's PTA Calculation," July 30, 2009
Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2011)

December 12, 2011

By Kevin E. Noonan —

The Federal Circuit reversed the grant of a preliminary injunction in Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharmaceuticals Inc., an ANDA case brought before Judge Martini in the New Jersey District Court. While not extending or changing the law on the requirements for a preliminary injunction grant, the decision illuminates the considerations the Court finds important in deciding whether a district court has abused its discretion.

The case involved the antibiotic doxycycline hyclate, sold in 75-, 100-, and 150 mg tablets by Warner Chilcott as Doryx® under a license from the NDA holder, Mayne Pharma International Pty. Mayne also owns Orange Book listed U.S. Patent No. 6,958,161, which is related to a modified release coated form of doxycycline. Suit was initiated subject to the Hatch-Waxman statutory scheme when defendant Mylan filed an ANDA for the 150 mg tableted version of the drug containing a Paragraph IV certification that the listed patent was invalid, unenforceable, and not infringed. Filing the lawsuit triggered the automatic 30-month stay of FDA approval of the generic drug, and Warner Chilcott moved the District Court for a preliminary injunction shortly before the period of the stay would have expired (when Mylan anticipated the FDA would grant its approval).

As part of the litigation below, the District Court construed the asserted claims in a Markman hearing. While claim construction was not directly at issue in the appeal, it was relevant to the first prong of the preliminary injunction test: whether Warner Chilcott had shown a reasonable likelihood of success on the merits. The District Court considered expert witness reports from both Warner Chilcott and Mylan regarding whether Mylan's product satisfied the recited limitations of the claims. (The Federal Circuit characterized this as "a battle of the experts.") The outcome of the "battle" was hardly definitive, the District Court saying that there were "some serious factual disputes" between the parties' experts that would need to be resolved after "further testimony and examination and credibility" at trial. The District Court denied Mylan's request for an evidentiary hearing and, despite its reservations about the differences between the experts, granted a preliminary injunction to Warner Chilcott, finding that it had fulfilled the requirements of (1) a likelihood of success on the merits; (2) irreparable harm; and (3) a balancing of the hardships in favor of the plaintiff. Neither the parties nor the Court appear to have considered the fourth prong, the public interest. "Notably," the opinion states, "the district court did not address Mylan's arguments that the '161 Patent is invalid because of anticipation or obviousness."

There is one additional factor at play in the case. The District Court informed the parties that it would not be able to conduct a trial on the merits until January 2012 due to a lengthy murder trial scheduled for autumn 2011.

The Federal Circuit reversed, in an opinion by Judge O'Malley joined by Chief Judge Rader and Judge Dyk. The Court applied the law of the regional (Third) Circuit for whether the preliminary injunction was granted as the result of "an abuse of discretion, an error of law or a clear mistake in the consideration of proof." Factual findings were reviewed for clear error. Here, the panel found clear abuse of discretion, based on the District Court's failure to hold an evidentiary hearing, which the Federal Circuit found was an absolute requirement in the Third Circuit for grant of a preliminary injunction. The opinion states that the District Court granted the injunction on "an unsettled record" in full appreciation that there was a factual dispute between the parties' experts that it did not resolve prior to the injunction grant. While the Federal Circuit "recognize[d] and [was] not unsympathetic to the district court's scheduling demands and the difficulty in balancing a busy criminal docket with pressing civil matters," the opinion reversed because the District Court's decision to grant the injunction was "contrary to Third Circuit law."

Finally, the opinion asserted as another ground for reversing the preliminary injunction that the District Court "failed to make any findings as to Mylan's invalidity challenge" and as a consequence the Federal Circuit was prevented "from engaging in any meaningful review of that issue." Under Federal Rule of Civil Procedure 52(a)(1), a district court must "find the facts specially and state its conclusions of law separately" and here the District Court failed to comply with the Rule. Supreme Court (Mayo v. Lakeland Highlands Canning Co., 309 U.S. 310, 316 (1940)) and Third Circuit (Kos Pharms., Inc. v. Andrx Corp., 369 F.3d 700, 708 (3d Cir. 2004)) precedent (as well as Federal Circuit law, for example, Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372, 1378-79 (Fed. Cir. 2009)) mandated compliance with Rule 52. The District Court's "utter failure" to comply with Rule 52 with regard to Mylan's invalidity allegations provided yet another basis for overturning the District Court's injunction. Nevertheless, the opinion vacated and remanded with instructions that the District Court could consider entering a temporary restraining order and consolidating the evidentiary hearing for the injunction with a (bench) trial on the merits. The opinion also "[took] no issue with the adequacy of the trial court's findings on irreparable harm and the balance of the hardships" and mandated no reconsideration of these prongs of the test "unless [the District Court] chooses to do so."

While not breaking new ground on preliminary injunction jurisprudence, the case does present an interesting issue, particularly in view of the Supreme Court's penchant over the last decade to chastise the Federal Circuit for adopting patent-specific rules for matters like injunctions. The High Court has made it very clear (in cases such as eBay Inc. v. MercExchange, L.L.C.) that the Federal Circuit is bound by and must apply the same rubrics for making decisions about injunctions and other procedural matters as are applied in the other several circuit courts. And as the Federal Circuit has done here, the Court must apply the law of the regional circuit in which the district court sits.

This raises the question of whether it might be better for appeals such as this one, which depends more on the application of procedural rules and precedent developed in said regional circuits (rather than Federal Circuit-specific case law) to be decided by the regional circuit courts of appeal. The question presented for review in this case is illustrative: the Federal Circuit did not apply any patent-specific rules or precedent to the matter; indeed, the cases cited were (by and large) Third Circuit cases. For both procedural consistency and as a way to reduce the workload on the Federal Circuit it might make sense for these cases not to go to that Court. The particular regional circuit court could always (on party motion or sua sponte) transfer the appeal to the Federal Circuit if the issues appeared to be controlled by questions of patent law. But for many cases, judicial efficiency might be better served to render unto the Federal Circuit those things limited to patent law, and to leave for the regional circuits those issues that are not so limited.

Warner Chilcott Labs. Ireland Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2011)
Panel: Chief Judge Rader and Circuit Judges Dyk and O'Malley
Opinion by Circuit Judge O'Malley
Court Report

December 11, 2011

By Sherri Oslick —

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

Pfizer Inc. et al. v. Alembic Ltd. et al.
1:11-cv-01213; filed December 7, 2011 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; Warner-Lambert Co. LLC; C P Pharmaceuticals International CV; Northwestern University
• Defendants: Alembic Ltd.; Alembic Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the complaint here.

Abbott Laboratories et al. v. Sun Pharmaceutical Industries Ltd. et al.
1:11-cv-01190; filed December 2, 2011 in the District Court of Delaware

• Plaintiffs: Abbott Laboratories; Abbott Respiratory LLC
• Defendants: Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE

Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), and 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia). View the complaint here.

Alkermes Pharma Ireland Ltd. et al. v. Wockhardt, Ltd. et al.
2:11-cv-07047; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs: Alkermes Pharma Ireland Ltd.; Fournier Laboratories Ireland Ltd.
• Defendants: Wockhardt, Ltd.; Wockhardt USA, LLC

Infringement of U.S. Patent Nos. 7,276,249 ("Nanoparticulate Fibrate Formulations," issued October 2, 2007) and 7,320,802 ("Methods of Treatment Using Nanoparticulate Fenofibrate Compositions," issued January 22, 2008), all licensed to Abbott, following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels). View the complaint here.

Abbott Laboratories et al. v. Wockhardt, Ltd. et al.
2:11-cv-07046; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs: Abbott Laboratories; Laboratories Fournier S.A.
• Defendants: Wockhardt, Ltd.; Wockhardt USA, LLC

Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate Pharmaceutical Composition Having High Bioavailability and Method for Preparing It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006), and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High Bioavailabilty," issued May 9, 2006) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels). View the complaint here.

Celgene Corp. et al. v. Teva Pharmaceuticals USA, Inc.
2:11-cv-07064; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs: Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendants: Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.

Alkermes Pharma Ireland Ltd. v. Teva Pharmaceuticals USA Inc.
1:11-cv-01186; filed December 1, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Apotex Inc. et al.
1:11-cv-01171; filed November 28, 2011 in the District Court of Delaware

• Plaintiffs: Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants: Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001), licensed to Allergan, in relation to Apotex's ANDA to manufacture a generic version of Allergan's Zymaxid® (gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis). View the complaint here.

Warner Chilcott Co., LLC et al. v. Teva Pharmaceuticals USA, Inc. et al.
2:11-cv-06936; filed November 22, 2011 in the District Court of New Jersey

• Plaintiffs: Warner Chilcott Co., LLC; Warner Chilcott(US), LLC
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010) and 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia^TM (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause). View the complaint here.
Conference & CLE Calendar

December 11, 2011

December 15, 2011 – Supreme Court Hearing in Prometheus v. Mayo (Intellectual Property Owners Association) – 2:00 – 3:00 pm (ET)

December 16, 2011 – A Review of the America Invents Act and Its Impact on the USPTO (Birch, Stewart, Kolasch & Birch, LLP and CONNECT) – San Diego, CA

January 4-8, 2012 – 29th Annual National CLE Conference (Law Education Institute) – Snowmass, CO

January 31 – February 1, 2012 – Patent Reform for Life Sciences Companies*** (American Conference Institute) – New York, NY

January 31 – February 1, 2012 – Pharma & Biotech Patent Litigation (C5) – Amsterdam, The Netherlands

February 22-23, 2012 – EU Pharma Law & Regulation*** (C5) – London, England

February 22-24, 2012 – Intensive Patent Law Training Seminar (Chisum Patent Academy) – New York, NY

February 27-29, 2012 – Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) – New York, NY

February 28-29, 2012 – Medical Device Patents*** (American Conference Institute) – Boston, MA

***Patent Docs is a media partner of this conference or CLE
ACI Conference on Medical Device Patents

December 9, 2011

American Conference Institute (ACI) will be holding its Advanced Summit on Medical Device Patents on February 28-29, 2012 in Boston, MA. The conference will allow attendees to:

• Revamp patent prosecution and litigation strategies in view of new America Invents Act (AIA) procedures specifically affecting medical device companies;
• Draft and protect medical device diagnostic claims to withstand challenge in the wake of Bilski and its progeny;
• Develop global patent prosecution and litigation strategies to minimize risk and maximize device market share in emerging and established markets;
• Combat obviousness rejections in light of increasingly more stringent standards post-KSR and patent reform; and
• Assess device method patents' increasing vulnerability to joint infringement and inducement allegations post-McKesson.

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

• Device industry state of the union: Maximizing device patent life and strategic portfolio building in a game-changing year;
• PTO keynote: Integrating the America Invents Act into medical device patents practice — presented by Teresa Stanek Rea, Deputy Director of the U.S. Patent and Trademark Office;
• The post-AIA world: Tailoring medical device patent strategies for litigation and PTO proceedings;
• Protecting diagnostic method claims post-Bilski: Lessons for prosecutors and litigators to comply with increasingly strict standards of patentability;
• Overcoming obviousness challenges: Evolving standards for evaluating validity for devices post-KSR;
• Resolving the written description / enablement dichotomy: Practical claim drafting strategies and litigation strategies post-Centocor;
• Maximizing market share in a global economy: Developing a plan for international medical device patent life cycle management;
• Proving or disproving inducement of infringement: Understanding McKesson's consequences for device method patents;
• Conducting effective freedom-to-operate searches: Guaranteeing the right to commercialize with certainty;
• Calculating and proving medical device damages and minimizing damages liability;
• Preparing your device portfolio for litigation: Limiting liability and managing and reducing costs; and
• Inequitable conduct: Navigating the crowded field of prior art for medical devices technology.

In addition, a pre-conference workshop entitled "Mastering the Intricacies of USPTO Practice Post-Patent Reform" will be offered from 9:00 am to 12:00 pm on February 27, 2012, and a second pre-conference workshop entitled "The 510(k) Process and Patentability: Reformulating Patent Strategies in Light of Changes in the Regulatory Approval Process" will be offered from 1:00 pm to 4:00 pm on February 27, 2012.

The agenda for the Drug and Medical Device Litigation conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3,295 (conference and both workshops). Those registering by January 13, 2012 will receive a $300 discount, and those registering by February 3, 2012 will receive a $200 discount. In addition, Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Medical Device Patents conference.
ACI Life Sciences Collaborative Agreements and Acquisitions Conference

December 9, 2011

American Conference Institute (ACI) will be holding its 16th Advanced Forum on Structuring, Negotiating, and Managing Life Sciences Collaborative Agreements and Acquisitions from February 27-29, 2012 in New York, NY. The conference will allow attendees to:

• Incorporate the right takeaways from the recently enacted America Invents Act into business development strategies;
• Negotiate creative deal terms that provide for greater leveraging of risks;
• Understand what savvy buyers look for in M&A or product licensing and how sellers can best position assets;
• Uncover hidden challenges that may negatively impact the value of acquired IP;
• Structure profitable public-private deals; and
• Build strategic end value into your agreements.

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

• What the America Invents Act means for deal makers and business development strategies;
• Identifying IP red flags that impact the value and success of a life sciences transaction;
• Deciphering alternative business models to select the best deal structure in a time of changing industry dynamics;
• Preparing your IP for M&A or product license: What savvy buyers look for;
• Partner selection for facilitating product development and maximizing commercial returns;
• Opening doors to new markets and products with strategic alliances;
• Bayh-Dole after Stanford: Revising research agreements with academic institutions;
• Exploring perspectives of innovative small companies on the industry's prospects for 2012 and beyond;
• Bridging gaps between buyers and sellers: Finding the right valuation and closing the deal;
• Overcoming negotiating hurdles in developing profitable public-private deals;
• "No regrets" drafting: Terms to include at the onset that facilitate product commercialization and profitable cooperation between partners; and
• Building strategic end value into your agreement.

A post-conference master class, entitled "Life Sciences IP Due Diligence Boot Camp," will be offered from 9:00 am to 3:30 pm on February 29, 2012. In this workshop, ACI faculty will offer presentations on the following topics:

• Understanding and contrasting the different and changing metrics for M&A;
• Mitigating global antitrust and other legal risks presented in life sciences M&A;
• Creating a practical and useful checklist that incorporates both the business objectives of the deal and a comprehensive IP assessment;
• Resolving ownership rights and inventorship issues arising under the target's prior contractual, third party and licensing obligations which could impact your deal; and
• Ethical considerations in protecting privileged documents and confidential information.

The agenda for the Life Sciences Collaborative Agreements and Acquisitions conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone), $3,095 (conference and master class), or $1,395 (master class alone). Those registering by January 13, 2012 will receive a $300 discount off the conference alone or conference and master class, and those registering by February 3, 2012 will receive a $200 discount off the conference alone or conference and master class. In addition, Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Life Sciences Collaborative Agreements and Acquisitions conference.

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