Patent Docs

USPTO’s Extended Missing Parts Pilot Program Is Extended

December 22, 2011

By Donald Zuhn —

In a Federal Register notice published last week (76 Fed. Reg. 78246), the U.S. Patent and Trademark Office announced that the Extended Missing Parts Pilot Program that was implemented last year will be extended for another year. The pilot program "effectively provides a 12-month extension to the existing 12-month provisional application period, providing applicants additional time to find financial help, evaluate a product's worth in the marketplace or further develop the invention for commercialization." In particular, the pilot program modifies the Office's current missing parts practice — which permits an applicant to pay the filing fees and submit an executed oath or declaration after the filing of a nonprovisional application within a two-month time period that is extendable for an additional five months on payment of extension of time fees — such that applicants can file a nonprovisional application with at least one claim within the 12-month statutory period after the provisional application has been filed (as well as pay the basic filing fee, submit an executed oath or declaration, and not file a nonpublication request) and then be given a 12-month period within which to decide whether the nonprovisional application should be completed by paying the required surcharge and the search, examination, and any excess claim fees.

Applicants wishing to participate in the pilot program must file a nonprovisional application within twelve months of the filing date of a provisional application, directly claim the benefit of the provisional application, and submit a certification and request to participate in the program with the nonprovisional application. In the Office's notice regarding the extension of the pilot program, the Office:

[C]autions all applicants that, in order to claim the benefit of a prior provisional application, the statute requires a nonprovisional application filed under 35 U.S.C. 111(a) to be filed within twelve months after the date on which the corresponding provisional application was filed. See 35 U.S.C. 119(e). It is essential that applicants understand that the Extended Missing Parts Pilot Program cannot and does not change this statutory requirement.

The pilot program is not without its drawbacks; for example, the form for requesting participation in the program (PTO/SB/421) outlines the PTA effects of participation in the program, stating that:

Any patent term adjustment (PTA) accrued by applicant based on certain administrative delays by the USPTO is offset by a reduction for failing to reply to a notice by the USPTO within three months. See 37 CFR 1.704(b). Thus, if applicant replies to a notice to file missing parts more than three months after the mailing date of the notice, the additional time that applicant takes to reply to the notice will be treated as an offset to any positive PTA accrued by the applicant.

In addition, under the pilot program, nonprovisional applications are still published according to the existing eighteen-month publication provisions. Most importantly, the Office has advised applicants that:

[T]he extended missing parts period does not affect the twelve-month priority period provided by the Paris Convention for the Protection of Industrial Property. Thus, any foreign filings must still be made within twelve months of the filing date of the provisional application if applicant wishes to rely on the provisional application in the foreign-filed application or if protection is desired in a country requiring filing within twelve months of the earliest application for which rights are left outstanding in order to be entitled to priority.

Where an applicant participating in the program fails to pay the basic filing fee, provide an executed oath or declaration, or submit application papers that are in condition for publication — i.e., comply with the requirements for participation in the program (which are essentially the requirements for publication of the application) — the applicant is given a two-month (extendable) time period within which to supply those items. In the notice regarding the extension of the pilot program, the Office notes that applications that are not filed electronically will still be assessed a $400 additional fee (or $200 for small entities) pursuant to the Leahy-Smith America Invents Act, that this fee will be due within the two-month (extendable) time period to reply to the Notice to File Missing Parts of Nonprovisional Application, and that applicants will not be given the 12-month time period under the pilot program to pay this fee.

The pilot program has been extended until December 31, 2012.

For additional information regarding the pilot program, please see:

• "USPTO Implements Pilot Program Extending Provisional Application Period," December 13, 2010
• "USPTO Seeks to Effectively Double Provisional Application Period," April 4, 2010
If Patents Become Irrelevant in a Biosimilars Future, What About University Patents and Startups?

December 21, 2011

By Kevin E. Noonan —

The pros and cons of patenting in the biosimilars scheme recently enacted as part of the Patient Protection and Affordable Care Act have been discussed, here and elsewhere (see "Will Patents Become Irrelevant in a Biosimilars Future?"). Whether envisioned by the bill's drafters or not, the provisions of the Biologics Price Competition and Innovation Act of 2009 (particularly the litigation provisions) contain incentives for biologic drug innovators not to rely on patents to protect these drugs and the return on investment (or at least the reasonable prospect thereof) needed to support the capital-intensive effort that must be exerted to bring such drugs to market. Limitations on claim scope, possibilities of successful "design arounds" and the limited scope available for infringement by equivalents, as well as the uncertainties associated with amino acid sequence and other variants, make biologic drugs different from conventional small molecule drugs, which have been protected by patents under the Hatch-Waxman regime. Also a factor in why small molecule drug innovators have relied more heavily on patent protection that is likely for biologic drugs is the difference in term of exclusivity under the two Acts: Hatch-Waxman gives small molecule drugs only five years of exclusivity while the BPCIA gives biologic drugs twelve years (a term fought by the FTC (who wanted no exclusivity; see "No One Seems Happy with Follow-on Biologics According to the FTC"), Congressman Waxman (5 years; see "Waxman Introduces Follow-on Biologics Bill"), and even President Obama (7 years; see "White House Recommends 7-Year Data Exclusivity Period for Follow-on Biologics"). Patent law provisions (including 35 U.S.C. § 271(e)(2), which make the filing of an Abbreviated New Drug Application an statutory act of infringement) and drug regulatory law (wherein filing a patent infringement lawsuit by an NDA holder after receiving a Paragraph IV letter regarding an Orange Book-listed patent from a generic drug maker provokes a 30-month stay in FDA approval of the ANDA) have made patent litigation the principal battle ground between innovator and generic drug makers for a generation. None of these advantages exist in the biosimilar approval pathway specified under the BPCIA.

Even though patenting may not hold its preeminent place in protecting biologic drugs that it has had in protecting small molecule drugs, it would be a mistake to think that patents have become completely irrelevant to biologic drug deveopment. They may be so with regard to the (generally adversarial) relationship between biologic drug innovators and companies (perhaps including traditional innovator companies) that make biosimilars. But there is another conventional purpose for biologic drug patenting: protecting startup companies early in the development cycle. In this regard, patents continue to serve their purpose of providing exclusivity for further development stages, and in prohibiting larger, better-funded companies from expropriating early-stage technology. Patents also satisfy the requirements imposed on universities under the Bayh-Dole Act, and enable federally funded grantees to reap the benefits of licensing their technology.

These advantages are unlikely to change even for biologic drugs. But the expected de-emphasis on patent protection for later-stage development (including regulatory approval) can be expected to change the relative importance of patents in the two stages. Such de-emphasis will also change where the valuation in biologic drugs may lie, because there will be a relatively greater advantage in optimizing cell lines and other process parameters (which even today rarely benefit from patenting) than in patents on the biologic drugs per se. That doesn't mean that patents will be any less important for startups, but thirty years of deal-making and negotiating behavior between small companies and their larger brethren will be impacted, probably not in a way that will inure to the benefit of the startups. While patents will remain essential to early-stage companies, their diminished value to larger partners (and the concomitantly greater value of the contributions of such companies) should also diminish the valuation of such deals.

The counter-argument is that startups will play an even more important role in providing the next generation of new potential "blockbuster" drugs, something is short supply from big pharma over the past few years. Whether due to inherent flaws in the "waiting for a blockbuster" drug development model or because the "low-hanging fruit" of small molecule drug development has been expended (or more likely because the diseases of aging garnering the most attention today are particularly intractable to pharmaceutical intervention, i.e., you can't put eating right and regular exercise into pill form), the prospects for startups (particularly university-generated startups) may be rosier than might be expected if patents become less important in protecting biologic drugs.

A good source of information on the interplay between patent protection and statutory protection under the BPCIA comes from Dr. Yaniv Heled, a recent Patent Docs commenter (see "Patents vs. Statutory Exclusivities in Biological Pharmaceuticals – Do We Really Need Both?"). Dr. Heled's paper contains some valuable tables comparing the terms of the two types of exclusivity (patent and statutory) for dozens of biologic drugs. One conclusion from the paper is that patent protection provides (on average) about one additional year (~327 days) of exclusivity past the end of the 12-year exclusivity provided by the BPCIA. (The table also indicates that the average time between patent application filing date and FDA approval is more than ten years (~3728 days).) Dr. Heled's paper (while coming to slightly different conclusions and couched in the language of academic patent law) is consistent with the idea set forth here that the future will be different than the past regarding biologic drug development and efforts to obtain the benefits of biologic drug development at a reduced price. For all these reasons, we may find that for biologic drugs the goals espoused by the proponents of the biosimilar approval pathway may be surprised at how that future turns out.
USPTO News Briefs

December 20, 2011

By Donald Zuhn —

USPTO Updates "Track I" Program

On Monday, the U.S. Patent and Trademark Office announced that it had issued a final rule, changing the Track I prioritized examination program. Under the new rule, applicants can request prioritized examination for "any patent application in which a proper request for continued examination (RCE) has been filed before, on, or after December 19, 2011." Additional information regarding the change was provided in a notice published Monday in the Federal Register (76 Fed. Reg. 78566). After postponing the launch of the Track I program due to funding limitations, the Track I program was finally implemented on September 26 as part of the Leahy-Smith America Invents Act (see "USPTO Implements Prioritized Examination Track under AIA").

USPTO and Rospatent Announce PCT Agreement

On Monday, the U.S. Patent and Trademark Office announced the implementation of an agreement with the Russian Federal Service for Intellectual Property (Rospatent), in which Rospatent will act as an available International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) for international applications filed with the USPTO as the Receiving Office. The agreement will take effect on January 10, 2012. According to the Office's notice on the agreement, "[t]he addition of Rospatent as an available ISA/IPEA choice will allow applicants additional flexibility in choosing a given international authority based on the technology disclosed in the international application, speed of services provided and cost of obtaining searches and examinations of international applications."

Applicants selecting Rospatent as the ISA will pay a search fee of $415, as compared with $2,080 for searches conducted by the USPTO. Applicants selecting Rospatent as the IPEA will pay an international preliminary examination fee of RUB 5400 ($169.41 at the current exchange rate) and a handling fee of $219 when Rospatent was the ISA, as compared with $600 for an examination conducted by the USPTO when the USPTO was the ISA. For examinations conducted by Rospatent where it was not the ISA, the examination fee will RUB 8100 ($254.11 at the current exchange rate), as compared with $750 for an examination conducted by the USPTO when the USPTO was not the ISA.

USPTO Director Davis Kappos noted that "[t]he collaboration between the USPTO and Rospatent will be beneficial for US applicants as it will provide additional choices at a lower cost."

USPTO and IPO Establish PPH Pilot Program

Last month, the U.S. Patent and Trademark Office announced the establishment of a new Patent Prosecution Highway (PPH) pilot program with the Icelandic Patent Office (IPO). As with other PPH programs, the USPTO-IPO PPH will permit an applicant having an application whose claims have been allowed in one of the offices to fast track the examination of an application in the other office, such that the latter application is examined out of turn. In particular, an applicant receiving a ruling from either the USPTO or IPO that at least one claim in an application is patentable may request that the other office fast track the examination of corresponding claims in the corresponding application in that office.

The USPTO-IPO PPH pilot program, which began on December 1, 2011, is scheduled to expire on November 30, 2012, but may be extended for up to one year or terminated earlier depending on volume of activity and other factors. USPTO requirements for participation in the USPTO-IPO PPH pilot program can be found here, and IPO requirements can be here.

Since implementing its first Patent Prosecution Highway (PPH) program with the Japan Patent Office (JPO) on July 3, 2006, the U.S. Patent and Trademark Office has established a total of twenty-two PPH programs with other patent offices. Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), the Mexican Institute of Industrial Property (IMPI), the Swedish Patent and Registration Office (PRV), Nordic Patent Institute (NPI), and the Israel Patent Office (ILPO), the Taiwan Intellectual Property Office (TIPO), the Norwegian Industrial Property Office (NIPO), China's State Intellectual Property Office (SIPO), and the Icelandic Patent Office (IPO).

In other PPH news, the USPTO issued a follow-up notice regarding its launch of new Paris Convention ("Paris Route") and Patent Cooperation Treaty (PCT) Patent Prosecution Highway (PPH) pilot programs with China’s State Intellectual Property Office (SIPO) (see "USPTO News Briefs," November 17, 2011).

USPTO Launches New Website Design

The U.S. Patent and Trademark Office launched a new home page design today. According to a notice regarding the new design, the redesigned website "better presents the activities and services of the USPTO to the public, and is more accessible to [the agency's] user community." The Office noted that the old design, which was launched in June 2009 (see "USPTO Issues Beta Release of New Website"), was criticized as being "too text heavy," and the new site places a greater reliance on graphic cues to help visitors find what they’re looking for. To help users transition to the new site, the old home page will be available until February 29, 2012. The Office is also accepting comments regarding the website at newhomepage@uspto.gov.
Will Patents Become Irrelevant in a Biosimilars Future?

December 19, 2011

By Kevin E. Noonan —

The future is always the undiscovered country. But it tends to be one that people believe they can understand based on what has happened in the past. This is the reason people invest with successful money managers, and why every prospectus carries the disclaimer that "past experience does not ensure future performance." It is also why learned (and not so learned) disquisitions on innovation and innovation policy are so incomplete and unsatisfying — innovation like the future comes from where we least expect it, both in substance and the people who turn out to be the innovators. As Niels Bohr said, "[p]rediction is very difficult, especially about the future."

But one thing that is predictable is that people will modify their behavior (at least to some extent) to adapt to changing circumstances. One such changing circumstance is the biosimilars provisions of the omnibus health care reform bill enacted into law almost three years ago. As has been discussed here and elsewhere extensively (and won't be repeated here), there are two general provisions to the law: the requirements and procedures for a biosimilar applicant to be granted approval of a biosimilar application (section 7002) and the provisions for litigation between the biosimilar applicant and the reference product sponsor (section 7003). The Food and Drug Administration is charged in large part with determining the requirements and procedures specified broadly by Congress in section 7002. The agency has hinted that it will propose rulemaking and issue guidelines by the end of the year, and these guidelines will not only establish the parameters of the biosimilar pathway but also affect how likely it will be that biosimilar drug manufacturers will apply for approval under the biosimilars provisions (codified under § 351(k) of the Public Health Service Act, codified at 42 U.S.C. § 262(k)) or under other sections (such as a full-blown Biologic License Application under § 505(a) of the Food, Drug and Cosmetics Act, codifed at 21 U.S.C. § 355(a)). These guidelines will also affect the likelihood that the biosimilar applicant will attempt to qualify for interchangeability and the incentives for producing so-called "bio-betters," i.e., biologic molecules having differences in structure and different (preferably improved) biological properties.

The ligation provisions, on the other hand, depend on the existence of patents to protect biologic drugs after expiration of the twelve-year data exclusivity period. Superficially, these provisions are modeled on the Hatch-Waxman regime, insofar as the statute guides how patent infringement litigation will proceed. Superficially is where the resemblance to Hatch-Waxman ends, of course; a significant difference is the absence of an "Orange Book" defining what patents are to be the subject of litigation. In its stead is a complex negotiation protocol by which the parties decide which patents will be the subject of infringement litigation triggered by the filing of a biosimilar application. There has been speculation that the statute was intended to discourage litigation and its labyrinthine, almost Byzantine provisions support this view. It is likely to take at least five years to almost a decade before there is any case law developed enough to test the effectiveness of these provisions.

There is an alternative, however, that may tend to change unpredictably the course of biosimilar development. That alternative is for biologic drug innovators to eschew patenting altogether and thus avoid the possibility of protracted patent infringement litigation under the statute. There are a number of vulnerabilities to patents that claim biologic drugs that are not shared with small molecule drugs and that may make such an approach attractive. Most of these vulnerabilities stem from the greater complexity of biologic drugs; as shown below, biologic drugs have 2-3 orders of magnitude more atoms than small molecule drugs. In addition, biologic drugs are made (generally) in genetically engineered cells that impose their own variabilities (in post-translation modifications such as glycosylation for example) on the processes used to make such drugs. Further, the complexity makes the scope of patent protection on biologic drugs to be less certain than for small molecules, since even small differences in structure (such as the single methylene group that distinguishes valine from isoleucine) may have unpredictable effects on biologic drug structure, biological activity and immunogenicity. As a consequence, broad coverage for even structurally similar species of the same biologic drug are infrequently granted, and even when obtained may be of dubious provenance and reliability.

But this very complexity might be a source of an advantage for a biologic drug innovator not to pursue patent protection. In that case, the incentives for the innovator would be to provide as little information as required by the FDA for biologic drug approval. This would of necessity involve disclosure of how the biologic drug was made and its characterization, but would not include disclosure of the cell itself. Even if the disclosure to the agency included a detailed description of the cells, the transgenes and the methods and conditions for producing the recombinant cells, optimization of the particular cell line should not need to be revealed. And the uncertainty that would produce would provide a clear obstacle to a biosimilar manufacturer that might be a disincentive to trying to readily (i.e., predictably) produce a biosimilar version of a biologic drug.

The benefits of this approach for biologic drug innovators are evident: producing obstacles to the biosimilar applicant (for whom it would be more difficult to produce a biosimilar drug) as well as avoiding biosimilars litigation under the statute. It is unlikely that the Congressional staffers and their patrons intended this result. It is equally unlikely that the promised benefits of biosimilar availability (and the expected massive cost savings, especially to the government) will be achieved were innovators to eschew patenting. But this is yet another consequence of (mis)applying our experience with small molecule drugs and the Hatch-Waxman regime to biosimilars, and another example of the past not reliably informing the future.
Court Report

December 18, 2011

By Sherri Oslick —

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

Shire LLC et al. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00201; filed December 15, 2011 in the Northern District of West Virginia

• Plaintiffs: Shire LLC; Supernus Pharmaceuticals, Inc.; Shire Development Inc.; Shire International Licensing B. V.; Amy F. T. Arnsten, Ph.D.; Robert D. Hunt, M.D.; Pasko Rakic, M.D.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan, Inc.

Infringement of U.S. Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral Disorders," issued December 19, 1998), 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001), and 6,811,794 (same title, issued November 2, 2004) based on Mylan's filing of an ANDA to manufacture a generic version of Shire's Intuniv® (guanfacine, used to treat attention-deficit hyperactivity disorder). View the complaint here.

Cephalon, Inc. et al. v. Celgene Corp. et al.
1:11-cv-12226; filed December 14, 2011 in the District Court of Massachusetts

• Plaintiffs: Cephalon, Inc.; Acusphere, Inc.
• Defendants: Celgene Corp.; Abraxis Bioscience, Inc.; Abraxis Bioscience, LLC

Infringement of U.S. Patent No. RE40,493 (""Porous Paclitaxel Matrices and Methods of Manufacture Thereof," reissued September 9, 2008) based on Celgene's manufacture and sale of its Abraxane® product (paclitaxel protein-bound particles for injectable suspension; used for the treatment of breast cancer). View the complaint here.

Janssen Pharmaceuticals, Inc. et al. v. Sandoz, Inc.
3:11-cv-07247; filed December 13, 2011 in the District Court of New Jersey

• Plaintiffs: Janssen Pharmaceuticals, Inc.; Peninsula Pharmaceuticals, Inc.; Shionogi & Co. Ltd.
• Defendant: Sandoz, Inc.

Infringement of U.S. Patent No. 5,317,016 ("Pyrrolidylthiocarbapenem Derivative," issued May 31, 1994) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Janssen's Doribax® (doripenem injecction, used to treat complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis). View the complaint here.

Warner Chilcott Co., LLC v. Lupin Ltd. et al.
3:11-cv-07228; filed December 12, 2011 in the District Court of New Jersey

• Plaintiff: Warner Chilcott Co., LLC
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 6,667,050 ("Chewable Oral Contraceptive, " issued December 23, 2003) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Warner Chilcott's Generess^TM Fe (norethindrone and ethinyl estradiol, used for oral contraception). View the complaint here.

Alza Corp. v. Mylan Pharmaceuticals Inc. et al.
2:11-cv-07158; filed December 9, 2011 in the District Court of New Jersey

• Plaintiff: Alza Corp.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent No. 5,591,454 ("Method For Lowering Blood Glucose," issued January 7, 1997), licensed to Pfizer, following a Paragraph IV certification as part of Mylan's filing of an amendment to its ANDA (adding additional dosage forms) to manufacture a generic version of Pfizer's Glucotrol XL® (glipizide extended release tablets, used to improve glycemic control in adults with type 2 diabetes mellitus). View the complaint here.

PAMLAB, L.L.C. et al. v. Macoven Pharmaceuticals, L.L.C.
1:11-cv-09022; filed December 9, 2011 in the Southern District of New York

• Plaintiffs: PAMLAB, L.L.C.; Metabolite Laboratories, Inc.; Breckenridge Pharmaceutical, Inc.
• Defendant: Macoven Pharmaceuticals, L.L.C.

Infringement of U.S. Patent No. 6,528,496 ("Compositions Treating, Preventing, or Reducing Elevated Metabolic Levels," issued March 4, 2003) based on Macoven's manufacture, sale, and offer for sale of folic acid products allegedly represented to be substitutable for plaintiffs' Foltx® and/or Folbic® products (vitamin B12, vitamin B6, and folic acid, used to treat hyperhomocysteinemia). View the complaint here.
Conference & CLE Calendar

December 18, 2011

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

January 25-26, 2012 – Biosimilars Forum 2012 (C5) – London, UK

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 13-14, 2012 – China IP Counsel Forum (C5) – Shanghai, China

February 21-22, 2012 – Biotech & Pharmaceutical Patenting (IBC Legal) – Munich, Germany

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
Biotech & Pharmaceutical Patenting Conference 2012

December 16, 2011

IBC Legal will be holding its 20th annual Biotech & Pharmaceutical Patenting conference on February 21-22, 2012 in Munich, Germany. Conference highlights include:

• Benefit from industry perspectives throughout the day with IBC faculty of experienced corporate counsel;
• Hear the tips and traps of current tactics for maximising patent life cycles and data exclusivity;
• Gain an excellent understanding of the latest SPC position including a consideration of the judgments of key decisions including Novartis v Actavis, Medeva and Georgetown University;
• Analyse the practical implications on everyday work of the recent developments and case law in Europe and the U.S. and the latest on the European Medicines Agency concept paper;
• Examine the EC Bolar implementation and discuss recent developments and trends in avoiding patent infringements in clinical trials;
• Review and discuss the advantages and pitfalls of HGS v Lilly — has it lowered the bar for industrial applicability?
• Obtain cutting-edge advice and insights on patent protection strategies and competitive patent filing, paediatrics and competition issues in patenting.

In particular, IBC Legal faculty will offer presentations on the following topics:

• A perspective from industry;
• Developments in European patent law in the last 12 months;
• Second medical use and dosing regimens claims in the UK and at the EPO;
• Functional claims — Ensuring they stand up to scrutiny;
• Patentability and enforcement of research tool patents;
• Patenting genes and theranostics;
• Stem cells: When are they patentable?
• Patent filing in Brazil — Maximising your chances of success;
• Patent filing — An industry perspective;
• Strategies for maximising patent life cycles — Exploring the application of SPCs to extend patent life;
• EPO update;
• Dealing with competition law issues in patenting;
• Avoiding patent infringements in clinical trials and the EC Bolar implementation;
• Comparison of EU biosimilars legislation and Hatch-Waxman act procedures in the U.S.;
• Patent strategies in biosimilars;
• What you need to know about data exclusivity;
• Paediatric extensions — Issues and challenges; and
• SPCs masterclass.

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 £1,499. Those registering by January 27, 2012 will receive a £100 discount. Those interested in registering for the conference can do so here, by calling +44 (0)20 7017 5503, or by faxing a registration form to +44 (0)20 7017 4746.

Patent Docs is a media partner of the Biotech & Pharmaceutical Patenting conference.
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.

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