Patent Docs

USPTO Holds Forum on Interim Guidance — Part II

February 18, 2015

By Donald Zuhn —

In a forum held last month on the U.S. Patent and Trademark Office's Alexandria campus, Office representatives discussed the Interim Guidance on Patent Subject Matter Eligibility, which was released in December, and received additional input from the public regarding that guidance. The forum, which ran almost four and a half hours, began with some opening remarks by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy at the USPTO, and then Raul Tamayo, Senior Legal Advisor in the Office of Patent Legal Administration at the USPTO, followed Mr. Hirshfeld's presentation with an overview of the Interim Guidance. The remainder of the forum was devoted to two groups of public presentations — in which the presenters were essentially divided into those on the life sciences side (group one) and those on the hi-tech side (group two) — and an "open participation/question/answer" session, in which attendees were allowed to give statements or ask questions of USPTO representatives participating in the forum. A replay of the forum can be viewed here.

Summaries of Mr. Hirshfeld's and Mr. Tamayo's presentations were provided in an earlier post. Today, we provide some of the highlights from the first group of public presentations, which consisted of nine presenters: Leslie Fischer of Novartis Pharmaceuticals Corp.; Hans Sauer of the Biotechnology Industry Organization (BIO); Courtenay Brinckerhoff of Foley & Lardner LLP; Suzannah Sundby of Canady + Lortz LLP; Anthony Sabatelli of Dilworth IP, LLC; Brian Stanton of Stanton Consulting Services, LLC; Hathaway Russell of the Coalition for 21st Century Medicine; and Amelia Baur and Kevin Greenleaf of the ABA Section of Intellectual Property.

During her presentation, Dr. Fischer argued that Step 2B of the Interim Guidance's test — which corresponds to part 2 of the Alice Corp./Mayo test, and which calls for the examiner to "[d]etermine whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception" — may not be a proper interpretation of case law. Pointing out that "there is only one Rome, but there are many roads to Rome," Dr. Fischer contended that "one test doesn't rule them all" and asked the Office to consider redrafting Step 2B to encompass other tests. She suggested that one of those tests — the markedly different analysis for nature-based products that the Office had placed in Step 2A — should be moved to Step 2B. A copy of Dr. Fischer's presentation can be obtained here.

Dr. Sauer addressed the impact of the Interim Guidance on innovation, noting that while several media reports had recently described the discovery of the first new antibiotic in thirty years (see, e.g., "U.S. Scientists Discover Powerful New Antibiotic"), those reports had failed to mention that a patent application directed to the antibiotic had been rejected by the USPTO. (Interestingly, the announcement of the discovery of the new antibiotic came only months after the President's Council of Advisors on Science and Technology issued a report for dealing with the problem of antibiotic resistance.) Dr. Sauer indicated that the President had touched on antibiotics in his State of the Union address, and reminded the Office that it was charged by statute with informing the President about patent issues such as subject matter eligibility.

Ms. Brinckerhoff's presentation focused on the Federal Circuit's decision in In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation ("Myriad II") which issued one day after the Interim Guidance was released (a decision that Dr. Sauer noted had tempered the optimism of the patent community for the Interim Guidance). According to Ms. Brinckerhoff, in Myriad II, the Federal Circuit ignored Supreme Court precedent and reached the wrong decision by confusing a molecule's property with its function (see slide below from her presentation).

A copy of Ms. Brinckerhoff's presentation can be obtained here.

Ms. Sundby's presentation addressed the impact of the Interim Guidance on "weighted" assay claims (diagnostic method claims wherein weighted values are assigned to a number of biomarkers and a diagnosis is made based on a total weighted value for those biomarkers). She argued that the biomarker weights had been assigned by the inventor and were not simply the discovery of a law of nature, and therefore that such claims should be found to be patent eligible. A copy of Ms. Sundby's presentation can be obtained here.

Dr. Sabatelli discussed some of the positive aspects of the Interim Guidance (e.g., discarding the 12-factor test) and then provided a critique of certain aspects of the Guidance that required further improvement. Echoing Dr. Fischer's comments, much of Dr. Sabatelli's criticism focused on the "detour" for nature-based products (see slide below from his presentation).

Dr. Sabatelli's proposed solution was to "ditch the detour." A copy of Dr. Sabatelli's presentation can be obtained here.

Mr. Stanton began his presentation by noting that he had worked on the written description guidelines during his tenure at the USPTO (he had since left the Office for private practice). With respect to the Interim Guidance, he provided a few proposals for improving the Guidance, including focusing on the issue of preemption in conducting a subject matter eligibility analysis, and establishing a working group that could propose claims which would serve as templates for drafters. He also called on the Office to release the long overdue report on genetic testing that was mandated by the Leahy-Smith America Invents Act.

Highlights from the second group of public presentations will be provided in a subsequent post.

For additional information regarding this topic, please see:

• "USPTO Holds Forum on Interim Guidance — Part I," February 2, 2015
• "USPTO Issues Post-Alice Abstract Idea Examples," January 28, 2015
• "Impact of Interim Guidance on Business Method and Software Claims," December 17, 2014
• "USPTO Issues Interim Guidance on Subject Matter Eligibility," December 16, 2014
• "USPTO to Release Revised Subject Matter Eligibility Guidance," December 15, 2015
A Genetic Basis for Beak Diversity in Darwin’s Finches

February 17, 2015

By Kevin E. Noonan —

One of the most iconic observations in biology is Charles Darwin's study of the finches of the Galapagos Islands, and his realization that they had all arisen from the same ancestral bird population. While pigeon breeding (as well as animal husbandry in general) had a long lineage in Europe, there was something about seeing the results of natural (as opposed to human) selection that gave Darwin (at right) a real world foundation for the concept that species evolved over time. A particularly significant observation made by Darwin is that the finches had evolved a variety of beak shapes that permitted them to exploit non-overlapping ecological niches, thereby providing a basis for why evolution had selected these particular varieties of finches and the biological advantages accruing to teach species that helped explain how evolution occurred (i.e., by natural selection).

The evolution of Darwin's finches has been understood as an example of adaptive radiation, where a founder population gives rise to related species having ecological and genetic biodiversity from each other and the founder population. Despite intensive study, the taxonomy of the finches is not completely clear (being based on morphology and breeding patterns). However, factors involved in speciation were thought to include geographic isolation (from S. America), volcanic activity, variations in sea levels due to glaciation, and the effects of climatic variations (for example, from El Nino events).

This week, an international interdisciplinary group of genomic researchers* reported in Nature the genome-wide sequencing of 120 individual finches representative of all the Darwin finch species plus two related species of birds (Tiaris bicolor and Loxigilla noctis) for comparison. (Lamichhaney et al., "Evolution of Darwin's finches and their beaks revealed by genome sequencing," Nature 2015). As reported therein, mitochondrial DNA sequencing confirmed that there are 14 species of finches from the Galapagos Islands and one from the nearby Cocos Islands that have evolved over the past 1.5 million years; advantageously, none of the species has gone extinct (inter alia, through human predation).

The study comprises ten-fold genome sequence coverage, assembled relative to a female medium ground finch, Geospiza fortis. Effective population sizes of 6,000 – 60,000 for each species were found, and genetic diversity within each species population was found to be similar to other birds and described as being "considerable." Based on the variation found in the sequencing study and using the tools of phylogenetic tree construction supported by these results the study confirmed generally the results of classical taxonomic determinations that the first group to split from the ancestral finch population were the warbler finches (Certhidea sp.) around 900,000 years ago, and that a "rapid radiation" of ground and tree finches were the latest evolutionary split to have occurred from 100,000-300,000 years ago. However, genomic sequencing also found some "interesting deviations" as described in the report:

A network constructed from autosomal genome sequences indicates conflicting signals in the internal branches of ground and tree finches that may reflect incomplete lineage sorting and/or gene flow.

The authors found evidence in introgression between species (interspecies gene flow) that could explain discrepancies between phylogenies based on morphology and genome sequences, wherein they considered hybridization between species to have resulted in mixed ancestry individuals.

The authors further reported the results of genome-wide scans of finch populations that "are closely related but show different beak morphology: G. magnirostris and G. conirostris on Española have blunt beaks, whereas G. conirostris on Genovesa and G. difficilis on Wolf have pointed beaks." These studies used non-overlapping 15-kilobase (kb) windows "to identify regions with the highest fixation indices . . . between groups." Taking the results of the 15 "most significant" genomic regions, the authors reported that they found six contained genes that had been associated with craniofacial development in mammals and beak development in birds; these included calmodulin (CALM), goosecoid homeobox (GSC), retinol dehydrogenase 14 (RDH14), ALX homeobox 1 (ALX1), fibroblast growth factor 10 (FGF10) and forkhead box C1 (FOXC1). Further, beak diversity was found to be associated with a 240 kb haplotype encompassing a gene (ALX1) that encodes a transcription factor involved in craniofacial development:

The region overlaps part of LRRIQ1 (leucine-rich repeats and IQ motif containing 1), the entire ALX1 gene and about 130 kb downstream of ALX1. No previous report indicates that LRRIQ1 has a role during development in vertebrates. By contrast, ALX1 is an excellent candidate for variation in beak morphology. It encodes a paired-type homeodomain protein that plays a crucial role in development of structures derived from craniofacial mesenchyme, the first branchial arch and the limb bud, and on migration of cranial neural crest cells, highly relevant to beak development. Loss of ALX1 in humans causes disruption of early craniofacial development. Also involved in the related species of the medium ground finch (Geospiza fortis).

Specific versions of the genetic haplotype in this 240 kb region were found associated with specific beak morphologies. For example, "[a]ll individuals in the blunt beak category were homozygous for a blunt beak-associated haplotype (denoted B)." Conversely, the pointed beak phenotype was associated with homozygosity for haplotype P "consistent with their phenotypic appearance (sharp-beaked ground finches)." The authors concluded that "[a] phylogenetic tree based on this region revealed a deep divergence between the B and P haplotypes that must have occurred soon after the split between warbler finches and other Darwin's finches." Moreover, "[t]he derived ALX1-B haplotype associated with blunt beaks has a long evolutionary history (hundreds of thousands of years), because its origin predates the radiation of vegetarian, tree and ground finches."

The authors also reported that they found "335 fixed differences between the B and P haplotypes (BB and PP) and that "[t]he short branch lengths among B haplotypes are consistent with a selective sweep" (i.e., a suppression of heterozygosity in the region). With regard to beak phenotype, so-called "derived" alleles (to distinguish later-arising genetic changes from the "ancestral" forms) were found to be "aggregated" in the region of ALX1, and 8 of the 335 conserved differences occurred at conserved sites, where the B haplotype "carried" the derived allele at seven of them.

Looking at these derived alleles, the authors found that four of these were at sites that in the human genome corresponded to transcription factor binding sites, suggesting a mechanism for the observed effects of these alleles on beak phenotype. Two other changes comprised missense mutations in ALX1 itself (L112P and I208V) at highly conserved residues in both bird and human versions of this gene. In the context of sequence comparisons of ALX1 between bird species these changes were considered by the authors to be "non-neutral," further affirming their putative role in adaptive radiation of finch beak morphology.

One particular observation supporting a role for ALX1 in beak diversity came from the results of the genome-wide scan on individuals from G. fortis species, which were found to be polymorphic, which the authors considered "particularly interesting," at least in part because this genetic polymorphism was associated with phenotypic diversity in beak shape in this species seen in field observations. Additional genotyping of 62 G. fortis birds found a diagnostic single nucleotide polymorphism (SNP) that was significantly associated with beak shape (reported as P = 8.8 × 10⁻⁵). Phenotypically, PP homozygotes tended to have proportionately long, pointed beaks, BB homozygotes had proportionately deep, blunt beaks, whereas heterozygotes (BP) had intermediate beak shapes.

The authors also found evolutionary change attributable to the past few decades resulting from natural selection on beak size and shape of G. fortis on Daphne Major Island, and that "genetic variation in beak shape has been increased through introgressive hybridization with two species of Geospiza, [Geospiza] scandens and [Geospiza] fuliginosa, that have relatively pointed beaks." Genetic analysis of haplotype frequencies between hybrid birds and backcrosses (to the original type) led these researchers to conclude that "ALX1-P alleles introduced by introgressive hybridization most probably contributed to evolution of more pointed beaks in 1987 following natural selection as a result of a change in food supply in the 1985–86 drought."

The authors concluded that beak shape diversity is "polygenic" based on their association of variations in beak shape with 15 genetic loci, and that "the ALX1 locus contributes to beak diversity, within and among species."

* The authors are from the Department of Medical Biochemistry and Microbiology, Uppsala University, Uppsala, Sweden; the Department of Animal Breeding and Genetics, Swedish University of Agricultural Sciences, Uppsala, Sweden; the Department of Plant Physiology, Umeå University, Umeå, Sweden; the Department of Ecology and Evolutionary Biology, Princeton University, Princeton, New Jersey; and the Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, Texas.
Game Over for Myriad — Update

February 16, 2015

(Or, and then there was one were none)

By Kevin E. Noonan —

As discussed for the past month, Myriad has finally given up trying to defend its BRCA gene testing franchise. The one remaining matter, Myriad's case against GeneDx has settled, as announced by the company today.

However, GeneDx has not moved before the Patent Trial and Appeals Board (PTAB) to dismiss its inter partes review (IPR) challenge under the Leahy-Smith America Invents Act. Although IPR actions can be settled, they can also be pursued to their conclusions sua sponte by the Board. The patents at issue in that action are U.S. Patent Nos. 5,654,155; 5,753,441; 6,033,857; 6,051,379; 6,083,698; 6,951,721; 7,470,510; 7,563,571; 7,622,258; 7,670,776; and 7,838,237. While such a decision would likely be a waste of taxpayer time and money, there may be some sentiment within the Office (which seems to have taken to heart criticisms from the Supreme Court and elsewhere regarding granting "gene patents" in the first place) to render an invalidity decision once and for all on these patents. Of course, because IPRs are limited to patentability challenges under §§ 102 and 103, the Board could arrive at the (politically) anomalous result that Myriad's claims are patentable despite being patent ineligible under § 101. The PTAB has previously avoided this outcome in the Sequenom/Isis claims in an earlier IPR by refusing to permit claims to be amended in view of a district court's determination that the claims at issue in that IPR were patent ineligible under § 101, but those circumstances are unlikely to recur here.
Court Report

February 15, 2015

By Sherri Oslick —

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

Novartis AG et al. v. Ezra Ventures LLC
1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware

• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. Ltd.
• Defendant: Ezra Ventures LLC

Novartis AG et al. v. HEC Pharm Group et al.
1:15-cv-00151; filed February 11, 2015 in the District Court of Delaware

• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. Ltd.
• Defendant: HEC Pharm Group; HEC Pharm Co. Ltd.; HEC Pharm USA Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis). View the Ezra complaint here.

Roxane Laboratories, Inc. v. Lupin Ltd. et al.
2:15-cv-01095 filed February 10, 2015 in the District Court of New Jersey

• Plaintiff: Roxane Laboratories, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease). View the complaint here.

Novartis Pharmaceuticals Corp. v. BPI Labs, LLC
8:15-cv-00272; filed February 9, 2015 in the Middle District of Florida

Novartis Pharmaceuticals Corp. v. BPI Labs LLC
2:15-cv-00950; filed February 5, 2015 in the District Court of New Jersey

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of BPI's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer). View the New Jersey complaint here.

Jazz Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals, LLC
2:15-cv-01043; filed February 6, 2015 in the District Court of New Jersey

• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Amneal Pharmaceuticals, LLC

Infringement of U.S. Patent Nos. 8,731,963 ("Sensitive Drug Distribution System and Method," issued May 20, 2014), 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014), and 8,859,619 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 14, 2014) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.

AstraZeneca AB et al. v. Perrigo Co. PLC et al.
3:15-cv-01057; filed February 4, 2015 in the District Court of New Jersey

• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Perrigo Co. PLC; Perrigo Co.; L. Perrigo Co.; Paddock Laboratories, LLC

Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Conference & CLE Calendar

February 15, 2015

February 19, 2015 - "Readjusting the USPTO 101 Guidance for Life Science Inventions to Alice and Public Input: Are We There Yet?" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

February 19, 2015 – "Structuring Patent Indemnification Provisions After the AIA — Allocating Infringement Risk While Accounting for AIA Changes to PTAB Estoppel and Statutory Bar Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

February 25, 2015 – European biotech patent law update (D Young & Co) – 3:00 am, 6:00 am, and 11:00 am (ET)

February 25, 2015 – "Prevailing Before the PTAB 'Death Squad': Practical Considerations for Petitioners and Patent Holders" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

February 26, 2015 – "Coordinating Post-Grant Patent Opposition in Europe and the U.S. — Navigating Timing, Grounds for Opposition, Discovery, and Amendments to Maximize Protection in Both Jurisdictions" (Strafford) – 1:00 to 2:30 pm (EST)

February 27, 2015 – 59th Annual Intellectual Property Law Conference (The John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

March 4-5, 2015 – Medical Device Patents (American Conference Institute) – Chicago, IL

March 5-6, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

March 10-11, 2015 – FDA Boot Camp*** (American Conference Institute) – New York, NY

March 19, 2015 – "Abstract Ideas after Alice Corp. v. CLS Bank Int'l: The USPTO Issues Interim Guidance and Examples" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

***Patent Docs is a media partner of this conference or CLE
Webinar on Abstract Ideas after Alice Corp. v. CLS Bank Int’l

February 13, 2015

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on "Abstract Ideas after Alice Corp. v. CLS Bank Int'l: The USPTO Issues Interim Guidance and Examples" on March 19, 2015 from 10:00 am to 11:15 am (CT). In this presentation, Patent Docs contributor and MBHB attorney Michael S. Borella will provide an integrated view of the guidelines and the examples, focusing on which post-Alice questions are answered, and which are not.

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

February 13, 2015

American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on March 10-11, 2015 in New York, NY. ACI faculty will help attendees:

• Master the basics of the application and approval processes for drugs, biologics, and devices;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Learn how devices are classified, monitored, and regulated;
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• Recognize the pivotal role of labeling in the drug and biologics approval process;
• See the importance of cGMPs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.

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

• Brief Overview of FDA Practice
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Drugs and Biologics: Labeling
• Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
• Part 1 — Patents, Trademarks and Other IP Protections and Mechanisms
• Part 2 — Hatch-Waxman and BPCIA Overview
• The Drug Supply Chain Security Act — Summarizing the Act and Its Effect on FDA Practice
• cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
• Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
• Using FDA's Citizen Petition Process and Litigation to Achieve Market Success
• How to Respond to FDA: Best Practices, Tips, Tricks, and Pitfalls to Avoid
• Adverse Events Monitoring, Pharmacovigilance and Risk Management, and Recalls

A pre-conference workshop on the "Fundamentals of FDA Regulatory Law" and "Resolving Ethical Challenges Encountered During the Drug Approval Process" will be offered on March 9, 2015 from 1:00 to 5:00 pm. Two post-conference master classes will be offered on March 11, 2015. The first master class is entitled "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics," and the second master class is entitled "Post-Approval Marketing Guidance and Preemption Protocols."

An agenda for the conference can be found here, and additional information regarding the workshop and master classes 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 is $2,295 (conference alone), $2,895 (conference and workshop or conference or one master class), or $3,495 (conference, workshop, and one master class). Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, 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 FDA Boot Camp conference.
European Biotech Patent Law Webinar

February 13, 2015

D Young & Co will be offering its next European biotech patent law update on February 25, 2015. The 45-minute webinar will be offered at three times: 3:00 am, 6:00 am, and 11:00 am (ET). D Young & Co European Patent Attorney Simon O'Brien will provide an essential update and live Q&A on EPO biotechnology case law.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
John Marshall Law School 59th Annual IP Law Conference

February 13, 2015

The John Marshall Law School Center for Intellectual Property Law will be holding its 59th Annual Intellectual Property Law Conference on February 27, 2015 in Chicago, IL. The conference will consist of the following sessions:

• Recent Developments in Intellectual Property Law
• Keynote speaker — Lisa K. Jorgenson, Executive Director, American Intellectual Property Law Association

The conference's afternoon patent track will consist of sessions on:

• Creative Use of Jury Research in Patent Cases
• Drafting Successful Applications for Life Science and Business Method Patents
• Patent Damages
• Strategies in Post-Grant Proceedings for Biotech/Pharma and Financial Services

Additional information about the conference, including a complete list of speakers, can be found here. Those interested in registering for the conference online can do so here; the registration fee is $195 (general rate), $95 (government, judicial, and academic rate), or free (JMLS students).
Webinar on Patent Indemnification Provisions

February 13, 2015

Strafford will be offering a webinar/teleconference entitled "Structuring Patent Indemnification Provisions After the AIA — Allocating Infringement Risk While Accounting for AIA Changes to PTAB Estoppel and Statutory Bar Requirements" on February 19, 2015 from 1:00 to 2:30 pm (EST). C. Andrew Keisner of Davis & Gilbert and Robert E. Krebs of Nixon Peabody will prepare counsel to IP owners, licensees and licensors to protect their interests by allocating patent infringement risks during negotiations of indemnification provisions in a patent license or vendor contract, and examine the impact of the AIA on indemnification and discuss indemnity issues in litigation. The webinar will review the following questions:

• How has the AIA impacted indemnity and how should patent counsel account for the changes when structuring indemnification provisions?
• When does an indemnification clause create privity under the IPR statutes?
• What approaches should counsel use to protect a client's interests when negotiating an indemnification provision?

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

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