Patent Docs

ACI Conference on Post-Grant PTO Proceedings

February 20, 2015

American Conference Institute (ACI) will be holding a conference on Post-Grant PTO Proceedings on March 25-26, 2015 in New York, NY. ACI faculty will help attendees:

• Evaluate and audit existing patent portfolios to identify patents which are most vulnerable to these new post grant challenges;
• Analyze the impact of CLS Bank v. Alice Corp. and Nautilus, Inc. v. Biosig Instruments, Inc. on 101 patent eligibility and 112 claim construction/indefiniteness relative to post grant proceedings;
• Explore trends in IPR decisions and devise best practices for petition drafting and discovery;
• Examine novel uses of CBM review proceedings;
• Appreciate the infinite possibilities and infinite grounds for which PGRs can be brought;
• Understand how Congressional action and pending legislation may affect post grant proceedings and related activity;
• Develop patent litigation strategies which account for parallel proceedings before the PTAB and District Court; and
• Master protocols and rules of engagement for appearing before the PTAB.

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

• Keynote Address — The Honorable James Donald Smith, CAPJ, Chief Judge, Patent Trial and Appeal Board, U.S. Patent and Trademark Office
• Evaluating Patent Portfolio Planning and Due Diligence Analysis in the Era of New Post Grant Proceedings
• Oyez, Oyez, Oyez!: Analyzing the Impact of the Supreme Court's Decisions in Alice Corp. and Nautilus on AIA Post-Grant Proceedings
• Survey of Developments in New Post Grant Proceedings: Inter Partes Review: A Procedural, Substantive and Cross-Industry Retrospective
• Harnessing the Power of Covered Business Method Patent Review
• Post Grant Review: Predictions for the Next Big Thing in Patent Law
• The Politics and Policy of Post Grant Proceedings: An Update on the Latest Legislative Developments Which May Impact and Amend the AIA and related Post Grant Proceedings
• New PTO Proceedings Playbook: Developing Strategies for PTO Patent Trial Practice
• May It Please the Court: Rules of Engagement for Appearing Before the PTAB

In addition, a pre-conference workshop entitled "Post-Grant PTO Proceedings Boot Camp: Assessing the Impact of New PTO Procedures Under the AIA on Patent Litigation" will be offered from 2:00 to 5:30 pm on March 24, 2015, and a post-conference workshop entitled "Anatomy of a PTO PTAB Patent Trial" from 1:30 to 4:00 pm on March 26, 2015.

An agenda for the conference can be found here (Day 1) and here (Day 2), and additional information regarding the workshops can be found here and 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 $2,195 (conference alone), $2,795 (conference and one workshop), or $3,295 (conference and both workshops). Special rates are available for in-house counsel (see brochure). 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 Post-Grant PTO Proceedings conference.
Global Biotech IP Update

February 20, 2015

Maschio & Soames will be offering a Global Biotech IP Update webinar on "Patent Eligibility Requirements in Life Sciences" on March 3, 2015 at 2:00 pm CST (Chicago), and Wednesday, March 4 at 12:00 noon AEDT (Melbourne) and 12:00 noon GMT (London). Robert Dempster of Maschio & Soames IP Ltd., David Gass of Marshall, Gerstein & Borun LLP, and Karen Innes of FB Rice will review what biotech inventions are patentable in major jurisdictions, and discuss recent court decisions and practice changes, including the new USPTO guidelines.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here.
Webinar on Drafting and Prosecuting Patent Applications to Withstand PTAB Scrutiny

February 20, 2015

Strafford will be offering a webinar/teleconference entitled "Drafting and Prosecuting Patent Applications to Withstand PTAB Scrutiny — Building Reasonable Claim Construction to Avoid Unpatentability and Using Declarations to Survive Post Grant Proceedings" on March 5, 2015 from 1:00 to 2:30 pm (EST). Anthony M. Gutowski, Thomas L. Irving, John Mulcahy of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel for drafting and prosecuting U.S. patent applications to achieve the broadest claim interpretation and avoid unpatentability and yet still be able to prove infringement, and offer best practices to solidify novelty, non-obviousness, enablement, and written description positions. The webinar will review the following questions:

• How can practitioners draft and prosecute patent applications and claims to minimize the threat and/or efficacy of a third-party’s post-grant challenges?
• How can patent owners obtain broad claims to keep competitors at bay while countering attempts to render those broad claims unpatentable under the broadest reasonable interpretation standards before the PTAB?
• How can practitioners introduce strong grounds for patentability under §§ 102, 103, and 112, in the specification and prosecution history so that IPRs and PGRs are either denied or otherwise ineffective against the challenged instituted claims?

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.
USPTO Holds Forum on Interim Guidance — Part III

February 19, 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 Part I of our series on the forum, and highlights from the first group of public presentations were provided in Part II of the series. Today, we provide some of the highlights from the second group of public presentations, the majority of which addressed how the Interim Guidance dealt with the Supreme Court's decision in Alice Corporation Pty. Ltd. v. CLS Bank International. The second group consisted of ten presenters: Bob Stoll of the Partnership for American Innovation (PAI); Jim Crowne of the American Intellectual Property Law Association (AIPLA); Robert Hardy of the Council on Governmental Relations (COGR); Micky Minhas of Microsoft Corp.; Thomas Isaacson of Novak Druce Connolly Bove + Quigg LLP; Kate Gaudry and Angel Lezak of Kilpatrick Townsend & Stockton LLP; Robert Sachs of Fenwick & West LLP; Sigram Schindler of TELES Patent Rights International GmbH; and Clark Jablon of Panitch Schwarze Belisario & Nadel LLP.

Leading off for the second group of presenters was the former Commissioner of Patents, now representing PAI, which describes itself as "a group of companies that represent diverse industries working together to promote a climate of technology innovation by telling the story of IP's value." Declaring the Interim Guidance to be "in quite good shape," and a "substantial improvement" with respect to nature-based products, Mr. Stoll indicated the Office had made "good on its promise to improve" the Myriad-Mayo guidance. However, he encouraged the Office to expand on its guidance regarding the impact of the Alice decision.

While pointing out areas in the guidance where the Office had positively responded to criticism, Mr. Crowne, who represented the AIPLA, noted that some work still needed to be done. In particular, he argued that there was a "certain circularity" to the Office's definition of claims that are "directed to" a judicial exception and those "involving" a judicial exception. He also contended that in defining "directed to" as including "reciting," the Interim Guidance included "vestiges of the original guidance" that continued to distort the examination of subject matter eligibility.

Mr. Hardy, who noted that in addition to COGR, he also represented the Association of American Universities (AAU), Association of Public & Land Grant Universities (APLU), and Association of University Technology Managers (AUTM), commended the Office for its "valiant effort" in navigating the "maze of sometimes contradictory court decisions" to craft the Interim Guidance. He observed that the Federal Circuit's decision in In re BRCA1- and BRCA2-based Hereditary Cancer Test Patent Litigation ("Myriad II") indicated that the CAFC had a different way of looking at the markedly different standard than the way the standard was discussed the Interim Guidance. He also encouraged the Office to develop additional examples and provide analysis of those examples, as well as to provide more clarification for claims reciting combinations of nature-based products.

After Mr. Hardy, the remaining presenters in the second group focused on the impact of the Interim Guidance on subject matter in the Alice space. Despite this focus, however, several presenters offered suggestions that seemed to resonate with practitioners and applicants in the Myriad/Mayo space. For example, Mr. Isaacson presented five proposals for improving the evaluation of subject matter eligibility for software applications, but which would likely improve the eligibility analysis in any Art Unit. His five suggestions included: (1) requiring examiners to use claim language in their analysis and not stray from the claim language (stating that "[t]he 'name of the game is the claim' must remain"), (2) placing a prima facie burden on examiners to provide some articulated reasoning with some rational underpinning to support ineligibility determinations (akin to the requirement for making obviousness rejections), (3) requiring examiners to produce evidence to support ineligibility determinations, (4) requiring examiners to consider applicants' rebuttal evidence, and (5) lowering the § 101 hurdle, which he asserted was too high and should instead be "very low." A copy of Mr. Isaacson's presentation can be obtained here.

Ms. Gaudry and Ms. Lezak presented data collected from business method art units, and concluded that the data indicated that following the Alice decision, the pendulum had swung too far towards rejection of applications directed to business methods.

They also noted that in the span of ten months, the allowance rate for business method art units had dipped from 24% in January to 5% in July to 3% in October. A copy of Ms. Gaudry's and Ms. Lezak's presentation can be obtained here.

The next presenter, Mr. Sachs, confessed to being "a critic of the Office," and expressed surprise that the Office had agreed to let him present. He explained that he had reviewed all of the Alice-related comments and had found that eighteen of the comments suggested that the Office require examiners to provide factual evidence and reasoning on the record in order to support a § 101 rejection. He noted that this is precisely what had been done in Bilski and Alice, and argued that examiners should not be permitted to make unsupported conclusory statements when finding a claim to be patent ineligible.

Mr. Sachs also noted that the Alice-related comments were in agreement that the focus of an eligibility analysis should be preemption, i.e., that preemption was the core of § 101. While pointing out that the Alice-related comments had all asked for more examples, what was also needed was more explanations. With respect to the Office's analysis of the cases, he argued that "the cases are inconsistent," which is "why we are here." A copy of Mr. Sachs' presentation can be obtained here.

The penultimate presenter in the second group, Dr. Schindler, warned the Office that they had "no chance" of settling the subject matter eligibility issue, and contended that the Supreme Court Justices were "excellent" and "brilliant" and had issued decisions in Alice and Myriad that were simply not understood. He also argued that while the Supreme Court was "absolutely on the right track," the Federal Circuit had "screwed it up" and would "sooner or later understand that they're dead wrong" on subject matter eligibility. A copy of Dr. Schindler's presentation can be obtained here.

For additional information regarding this topic, please see:

• "USPTO Holds Forum on Interim Guidance — Part II," February 18, 2015
• "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
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.

recent posts

about