Patent Law Weblog

recent posts

about

  • Guest Post — Patent Beauty: IP and the Cosmeceutical Industry

    By Shin Hee Lee* and Anthony D. Sabatelli** —

    The cosmeceutical industry is ever more competitive and continues to grow with a myriad of new cosmeceutical products entering the market every day.  Well-established and new companies are busily adapting to new trends created by people's changing tastes.  The total revenue of the U.S. cosmeceutical industry has only been increasing since 2009, marking $62.46 billion in 2016.  While this revenue comes from a number of cosmeceutical product categories, skin care has always been the most profitable category, covering 36% of the global market.  In this article, we discuss some of the recent growth and trends in skin care cosmeceutical patents.

    It is often unknown that the 182 most recognized beauty brands in the world are actually owned by seven major cosmeceutical companies:  L'Oréal, Johnson and Johnson, Shiseido, Estée Lauder Companies, Unilever, Coty, and Procter & Gamble.  L'Oréal umbrellas the most brands with a total of 39 prevalent companies in an array of beauty stores.  These store brands are very well-known, including Kiehl's, Lancôme, The Body Shop, Urban Decay, and Maybelline.  On the other hand, the Estée Lauder Companies own internationally recognized luxury brands such as Clinique, Bobbi Brown, MAC, Jo Malone, Lab Series, and Glamglow.  These brands highly occupy the shelves in Sephora and other popular beauty vendors.  The plethora of products and the explosion of marketing venues suggests how competitive it can be for new cosmeceutical companies to succeed in the market.

    To be competitive in the cosmeceutical industry, a company, whether new, rising or established, should focus on establishing solid intellectual property (IP) rights.  IP rights protect and support elements that help companies distinguish their products from rival companies.  Furthermore, the number of patents can be a powerful marketing tool, especially when touting the "patented" technology used to develop the product.

    Because of the significance of IP rights in the cosmeceutical industry, there is currently an overwhelming number of cosmeceutical patents.  Skin care has the leading number of patents, correlating to its enormous global sales (projected to reach $130 billion by 2019).

    Anti-aging has been the most popular category within skin care, attributed to the high demand of products promoting youthful looks that defy a consumer's biological age.  The majority of anti-aging patents relate to inventions based on unique compositions of known or novel ingredients.  An assortment of vitamins like retinol (made from vitamin A), vitamin C, coenzyme Q-10, and alpha-hydroxy acids (AHAs) have traditionally been touted to have anti-aging efficacies.  However, with the recent beauty trend of "clean cosmeceuticals," some patentees have pointed at the toxicity of some complementary additives in these vitamins and have filed patents for supposedly more natural plant-based components.  Some anti-aging products contain peptides instead of vitamins as their main component.  A recent study has shown that defensins, a group of antimicrobial peptides that activate stem cells to produce new skin, provide incredible anti-aging effects.  Many reporters have been labeling defensins as "a game changer," and "the newest anti-aging weapon."  Patents on anti-aging formulations will likely surface in the near future.

    Another area of intense patent activity relates to cosmetic devices.  Portable home skin care devices for measuring and improving skin conditions have been increasingly patented and commercialized.  One of the pioneers that popularized hand-held devices was a company named Clarisonic (or Pacific Biosciences Laboratories), which owns 40 patents on their devices.  Clarisonic's iconic cleansing tool is a mechanically rotating face brush that oscillates back and forth over the skin to thoroughly remove any oil, debris, makeup and environmental pollutants.  Recently, Neutrogena has introduced small portable stick that treats acne using phototherapy.  Depending on the light color, the stick can treat different types of skin problems.  One futuristic skin care device on the rise is a mirror with built-in digital sensors that detect and analyze the skin's moisture, oiliness, and redness.  Devices that were only accessible at a dermatologist's office are increasingly becoming home-friendly.  We expect the skin care device patents continue to increase in the coming years, especially the design patents.

    Shown below are two tables summarizing some of the patent trends for cosmetics and recent devices.

    Table 1
    Table 2

    * Shin Hee Lee is a Ph.D. Candidate in the Chemistry Department at Yale University.  She is currently associated with the Yale Energy Sciences Institute, where she specializes in organic synthesis of novel light-harvesting dye molecules for solar cells.  Prior to attending Yale, Shin Hee obtained her B.S. in Chemistry with High Honors at the University of Michigan – Ann Arbor, during which she published patents and papers on developing synthetic methodologies for fluorinated small molecules.
    ** Dr. Sabatelli is a Partner with Dilworth IP

  • Genetic Analyses of Sweet Potato Genome Sheds Light on Speciation and Global Dispersion Patterns

    By Kevin E. Noonan —

    Sweet PotatoHiram Bentley Glass and classical geneticists of the Twentieth Century elucidated some of the ways that genetics could inform regarding human populations and their history, using observations like genetic drift (famously, among the Amish) and the "founder effect."  The "genomics" revolution of the last thirty years has extended these observations, for human populations as well as many other animal and plant species (see, e.g., "Genetic Assessment of Squash Genomes in Related Species"; "The Domestication History of Apples Revealed by Genomic Analysis"; and "Domestic Cat Genome Sequenced").  Recently, several outstanding questions regarding the genetics of sweet potato were resolved, in a report in Current Biology, entitled "Reconciling Conflicting Phylogenies in the Origin of Sweet Potato and Dispersal to Polynesia," resulting from genomic and chloroplast DNA analyses that establish the phylogenetic, temporal and geographical relationships between this important crop species and its wild naturally occurring relatives.

    The paper, from an international group of researchers* from the University of Oxford, Oregon State University, International Potato Center (Lima, Peru) and Duke University, used genome skimming and target DNA capture on 199 specimens comprising sweet potato (Ipomoea batatas) and all its wild relatives (I. trifida, I. triloba, I. ramosissima, I. cordatotriloba, and I. leucantha).  One of the most consumed crops worldwide, the species originated in the Caribbean region (Central and northeastern South America and the islands comprising the region) but is also endemic to Polynesia.  In addition to the evolutionary relationship between I. batatas and its wild relatives, this geographical distribution pattern has long raised the question of whether dispersion occurred without human intervention (wind, water, birds) or whether there were humans transiting the Pacific much earlier than anthropological evidence suggests.  The genetic evidence shows that human intervention is not necessary to explain sweet potato presence in Polynesia based on comparisons of the relationship (and divergence) of the Polynesian species (Ipomoea littoralis Blume) with I. batatas and other New World members of its family.

    The researchers report that their dataset consisted of 199 individuals representing all sixteen species in Ipomoea series Batatas and twenty-four other species across the Ipomoea genus.  These included fresh samples growing contemporaneously as well as herbarium specimens dating back to 1769.  Probes for 605 putative single copy nuclear regions of Ipomoea were derived from a comparison between genomic information from I. lacunosa and coding sequence-restricted data from the related Solanum tuberosum (potato).  The team interrogated genomic regions with a one-to-one match at 70% identity along at least half the length of a Solanum CDS and the results were filtered to retain Ipomoea loci that were at least 1000 bp long.  From these loci 100 bp-long RNA probes were developed, excluding probes with GC content < 25%.  In addition, the researchers obtained complete chloroplast DNA sequences from each specimen.

    From these comparisons the scientists concluded that the I. batatas sweet potato species is most closely related to I. trifida.  Speciation arose from a first autohexaploidy event, with the related species having the following family tree set forth in A:

    Figure 2_lrg
    Muñoz-Rodríguez et al., 2018, Current Biology 28(8): 1246-56, Figure 2

    Sweet potato is also the only member of this extended family whose evolution contains an autohexaploidy event.  This origin was supported by an analysis of the six alleles in each I. batatas genome, which the researchers found were more closely related to each other than to any other species (shown in B).

    When did I. batatas diverge from I. trifida?  Using nuclear DNA comparisons over 21 nuclear regions, the researchers estimated that divergence occurred at least 800,000 years ago; there was also evidence of a population bottleneck ~640,000 years ago.

    Whole chloroplast genome analysis was performed and revealed two genetically distinct lineages, with one (termed CL2) being more closely related to chloroplasts contained in I. trifida.  The relationship between the two chloroplast species compared with chloroplasts from I. trifida reported showed no shared insertion/deletion events (indels) between CL1 and CL2, but that I. batatas CL2 chloroplasts shared indels in common with I. trifida chloroplasts.  The results of these analyses suggested that the sweet potato species had undergone two speciation events:  the first, autohexaploidy from an I. trifida-like ancestor, followed by later introgresssion (occurring within about 56,000 years from the autohexapolidy event) by I. trifida, resulting in two populations of chloroplasts in natural species.  The Figure represents this history:

    Figure 4_lrg

    Muñoz-Rodríguez et al., 2018, Current Biology 28(8): 1246-56, Figure 4

    This Figure shows two alternative histories to explain the two chloroplast lineages in natural populations, with the evidence being more consistent with Figure C, resulting in an I. batatas species having CL1 and Cl2 chloroplasts.

    Turning to the genetic evidence for Polynesian dispersion (which extends today from Polynesia to Madagascar), comparison between the Ipomoea littoralis Blume species and I. batatas indicated (through genetic differences that would have been familiar to Bentley Glass and colleagues) that the sweet potato dispersed to Polynesia 111,500 – 139,000 years ago, predating human contact and putting to rest speculation for the occurrence of trans-Pacific exploration by Polynesia populations earlier than anthropological and other more conventional data suggest.

    One of the benefits noted by the scientists in their paper is the practical consequence that, by knowing the relationships between sweet potato and its relatives it may be possible to improve production or other aspects of breeding for a commercially important crop.  More broadly, though, researches such as these extend to more quotidian questions the reach of modern genetic analysis to address long-standing historical conundrums (both human and natural) that were hoped for by the pioneers of the genomics revolution.  Indeed, in view of the transitory nature of history and its artifacts, it is likely that many such questions can only reliably be answered from the history of life written in the genetic code of the organisms that have survived (which makes preserving them all the more important).

    *Pablo Muñoz-Rodríguez, Tom Carruthers, John R.I. Wood, Bethany R.M. Williams, Kevin Weitemier, Brent Kronmiller, David Ellis, Noelle L. Anglin, Lucas Longway, Stephen A. Harris, Mark D. Rausher, Steven Kelly, Aaron Liston, and Robert W. Scotland

    Image of Ipomoea batatas, Sweet Potato by Llez, from the Wikimedia Commons under the Creative Commons Attribution-Share Alike 3.0 Unported license.

  • IPLAC Offers § 101 Revision That Attempts to Harmonize IPO and AIPLA Proposals

     By Donald Zuhn —

    IPLACIn a letter sent to U.S. Patent and Trademark Office Director Andrei Iancu earlier this month, the Intellectual Property Law Association of Chicago (IPLAC) presented its proposal for a revised version of 35 U.S.C. § 101.  IPLAC described its proposal as a harmonized version of revisions to § 101 proposed by the Intellectual Property Owners Association (IPO) and American Intellectual Property Law Association (AIPLA), which IPLAC indicated "represent the most straightforward and comprehensive revisions to Section 101."  In crafting a harmonized version of § 101, IPLAC sought "to combine the recommendations from IPO and AIPLA into a single proposal furthers the current dialog regarding possible Section 101 revisions that can address the ambiguity and uncertainty recent Supreme Court precedent has created."

    The IPLAC proposal reads as follows:

    101(a) Eligible Subject Matter: Whoever invents or discovers, and claims as an invention, any useful process, machine, manufacture, composition of matter, or any useful improvement thereto, shall be entitled to a patent for a claimed invention thereof, subject only to the exceptions, conditions, and requirements set forth in this Title.

    101(b) Sole Exceptions to Subject Matter Eligibility: A claimed invention is ineligible under subsection (a) if and only if the claimed invention as a whole exists in nature independently of and prior to any human activity, or exists solely in the human mind. In determining eligibility, each claimed invention shall be considered as a whole.

    101(c) Sole Eligibility Standard: The eligibility of a claimed invention under subsections (a) and (b) shall be determined without regard to (i) the requirements or conditions of sections 102, 103, and 112 of this Title, (ii) the manner in which the claimed invention was made or discovered, or (iii) the claimed invention’s inventive concept.

    In its letter to Director Iancu, IPLAC declared that "[o]ver the last few years, the Supreme Court has been injecting ambiguity into the Section 101 subject-matter eligibility requirement, moving farther away from the language of the statute itself," adding that "[t]he recent patent eligibility case law is confusing and creates uncertainty as to both the availability of future patents and the validity of existing patents."  Expressing the belief that "judicial interpretation is unlikely to correct existing ambiguity and uncertainty," and arguing that subject matter eligibility should not "be subject to changing definitions developed and adjusted by courts over time," the association seeks Congressional intervention to "clarify[] and re-establish[] the distinct role of section 101 in limiting patent eligibility to practical uses of processes, machines, manufactures, and compositions of matter as recited in the statute."

    IPLAC also provided a section-by-section comparison of its proposal with the current statutory text of § 101 as well as the IPO and AIPLA proposals, along with comments regarding the language that IPLAC used in its own proposal.  For example, with respect to IPLAC's decision to replace the phrase "subject to the conditions and requirements of this title" in the current text of § 101 with the phrase "subject only to the exceptions, conditions, and requirements set forth in this Title" (emphasis in IPLAC's comments), the association noted that the revised language "makes clear that the conditions and requirements of patentability are set forth in the patent statute, and the conditions and requirements set forth in the statute are the only conditions and requirements of patentability," adding that "[t]his means that Congress has not granted the USPTO nor the courts the ability to create its own conditions and requirements of patentability that are not expressly set forth in the patent statute."  In addition, IPLAC explains that § 101(c) of its proposal "addresses the increasing problem with the USPTO and courts confusing patent eligibility with other standards under the Patent Act," and "expressly prohibits the USPTO and courts from determining patent eligibility by considering whether the claimed invention, in whole or in part, include an 'inventive concept'" (emphasis in IPLAC's comments).

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

    • "AIPLA Proposes Legislative Changes to 35 U.S.C. § 101," May 16, 2017
    • "ABA IP Law Section Sends Section 101 Revision Proposal to USPTO Director Lee," March 29, 2017
    • "What to Do about Section 101? IPO Provides Its Answer," February 9, 2017

  • U.S. Trade Representative Releases 2018 Special 301 Report

    By Kevin E. Noonan —

    U.S. Trade RepresentativeOn April 28th, Ambassador Robert Lighthizer, U.S. Trade Representative (USTR), issued the 2018 Special 301 Report.  According to the USTR website, "[t]he ideas and creativity of American entrepreneurs fuel economic growth and employ millions of hardworking Americans" and "[t]his report sends a clear signal to our trading partners that the protection of Americans' intellectual property rights is a top priority of the Trump Administration," language reiterating last year's Report and consistent with much of the trade-related rhetoric emanating from the White House this year.  The press release accompanying the report again recites statistics as the basis for these views, citing government estimates that 45.5 million American jobs that depend (directly or indirectly) on IP-intensive industries, representing 30% of all employment.  The Report "calls on U.S. trading partners to address IP-related challenges" and "draws attention to IP-related trade barriers and the steps foreign countries can take to open their markets to IP-intensive goods—steps that help to protect U.S. jobs, create opportunities for job growth, and promote free and fair trade that benefits all Americans."

    As it has done for the past several years over very different administrations, the Report highlights China as a country in which both "[l]ongstanding and new IP concerns merit attention," including with respect to "coercive technology transfer requirements, range of impediments to effective IP enforcement, and widespread infringing activity" (enumerated as "trade secret theft, rampant online piracy and counterfeit manufacturing").  It is the 14th consecutive year that China has been placed on the Priority Watch List, which as it sounds reflects greater concern and greater scrutiny.

    The USTR also cites India for what he calls "longstanding challenges in its IP framework and lack of sufficient measurable improvements, particularly with respect to patents, copyrights, trade secrets, and enforcement, as well as for new issues that have negatively affected U.S. right holders over the past year."

    Canada once again is singled out, being "downgrade[d]" from the Watch List to the Priority Watch List, for "for failing to make progress on overcoming important IP enforcement challenges."  These include "key concerns" related to "poor border enforcement generally and, in particular, lack of customs authority to inspect or detain suspected counterfeit or pirated goods shipped through Canada, concerns about IP protections and procedures related to pharmaceuticals, deficient copyright protection, and inadequate transparency and due process regarding the protection of geographical indications."

    The Report also announces that the USTR has closed "Out-of-Cycle" reviews of Kuwait albeit "without a change in status", because, inter alia, the country "has not yet brought its copyright regime in line with its international commitments and still needs to make necessary improvements to the regulations implementing its 2016 Copyright and Related Rights Law."  Closure of OCR of Tajikistan resulted in that country being downgraded to the Priority Watch List, for "fail[ing] to address unlicensed software use by government agencies during the OCR."  The USTR also announced that he will begin an OCR Colombia, Kuwait, and Malaysia.

    The Report is promulgated pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994).  The Trade Representative is required under the Act to "identify those countries that deny adequate and effective protection for IPR or deny fair and equitable market access for persons that rely on intellectual property protection."  The Trade Representative has implemented these provisions by creating a "Priority Watch List" and "Watch List."  Placing a country on the Priority Watch List or Watch List is used to indicate that the country exhibits "particular problems . . . with respect to IPR protection, enforcement, or market access for persons relying on intellectual property."  These watch lists are reserved for countries having "the most onerous or egregious acts, policies, or practices and whose acts, policies, or practices have the greatest adverse impact (actual or potential) on the relevant U.S. products."

    The USTR reviewed  "more than 100" of this country's trading partners and identified twelve countries on a "Priority Watch List" (increased by one from last year) and another 24 countries on the "Watch List" (also increasing by one from last year), all relating to deficiencies in intellectual property protection in these countries.  The Priority Watch List in the 2018 Report adds Canada to those countries cited in the 2017 Report (Algeria, Argentina, Chile, China, India, Indonesia, Kuwait, Russia, Thailand, Ukraine, and Venezuela).  Countries on this list "present the most significant concerns this year regarding insufficient IP protection or enforcement or actions that otherwise limited market access for persons relying on intellectual property protection."  On the Watch List this year are Barbados, Bolivia, Brazil, Costa Rica, Dominican Republic, Ecuador, Egypt, Greece, Guatemala, Jamaica, Lebanon, Mexico, Pakistan, Peru, Romania, Switzerland, Turkey, Turkmenistan, Uzbekistan, and Vietnam.  Saudi Arabia, Tajikstan, Thailand, and the United Arab Emirates were added, Bulgaria was removed, and Canada and Columbia moved to the Priority Watch List this year.

    The Report also notes the USTR's continued efforts to enhance public engagement.  In addition to written comments (from 62 interested parties, including 23 trading partner governments), there was a public hearing on March 8, 2018 that heard testimony from "representatives of foreign governments, industry, and non-governmental organizations" (where the comments and a transcript of the hearing are available on the USTR website).

    The Report identifies "foreign trading partners where IP protection and enforcement has deteriorated or remained at unacceptable levels and where U.S. persons who rely on IP protection have difficulty with fair and equitable market access."  The Executive Summary captures this Administration's combative tone:

    The Report reflects the resolve of this Administration to call out foreign countries and expose the laws, policies, and practices that fail to provide adequate and effective IP protection and enforcement for U.S. inventors, creators, brands, manufacturers, and service providers.  The identification of the countries and IP-related market access barriers in this Report and of steps necessary to address those barriers are a critical component of the Administration's aggressive efforts to defend Americans from harmful IP-related trade barriers.

    The Report notes that "[i]n virtually all countries mentioned in the Report, IP enforcement is lacking," based on (a) "[in]adequate or [in]effective border enforcement against counterfeit and pirated goods" (Canada, Egypt, Indonesia, Mexico, Turkey, Turkmenistan, UAE, and Uzbekistan); (b) copyright piracy in China, Mexico, Russia, Ukraine and Vietnam, with particular emphasis on use of unlicensed software by government agencies in Argentina, Greece, Tajikistan, Turkmenistan, Uzbekistan, and Venezuela; (c) online piracy in Canada, China, India, the Netherlands, Romania, Russia, Switzerland, Taiwan, Ukraine, "and elsewhere"; (d) restrictive patentability criteria in Argentina, China, India, Indonesia Saudi Arabia, Thailand, and Russia, including "a lack of adequate and effective protection for regulatory test or other data submitted by pharmaceutical and agricultural chemical producers"; (e) inadequate trade secret protection in China and India, which "U.S. trade secrets at unnecessary risk"; and (f) negative market access effects on regulatory agencies in the European Union."

    The Report contains two Sections (on "Developments in Intellectual Property Rights Protection and Enforcement" and "Country Reports") and two Annexes on particular issues (the statutory bases of the Report, and government technical assistance and capacity building efforts).  In Section I, the Report reiterates its raison d'etre, that:

    IP infringement undermines U.S. competitive advantages in innovation and creativity, to the detriment of American businesses and workers.  In its most pernicious forms, IP infringement endangers the public, such as through exposure to health and safety risks from counterfeit products like semiconductors, automobile parts, apparel and footwear, toys, and medicines.  In addition, trade in counterfeit and pirated products often fuels cross-border organized criminal networks and hinders sustainable economic development in many countries.  Fostering innovation and creativity is essential to U.S. economic growth, competitiveness, and an estimated 45 million American jobs that directly or indirectly rely on IP-intensive industries.  USTR continues to work to protect American innovation and creativity in foreign markets with all the tools of U.S. trade policy, including through the annual Special 301 Report.

    It then reviews "initiatives for strengthen IP protection and enforcement," which includes "examples of initiatives to strengthen IP protection and enforcement; illustrative best practices demonstrated by the United States and our trading partners; [and] U.S.-led initiatives in multilateral organizations; and bilateral and regional developments."  It also highlights areas of continued concern, including "counterfeits, online piracy, forced technology transfer, innovative pharmaceutical products and medical devices, and geographical indications (GIs)."  As in earlier years, it mentions how important IP protection is to innovations in the environmental sector.  Finally, Section I includes a discussion relating to "the importance of full implementation of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and developments on the U.S. use of WTO dispute settlement procedures to resolve IP concerns."

    In a section entitled "IP Protection and Enforcement and Related Market Access Challenges," the Report discusses innovation in the pharmaceutical industry, medical devices and market access concerns.  In this regard the Report states that "USTR has been engaging with trading partners to ensure that U.S. owners of IP have a full and fair opportunity to use and profit from their IP, including by promoting transparent and fair pricing and reimbursement systems."  These efforts have included "ensur[ing] robust IP systems; reduc[ing] market access barriers to pharmaceutical products and medical devices, including measures that discriminate against U.S. companies, are not adequately transparent, or do not offer sufficient opportunity for meaningful stakeholder engagement; and has pressed trading partners to appropriately recognize the value of innovative medicines and medical devices so that trading partners contribute their fair share to research and development of new treatments and cures" (echoing the "fair share" mantra recited by the President in stump speeches and tweets).  The Report calls out in this regard the following efforts in particular countries:

    • Canada and Mexico: in the context of renegotiating the North American Free Trade Agreement (NAFTA), seeking strong IP provisions, and provisions to "ensure that national-level government processes for the listing and reimbursement of pharmaceutical products and medical devices are transparent, provide procedural fairness, are nondiscriminatory, and provide full market access for U.S. products";

    • Korea: as part of renegotiating the U.S.-Korea Free Trade Agreement (KORUS FTA), obtain a commitment to reform "a[n unnamed] key measure" to "provide fair and non-discriminatory treatment of pharmaceutical products, including imported products, under certain medical pricing and reimbursement programs";

    • Japan: as part of "the U.S.-Japan Economic Dialogue," seeking "to ensure transparency and fairness and address other concerns with respect to pharmaceutical and medical devices pricing and reimbursement policies";

    • China: here, there are "a range of issues affecting the pharmaceutical sector, negotiate to provid[e] for effective protection against unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical products, as well as expediting its implementation of an effective mechanism for the early resolution of potential patent disputes";

    • India: obtain "meaningful IP reforms on longstanding issues," which include patentability and compulsory licensing criteria, protection against unfair commercial use and unauthorized disclosure of test or other data generated to obtain marketing approval for pharmaceutical products;

    • Indonesia: address issues of Indonesian patent law, including patentability, compulsory licensing, and requirements for local manufacturing and use;

    • Argentina: (somewhat ironically) discussing patentable subject matter as well as unfair commercial use and, like in many emerging countries, unauthorized disclosure of "undisclosed test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products, among other issues";

    • Saudi Arabia: patent enforcement and protections against commercial use, and also unauthorized disclosure of "undisclosed test or other data generated to obtain marketing approval for pharmaceutical products, among other issues"; and

    • United Arab Emirates (UAE): seeking reassurance that UAE will provide protection for pharmaceuticals through, inter alia, the Gulf Cooperation Council (GCC) patent system.

    Compulsory licensing poses particular concerns with regard to pharmaceuticals and medical devices, according to the Report, because "[s]uch actions can undermine a patent holder's IP, reduce incentives to invest in research and development for new treatments and cures, unfairly shift the burden for funding such research and development to American patients and those in other markets that properly respect IP, and discourage the introduction of important new medicines into affected markets."  Even when compulsory licenses are justified they should be used in only "limited circumstances" and only after attempting to negotiate with the rights holder; the Report cited these concerns particularly with Chile, Colombia, El Salvador, India, and Malaysia.  More generally, the Report points to "non-transparent" and discriminatory practices and "unreasonable regulatory delay" as being of concern to the USTR and administration.  In contrast, national systems that accelerate approval based on regulatory in other countries is praised in the Report.  The Report notes that stakeholders have identified industries have expressed concerns regarding the policies of several trading partners, including Algeria, Australia, Canada, China, Colombia, Ecuador, Japan, Korea, New Zealand, and Turkey with regard to these issues, citing specific examples falling within these general categories for each country.

    The Report next turns to technology transfer issues, including innovation by indigenous peoples and "localization."  In this portion of the Report, compulsory technology transfer is emphasized as causing difficulties for American innovators, particularly in China.  The Report identifies the anti-innovation cycle of imposing such measures to incentivize local innovation, which leads to create market entry barriers and thus discourages foreign (i.e., U.S.) investment, which not only hurts domestic industry in those countries but also can produce "non-market distortions" which in turn can lead to "suboptimal outcomes."  The Report sets forth a litany of these practices, including requirements for technology transfer as the price for regulatory or other governmental approval; permitting state-owned enterprises to seek "non-commercial terms" for IP licensing or otherwise; providing unfair competitive advantage to local industry (if only passively by permitting U.S. IP-rights infringement); permitting cyber-intrusions; giving preference to local products and services dependent on indigenous IP; "[m]anipulating" processes of standards to prefer local concerns; and conditioning regulatory approval or other governmental approvals on disclosure of confidential business information and then "failing to protect such information appropriately."  China, Indonesia, Nigeria, and Turkey are particularly cited for these concerns.

    Trade secret protection, or lack of it, is also a concern discussed in the Report.  It cites "growing need for trading partners to provide effective protection and enforcement of trade secrets" in "a wide variety of industry sectors, including information and communications technologies, services, pharmaceuticals and medical devices, environmental technologies, and other manufacturing" areas.  The Report cites "various sources, including the U.S. Office of the National Counterintelligence Executive (ON- CIX)" for reporting these concerns, which are discussed in the Report with specificity regarding Brazil, China, India, Indonesia, and Nigeria for a wide variety of trade secret related breaches, including permitting (or not stopping) departing employees from taking with them trade secret information-containing electronic storage devices, cyber intrusion and computer hacking, misuse of trade secrets disclosed to government agencies, for example, as part of a regulatory approval process, and others.  The Report on a positive note cites efforts by China, the European Union, and Taiwan to address these issues (albeit noting that China's efforts have come up short), and supports he Organization for Economic Co-operation and Development (OECD)'s work on trade secret protection.

    The Report next addresses geographical indications (GIs) issues (which is ironic, in view of the Administrations withdrawal from the Trans-Pacific Partnership treaty, which addressed this issue in a U.S-friendly fashion).  The Report cites U.S. efforts "through bilateral and multilateral channels" to improve U.S. access to a variety of goods having geographic specificity, as the Report states the issue where the goods identifier includes "place names (or words associated with a place) and identify products as having a particular quality, reputation, or other characteristic essentially attributable to the geographic origin of the product."  This is a particular problem with the EU where it poses a significant barrier to entry (for example, for U.S.-sourced parmesan or feta cheeses), and the bases for the issue (including impairment of trademark and trade dress rights and interference with international standards) are discussed in depth.  Part of the reason for U.S. concern is frankly admitted to be that "[t]he United States runs a significant deficit in food and agricultural trade with the EU" and "[t]he EU's GI system contributes to this asymmetry in U.S.-EU trade in agricultural products for products subject to the EU's GI regime."  The Report also notes that this issue is being addressed in bilateral or multilateral agreement with other nations, including Argentina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Indonesia, Japan, Malaysia, Mexico, Morocco, Paraguay, the Philippines, South Africa, Tunisia, Uruguay, and Vietnam.

    The Report next addresses border control and criminal enforcement against counterfeiting; insofar as placement of the issues discussed in the Report indicates the importance the Trump administration places on them this is a change from the prior administration.  Counterfeit goods (including "semiconductors and other electronics, chemicals, automotive and aircraft parts, medicines, food and beverages, household consumer products, personal care products, apparel and footwear, toys, and sporting goods") "make their way from China" and other countries, particularly those having an "ineffective or inadequate IP enforcement system."  The Report states that such counterfeit goods harm "consumers, legitimate producers, and governments," particularly with regard to medicines, automotive and airplane parts, and food and beverages" because the counterfeit products do not meet the "rigorous good manufacturing practices used for legitimate products."  The Report enunciates particular concern for such activities in China, Hong Kong, India, Indonesia, Singapore, Thailand, Turkey, and the United Arab Emirates, and alleges that 90% of all counterfeit drugs entering the U.S. come from China, the Dominican Republic, Hong Kong, and India, with China and India being particularly singled out as a source of counterfeit drugs.  The USTR notes the efforts of ICANN to withdraw the Registrar Accreditation Agreement for Nanjing Imperiosus Technology a known Internet-based source of counterfeit medicines.  Accordingly, the Report "urges" U.S. trading partners to "undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of counterfeit goods" and states that the Office engages trading partners bilaterally, through trade agreement and international organizations on this issue.

    The Report next turns to online and broadcast piracy of copyrighted works (again, seemingly of less important to this administration than the prior one), citing the "increased availability of broadband Internet connections around the world" as being a "boon" to the U.S economy and foreign trade.  But while advances in technology have enabled U.S. creative producers to better distribute copyrighted materials it has also made the Internet "an extremely efficient vehicle for disseminating infringing content, thus competing unfairly with legitimate e-commerce and distribution services that copyright holders and online platforms use to deliver licensed content."  A variety of forms of this issue are discussed in the Report, which names China, India, Mexico, Peru, and Vietnam for optical piracy; Canada, China, Cyprus, India, the Netherlands, Russia, Switzerland, and Ukraine for "commercial-scale online piracy; Canada, Mexico, the Netherlands, Saudi Arabia, Sweden, and Switzerland for "stream-ripping" (which is "the unauthorized converting of a file from a licensed streaming site into an unauthorized copy" and is now a "dominant" method for music piracy); and Argentina, Brazil, Chile, China, Hong Kong, Indonesia, Mexico, Peru, Singapore, Taiwan, and Vietnam for the use of illicit streaming devices.  Illicit camcording continues to be a particular concern in the Report, with Brazil, Canada, China, Ecuador, India, Japan, Mexico, Peru, the Philippines, Russia, and Taiwan being cited in this regard.  Other aspects of copyright enforcement contained in the Report are royalty payment and administration regimes including collective management organizations (CMO), which the Report states are "flawed or non-operational" in many countries (Argentina, India, Korea, the UAE, and Ukraine, specifically).

    Trademarks and impediments to obtaining and enforcing them in some countries make up the next topic in the Report, with Brazil, China, India, Malaysia, and the Philippines, having "slow" opposition proceedings and Russia and Panama having no administrative opposition proceedings.  Even registering (i.e., making a record of) trademarks is problematic in some countries, with "unnecessary administrative and financial burdens" imposed on owners and there being unnecessary difficulties in maintaining and enforcing trademarks (albeit without naming any countries where these and other difficulties contained in the Report have arisen).  There are also issues with cybersquatting and particularly with country code top-level domain names (ccTLDs) for U.S. rights holders.  The governments of Argentina, Chile, China, Costa Rica, Greece, Kazakhstan, Korea, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, and Vietnam are named for unlicensed use of software, and the Report cites a commercial value for such illicit use of software at $52 billion worldwide.

    The Report sets forth efforts related to initiatives to strengthen IP protection and enforcement in foreign markets, either supported or assisted by the U.S. (in Bosnia and Herzegovina, Bulgaria, China, Greece, India, Jordan, Kuwait, Pakistan, Taiwan, Thailand, and the United Arab Emirates) and sets forth "illustrative best IP practices" in detail for Brazil, India, Jamaica, Malaysia, Spain, and Thailand.  The Report also discussed bilaterial, regional, and international agreements.

    Section I of the Report ends by mentioning the role of intellectual property and the environment and intellectual property and health as areas of concern raised by stakeholders in their comments.  In India, for example, compulsory licensing of "green" technology "will discourage, rather than promote, investment in and dissemination of green technology innovation, including those technologies that contribute to climate change adaptation and mitigation."  The Report contains an affirmation of the provisions regarding IP and public health set forth in the Doha Declaration and states that it "recognizes the role of IP protection in the development of new medicines, while being mindful of the effect of IP protection on price" (a change from the pledge not to interfere with Doha provisions permitting compulsory licensing under certain specified conditions contained in earlier Section 301 Reports).  And the final portion of the Report discusses efforts at dispute resolution of IP matters under the GATT/TRIPS provisions as they are implemented by the WTO.

    Finally, the last portion of Section I of the Report relates to dispute settlement and enforcement.  It states that while the U.S. believes that "[t]he most efficient and preferred manner of resolving concerns is through bilateral dialogue," when that doesn't work "the United States will use enforcement tools including those provided under U.S. law, the WTO and other dispute settlement procedures, as appropriate."  Specifically cited is the August 14, 2017 Presidential Memorandum regarding an investigation by the USTR of "laws, policies, practices, or actions of the government of China that may be unreasonable or discriminatory and that may be harming American intellectual property rights, innovation, or technology development" (82 FR 39007) and its subsequent institution on August 18, 2017.  The Report notes that the investigation reported, in March 22, 2018 that "the investigation supports findings that acts, policies, and practices of the China related to technology transfer, intellectual property, and innovation covered in the investigation are unreasonable or discriminatory and burden or restrict U.S. commerce" and the subsequent actions of the Administration to impose tariffs on Chinese goods.  Other enforcement actions, mostly of historical significance, are also discussed.

    Section II of the Report is a detailed, country-by-country discussion for each country on the Priority Watch List and the Watch List, relating to the activities (or lack thereof) of each country that results in placement of that country on these lists.

    As it has for the past several years (and across otherwise very different Administrations), the U.S. Trade Representative Special 301 Report provides insights into both the concerns of U.S. IP rights holders and the Administration's intentions to work with, cajole, coerce, or threaten other countries to increase protection for IP rights of U.S. IP rights holders.  The substance of the Report is decidedly more aggressive than Reports issued during the Obama Administration, and while the 2017 Report (the Trump administration's first) was less pugnacious than might have been expected, the tone of this Report is much more consistent with its stated policy positions.  As with last year's Report, the tone and tenor of this Report is robustly assertive regarding IP rights and America's intention to negotiate international agreements and confront its trading partners in ways that protect American innovation and commercial interests first and foremost regardless of consequences.

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

    • "U.S. Trade Representative Issues 2017 Special 301 Report," May 4, 2017
    • "U.S. Trade Representative Issues 2016 Special 301 Report," May 19, 2016
    • "U.S. Trade Representative Issues 2015 Special 301 Report," April 30, 2015
    • "U.S. Trade Representative Issues 2014 Special 301 Report," May 19, 2014
    • "U.S. Trade Representative Issues 2013 Special 301 Report," May 30, 2013
    • "U.S. Trade Representative Issues 2012 Special 301 Report," May 1, 2012
    • "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 4, 2011
    • "U.S. Trade Representative Releases Special 301 Report on Global IPR," May 19, 2010
    • "New Administration, Same Result: U.S. Trade Representative's Section 301 Report," May 6, 2009
    • "Congressmen Criticize U.S. Trade Representative over Special 301 Report," July 1, 2008
    • "U.S. Continues Efforts to Protect Patent Rights Abroad," April 29, 2008

  • Conference & CLE Calendar

    CalendarMay 1, 2018 – "Patent Inventorship: Best Practices for Determination and Correction — Distinguishing Between Inventor and Contributor; Navigating Joint Inventorship, Disclosure of Ownership, Real Party in Interest" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 2, 2018 – "Recent Developments in Double Patenting: ODP Challenges and Considerations" (The Knowledge Group) – 12:00 to 1:30 pm (ET)

    May 2, 2018 – "The Supreme Court Decided Oil States & SAS Institute: Now What?" (Federal Circuit Bar Association) – 3:00 pm to 4:00 pm (EST)

    May 3, 2018 – "Patent Ownership Rights: Structuring Assignment and Employment Contracts — Key Provisions, Implications for Litigation, Recent Court Treatment" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 3, 2017 – "The Very Essence of Romance is Uncertainty" (Intellectual Property Owners Association European Practice Committee) – Amsterdam, Netherlands

    May 3, 2018 – "The Evolving State of Sovereign Immunity Before the Patent Trial and Appeal Board" (Technology Transfer Tactics) – 1:00 to 2:00 pm (ET)

    May 8, 2018 – Symposium on Intellectual Property (George Washington University Law School, Pillsbury, NERA Economic Consulting, and Mayer Brown) – Washington, DC

    May 8, 2018 – "Intellectual Property Valuation and Damages: Nuts and Bolts in 2018" (The Knowledge Group) – 12:00 to 1:30 pm (ET)

    May 9, 2018 – "Supplemental Examination Requests: Benefits and Limitations, Strategic Use — Assessing Enforceability of Patent Portfolios, Evaluating the High Burden" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 8-10, 2018 – Patent Fundamentals Bootcamp 2018: An Introduction to Patent Drafting, Prosecution, and Litigation (Practising Law Institute) – Chicago, IL

    May 10, 2018 – "Will the Supreme Court Step in Again in Helsinn v. Teva? Does a Sale of Confidential Materials Trigger the On-Sale Bar?" (Federal Circuit Bar Association) – 3:00 pm to 4:00 pm (EST)

    May 10, 2018 – European Patent Strategies (Intellectual Property Law Association of Chicago Corporate Committee and Weickmann & Weickmann) – 5:00 pm to 6:05 pm (CT), Chicago, IL

    June 13-15, 2018 – Patent Fundamentals Bootcamp 2018: An Introduction to Patent Drafting, Prosecution, and Litigation (Practising Law Institute) – New York, NY

    June 25-27, 2018 – Summit on Biosimilars (American Conference Institute) – New York, NY

    July 18-20, 2018 – Patent Fundamentals Bootcamp 2018: An Introduction to Patent Drafting, Prosecution, and Litigation (Practising Law Institute) – San Francisco, CA

  • FCBA Webast on Oil States & SAS Institute

    Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "The Supreme Court Decided Oil States & SAS Institute: Now What?" on May 2, 2018 from 3:00 pm to 4:00 pm (EST).  Emily Johnson of Amgen, Inc. will moderate a panel consisting of Allyson Ho of Morgan Lewis & Bockius LLP, Christopher Suarez of Williams & Connolly LLP, Gregory Castanias of Jones Day, and Russell Cass of Clark Hill PLC.  The panel will discuss the Supreme Court's decisions in Oil States and SAS Institute, including their holdings and the issues left for another day, potential implications for patent owners and petitioners involved in IPR proceedings, anticipated changes to PTAB adjudication of IPR challenges, likely impact on district court litigations and appeals to the Federal Circuit, the next expected constitutional challenges to IPR proceedings, and potential consequences of labeling patent grants as "public rights" and "public franchises."

    The webinar is complimentary for FCBA members and $50 (government/academic/retired) or $125 (private practitioner) for non-members.  Those interested in registering for the webcast, can do so here.

  • FCBA Webast on Helsinn v. Teva

    Federal Circuit Bar AssociationThe Federal Circuit Bar Association (FCBA) will be offering a webcast entitled "Will the Supreme Court Step in Again in Helsinn v. Teva? Does a Sale of Confidential Materials Trigger the On-Sale Bar?" on May 10, 2018 from 3:00 pm to 4:00 pm (EST).  Mark Freeman, Appellate Staff, Civil Division, U.S. Department of Justice will moderate a panel consisting of Joe Matal of the U.S. Patent & Trademark Office, Amy Saharia of Williams & Connolly LLP, and Dmitry Karshtedt of the George Washington University School of Law.  The panel will discuss the prospects for Supreme Court review in Helsinn v. Teva, in which the Federal Circuit construed the amended on-sale bar of the Leahy-Smith America Invents Act, determining that Congress did not alter the scope of the bar, and the ramifications of each possible outcome for future users of the first-to-file patent system.

    The webinar is complimentary for FCBA members and $50 (government/academic/retired) or $125 (private practitioner) for non-members.  Those interested in registering for the webcast, can do so here.

  • Presentation on European Patent Strategies

    IPLACThe Intellectual Property Law Association of Chicago (IPLAC) Corporate Committee and Weickmann & Weickmann will be offering a panel discussion on European Patent Strategies by Alfred Keyack, EPO Attaché to the United States, and Dr. Frank Feller, European Patent Attorney on May 10, 2018 from 5:00 pm to 6:05 pm (CT) at SRAM, LLC in Chicago, IL.  George Jonas, Downstream Managing Counsel, Global Patents and Technology, BP America, Inc. will moderate the discussion.

    There is no registration fee for event, but attendees must register in advance.  Those interested in registering for event can do so here.

  • USPTO Issues Guidance on Supreme Court Ruling in SAS v. Iancu

    By Kevin E. Noonan —

    USPTO SealWell, that didn't take long.  The U.S. Patent and Trademark Office issued Guidance today, just two days after the Supreme Court decision in SAS Institute Inc. v. Iancu came down, regarding how the Patent Trial and Appeal Board (PTAB) will apply the Court's mandate in that inter partes review (IPR) decisions are all or nothing with respect to challenged claims ("Guidance on the Impact of SAS on AIA Trial Proceedings").

    The Guidance is simple:  going forward (i.e., for all pending and future-filed petitions), the Board will institute on all challenged claims so long as the petitioner has shown a reasonable likelihood of invalidating at least one of the claims.  For cases where the Board has engaged the parties in partial institution proceedings, the Board "may" issue an order "supplementing the institution decision to institute on all challenges raised in the petition."  In such cases the Board also has discretion to take action "permitting additional time, briefing, discovery, and/or oral argument."  Examples included in the Guidance include granting additional time for the Patent Owner Response or, if the statutory twelve-month time is close to expiry, taking advantage of the additional six months provided by the statute for extraordinary cases.  The Guidance stresses however that such decisions will be made on a case-by-case basis.

    The Petitioner and Patent Owner responses to such a supplementation order are specified to include a "meet-and-confer" discussion between the parties on whether additional briefing, time, etc. is needed; the Guidance notes that while the Board may (i.e., has the discretion to) act sua sponte, there may be no accommodation of the parties unless they request it.  And of course the parties can affirmatively waive any changes to the briefing schedule or timing, the Guidance suggests.  The result of such a meet-and-confer will be a conference with the Board, which will resolve any failure to agree between the parties.  The Final Written Decision arising from such cases will contain a decision on all challenged claims, both as originally instituted and added through amendment of the institution decision.

    The Guidance directs parties to contact the panel (only for case-specific questions) or to submit written questions to the Trials@uspto.gov mailbox.

    The Guidance closes by reminding the public that the Office fortuitously scheduled a "Chat with the Chief" webinar on Monday, April 30 at noon EDT, where Chief Patent Judge David Ruschke will discuss the Guidance.

  • Genome Structure of the American Cockroach

    By Kevin E. Noonan —

    CockroachesPerhaps somewhat ironically, a group of Chinese researchers* recently published a report on the genome of the American cockroach (Periplaneta americana), entitled "The genomic and functional landscapes of developmental plasticity in the American cockroach" in Nature Communications.  These researchers,** applying a variety of modern genomic analysis techniques, elucidated aspects of the animal's genomic DNA having implications for its range, behavior, and ecology.

    The report details genetic assessment of the P. americana genome, comprising 3.38Gb; this is the second largest genome to locusts (Locusta migratoria) among insect species.  P. americana was introduced into Americas from Africa in 16th century and is related to other cockroach species as well as two termite species.  Using a consensus gene set, the researcher found expansion of genes associated with environmental adaptation, including chemoreception and detoxification.  "Multiple pathways" that regulate metamorphic development well-conserved, and 20-hydroxyecdysone, juvenile hormone, insulin, and decapentaplegic signals are involved in regulating developmental and behavioral plasticity.

    The report details the results produced from more than 1 terrabasepairs from 3 individuals, assembled de novo to 295-fold coverage; for comparison, samples from the Australian cockroach (P. australasiae) and the smoky brown cockroach (P. fuliginosa) were sequenced to forty-fold coverage.  About 60% of genomic sequences comprise repetitive elements, but otherwise the genomic DNA composition found for this species is typical for species in Order Blattodea (which comprises more than 4,000 species of cockroaches and more than 3,000 species of termites).  The American cockroach genome comprises 21,336 protein-coding genes, 95% of which were detected to be expressed; 90% of these genes are inherited in common with other species in this Order, with 84% found in related cockroach species and 82% in the dampwood termite.  13,555 of these are genes are termed "multicopy universal" genes.  Median intron length (3 kp) found in the cockroach genes is half the average size in locust genes but larger than in other insect species.  A total of 17.5 Gb transcriptome sequencing data were generated from three independent libraries, with inserts of 1–2 Kb, 2–3 Kb, and 3–6 Kb, for the messenger RNA pool of all stages of cockroach development.

    Using this data the researchers compared 12 insect species for "gene repertories" and found 479 orthologs specific for species in Order Blattodea in ~1,000 cockroach genes; the American and German cockroaches (B. germanica) encode largest gene sets, but showed fewer species-specific genes than other insect species.  In more detail analyses, 2,000 single copy universal genes were identified, 538 chosen to establish phylogenetic relationships between the 12 insect species.  Comparisons with other cockroach species showed that P. americana, P. fuliginosa and P. australasiae, shared about 88% amino acid identity between orthologous proteins.  P. americana shares only 75% sequence identity with B. germanica, which was a lesser degree of relatedness than was found between P. americana and two termite species:  Z. nevadensis (which shares 79% sequence identity) and M. natalensis (which shares 80% sequence).  Among 7,640 common orthologs between these species, approximately two-thirds of the American cockroach genes are more closely related to the termite genes in sequence identity, while only one-third being more closely related to the German cockroach.

    The genes shared between the American cockroach and termite species were "significantly over-represented in 29 pathways, including a number of classic functional components in insects, such as development, nutrition, and immunity."  In contrast, genes shared between the American cockroach and the German cockroach were "significantly enriched" in only 6 such pathways, two of which are related to signal transduction.

    With regard to the genes analyzed to identify those genes important to evolution of the cockroach, the researchers started from the presumption that "[a]daptation to host and environment is mainly mediated by chemical communication and subsequent abilities to tolerate chemical and biological factors, such as toxins or pathogens."  These were genes from families involved in chemoreception, detoxification, and immunity.  For chemoreception genes, a total of 154 olfactory receptor genes (ORs) were found in the P. americana genome, while other Blattodean species were found with only half as many ORs.  The P. Americana genome comprises 522 gustatory receptor genes (GRs), which represents the greatest expansion of GRs in the insect species reported to date.  Interestingly, 329 of these GRs formed a specific clade in the phylogeny and were annotated as potential bitter receptors.  The ionotropic glutamate receptor (IR) gene family also has experienced a substantial expansion in the P. americana genome, in which were found a total of 640 candidate IRs (Fig. 2c), much more than that in the termite genome (148 in Z. nevadensis; Fig. 2a) (see Figure 2).

    Other genes arising from this analysis include odorant binding protein (OBP) genes, the number of OBPs in Blattodean species (with the most in P. americana) being dramatically reduced compared to Drosophila and other insects (Fig. 2a), suggesting to these researchers that the transport of odorant molecules may be functionally conserved in cockroaches.

    With regard to genes involved with detoxification, 178 cytochrome P450s, 90 carboxyl/choline esterases, 39 glutathione transferases, and 115 ATP-binding cassette transporters were detect in the P. Americana genome.  The P450 genes showed the greatest expansion in the American cockroach, compared with other Blattodean species.  Phylogenetic analysis of P450s across Blattodean species could be collected into four major clans, the CYP2, the CYP3, the CYP4, and the mitochondrial clade (Fig. 2d).  Most P450 genes in P. americana clustered with CYP3 (79/178 genes) and CYP4 (62/178 genes) lineages (Fig. 2d).  The researchers speculated that specific expansion of these P450 genes improved insecticide resistance in the American cockroach, which clearly has implications for improved survival.

    Genes involved in immunity comprise "innate" immunity genes in the Imd, Toll, and Janus kinase-signal transducer and activator of transcription (JAK-STAT) gene pathways.  Compared with other insects, many of these genes, particularly in the Toll pathway, were found to have been extensively expanded.  In addition, Gram-negative binding proteins (GNBPs), pattern recognition proteins responsible for the detection of pathogens and activation of the Toll pathway, were found to be expanded, there being 12 GNBP1-like and 2 GNBP3-like genes in the American cockroach genome, which is more than in any of those insect species examined (for example, there are a maximum of 6 GNBPs in Z. nevadensis).  Similarly, Toll protein genes were expanded in American cockroach DNA (14 Toll protein genes) compared, for example, with the Drosophila genome (which encodes 9 Toll protein genes).  Eleven antimicrobial protein (AMP) genes were detected in the P. americana genome, including defensins, termicins, attacin, drosomycin, Pro-rich peptide (Paprp-1), and anti-fungus peptide (AFP).  In functional testing, these researchers found strong antimicrobial activity after injection with Escherichia coli (Gram-negative bacterium), moderate antimicrobial activity with Staphylococcus aureus (Gram-positive bacterium), and weak antimicrobial activity with Candida albicans (fungi), consistent with the cockroach habitat including decaying animal matter and other offal.

    What the researchers termed "crucial biosynthesis and signaling pathways for regulating insect development" were "substantially expanded" in the American cockroach genome, including insulin-like peptide and genes involved in juvenile hormone biosynthesis and metabolism, and the cuticle protein family also appeared to be one of the most expanded gene families in P. americana.  These results are consistent with the increased size of the American cockroach, which has the largest size (up to 53 mm in body length, the frequency of molting (6-14 times), and the longest life cycle (700 days).  The researchers also report that signaling pathways thought to be involved in wound healing and tissue repair in insects (Drosophila) and vertebrates, were expanded in certain pathways (including the Grainy head (GRH), Wingless (Wg), and Notch pathways), which may also contribute to the hardiness of these insects.

    In addition to the intrinsic interest of these results for understanding insect relatedness, ecology, and behavior, the results reported in this paper elucidate for the first time specific genetic correlates to traits that have permitted the American cockroach to thrive in disadvantageous environments.  To the extent that the common perception of this insect, that it can (and will) outlive the human species and even a nuclear holocaust, has any validity, this capacity relies at least in part on the genetic characteristics set forth in this paper.  There is something to be learned, about evolution, survival, and life on this planet, from these beasts.

    *Sheng Li, Shiming Zhu, Qiangqiang Jia, Dongwei Yuan, Chonghua Ren, Kang Li, Suning Liu, Yingying Cui, Haigang Zhao, Yanghui Cao, Gangqi Fang, Daqi Li, Xiaoming Zhao, Jianzhen Zhang, Qiaoyun Yue, Yongliang Fan, Xiaoqiang Yu, Qili Feng & Shuai Zhan

    **From Guangzhou Key Laboratory of Insect Development Regulation and Application Research, Institute of Insect Science and Technology & School of Life Sciences, South China Normal University, Guangzhou; CAS Key Laboratory of Insect Developmental and Evolutionary Biology, CAS Center for Excellence in Molecular Plant Sciences, Institute of Plant Physiology and Ecology, Chinese Academy of Sciences, Shanghai; the University of Chinese Academy of Sciences, Beijing; the Research Institute of Applied Biology, Shanxi University, Taiyuan; Zhongshan Entry-Exit Inspection and Quarantine Bureau Technology Center, Zhongshan; and State Key Laboratory of Crop Stress Biology for Arid Areas and Key Laboratory of Integrated Pest Management on the Loess Plateau of Ministry of Agriculture, Northwest A&F University, Yangling