1. U.S. Tops Leaderboard on Chamber of Commerce 2018 IP Index – Slips to #13 in Patent Protection

    Posted on 20.02.18 David Puleo, on Articles, Patent Trends & Activity, Recent News & Articles

    The United States Chamber of Commerce (USCC) released the 6th Edition of the International IP Index on its Global Intellectual Property Center (GIPC) website last week.  The Index highlights the importance of establishing a strong intellectual property infrastructure to catalyze economic growth, development, and innovation.

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  2. Nanomedicine: A Vast Horizon on a Molecular Landscape – Part XI, Cosmeceuticals

    Posted on 14.02.18 Jing Zhou, on Articles, Biologics/biosimilars, Nanomedicine Series

    In previous installments of Nanomedicine, we have discussed the usage of nanoparticles in cancer and other diseases as both diagnostics and therapeutic agents. See, for example, magnetic nanoparticles for theranostics (Part VIII and Part X), quantum dots for bioimaging (Part VII), nanoparticles as cancer biomarkers (Part VI) and for cancer therapy (Part V), and nanoparticles as drug delivery carriers (Part IV).  These applications of nanotechnology not only have attracted increased attention from pharmaceutical companies and academic researchers, but have led to the development of innovative candidatesin clinic trials and even successful products selling in global markets. Beyond this thriving therapeutic field, another huge market for utilizing nanotechnology that might not be as widely recognized, but which already has had a great impact, is the market for cosmeceuticals.

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  3. FDA Orange Book – Patent Procedural Update

    Posted on 06.02.18 Shin Hee Lee, on Articles, Patent Trends & Activity

    The Food and Drug Administration (FDA) made a technical change to the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)[1], effective November 21, 2017. The Orange Book will now show patent submission dates where available. A patent submission date is defined as the date on which the FDA receives patent information from the New Drug Application (NDA)[2]  holder, often referred to as the innovator. Previously, patent submission dates could only be ascertained by directly contacting the FDA.

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  4. Be Specific: Further Thoughts from Two-Way Media to Avoid a 101 Misstep

    Posted on 30.01.18 Michael Hinrichsen, on Articles, Patent Related Court Rulings, Patent Trends & Activity

    Developments on the topic of patent subject matter ineligibility continue to progress rapidly.  In this piece we revisit the Federal Circuit Court decision in Two-Way Media v. Comcast.  This case provides comments in part on the role the patent specification should play when looking for inventive concepts in the second step of the Alice/Mayo test.  Two-Way also serves as an important reminder to patent professionals to avoid conflation of the § 101 subject matter eligibility inquiry with § 102 and § 103 novelty and obviousness considerations.

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  5. Does It Still Cost $2.7B to Develop a Drug? Regardless, Patent Protection is Key!

    Posted on 23.01.18 David Puleo, on Articles, Biotech/Pharma

    We have previously reported that the cost to develop a new drug is roughly $2.7B (inflation adjusted).  This price tag was determined by the Tufts Center for the Study of Drug Development (CSDD).  However, a new study published in JAMA Internal Medicine calls this number into question.  The disparity in drug development cost estimates between the CSDD and other groups prompted the JAMA authors to conduct their own study.  For instance, the independent group Public Citizen estimated the cost to be around $320M (inflation adjusted).  Unlike other estimates, the JAMA study places the cost of developing a new cancer drug to be around $648M.  The authors go into further detail to compare and contrast the metrics and methods by which other groups have calculated drug costs.  Whereas the CSDD study used private information from ten large pharmaceutical companies, the Public Citizen study used publicly available Securities and Exchange Commission filings.  Both analyses looked at companies with multiple drugs on the market.  However, the JAMA study focused on ten companies that each only developed a single drug, which, the authors argue, yields a more “transparent” analysis.

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  6. Diagnosing Patent Subject Matter Eligibility

    Posted on 14.12.17 John Wizeman, on Articles, Patent Related Court Rulings, Patent Trends & Activity

    Clarity on patent subject matter eligibility is still being sought five years after Mayo[1] and three years after Alice[2]. Further adding to the confusion is the fact that discoveries in diagnostics, despite their apparent importance to the biomedical sciences, have been repeatedly determined as ineligible subject matter under 35 USC § 101. The two step Alice/Mayo test has increased the percentage of invalid patents, and the decision by the Supreme Court to deny certiorari in the case of Ariosa vs. Sequenom[3] in 2016 means we are unlikely to see a reversal of this trend in the near future. Inventors are still finding it challenging to implement the current guidelines toward a successful diagnostics patent grant.  In this piece we provide perspective from a 2016 Federal Circuit decision that provides some over-looked hints for moving forward with inventions relating to diagnostics.

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  7. Federal Circuit Further Clarifies Inventive Concept Under The Two-Part Mayo/Alice Test

    Posted on 12.12.17 David Puleo, on Articles, Patent Related Court Rulings, Recent News & Articles

    In Two-Way Media Ltd. v. Comcast Cable Communications, LLC, the Federal Circuit affirmed the decision of the District Court of Delaware that the Two-Way Media patents and claims were ineligible under 35 U.S.C. § 101.  See the Federal Circuit decision here.  Two-Way sued Comcast, alleging that Comcast violated U.S. Patent Nos. 5,778,187 (‘187); 5,983,005 (‘005); 6,434,622 (‘622); and 7,266,686 (‘686) relating to a “Multicasting method and apparatus”.  These patents are directed to a “scalable architecture … or delivery of real-time information over a communications network”.  This essentially refers to methods for streaming data over the internet to multiple users at a time.  The outcome of this case teaches important lessons on how and where to define inventive concept under the two-part Mayo/Alice test.

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  8. No More Monkey Business: “Selfie” Copyright Case Settled?

    Posted on 28.11.17 Shin Hee Lee, on Articles, Recent News & Articles

    On September 11, 2017, the two parties involved in Naruto v. Slater – publicly known as “the Monkey Selfie” – jointly asked the U.S. Court of Appeals for the Ninth Circuit to dismiss their appeal, and nullify the judgment already made by the lower court. This case has been frequently reported and discussed by both the popular press and serious legal sources, because it unearths our fundamental human assumptions that animals lack a level of awareness to take self-portraits of themselves, let alone raises a copyright question.

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  9. Keeping Score: Over 50 Briefs for Upcoming IPR Case in the Supreme Court

    Posted on 16.11.17 Shin Hee Lee, on Articles, Patent Related Court Rulings, Recent News & Articles

    We are fast approaching the Supreme Court oral arguments in the case of Oil States Energy Services LLC v. Greene’s Energy group on Monday, November 27th. We had previously reported on this case in a recent piece, Oil Battles Greene Energy to War over Inter Partes Review in the Supreme Court.  A whopping 57 amicus curiae briefs have been filed, underscoring the intense interest in the outcome of this case.  The briefs represent a vast array of interested parties, including law professors, legal associations, small businesses, and recognized companies in the fields of medicine, electronics, automobiles, and technology. The key issue of the case is simple – whether the Patent Office’s inter partes review (IPR) process is an unconstitutional denial of the right to a jury trial.

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  10. Decrypting the Human Genome: Next Generation Sequencing – Part II

    Posted on 06.11.17 Jing Zhou, on Articles, Biotech/Pharma

    Sequencing whole human genomes presents many technical challenges. Whole human genomes have a large number of long repetitive sequence segments of more than 1,000 bp, which cannot be distinguished by short-read instruments. Since it has been reported that each individual human genome has 2.7 to 4.1 million variants, then, for the 3.2 Gigabyte whole human genome, there is at least one variant per every 1,000 bases. These long repetitive sequence segments could include structure alteration and gene mutations relating to diseases, but might not be efficiently and accurately characterized by short-read NGS technologies.  To address these challenges, long-read sequencing technologies have been developed and have already provided some astounding applications. For example, in 2014, scientists successfully applied nanopore sequencing technology developed by Oxford Nanopore Technologies (ONT) to monitor the transmission history and disease evolution of the Ebola virus, essentially in real time, during its outbreak. In this installment, we will discuss two of the main long-read sequencing technologies: (i) the synthetic approach and (ii) the single-molecule sequencing approach, and will review the relevant patents.

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