1. The A-B-C’s of R-N-A-i: Therapeutic Applications and §101 Implications

    Posted on 06.11.18 David Puleo, on Articles, Biotech/Pharma, Patent Resources

    Now that the first RNA interference (RNAi)-based therapeutic, ONPATTROTM (patisiran, developed by Alnylam Pharmaceuticals), recently received FDA approval, it is not surprising that such drugs are gaining considerable attention.  However, the underlying technology has been around for quite some time.  Craig Mello and Andrew Fire won the 2006 Nobel Prize in Physiology or Medicine for their discovery of RNAi.  There has since been a trend towards developing RNAi-based therapeutics, which is reflected in the number of patent applications that have been filed in this area.  In this article, we will be reviewing the RNAi methodology and relevant patents, as well as potential challenges for patenting this technology going forward.

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  2. The Priority Review Voucher: An Untapped Asset

    Posted on 03.10.18 David Puleo, on Articles, Patent Resources, Patent Trends & Activity

    Typically, we think of patents as the main tool that allows for product exclusivity in the pharmaceutical industry.  However, exclusivity has a regulatory component.  For example, a new drug product cannot be marketed until it has undergone review and approval by the US Food and Drug Administration (FDA) or other foreign counterpart.  Probably the most familiar regulatory exclusivity is the five years given upon approval of a new drug application (NDA) during which no generic drug application can be filed.[1]  This regulatory exclusivity is a valuable asset, so much so in fact that it is often desirable to accelerate the drug approval process.  An untapped asset that has arisen out of this framework is the priority review voucher (PRV).  A helpful summary on PRVs was recently published in a piece from the Regulatory Affairs Professional Society.

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  3. Stone Basket Innovations v. Cook Medical LLC : When Is a Case “Exceptional” for the Purposes of §285?

    Posted on 26.06.18 William Reid, on Patent Related Court Rulings, Patent Resources

    Stone Basket Innovations (SBI) sued Cook Medical LLC (Cook) for infringement of its patent, U.S. Patent No. 6,551,327 (‘327 Patent) in the U.S. District Court for the Eastern District of Texas.[1]  Subsequently, the case was transferred to the U.S. District Court for the Southern District of Indiana (Southern District).[2]  The subject patent related to stone extraction medical devices for removing stones from biological systems, and contained elements directed to a “support filament,” “a handle comprising a sheath moving element,” and a “collapsible wire basket.”[3]  At deposition, in a moment that SBI’s attorneys’ will probably dream of again and again in a kind of horrible Groundhog Day remake, when questioned about the addition of the sheath movement element during prosecution, the inventor of the ‘327 replied, “I realize there is nothing novel about it.”[4]  Yikes!  But this is exactly what happened in Stone Basket Innovations, LLC v. Cook Medical LLC, 2017-2330 (Fed. Cir. June 11, 2018).

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  4. Updates from the USPTO on Subject Matter Eligibility

    Posted on 15.01.18 Shin Hee Lee, on News and Events, Patent Resources, Recent News & Articles

    On January 4th, the U.S. Patent and Trademark Office updated their webpage on subject matter eligibility with two new supplementary documents providing further guidance under 35 U.S.C. §101. The two new documents are useful summaries and references for practitioners and others having an interest in the area. The two documents, which are briefly described below are:

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  5. Upcoming Free Webinar from Dilworth IP: Laying Your Claim: Best Practices for Patent Claim Construction in a Post-Teva World

    Posted on 24.05.17 Thomas Pia, on Announcements, Patent Resources, Webinar

    William Reid, Partner at Dilworth IP, will be presenting a free webinar on Wednesday, June 14th at 1:00 PM EDT entitled, “Laying Your Claim: Best Practices for Patent Claim Construction in a Post-Teva World.” The interpretation of a patent claim’s meaning is fundamental to the scope of its coverage and, thus, is a pivotal consideration when drafting and prosecuting an application or when assessing infringement. This webinar will summarize current law with respect to claim construction in the post Nautilus, Inc. v. Biosig Instruments, Inc. and Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. world. Patent practitioners will be armed with current best practices and advice regarding claim construction for their use when drafting patent applications, writing patent infringement opinions, or litigating a case.

    To register for this free webinar, Click Here

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  6. The IP Manager’s Playbook: Leveraging the Tools of the USPTO, Part II – Track One – When There is a Need for Speed

    Posted on 02.05.17 William Reid, on Articles, IP Manager's Playbook, Patent Resources

    This is the second article in a series related to programs initiated by the Patent Office to assist patent practitioners; for part one in this series, Awaiting the Return of P3, Click Here. This article discusses the Track One program. Track One is one of three programs directed to expediting the front end of patent prosecution. Besides Track One, the other programs include the patent prosecution highway and Accelerated Examination. The value of these programs is evident when one considers that total prosecution time is dominated by the time waiting to receive an Office Action. In fact, this time amounts to over 60% of the total prosecution time. So, any effort to reduce overall patent prosecution time must affect the time awaiting the first office action. Track One addresses this. The saved time translates to earlier issue dates, which can aid the client in terms of licensing opportunities, or in blocking the patent applications of the client’s competitors, and potentially reduce prosecution costs.

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  7. Enhanced Oil Recovery Patents – 2016 (Part 2) Radiation-Assisted Oil Recovery

    Posted on 13.04.17 William Reid, on Articles, Patent Resources, Patent Trends & Activity

    Enhanced oil recovery techniques can loosely be grouped into methods conducted at ambient temperatures and those at high temperature. Ambient temperature methods include techniques using water flooding, solvent or surfactant injection, and cold heavy oil production with sand (CHOPS). High-temperature techniques function by heating recoverable material in the reservoir to lower its viscosity and improve flowability. Such techniques typically use steam, i.e., steam injection in various ways, although radiation assisted oil recovery would also fall into this group. However, while conventional heat treatments using steam are effective, they can sometimes result in a wastewater stream that is not desirable. While radiation techniques may additionally utilize other injectable streams, they need not rely on a separate heat-input stream to transfer heat, so typically don’t generate the wastewater streams characteristic of steam injection.

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  8. Enhanced Oil Recovery Patents – 2016 (Part 1) Microbial/Enzyme Enhanced Oil Recovery

    Posted on 29.03.17 William Reid, on Articles, Patent Resources, Patent Trends & Activity

    This is an article in a series reviewing 2016 patents focused on Enhanced Oil Recovery (EOR). In particular, this article relates to the technology area of Microbial Enhanced Oil Recovery (MEOR), which concerns the use of microbes to extract oil from oil-containing formations, and Enzyme Enhanced Oil Recovery (EEOR) which similarly concerns the use of enzymes.

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  9. The IP Manager’s Playbook: Leveraging the Tools of the USPTO, Part I – Awaiting the Return of P3

    Posted on 13.03.17 William Reid, on Articles, IP Manager's Playbook, Patent Resources

    In July, 2016 the Patent Office initiated the Post-Prosecution Pilot program (P3), designed to reduce the use of RCE’s and the pendency of applications, as well as to improve the collaboration between applicants and Examiners. The program ended this past January, when the six-month time frame for the test program was reached. While the program’s results are currently being reviewed by the Patent Office, in view of its popularity, there’s a good chance that the P3 program will be reconstituted in one form or another. It’s worth taking another look to review what the program was all about.

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  10. Fluid Catalytic Cracking Patents – 2016, Part II: Equilibrium Catalyst (ECAT)

    Posted on 09.01.17 William Reid, on Articles, Patent Resources, Patent Trends & Activity

    For as long as there have been FCC’s, refiners have had to manage catalyst additions and losses. If the catalyst additions were the same as the losses then catalyst inventory would be maintained. If catalyst losses were greater than additions, then purchased ECAT would have to be added. If additions were greater than losses, then ECAT would need to be withdrawn from the unit. Withdrawn catalyst is sometimes transferred to brokers who then sell it to refiners needing ECAT for their units, otherwise it is disposed of, e.g., sold into cement manufacturing applications. The following three patents demonstrate attempts to upgrade the value of ECAT. The first treats ECAT to convert it to a metals trap, the second and third adjust the ECAT particle size distribution. It will be interesting to see whether this trend in ECAT-related inventions continues.

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