1. The Final Score: 2018 Drug & Biologic Patent Approvals

    Posted on 15.01.19 Brittany Knight, on Articles, Biologics/biosimilars, Patent Trends & Activity

    The past year was a big year for FDA approved new drugs and biologics – 59 in fact, compared to 46 in 2017 and a mere 22 in 2016. From the published list of approvals on the FDA website Novel Drug Approvals for 2018, we compiled data on the listed patents associated with these drugs. As a whole, the 59 drugs included 42 “conventional”, i.e. small molecule drugs, of which 35 were new chemical entities (NCEs approved via a New Drug Application or NDA), and 17 were biological molecules (approved via a Biological License Application or BLA). For background, “conventional” drugs are small (i.e. generally under 1000 molecular weight), synthetically manufactured chemical entities that are chemically and molecularly well-characterized. Currently, these drugs make up the majority of approved drugs. Information regarding patents and exclusivity for these “conventional” drugs is referenced in the Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the ‘Orange Book’.

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  2. Linking It Up: Antibody-Drug Conjugates

    Posted on 08.01.19 Steve Kennedy, on Articles, Biotech/Pharma, Patent Trends & Activity

    As discussed in our previous article, antibody-drug conjugates (ADCs) have emerged as a highly promising class of anti-cancer drugs, and significant technical innovations are being made in all three components of the ADC, i.e. the antibody, the drug payload, and the linker joining them. The linker has been an area of particular focus, both within pharmaceutical development and the patent space. The primary considerations for effective ADC linkers are their stability during circulation followed by release at the target site and their method of attachment to the antibody. The latter can determine the ratio of payload to antibody, formulation homogeneity, and ease of manufacture, and will be the focus of the current article.

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  3. Not Yet Evolved? Where is 35 USC §101 going?

    Posted on 12.12.18 Brittany Knight, on Articles, News and Events, Patent Trends & Activity

    Software is a generic term to refer to a collection of data or executing code used by a computer to implement arithmetic operations or logical operations. Back in 1936, Allen Turing, in his landmark paper On Computable Numbers proposed the capable use of instructions (i.e. software) to execute functions through his Turing Machine, an early precursor of the general purpose computer[1]. Today the modern computer is instrumental for complex computations, data analytics, high-powered graphing, simulations, and so on. Although, the development and use of software for these computer functions has become mainstream, determining the patent eligibility of software inventions under 35 USC §101 has been less intuitive.

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  4. Never Too Rich or Too Thin: The Strong Trademark Standard

    Posted on 27.11.18 Shin Hee Lee, on Articles, Recent News & Articles, Trademarks

    “You can never be too rich or too thin” has been attributed to Wallace Simpson, the colorful Duchess of Windsor who charmed King George to abdicate the throne of England in 1936.[1] However, when it comes to trademarks, a mark that is lacking a bit of heft is not likely to stand.

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  5. Assignor Estoppel & Inter-Partes Review: Arista Networks, Inc. v. Cisco Systems, Inc.

    Posted on 13.11.18 William Reid, on Articles, News and Events, Patent Related Court Rulings

    Arista Networks, Inc. (Arista) petitioned for an IPR of Cisco Systems, Inc.’s (“Cisco”) patent, U.S. 7,340,597, relating to protecting computer network systems from outside attack using a logging module.[1] Claims 1 and 29 are as follows:

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  6. 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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  7. 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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  8. Royal Trademark Battles over Beverages

    Posted on 18.09.18 Frederick Spaeth, on Articles, Recent News & Articles, Trademarks

    The story is about diet drinks named “zero”: SPRITE ZERO, the various flavors of COCA-COLA ZERO, FANTA ZERO, POWERADE ZERO, and VAULT ZERO. What these particular names share in common is that they are all products of The Coca-Cola Company (TCCC). Moreover, TCCC applied to register these ZERO-inclusive names, and others, in the U.S. Patent and Trademark Office (USPTO) as trademarks, so that they could claim the right to exclusive use of these names and similar names for such products.

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  9. Patent Beauty: IP and Hair Coloring Products

    Posted on 05.09.18 Shin Hee Lee, on Articles, Biotech/Pharma

    The global hair coloring product market is projected to grow into a 200 billion-dollar industry by 2025. Coty reported in 2017 that more than half of all women color their hair regularly. For example, these figures have reached 62% in the United States, 67% in the United Kingdom, 69% in Germany, and 88% in Russia. An in-depth data analysis reported by Grand View Research, Inc. attributes this rapid growth to a global increase in the aging population, environmental insults such as air pollution, and new trends in the fashion industry. Alongside the other lucrative sectors in the beauty industry that were discussed in our previous articles (see link https://www.dilworthip.com/patent-beauty-ip-cosmetics, and link https://www.dilworthip.com/patent-beauty-ip-and-hair-care), the hair coloring sector also deserves a great amount of attention, especially in view of advancing technologies and the intellectual property covering it.

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  10. Antibody Drug Conjugates: The Patent Landscape for a New Class of Cancer Treatment

    Posted on 07.08.18 Steve Kennedy, on Articles, Biotech/Pharma

    Over the last decade, antibody-drug conjugates (ADCs) have emerged as a highly promising new class of biopharmaceuticals. By taking advantage of the specificity of monoclonal antibodies and the potency of small-molecule chemotherapy drugs, ADCs have proven to provide a highly effective combination – particularly in the oncology space,. The recent FDA approvals of Kadcyla (Genentech), Adcetris (Seattle Genetics), Mylotarg (Wyeth Holdings / Pfizer), and Besponsa (Wyeth Holdings / Pfizer), as well as the over sixty other ADCs in clinical trials, show that these drugs represent an increasing proportion of newly approved cancer therapies and will generate growing revenues for firms innovating in the field.  Accompanying this burst in ADC development is the corresponding activity in the patent space.  This article summarizes some of the important developments.

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