1. Obviousness, Prodrugs and the Rule of 5: Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH

    Posted on 07.02.19 William Reid, on Articles, Patent Related Court Rulings, Patent Trends & Activity

    In Amerigen Pharmaceuticals Limited v. UCB Pharma GMBH, 2017-2596 (Fed. Cir. January 11, 2019), the Federal Circuit upheld the Board’s IPR finding that claims 1-5 and 21-24 of UCB’s U.S. Patent 6,868,650 were not obvious.[1]  The patent claims cover Toviaz® (Fesoterodine), an antimuscarinic drug to treat urinary incontinence.[2]  Judge Lourie included a remark near the end of the Opinion that will warm the heart of anyone who has wrestled with an Examiner on an issue of hindsight analysis:

    Any compound may look obvious once someone has made it and found it to be useful, but working backwards from that compound, with the benefit of hindsight, once one is aware of it does not render it obvious.[3]

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  2. Rising Carbon Dioxide Levels: Capture Methods & Patent Trends

    Posted on 22.01.19 Brian Pattengale, on Articles, Patent Trends & Activity

    Recent data from NOAA, the National Oceanic and Atmospheric Administration, indicates that current atmospheric carbon dioxide (CO2) levels are at 409 ppm as of October 2018. This is a 36% increase from the highest historical CO2 level,1 and is increasingly being attributed to human activity, namely fossil fuel combustion in power generation, transportation, and industrial processes.

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  3. 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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  4. 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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  5. 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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  6. 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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  7. Hold the Mayo: Guide to a Healthy Patent Application

    Posted on 24.08.18 John Wizeman, on Patent Related Court Rulings, Patent Trends & Activity, Recent News & Articles

    Back in April, the Court of Appeals for the Federal Circuit (CAFC) handed down a split decision that breathes life into an otherwise suffocating Mayo/Alice world.  This case, Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd. has been contrasted and compared to the Supreme Court’s original Mayo finding, since both Mayo and Vanda related to drug dosing and involved a law of nature. However, the comparison ends there, as the underlying patent in Vanda was deemed subject matter eligible, whereas the patent in Mayo was not. The Mayo decision, in conjunction with the Alice decision of course, led to the creation of the current two-step patent eligibility test that has proven difficult to consistently apply. Three key differences likely led to the divergence between the Vanda and Mayo decisions:  (i) the focus of the innovation, (ii) the actual method steps recited, and (iii) the clarity in presenting the result of the application of the method. Furthermore, the USPTO recently issued a guidance memorandum analyzing the decision.

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  8. Does USPTO Memo on Patent Eligibility Bring Confusion?

    Posted on 17.07.18 David Puleo, on Patent Related Court Rulings, Patent Trends & Activity

    In April, the USPTO published a memorandum that revises procedures set forth in MPEP §2106.05. The memorandum was issued in response to the Federal Circuit’s decision in Berkheimer v. HP Inc. Now that the Federal Circuit denied the request for en banc rehearing of the decision, we thought it would be a good time to offer some thoughts on the memo.

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  9. Let Us Now Praise Unfamous Inventors, Part II:  The “Almost-10 Millionth” Patentee

    Posted on 11.07.18 Jon Schuchardt, on Articles, Patent Trends & Activity, Recent News & Articles

    It seems like only yesterday that the United States Patent and Trademark Office (USPTO) issued U.S. Pat. No. 9,000,000 for a “windshield washer conditioner” that collects and conditions rainwater or dew from a windshield for use as washer fluid.  And now we’ve surpassed 10,000,000!  If patents were Wonka Bars, the millionth ones would surely include a Golden Ticket.

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  10. Fluid Catalytic Cracking Patents – 2017, Part I: Catalytic Compositions/Synthesis

    Posted on 15.06.18 William Reid, on Articles, Patent Trends & Activity

    One technique for categorizing patents related to Fluid Catalytic Cracking is to group them in certain categories:  those related to catalyst zeolite, matrix or the catalyst per se, their synthesis or crossover patents directed to additive/FCC catalyst systems; catalyst additives per se, such as metals passivation catalysts, octane additives or combustion promoters; reactor internals; regenerator internals; FCC-related process conditions, operations, and treatment of FCC feed or products; or incorporation of the FCC in a broader process, and ancillary FCC-related processes.  In 2017, there was a concentration in the final category, with lighter representation in all other areas.

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