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. 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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  4. The I-O Movement:  Priming the Immune System to Fight Cancer – Part I:  Chimeric Antigen Receptor T (CAR-T) Cell Technology

    Posted on 27.03.18 David Puleo, on Articles, Biotech/Pharma

    There has been a lot of recent buzz about chimeric antigen receptor (CAR) T cell technology.  Novartis and Gilead have FDA-approved CAR-T therapies offering complete patient remission from certain cancers.  A flood of new CAR-based technologies is likely to hit the market.  As with any novel therapy, patent protection is essential.  The large number of patent filings suggest that intellectual property protection is an important part of the research efforts in this field.  The bolded patent documents cited in this article are further summarized in the table at the end of this installment.

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  5. The Emergent Microbiome: A Revolution for the Life Sciences – Part XIV, Revisiting Immunotherapy and Combination Therapies

    Posted on 08.03.18 David Puleo, on Articles, Biotech/Pharma, The Emergent Microbiome Series

    Three recent articles in Science discuss how the composition of the gut microbiome affects anti-PD-1 therapy for the treatment of melanoma, metastatic melanoma, and epithelial tumors, further bolstering the idea of gauging immunotherapeutic efficacy based on one’s microbiome composition.  We first reviewed this concept in Part VIII of The Emergent Microbiome Series and are revisiting it here.  Bolded patent documents are further summarized in the table at the end of this installment.

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  6. 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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  7. 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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  8. 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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  9. Berkeley Hatches a Plan for Patent Reform

    Posted on 08.11.17 David Puleo, on Patent Trends & Activity, Recent News & Articles

    The Berkeley Center for Law & Technology (BCLT) held a round table discussion workshop with opinion leaders from science, technology, and the law to discuss patent subject matter eligibility.  A Report on the workshop, which is quite extensive and contains a number of tables and charts, should be of interest to a wide audience.  This Report comes on the heels of Senator Orrin Hatch’s op-ed article that also called for reform of subject matter eligibility (reviewed by Dilworth IP here).  A number of recommendations, some of which are detailed below, were proposed by workshop participants to clarify subject matter eligibility as related to 35 U.S.C. § 101.  Of note, this workshop was further detailed in a blog piece on PatentlyO.

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  10. Patenting the Microbiome: Trends, Challenges and Insights

    Posted on 31.10.17 David Puleo, on Articles, Biotech/Pharma

    We may not realize it, but the human body is home to an astonishingly large number of microorganisms that live both in us and on us. This resident microbial population, which is estimated to number over 100 trillion microorganisms, is collectively known as the ‘microbiome’ or, more specifically, the ‘human microbiome’ [1].The microbiome can also refer to microbial communities in or on other living organisms such as our pets, livestock and food crops, as well as those external to us, for example, those found in the air, soil and sea, or those found in or on inanimate objects ranging from computer keyboards to office buildings

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