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The FDA just approved the first biosimilar drug, breaking the way for a new industry of drugs that could change the forecast of drug spending in the USA. In the simplest definitions, a biosimilar is comparable to the generic form or a copy of a biological drug. They differ from the reference drug in that they could contain differences in materials or methods of manufacture. They are meant to replicate or copy the reference biologic but because they tend to be much larger and highly complicated, than common small molecule drugs, these differences only make them highly similar, not identical, hence “bio-similar”.

In September 2014, the US FDA published its first edition of the so-called ‘Purple Book,’ with the rather lengthy title – ‘Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.’ This new publication, like its well-established ‘Orange Book’ counterpart, will list approved biologic drug products and also their biosimilar and interchangeable generic equivalents. However, the Purple Book is still in its infancy. As of this writing, the published information is far from complete. Furthermore, the FDA has been slow in publishing the necessary guidance documents. Will the new Purple Book rise to the challenge of providing the necessary bridge between the patent and regulatory systems governing biologics? Will the requirements for demonstrating biosimilarity and interchangeability for biosimilar drug products turn out to be too onerous? This commentary explores the regulatory challenges for the role of the Purple Book as the first biosimilars begin receiving FDA approval this year.

My mother stood 4’ 10” tall, tipped the scales at 98 pounds, and was a stickler for correct grammar. She bristled when anyone uttered “I ain’t going,” “He’s taller than me,” or “Are youse goin’ down the shore this year?” And she would have agreed with Judge Newman (and me) that the majority erred in its March 16, 2015 ruling in Enzo Biochem Inc. v. Applera Corp.

Dr. Anthony Sabatelli, Partner and Chair of Dilworth IP’s Pharmaceutical and Biotechnology group has recently also been named Chair of CURE’s (Connecticut United for Research Excellence) Government Affairs Committee. In that role last week, he testified before the State of Connecticut’s Finance, Revenue, and Bonding Committee advocating for the continued R&D tax credit for businesses as a “competitive necessity”, especially as it impacts the state’s growing biotechnology and pharmaceutical industry.

This is the sixth and final article in a review of patents in the area of Fluid Catalytic Cracking (FCC) for 2012-2013. The next article in this series will focus on FCC patents from 2014. The first five articles reviewed patents on catalyst additives, zeolites, cyclones, cracking catalysts and reactors. The current article will cover eight patents relating to FCC regenerators. Five of the eight patents relate to better mixing of the coked catalyst in the regenerator aimed at improving catalyst distribution, and permitting more even burning. These include systems to mix the coked catalyst with regenerated catalyst, systems to mix the coked catalyst with a carrier fluid, and systems to provide better mixing with combustion air. Of the three remaining patents, one relates to the use of a catalyst cooler, another relates to a fuel nozzle configuration for providing reactor heat demands for light feedstocks. The last relates to a two-step regenerator for operating at an increased level of coke on the catalyst. The accompanying reduced catalyst activity is useful for operating in a max-LCO mode.

On December 16th of last year the US Patent and Trademark Office issued the “2014 Interim Guidance on Patent Subject Matter Eligibility” as further guidance to its examining corps for assessing patent eligible subject matter under 35 USC §101. The guidelines were issued in light of what some see as a spate of controversial Supreme Court decisions such as Mayo, Alice Corporation, and others. This webinar will provide practical advice, proposing strategies and offering tips for drafting claims, to patent practitioners writing applications under this latest Guidance. The presentation will also highlight the implications of the Guidance on patent eligibility to help guide scientists and industry executives in formulating their respective strategies. Finally, the panelists will speculate a bit as to future iterations of this Guidance in light of the USPTO’s requests for public comments.

As the cost of bringing a new drug to market soars, it is becoming ever more important for drug developers to ensure that their development efforts are adequately protected. Even though the FDA awards up to five years of regulatory exclusivity upon approval of a new drug compound (twelve years for a biologic), this period is often far too short for a drug innovator to recoup their development costs. Therefore, it is essential that drug developers construct a well thought out patent strategy. This strategy should fully consider managing the product life cycle for a new drug from the earliest development efforts through to the mature stages of marketing when the drug is facing competition from generic manufactures.

The Map Room, a branch of the innovative site Way Better Patents™ recently presented an interesting “down to earth” look at innovation: heat maps of the topology of invention across the geography of the United States. Invention activity is presented at the national, state level, and county level, providing a view of the number of patents issued in 2015. Data is also provided on a weekly basis. Additionally, the data is also broken out by individual inventors versus companies, universities, and entities for the time periods.

In Teva v. Sandoz, Justice Breyer starts thirteen sentences with “And” and six with “But.” Justice Thomas, in the dissenting opinion, counters by starting thirteen sentences with “But” and four with “And.” What makes this rhetorical device so effective for each writer?

Both 2013 and 2014 had been roller coaster years for proposed patent reform legislation to curb abusive activities by non-practicing entities – so-called “patent trolls”. The roller coaster is again gaining momentum as House Judiciary Committee Chairman Bob Goodlatte (R-VA) reintroduced the “Innovation Act” (H.R. 9) on February 5th.