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This is the first article in a series reviewing 2014 patents focused on Enhanced Oil Recovery (EOR). The initial 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.

Although only five MEOR-related patents issued in 2014, patent activity generally in the EOR area was robust, with 50+ patents having issued. In the upcoming articles, these remaining patents will be similarly reviewed according to their particular subject matter. While this article covers patents in MEOR, which is a biological method of oil recovery, other recovery methods such as chemicals: polymer flooding, chemical flooding, liquid carbon dioxide flooding, and hydrocarbon displacement; physical methods: thermal recovery, steam flooding, gas drive oil; and technical methods: hydraulic fracturing, hydraulic jet drilling, etc. will be covered in upcoming articles to the extent patents in these areas have issued.

As you may have heard, the United States Patent and Trademark Office just issued U.S. 9,000,000, assigned to WiperFill Holdings, for a “windshield washer conditioner” that collects and conditions rainwater or dew from a windshield for use as washer fluid. What you may not realize is that the Patent Office hand-selects certain patents to be recognized as a “milestone millionth.” In 2011, Second Sight Medical Products received U.S. 8,000,000 for a visual prosthesis that enhances visual perception for people who have gone blind due to outer retinal degeneration. And in 2006, U.S. 7,000,000 was awarded to a DuPont inventor for biodegradable polysaccharide fibers useful for textiles.

Frederick Spaeth, Partner at Dilworth IP, will be presenting at the Joint Patent Practice Seminar at the Marriott Marquis in NYC on May 12th. Fred will be speaking briefly as part of a panel which will discuss the impact on patent law of recent and various Supreme Court decisions. His talk is entitled The Nautilus Decision Defines the Test for Indefiniteness: Nautilus v. Biosig Instruments.

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.