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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.

Dr. Anthony Sabatelli, chair of Dilworth IP’s biotech and pharmaceutical patent practice group, has been appointed by CURE (Connecticut United for Research Excellence) to serve on its newly convened government affairs committee. The committee comprises representatives from CURE’s board of directors, the pharmaceutical and bioscience sectors, and the legal community. In this new role, Dr. Sabatelli will spearhead federal outreach initiatives for CURE and will work closely with the government relations firm Rome, Smith & Lutz to assure synergy of action and alignment of state and federal initiatives. “I look forward to working with this committee on issues of importance to the biotech and pharmaceutical industries and to being a voice for our industry here in Connecticut”, says Dr. Sabatelli.

Dr. Anthony Sabatelli, leader of Dilworth IP’s biotech and pharmaceutical patent practice group, has once again been invited by the USPTO to share his thoughts and insights on the Office’s recently issued 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), a supplement to the patent eligibility Guidance issued earlier in 2014. Dr. Sabatelli’s presentation will take place this Wednesday, January 21st, between 1pm and 5pm EST at the public eligibility forum held at the USPTO’s Madison Building. A live internet feed of the forum will be made available by the USPTO. Further information about the Guidance and the forum can be found at the USPTO’s website found here.

If innovation drives progress, then 2014 was the year of progress! During the past year the U.S. Food and Drug Administration approved 41 new drugs. That is 14 more than 2013 and the highest number in 18 years! What spurred this increase? And what challenges do these new drugs face in the 2015 market?

Dr. Jonathan Schuchardt, Partner at Dilworth IP will be presenting as a panelist for the upcoming Strafford webinar Obviousness Standard After the AIA: Leveraging Latest PTO and Court Guidance. This webinar can be used to obtain CLE credits through Strafford. The webinar is scheduled for Thursday, January 15th from 1:00pm to 2:30pm EST.

The revised Guidance is a step in the right direction by the PTO to simplify the somewhat cumbersome and confusing patent claim analysis set out in the previous guidance and memo documents. The Guidance is an attempt to consolidate the separate frameworks the PTO had previously created for analyzing the patent eligibility of claims relating to laws of nature, natural phenomena, and natural products, versus claims relating to abstract ideas. I agree with the PTO that it is important to have a guidance that “promotes examination efficiency and consistency across all technologies.”

Dr. Cambria Alpha-Cobb has joined Dilworth IP’s Biotech and Pharmaceutical Practice Group as a Technology Specialist. Dr. Alpha-Cobb holds a Ph.D. in Molecular Biophysics and Biochemistry from Yale University where her research focused on bacterial resistance to antibiotics in addition to exploring small molecule signaling through the design of cell permeable drugs. Although her primary focus has been on advancements in the biological field, her research has broadly encompassed genetic engineering, protein and antibody design, and mycological studies. Cambria’s undergraduate work at Rice University included a study of the structural evolution of hemoglobin, while also majoring in Spanish language and culture. She speaks Spanish fluently and is also conversant in German.