Development Management
Resume:
SARIKA SINGH
**** ****** ***** *****, **********, NJ 08540 ? ************@*****.*** ?
EDUCATION
Rutgers School of Law - Newark, Newark, NJ
J.D., 2010
Academics: GPA: 3.36
University Of Delhi, Delhi, India
Ph.D., Synthetic Organic Chemistry, 1998
Honors: Research Fellowship, Council of Scientific & Industrial Research,
1993 - 1998
University Of Delhi, Delhi, India
M.Sc., Chemistry, Specialization: Organic Chemistry, 1992
Academics: GPA: 4.00 (from foreign credential evaluation equivalence)
University Of Delhi, Delhi, India
B.Sc., Chemistry, Physics and Mathematics, 1990
Academics: GPA: 3.54 (from foreign credential evaluation equivalence)
ADMISSIONS
State Bars of New Jersey and New York
Passed the USPTO examination for registration and granted Limited
Recognition to practice before the USPTO.
EXPERIENCE
Mcneely & Hare LLP, McNeely Bodendorf LLP (predecessor firm), Washington,
DC, May 2009 to Present
Consulting Patent Law Clerk/ Agent. Draft patent non-infringement and
validity opinions on pharmaceutical drug productsfor para-IV ANDA filings
under the Hatch-Waxman Act. Conduct legal research and file wrapper
analysis to develop grounds for defence of patent infringement, false
advertising, and Lanham Act violation claims for nutraceuticals and dietary
supplements. Evaluate proposed generic nutraceutical and dietary
supplement compositions against third party patents and draft memoranda for
freedom to operate.
Ranbaxy Inc., Princeton, NJ
Director, Global Intellectual Property, January 2008 to April 2009
Senior Patent Scientist, Global Intellectual Property, August 2006 to
December 2007
? Patent Prosecution: Reviewed and modified in-house drafts of patent
applications for PCT filings and national stage entries. Prosecuted patent
applications at the USPTO and assisted outside counsel in prosecution of
patent applications worldwide. Developed grounds for rebutting rejections
by the examiner including designing experiments for necessary data
generation for non-obviousness. Developed grounds for and drafted
oppositions, reexamination requests and observations against competitors'
patents and patent applications.
? Risk Assessment and Business Development: Assisted in-house intellectual
property group in conduct of freedom to operate analysis for product
development and launch by researching and advising on US, European and
other national patent laws, case laws and patent practices, patent
extensions, data and market exclusivities. Advised senior management and
country business heads on early/at-risk product launch strategies in US,
Canada, Europe, Russia and South Africa, addressing patent challenges,
outsourcing, and licensing. Prepared invalidity and non-infringement
positions with respect to contentious third-party patents, evaluated
business cases, assessed risk of preliminary injunctions and damages
awards. Reviewed proposed intellectual property related clauses in
business contracts.
? Patent Litigation: Assisted outside counsel on strategic and technical
matters and reviewed and provided inputs for briefs, motions and draft
expert opinions. Suggested and strengthened invalidity and non-infringement
arguments by analyzing file wrappers, searching for prior art, and
researching case law on obviousness type double patenting, inherent
anticipation, prosecution history estoppel and latches, inventorship, etc.
Ranbaxy Europe Ltd., London, UK, August 2004 - July 2006
Senior Patent Scientist, Intellectual Property - Europe, CIS and Africa.
Drafted office action responses, oppositions and observations against
competitors' patents and patent applications. Researched European
regulations and directives and national laws relating to patents,
Supplementary Protection Certificate, data exclusivity, pediatric
exclusivity, free movement of goods and approval of generic medicinal
products. Assisted in patent clearance for projects by researching case law
on contentious patent issues. Reviewed and modified proposed intellectual
property related clauses in contracts and licensing agreements. Identified
opportunities for early launches of products through patent challenges.
Developed grounds for patent invalidity and/or non-infringement for
potential and ongoing litigation. Advised regional management on
pharmaceutical patent and patent related regulatory issues.
Ranbaxy Research Laboratories, Gurgaon, India
Group Leader, Intellectual Property, January 2004 to July 2004
Research Scientist, Intellectual Property, May 2000 to December 2003
Identified patenting opportunities in close consultation with scientists.
Drafted more than 40 patent applications and supported their successful
prosecution by developing grounds for rebutting rejection. Searched and
analyzed third-party patents on more than 50 small therapeutic molecules
and their synthetic processes. Prepared freedom to operate opinions, after
consulting with in-house and outside counsel, for in-house development of
products for world-wide markets, especially for US, Europe, and Japan.
Identified opportunities for early launch of products through patent
challenges. Prepared grounds for third-party patent invalidity and non-
infringement through extensive file wrapper analysis and prior art search
and evaluation. Analyzed product filing strategies in view of FDA laws,
especially FDC&A 505(b)(2) and 505(J). Developed grounds for Primaxin and
Nexium (first to file para-IV ) patent challenges.
J. K. Drugs & Pharmaceuticals, Faridabad, India, February 1998 to May 2000
Research Associate, Process Development. Developed generic second and
third generation cephalosporin antibiotics. Conducted exhaustive literature
search for third-party patent and publications. Developed synthetic
processes avoiding third-party patent infringement. Optimized process
parameters for better quality and lower production cost. Up-scaled
laboratory technology to pilot and commercial scale.
Max-GB Ltd., Delhi, India, August 1992 to July 1993
Trainee Chemist, Process Development. Developed synthetic processes for
various penem and cephem antibiotic bulk drugs and optimized process
parameters for yield and quality.
REPRESENTATIVE PATENTS/APPLICATIONS
US 6,894,188, WO 200-***-****, WO 200-***-****, WO 200-***-****, WO 200499132, US
7,332,600, US 7,462,712
PUBLICATIONS & A PRESENTATION
? Panelist, "Early Access Agreements In Pharma." Licensing Executives
Society, Vancouver, October 2007
? "Reductive coupling of Nitroarenes to Hydrazoarenes with Al-KOH in
methanol", Jitender M. Khurana and Sarika Singh, J. Chem. Soc., Perkin
Trans. 1., 1999, 1893
? "Deoxygenation of Sulfoxides and Selenoxides with Nickel Boride" Jitender
M. Khurana, Abhijit Ray and Sarika Singh, Tetrahedron Lett. 1998, 3829
? "Oxidative Coupling of Thiols to Disulfides", Jitender M. Khurana, Arti
Sehgal and Sarika Singh, Ind. J. Chem. 1997, 36 B, 819
? "Oxidative hydrolysis of Hydrazones, Semicarbazones and Phenylhydrazones
with Sodium hypochlorite", Jitender M. Khurana, Sarika Singh and Atulya K.
Panda, J. Chem. Res. (S) 1996, 532
? "Reduction of Nitroarenes with Sodium dithionite'', J.M. Khurana and
Sarika Singh, J. .Ind. Chem.Soc. 1996, 487
PROFESSIONAL COURSES
? "Drafting and prosecuting winning patents," by Patent Resources Group,
Inc., Arlington, VA, August 2002
? "Chemical Patent Practice," by Patent Resources Group, Inc., Naples, FL,
April 2004
? "Miscalculated Patent Term Adjustment Consequences," by Patent Resources
Group, Inc., Naples, FL, April 2004
? Advanced STN courses on patent searching for Chemistry, including Markush
Structures.
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