Deborah H. Yellin is a partner in Crowell & Moring's Washington, D.C. office. She focuses her practice on U.S. Patent and Trademark Office post-grant proceedings, intellectual property portfolio management, patent procurement, counseling and district court litigation.
Debbie has extensive experience in post-grant proceedings, including those that accompany Hatch-Waxman and BPCIA cases. She helped secure the first successful IPR challenge filed by generics makers, in an IPR before the PTAB and Federal Circuit, challenging a formulation patent on the multiple sclerosis drug Gilenya®, and has secured other victories including in IPRs relating to patents on Neulasta® and Neupogen®.
Debbie has a diverse range of experience in patent law, including preparing and prosecuting patent applications in the chemical, medical device and pharmaceuticals areas; providing infringement and validity opinions; conducting due diligence and patent landscape analyses; counseling in litigation and post-grant proceedings, including pharmaceutical litigation arising under the Hatch-Waxman Act; and participating in inter partes interferences. She is experienced in preparing Patent Term Extensions under the Hatch-Waxman Act for both drugs and medical devices, and counseling clients in related issues.
Her practice involves assisting both large and small clients with the creation and implementation of intellectual property protection and procurement programs. She works with clients to develop creative solutions
to managing intellectual property assets. Ms. Yellin counsels clients regarding domestic and foreign patent filings and provides
world-wide patent portfolio oversight.
Debbie has experience with a wide range of chemical and pharmaceutical technologies, including polymers, small molecules and new chemical entities, formulations, research tools, adhesives, catalysts, lignins, lubricants, cosmetics, pesticides and herbicides, chemical processes, adhesives, concrete, coatings, nanomaterials, biologics, recombinant technologies, and drug delivery technologies. She has particular experience in plant biotechnology. Prior to attending law school, she worked in the laboratory. Some of her research projects include studies of the molecular biology of reproduction and the role of dihydrotestosterone in prostate cancer.
She received her bachelor's degree in biochemistry from Tufts University. She has a masters of public health from George Washington University. She is admitted to the District of Columbia Bar, the Virginia State Bar and is registered to practice before the United States Patent & Trademark Office. She teaches at the Food and Drug Law Institute’s Introduction to US Drug Law and Regulation program.
Representative Cases
- Apotex, Inc., et al. v. Amgen, Inc. Representing petitioner Apotex in inter partes review before the PTAB related to anti-cancer drugs, securing victory for Apotex at the PTAB.
- Apotex, Inc., et al. v. Novartis AG, et al. Representing petitioner Apotex in inter partes review before the PTAB related to a multiple sclerosis drug, securing victory for Apotex at the PTAB and in the resulting appeal at the Federal Circuit.
- Moderna v. CureVac, representing patent owner CureVac in inter partes review before the PTAB relating to purification of RNA.
- LifeNet Health v. Life Cell Corp., No. 2:13-cv-00486 (E.D. Virginia): Represented plaintiff LifeNet in patent-infringement action involving soft-tissue grafts. Jury awarded LifeNet over $34 million; decision affirmed on appeal.
- Takeda Pharmaceutical Co., Ltd. et al. v. Handa Pharmaceuticals, LLC and Par Pharmaceutical, Inc., No. 3:11-840 (N.D. Cal.), and Par Pharmaceutical, Inc. and Handa Pharmaceuticals, LLC v. Takeda Pharmaceutical Co., Ltd. et al., No. 5:13-1927 (N.D. Cal.). Represented Handa and Par in patent infringement cases concerning Par's ANDA for a generic version of Dexilant® (dexlansoprazole).
- E.I. du Pont de Nemours and Company v. Kolon Industries, Inc., et al., No. 3:09-cv-58 (E.D. Virginia). Represented plaintiff DuPont in case alleging misappropriation of over 100 trade secrets relating to KEVLAR® fiber technology in one of the largest trade secret misappropriation cases in the United States. Obtained a $919 million verdict against Kolon for the theft of KEVLAR® technology after a seven-week jury trial held in Richmond, Virginia.
Affiliations
Admitted to practice: District of Columbia, Virginia, U.S. Patent and Trademark Office (USPTO), Supreme Court of the United States, U.S. Court of Appeals for the Federal Circuit, U.S. Court of Appeals for the Fourth Circuit
Professional Memberships
- Patent Trial and Appeal Board (PTAB) Bar Association
- American Intellectual Property Law Association
- American Chemical Society
- Virginia Bar Association
Speeches & Presentations
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"Biosimilar Biological Products," FDLI's Introduction to Biologics and Biosimilars Law and Regulation, Washington, D.C.
(October 1, 2019).
Presenters: Deborah H. Yellin and Mary Anne Schofield, Ph.D.
Publications
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"Intellectual Property – 3-D Printing: Manufacturing, Disrupted," Crowell & Moring's Regulatory Forecast 2019
(February 27, 2019).
Contributors: Deborah Yellin and John Gibson.
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"The Long and Winding Road for BIOSIMILARS: Charting a Pathway through Patent, FDA, Antitrust, Prescription Filling, Reimbursement and Liability Law," Bloomberg BNA Pharmaceutical Law & Industry Report
(September 18, 2015).
Authors: Chiemi Suzuki, Deborah H. Yellin, Barbara H. Ryland, Lauren B. Patterson, and John Fuson.
Client Alerts & Newsletters
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"Federal Circuit Finds That the USPTO Cannot Reduce PTA for a Time Period Where the Applicant Could Not Have Advanced Prosecution,"
IP Insights
(January 31, 2019).
Contacts: Deborah H. Yellin, Terry Rea
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"Federal Circuit Gives IPR Petitioners Burden of Persuasion for Proving Patentability of Amended Claims,"
IP Insights
(October 9, 2017).
Contacts: Deborah H. Yellin, Ali Tehrani, Kainoa Asuega
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"When it Comes to IPRs are University Patents Bullet Proof?,"
IP Insights
(February 2, 2017).
Contacts: Mary Anne Schofield, Ph.D., Terry Rea, Deborah H. Yellin
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"The Name Game – The FDA Issues Draft Guidance of Biologics Naming,"
Life Sciences Alert
(August 28, 2015).
Contacts: Terry Rea, Mary Anne Schofield, Ph.D., Deborah H. Yellin
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"Supreme Court's Bilski Decision: Business Method Patents Survive, at Least for Now,"
IP Insights
(June 28, 2010).
Contacts: Mark Supko, Deborah H. Yellin
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"Patent Owner's Self-Contradictory Expert Testimony Leads To JMOL Of No Infringement,"
Intellectual Property Bullet Analyses
(October 8, 2008).
Contacts: Mark Supko, Deborah H. Yellin
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"Mere Possibility of Delay by First ANDA Filer Does Not Support Declaratory Judgment Jurisdiction,"
Intellectual Property Bullet Analyses
(September 12, 2008).
Contacts: Mark Supko, Deborah H. Yellin
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