Jill MacAlpine, Ph.D., leader of the Finnegan’s patent office practice, focuses on strategic counseling, prosecution, and patent litigation, primarily in the chemical and pharmaceutical areas. With over 15 years of experience in intellectual property law, she spends a significant portion of her time involved in pre-litigation analyses, due diligence investigations, opinion preparation, and strategic client counseling, including patent portfolio management, Orange Book listings of patents covering FDA-approved drugs, and patent term extensions.
As a registered patent attorney, Jill has extensive experience in handling a wide variety of patent matters before the U.S. Patent and Trademark Office (USPTO), including post-grant proceedings specifically inter partes reviews (IPRs), appeals, and oral hearings at the Patent Trial and Appeal Board (PTAB); drafting and prosecuting patent applications; reissue and reexamination proceedings; and interferences.
In addition to counseling and prosecution, Jill’s practice includes patent litigation, in particular Abbreviated New Drug Application (ANDA) cases arising under the Hatch-Waxman Act. She has experience in all aspects of patent litigation at both U.S. district court and appellate levels, including managing day-to-day activities during every phase of litigation, conducting offensive and defensive discovery, drafting dispositive motions, and taking and defending depositions. Jill has been extensively involved in matters procuring, assessing and/or defending patent rights related to pharmaceutical drugs, including Farxiga®, Brilinta®, Lovenox®, Taxotere®, Allegra®, Rimonabant,® Nuvigil®, and Gabitril®, and other products such as Cerament.
Jill has handled matters involving a wide range of technologies, many having complex issues concerning solid state forms (polymorphs), including pharmaceuticals, small molecule chemistry, cosmetics, food science, bone substitutes, polymers, and drug delivery systems. She also has significant experience in organic chemistry. Jill earned her Ph.D. in organic chemistry at the University of British Columbia, where she studied porphyrins and porphyrin derivatives for use as pharmaceutical products in photodynamic therapy.
Jill is listed in LMG Life Sciences as an Intellectual Property: Life Sciences Star. She has written and lectured on diverse patent law issues and was a permanent faculty member of the Patent Resource Group’s “Chemical Patent Practice,” a comprehensive U.S. chemical patent law course taught multiple times a year.
The U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) recently released an update to its Orange Book patent and biologic patent study, examining post-grant petitions filed against Orange Book patents and biologic patents between September 16, 2012, and June 30, 2021. The PTAB classified a petition as challenging an Orange Book-listed patent by comparing the petition’s filing date with data from the U.S. Food and Drug Administration’s (FDA’s) electronic Orange Book indicating when the patent was listed. The PTAB manually identified biologic patents as any patent potentially covering a Purple Book-listed product and any non-Orange Book-listed patent directed to treating a disease or condition.