PHARMACEUTICAL PATENT APPLICATION PROSECUTION TIPS Innovation Advancement Workshop WENDY MARSH Direct Number: (515) 645-5502 | Facsimile: (515) 283-3108 | E-Mail: wkmarsh@nyemaster.com 700 Walnut, Suite 1600 | Des Moines, IA 50309-3899 | (515) 283-3100   Attorneys at Law | Offices in Des Moines, Ames and Cedar Rapids WENDY MARSH is a shareholder in the firm's Intellectual Property Department, practicing primarily in the area of intellectual property matters, including patents, trademarks, and copyrights. Wendy received her degree from Drake University in pharmacy, and practiced as a pharmacist for several years following graduation. She received her law degree from Drake in 1994. Wendy frequently appears before the Patent Office Board of Appeals and Interferences as well as the Trademark Trial and Appeal Board, before which she has argued numerous patent and trademark appeals. In addition to prosecuting patent and trademark applications, Wendy counsels clients on intellectual property issues relating to intellectual property acquisition, protection, enforcement, and management. She is a past chair of the Iowa Bar Association Intellectual Property Law section and past president of the Iowa Intellectual Property Law Association. www.nyemaster.com 2017 ©2017 Nyemaster Goode, P.C. 1

Goals in patent claim drafting PATENTS Goals in patent claim drafting First, you must define a working invention Second, the invention must be novel and non-obvious 2

PATENTS An invention must be patent eligible - § 101 Things that are NOT patent eligible: Abstract ideas Naturally occurring compositions Natural principles Previously unknown natural phenomenon 3

Tips for Navigating § 101 Apply naturally occurring substance to a new, useful end, i.e. a new drug Focus on having a step that is not routine or conventional Define unconventional step narrowly and specifically 4

An invention must meet the requirements of § 112: PATENTS An invention must meet the requirements of § 112: The claims must set forth the subject matter that the inventor regards as the invention - subjective The claims must particularly point out and distinctly define the metes and bounds of the invention - objective (person of ordinary skill in the art) 5

Tips for Navigating § 112 Describe invention broadly and definitely. Words of degree are risky, i.e. more stable, faster, stronger, etc. Discern the boundaries Sufficiently describe how to make and use the invention – only objective enablement required Claim encompassing 10,000 combinations with only one example is probably not enabled 6

General Tips Dream up alternatives: describe invention specifically but capture it broadly. Try to predict where competitors might be going Think of different embodiments and convey in the specification there are many ways to carry out the invention. Describe more than a single embodiment if possible 7

General Tips Consider your competitors: how could they get around your claims? Take advantage of different claim types: i.e. composition, method of using the composition, method of manufacturing the composition 8

Define a New and Non-Obvious Invention Include something in the claim that is different from what is in the prior art Differences can include differences in the composition, dose, method of manufacturing, new and unexpected combination, unexpectedly good results/synergistic effect, different dosage form, dosing schedule, etc. 9

10

11

12

13

14