Wayne W. Rupert Klarquist Sparkman, LLP 121 SW Salmon Street, 16 th Floor Portland, OR 97204

1. Patenting Protein Therapeutics: In the Shadow of Uncertainty 4th Protein Discovery and Therapeutics Global Technology Community New Patent Law Paradise Point Resort & Spa San Diego, CA October 19-21, 2011 Wayne W. Rupert Klarquist Sparkman, LLP 121 SW Salmon Street, 16th Floor Portland, OR 97204 (503) 595-5300 wayne.rupert@klarquist.com University of Oregon Eugene, Oregon January 2012

2. New Patent Law (American Invents Act (AIA)) • Big Deal + Complex • Switching from First-to-Invent to First-to-File (March 2013) • Derivation Proceedings • More Foreign Prior Art But first, what has not changed…

3. What is a Patent? A patent is a grant (from the government to a patent owner) to exclude others from making, using, selling, offering for sale, or importing the invention as defined by the claims of the patent.

4. What inventions are patentable? Must be directed to a type of subject matter that is eligible for a patent Must be novel and nonobvious when compared to the prior art Must be able to describe invention in sufficient detail to enable the making and using of the invention

5. Subject Matter Eligible for a Utility Patent Eligible Subject Matter: Process Machine Article of Manufacture Composition of Matter Improvement Thereof Ineligible Subject Matter: Laws of nature Physical phenomena Abstract ideas Literary, dramatic, musical, and artistic works Inventions which are considered not useful or possible by the USPTO, for example, perpetual motion machines; or offensive to public morality

6. Subject Matter Eligible for a Utility Patent • Process • Therapeutic or diagnostic method (except outside the U.S. in certain circumstances) • Method for making a product • Business method • Machine • Nano-robot • Article of Manufacture • A protein array • A pen • Composition of Matter • Isolated/purified naturally-occurring substance • Chemical compound • Multi-ingredient composition • A new use of or improvement to an existing invention

7. Basic Principles for Patentability Two hurdles – Novelty and Obviousness • Invention must be both novel and nonobvious when compared to the prior art Prior Art • Generally, any information that is available to the public before the date of invention (currently in the U.S.) or the filing date of the patent application (in the U.S. starting 2013 and foreign) • Important exception to the general rule of publicly available information - other patent applications having an earlier filing date in the patent office can be prior art

8. Novelty Basic Rule – Invention lacks novelty if every claimed feature of the invention is disclosed in a single prior art source Inherency – Although a feature is not explicitly described in prior art source as being present, it may be inherently (i.e., necessarily) present based on the explicit description

9. Obviousness Invention is novel, but… Not patentable if the difference(s) between the claimed invention and the prior art would have been obvious to a person of ordinary skill in the art

10. Examples of Evidence of Nonobviousness The prior art teaches away from the invention Unexpectedly superior results Long felt need in the industry for the invention Commercial success of the invention Licensing Copying

11. Written Description of How to Make and Use Application must sufficiently describe invention so that a person of ordinary skill in the art reading the application would recognize that the inventor “possessed” the invention • Can be satisfied by: • Details of actual reduction to practice • Identifying characteristics – can be structure and/or properties (should be chemical and/or physical properties) as opposed to functional properties • Common problem – limited reduced-to-practice examples do not support desired broad breadth of protection

12. Patent Application • Specification • Description of invention (including alternative embodiments and specific examples) • Claims • Define the property boundary of the patent • Drawings

13. Patent Office Examination • File application at Patent Office • Continuing duty to disclose known prior art to USPTO • Patent Office will determine whether application satisfies patent requirements • Claimed subject matter sufficiently different compared to prior art • Patent Office will do an independent search • Novelty – claimed subject matter must be different from the prior art • Nonobvious – difference from prior art must be more than trivial • Disclosure adequately describes how to make and use • Claim language is not vague or ambiguous

14. First-to-Invent vs. First-to-File The U.S. patent system is moving from first-to-invent to first-true-inventor-to-file in March 2013 due to passage of the America Invents Act (AIA) that was enacted in September 2011. U.S. patent system is first-to-invent for patent applications filed before 3/16/2013 (AIA). After 3/16/2013, U.S. patent system is first-true-inventor-to-file patent application. Most foreign patent systems are already first-to-file application. Inventorship and date of invention are important under both systems, thus lab notebooks remain important. Should not be a significant change to current procedures at the University of Oregon (except more important to file enabled patent application earlier).

15. First to File – Prior Art, the What Effective March 2013 What is Prior Art?(New types of Prior Art shown in red) Patent or printed publication anywhere In public use in U.S. In public use in foreign countries On sale in U.S. On sale in foreign countries Available to public in US (“known or used by others”) Available to public in foreign countries U.S. patents and published applications as of effective filing date, including foreign priority dates

16. First to File – New 102 Summary Effective March 2013 • First inventor to file is entitled to patent • Prior art is established as of effective filing date • Date of invention is no longer relevant to prior art • E.g., can’t swear behind a reference published within a year before filing • Public use or sale of the invention in a foreign country is now prior art • Current statute limits prior art to public use or sale in the U.S. • One-year grace now limited only to inventors that disclose “subject matter” before date of prior art

17. First to File – Prior Art, the When Effective March 2013 Prior art under First to File Prior art now A files app A invents New “Red Zone” of Prior Art Until you file application (or disclose), prior art keeps accumulating.

18. First to File – Shortening the Red Zone Effective March 2013 Prior art after March 16, 2013 Prior art now Practice Tips • File early and often to reduce the length of the red zone subject to budget constraints. • Consider quickly filing of provisional application, especially in fast-moving technologies, before preparing more detailed application. • Risk: Non-enabled disclosures not entitled to priority date.

19. First to File – Shortening the Red Zone Effective March 2013 Risks in Filing Too Quickly • Likely see more non-enabled disclosures, especially provisionals • Balancing test required • File now with enablement in question? OR • Delay and risk someone else beating you to the Patent Office? Best Answer? • File early, even if enablement in question. AND • File again when additional information obtained.

20. Disclosures Effective March 2013 INVENTOR DISCLOSES FIRST • One year grace period for inventors own disclosure. Have a year to file a patent application once a disclosure occurs. • But what is a “disclosure” under the new law? • No guidance in the AIA • Does a disclosure have to be enabling? • Does an offer for sale without the details of the invention count? The content of the disclosure is important.

21. Disclosures Effective March 2013

22. Disclosures Effective March 2013 35 USC 102(b) – Exceptions A third party disclosure within one-year of the applicant's filing date does not count as prior art if: • INVENTOR DISCLOSED FIRST - Not prior art if the inventor had already publicly disclosed the invention prior to the third party disclosure • DERIVATION OCCURRED - Not prior art if the third party disclosure was somehow derived from the inventor

23. First to File – Disclosure Example Effective March 2013 B publishes SUBJECT MATTER A Mar. 2014 A publishes SUBJECT MATTER A Jan. 2014 A files app for SUBJECT MATTER A Dec. 2014 (<1 year from A’s publication) B’s publication is NOT prior art to A (But would be prior art to anyone else)

24. First to File – Disclosure Effective March 2013 B publishes SUBJECT MATTER X + Y Mar. 2014 A files app for SUBJECT MATTER X + Y Dec. 2014 (<1 year from A’s publication) A publishes SUBJECT MATTER X Jan. 2014 B’s publication is NOT prior art to A as to SUBJECT MATTER X. But SUBJECT MATTER Y is prior art. Claims to Y cannot be obtained.

25. First to File – Prior Art Effective March 2013 Prior art after March 16, 2013 A invents Jan. 2014 A files app Dec. 2014 Result: A is NOT entitled to patent if any one of the activities by B occurs B sells invention in foreign country B Publishes B files foreign app, and later claims priority to it in US A publishes Oct. 2014

26. Disclosures Effective March 2013 PROS CONS Practice Tips • When should you rely on the “disclosure” grace period? • After the inventor has already made a disclosure! • CONS! • Foreign rights will be lost in many countries by disclosure before filing. • Unclear how “disclosures” will be treated by courts. • Is a sale a disclosure? Does the disclosure need to be enabling? • Gives competitors the chance to begin “improving” upon your ideas. • Can a competitor file on SUBJECT MATTER A+B if you disclose SUBJECT MATTER A? • Extra cost associated with proving first disclosure. • PROS? • Cheaper than filing a provisional or other patent application? • Ensures prior art effect as of publication. • Abandoned provisional applications don’t publish. • Prevents others from filing on the same invention while provides the potential to file on the subject matter in the future.

27. First to File - Timing Effective March 2013 Practice tips – During the Transition to FTF • File new applications by March 15, 2013. • Includes any application with “new” subject matter, even if it claims priority to earlier-filed application. • On or after March 16, 2013, consider impact of filing applications with claims unsupported by priority application. • To maintain first to invent, file continuing applications with claims to only the earlier-filed subject matter. • “New” subject matter can be claimed in later-filed continuation in part applications or new applications. • The US PTO is not intending to make rejections on first-to file. They intend to let the Courts make this determination. • Defensive “Disclosure” provisions start March, 2012!

28. Derivation Proceedings Under new U.S. patent system there will be a process for determining who is a true inventor – process is known as a “Derivation” proceeding. Derivation proceedings conducted by the U.S. Patent and Trademark Office (USPTO) for patent applicants; similar provision in patent owners in district court. This means that you have to file an application or obtain a patent to utilize a derivation proceeding. Basics: First-to-file patent applicant is not awarded patent if they “derived” invention from someone else not named as an inventor on the application or patent. Later-filed patent applicant must file a petition in USPTO “within one year of publication of a claim to the invention or to a substantially similar invention.” “Publication” presumably means publication of the alleged deriver’s patent application or patent or the petitioner’s patent application, but what about a new claim filed after publication of the application? Petition must be supported by “substantial evidence” of derivation.

29. Proving Derivation USPTO has not established any procedural regulations or guidelines yet. Apply current law under derivation-related statute? (1) Petitioner first conceived of the invention; and (2) Petitioner communicated invention to the alleged deriver with enough particularity to enable the claimed invention.

30. Proving Derivation What is “communication?” What if only evidence of “communication” is a prior research paper by petitioner? Prior research paper is prior art against alleged deriver’s patent application. Alleged deriver’s earlier-filed patent application is not prior art against petitioner’s later-filed patent application. Derivation proceedings more likely directed to communications between petitioner and alleged deriver where there is no public disclosure or in situations where there is a research paper and additional communication between petitioner and alleged deriver. LAB NOTEBOOKS! How much information must be “communicated?” What if alleged deriver’s patent application claims obvious variations of information communicated by petitioner to alleged deriver? LAB NOTEBOOKS!

31. Good Notebook Practices(Paper or ELN) Record ideas (“definite,” “complete,” “operative”), experimental protocols, results (e.g. structures of novel materials), observations (e.g., appreciation of significance of results). BE PROMPT! Document potential variations of concept, even if do not intend to actually reduce the variations to practice. Document communications to others, particularly with people outside of the University – important for proving joint inventorship or derivation (who? what? when?) Identify abbreviations, acronyms, shorthand notations, etc. if not commonly understood.

32. Important Takeaways • Timing is Critical • Submit invention disclosure to University of Oregon Technology Transfer office prior to publication or public demonstration • Consider evidence of nonobviousness • Consider reducing to practice sufficient number of different examples

33. Thank You Wayne W. Rupert Klarquist Sparkman, LLP 121 SW Salmon Street, 16th Floor Portland, OR 97204 (503) 595-5300 wayne.rupert@klarquist.com Questions?