Global Patent Issues:

1. Global Patent Issues: AUTM February 28, 2008 Ronald I. Eisenstein, Esq. Partner, Nixon Peabody LLP reisenstein@nixonpeabody.com

2. In Order to Properly Draft an International Application it is Important to Understand Both Similarities and Differences in Patent Policies Between Different Countries • For Example: • In the U.S. • Can claim “methods for treatment” • e.g. A method for treating an individual having a solid tumor comprising administering a pharmaceutically effective amount of compound X to said individual. • Cannot claim “use of” • e.g. Use of compound X to treat an individual having a solid tumor.

3. In Europe and Canada, the exact opposite rules apply. • This is why U.S. patent attorneys rely on foreign associates for assistance when filing in foreign jurisdictions • However, there must be adequate support in the original specification or you cannot appropriately deal with the differences between countries. Thus, you need to have some idea of patent procedures in the main countries in which you want to file.

4. Other Key Differences • Most of the world allows multiple dependent claims • e.g. “Claim 10. The composition of claims 2-9, further comprising…”. • And allows multiple dependent claims to depend upon multiple dependent claims • e.g. “Claim 11. The composition of any of the preceding claims, further comprising… Claim 12. The composition of any of the preceding claims, further comprising…”.

5. Other Key Differences (Cont.) • The U.S. PTO does not allow multiple dependent claims to depend upon other multiple dependent claims and counts each claim upon which a multiple dependent claim depends as a separate claim.

6. Why is this Important? • The U.S. PTO would like to limit you to 5 independent claims and 25 total claims for each invention—multiple multiple dependent claims increase the number of claims factorally. So, just don’t include them.

7. Why is this Important? (Cont.) • However, in the EPO there is a very strict requirement to show support for later amendments (e.g. “directly and unambiguously derivable test”). • The use of multiple dependent claims depending upon other multiple dependent claims in both the priority application and the international application can be a tremendous help.

8. Why is this Important? (Cont.) • In U.S. vs. Europe the ability to freely amend claims is substantially more limited. • For example, you can amend claims during appeal. However, you must have clear basis in your application.

9. Filing Date of A Filing Date of B A wins First to File vs. First to InventThe 2 Concepts Are Not Mutually Exclusive • Statistics suggest that the first to file is usually the first to invent. • However, in a first to file system, you do not look beyond this. • As will be explained later in a first to invent system you look at earlier events. • The U.S. is at this moment a first to invent. The process used to determine who was first to invent is called an Interference.

10. What is an Interference? • Contested proceeding in the U.S. Patent and Trademark Office (PTO) • between at least one patent application and either another patent application or • a patent claiming the same patentable subject matter to determine who is entitled to a patent

11. What is an Interference? (Cont.) In the U.S. the winner is (A) first party to conceive of the invention and reduce it topractice • making it and testing it to see that it works (“actual reduction to practice”) • filing a patent application (“constructive reduction to practice”) • without abandoning, suppressing or concealing the invention.

12. What is an Interference? (Cont.) (B) first party to conceive and use diligence until reduction to practice Diligence is establishing that the party was continually working on the invention or had a good excuse for not working on or reducing the invention to practice.

13. What is an Interference? (Cont.) • This system is unique to the United States • The rest of the world determines priority of inventions by the “First to File” system • The First to File system says the first applicant to file a patent application on the same patentable invention wins

14. However, even with a First to File system, you still look at other things. • Namely, does that first application actually support what is being claimed. • Namely, does it describe with clarity, enable, etc. the invention claimed. • This can be very important if a third party application is filed between the priority application and the international application.

15. If A’s Priority Application does not support the claim, B may be able to get the claim. • This reiterates the importance of a good provisional application containing multiple embodiments Party A’s Priority Application Party B’s Priority Application Party A’s International Application

16. Interference Timeline • Before an interference can be declared, the claims must be allowed. • At least 2-5 years after substantive examination begins.

17. Why Should You Care About Interferences? • They are expensive. • Even “settled” interferences can cost $50,000 in legal costs to resolve. • Contested interferences can cost well over a million dollars in legal fees for each side. • They also take up a lot of your time.

18. Scenarios for Interferences • Party with pending patent application wants to challenge the validity of another party’s claims to similar subject matter. • Parties make same invention separately and file their own patent applications. • Parties make same invention through collaboration with each other and file their own patent applications.

19. Why you would NOT want to be involved in an interference… • It is too time consuming. • The delay in resolution of interferences by the Board results in too much uncertainty to be able to invest in the product. • It is too expensive. • The invention is not worth the investment of time or money. • You may lose.

20. So How Can You Avoid An Interference? • Plan Ahead • It is much easier to minimize your chance of being in an interference if you do not wait for the interference to be declared.

21. There is Little Excuse For Not Knowing About A Potential Interference • PCT and almost all U.S. patent application are readily available on-line within 18 months of initial filing date. • Publications and presentations readily available on-line. • Your inventors know the field. • You know your competitors.

22. U.S. Patent File Histories Are Now Available On Line http://portal.uspto.gov/external/portal/pair

23. The PTO Does Not Like Interferences • 2 Way Patentability Is Now Typically Required • This means invention A must not be patentable if invention B was prior art AND invention B must not be patentable if invention A was prior art.

24. In Other Words…. • No interference between species and genus. • The practical effect of this is that one can write claims to avoid interferences. • Focus on distinctions between your invention and someone else’s. • Place those claims in a separate application from one with conflicting claims.

25. For example, focus on a preferred species. Alternatively, if you have a broader genus, avoid subgeneric claims of the same scope as your potential opponent.

26. Phases of Interferences • File priority statement • Sets forth earliest dates of invention intended to be relied on. • Motion phase • Priority phase

27. Even If you Get Into An Interference, The PTO Is Looking To Avoid Interferences • Two key motions: • No Interference-In-Fact • Claims added more than one year after the patent issued. • No Interference-In-Fact • Point to how your claims differ from your opponents. Look at any and all distinctions.

28. Claims Not Timely – Only Valid If You Are First party Whose Claims Are Allowed Or Published 35 U.S.C. § 135(b)(1) A claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.