1. What’s Patentable? Eduardo Quinones, Ph.D., Esq. Amy A. Dobbelaere, Ph.D.

2. A patent is a property right – Prevents others from making, using or selling your invention without your permission – Exclusionary Right – One Patent – One Jurisdiction WHAT IS A PATENT?

3. DesignPlantUtility For today, we will focus on Utility Patents TYPES OF PATENTS

4. In the United States – Provisional Applications – Non-provisional Applications Around the world – Patent Cooperation Treaty (PCT) Application and National Stage Filings – Direct National Filings Timing – File first application before your first public disclosure* – File subsequent applications around the world within a year or country-specific deadlines for PCT. TYPES OF UTILITY APPLICATIONS

5. 35 U.S.C. 101: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. Inventions must be new, useful, and non-obvious Around the world: New, involve an inventive step (~non-obvious), and have industrial applicability (~useful) SO WHAT CAN I PATENT?

6. “Engineering” – Mechanical, Electrical, Chemical, Software or combinations thereof – Usually protecting: Devices/systems or components thereof Methods of operation, use, or manufacture Biotechnology Inventions – Molecular biology, Gene therapy, Virology, Genetics, Immunology, Stem cell technology, etc. – Usually protecting: Compositions, methods of making & using Diagnostic kits/methods Transgenic organisms TYPES OF INVENTIONS

7. Prepare invention disclosure or other materials to share with patent professional Patent professional prepares application* – Specification/Description – Drawings – Claims Application is filed Examination Allowance Patent is Issued! Total time – Several years PATENT APPLICATION PROCESS

8. In the U.S., application will generally be examined to ensure compliance with: – 35 U.S.C. 101 – Something that can be patented? – 35 U.S.C. 102 – Is it new in view of the prior art? – 35 U.S.C. 103 – Is it non-obvious in view of the prior art? – 35 U.S.C. 112 – Does the application have (1) An adequate description of the invention? (2) Enough details to practice the invention? PATENTABILITY REQUIREMENTS IN THE U.S.

9. Most Engineering-type inventions – Typically straightforward to describe and claim in application – Examination typically limited to claim form in view of prior art However, certain types of inventions require additional considerations: – Biotech inventions – Software inventions PATENTABILITY REQUIREMENTS IN THE U.S. (Cont’d)

10. CONSIDERATIONS FOR BIOTECH PATENT APPLICATIONS

11. Description and Figures ―As detailed a description as possible, including examples of several embodiments for a given invention ―In the ‘Examples’ section, inclusion of all relevant data, in vivo data always preferred ―Data figures Claims ―Composition consisting of or comprising… ―Method of treating disease X in a subject comprising administering the composition… ―Method of making a composition comprising…, the method comprising the steps of: a, b and c ―Method for analyzing X in a sample… ―A kit for analyzing X or treating disease X… TYPICAL BIOTECH PATENT APPLICATION/PATENT

12. In EPO, plant & animal varieties & biological processes for production thereof, methods for treatment of the human or animal body by surgery or therapy & diagnostic methods practiced on the human or animal body not patentable In EPO, patenting of stem cells is controversial – EPO does not process stem cell applications while the UK & DE patent offices follow a less stringent approach In JPO, methods to treat humans, specifically through surgery, general treatment, or diagnosis are not patentable. In Canada, methods of medical treatment & higher life forms are not patentable BIOTECH PATENTS AROUND THE WORLD

13. U.S. patent rules provide applicants with relatively flexible rules for amending claims during patent prosecution. EP in particular has more stringent claim support requirements – EP examiners typically don’t allow cobbling together an amended claim out of different embodiments. In EP, providing numerous embodiments of a given invention is a necessity, & describing how to combine various features of the disclosed embodiments may also be. China and Australia moving in EP’s direction JPO strictly requires that patent applications claiming medical uses (pharmaceutical inventions) should disclose "pharmacological test data or the equivalent" in the specification. BIOTECH PATENTS AROUND THE WORLD (cont.)

14. The USPTO considers non-naturally occurring, non- human multicellular organisms, including animals, to be patentable subject matter ―Microorganisms (bacteria, yeast, fungi) ―Embryonic stem cells ―Plants ―Animals ―Cellular / Biological Processes ―Genes and Nucleotide Sequences ―Gene Products (proteins) ―Biologically Derived Chemicals / Pharmaceuticals ―Diagnostic reagents ―Methods of treatment ―Medical Devices BIOTECH PATENTS IN THE U.S.

15. Recent Case Law/Issues ―2012 - Mayo Collaborative Services v. Prometheus Laboratories, Inc. ―2013 – Ass’n for Molecular Pathology v. Myriad Genetics ―2014 – AbbVie v. Janssen Biotech and Centocor Biologics ―Higher enablement (35 U.S.C. 112) standard compared to other fields ―Experimental data very important in many cases, in vivo more compelling than in vitro, e.g., claims for ‘method of preventing…’ & vaccines require substantial in vivo data for support BIOTECH PATENTS IN THE U.S. (cont.)

16. CONSIDERATIONS FOR SOFTWARE PATENT APPLICATIONS

17. Generally two main aspects for any type of software: – Algorithms, methods, and other general concepts that describe, at a high level, how the software operates; and – Actual computer code for implementing these concepts. Patents - Target the high level concepts Other types of protection are typically used for computer code (e.g., Copyright) PATENTING SOFTWARE

18. Description and Drawings: – Operating Environment – Particular/specialized components – Flow charts for each process – General Computer description/schematic Claims – Method – Computer-Product Claims – System Claims TYPICAL SOFTWARE-BASED PATENT

19. EXAMPLE OF SOFTWARE PATENT

20. Outside the U.S., obtaining software-based patents can be difficult: – Excluded by law; or – Excluded by problem/solution examination Problem/Solution Examination requires determining: – Problem being solved  A technical one?; – Solution being claimed: Would it be obvious to adapt the closest prior art to provide the solution? Does solution provides a technical effect or advantage over the closest prior art.* Thus, completely new software methods may be unpatentable overseas unless one can demonstrate a tangible, technical advantage of the method or system implementing the method. SOFTWARE PATENTS AROUND THE WORLD 20

21. Patents can be obtained for software-based inventions in the U.S. – Software per se is not patentable in the U.S. – However, methods implementing software-based inventions or articles of manufacture implementing such methods may be patentable To a major extent, examination is straight forward However, recent developments have imposed additional requirements SOFTWARE PATENTS IN THE U.S.

22. 35 U.S.C. 101: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Pre-2010 – Machine or Transformation (MT) Test 2010 - Bilski V. Kappos – MT test not sole measure of patentability. 2014 - Alice v. CLS - Claims directed to an abstract idea or a generic computer implementation of an abstract idea are ineligible for patent protection MAIN ISSUE - IS A SOFTWARE-BASED INVENTION ELIGIBLE FOR PATENT PROTECTION?

23. USPTO Examination (still developing) (1) Is the claim directed to an abstract idea? (2) If so, are there other claim features that show a patent-eligible application of the abstract idea, e.g., more than a mere instruction to apply the abstract idea? What does this mean? – Does the claim recite a way to use the abstract idea solve a technical problem?; or – Does the abstract idea provide some type of technical advantage? In sum  a problem/solution or technical step type approach to determine patent eligibility – No clear guidance yet, but consistent with Post-Alice decisions SOFTWARE-BASED PATENTS AFTER ALICE V. CLS?

24. Invention disclosures – Don’t limit description to just the software and how it works – Describe, in detail, technical problems solved by the software or a system implementing the software – Describe, in detail, any technical advantages of using the software e.g., improved computational speed, reduced memory demands, not just a business advantage. Working with patent professionals – Read draft applications in their entirety (you are supposed to do so anyways!) and make sure technical advantages and/or technical problems solved by the software are discussed as fully as possible. SO WHAT DO YOU NEED TO DO?

25. Eduardo Quinones, Ph.D., Esq. eduardo.quinones@novakdruce.com (561)847-7822 Amy A. Dobbelaere, Ph.D. amy.dobbelaere@novakdruce.com (561)847-7809 Novak Druce Connolly Bove + Quigg LLP Cityplace Tower, 15 th Floor 525 Okeechobee Blvd West Palm Beach, FL 33401 www.novakdruce.com CONTACT INFORMATION

26. Questions?