1. www.burnslev.com INTELLECTUAL PROPERTY PROTECTION WPI Presentation March 27, 2007 Presenters: Jacob N. (Jesse) Erlich, Esq. Dr. Orlando Lopez, Esq. Dr. Janine M. Susan, Esq.

2. Understanding Intellectual Property

3. INTELLECTUAL PROPERTY Formal definition Intellectual property is an intangible or proprietary asset such as a patent, copyright, trademark or trade secret My definition Intellectual property is a protectable development of the mind

4. EXAMPLES OF INTELLECTUAL PROPERTY PROTECTION Trade secrets Patents Copyrights Trademarks

5. TRADE SECRETS Used to protect important business information that a business does not want to disclose to the public Effective only if kept confidential Do not release trade secrets without a nondisclosure agreement Always place appropriate marking on trade secret information (e.g., Proprietary Information, Not for Public Release) Last indefinitely as long as they are kept secret

6. WHAT IS A U.S. PATENT Grant by the government to provide individuals with legal protection for their discoveries (inventions) Article 1, Section 8, of the U.S. Constitution states that Congress is empowered to "...promote the progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries" Covered by Federal law (Title 35 of U.S. Code)

7. TERM AND EXCLUSIONARY RIGHT OF A UTILITY PATENT Patent applications filed after June 8, 1995—20 years from effective filing date Patent applications actually filed before June 8, 1995 or patents in effect on June 8, 1995—The longer of either 20 years from the effective filing date or 17 years from the issue date Patent owner given the right to prevent others from making, using, offering for sale, selling, or importing the claimed invention within the U.S.

8. TERM AND EXCLUSIONARY RIGHT OF A UTILITY PATENT Process patent owners also given the right to prevent others from importing a product obtained from patented process

9. TYPES OF PATENTS Utility Process (method) Machine Article of manufacture Composition of matter Improvements on all of the above Plant Design

10. WHO IS ENTITLED TO A PATENT To obtain a patent, individual(s) must be original and first inventor Invention must be conceived Invention must be reduced to practice (actual or constructive) Must file a patent application

11. CONDITIONS FOR PATENTABILITY Invention must be: Novel Useful Non-obvious Statutory bars against obtaining patent set forth in 35 USC 102 Examples Unrestricted printed publication more than 1 year prior to filing patent application Public use or on sale in U.S. more than 1 year prior to filing patent application

12. Provisional Patent Applications Effect Of An Inadequate Provisional Case NEW RAILHEAD MANUFACTURING, L.L.C., Plaintiff-Appellant, v. VERMEER MANUFACTURING COMPANY, Defendant-Appellee, and EARTH TOOL COMPANY, L.L.C.

13. FOREIGN PATENTS Patentability based on absolute novelty Applicant need not be inventor Filing of foreign applications Directly in foreign country Under regional patent systems Under Patent Cooperation Treaty (PCT)

14. FOREIGN PATENTS Foreign applications must be filed within 1 year of U.S. provisional/patent application filing date to receive priority date

15. Provide individuals and companies with legal protection for a wide variety of works of “authorship” COPYRIGHTS Pictorial, graphic and sculptural Audiovisual Sound recording Computer databases and software Literary Musical Dramatic Pantomimes Choreographic

16. COPYRIGHTS Copyright protection Occurs upon creation Lasts for the life of the author plus 70 years For “works for hire,” lasts 95 years from publication or 120 years from creation, whichever expires first Copyright registration Not required Beneficial when taking infringement action Copyright ownership resides with: Author Employer when work for hire

17. TRADEMARKS Provide protection for words or symbols or combination used by manufacturer or merchant to identify source of goods Become effective when used on goods in commerce Federal registration—interstate commerce State registration— intrastate commerce Protection lasts indefinitely If properly used If renewed

18. SERVICE MARKS Provide protection for words or symbols or combination identifying services rendered by a business Covered by trademark laws Become effective when used to advertise service Use in commerce not required

19. TRADE NAMES Used to identify name under which an organization does business Not federally registered

20. Understanding Claims of a Patent Application

21. READING A PATENT APPLICATION Suggested approach Start with the claims (at the end of the application) Then compare the claims to the drawings Finally, read the entire application Or, you can follow the Mad Hatter advice (start at the beginning)

22. THE CLAIMS The claims define the invention (they are similar to the metes and bounds in the property deed) If you describe an invention in the specification (the narrative part of the patent application) but do not cover that invention in the claims, the patent does not protect that invention

23. A System Claim

24. Drawing corresponding to claim example

25. A method claim A method of calibrating a line sensor the method comprising the steps of: generating a two dimensional image from the line sensor analyzing said two dimensional image generating calibration information for the line sensor based on the analysis in order to calibrate the line sensor

26. Figure corresponding to the method claim

27. How the patent is asserted (used to exclude others) Each claim of the patent is compared to a potentially infringing product A product must have all the limitations of a claim in order to infringe the claim (make claims with few limitations!! Less is more in this case)

28. Protecting Chemical and Biotechnology Inventions

29. Chemical Inventions Chemical Compound or Composition Structure Name Formula Definitive chemical and physical properties

30. Utility Use of a chemical compound for general research purposes is not sufficient Use of a compound as an intermediate in preparing a known material was not sufficient utility when a method of transforming the intermediate into the final product was not known (Brenner v. Manson, 383 U.S. 519 (1966))

31. Written Description A broad generic claim directed to a large number of chemical compounds has been held not to be a written disclosure of each compound encompassed within the generic claim (In re Ruschig, 379 F.2d 990 (CCPA 1967) Include a lengthy list of compounds falling within the scope of the generic claim Can be time-consuming and expensive May be possible to list the compounds not in the genus

32. Enablement How to make a chemical compound or composition Identify starting materials Describe how to make or obtain starting materials Reaction conditions Broad ranges/preferred ranges/alternative methods Working examples If possible should meet “scientific paper” standards Include e.g.: exact amounts of starting materials, order of addition of reactants, reaction conditions, purification steps, identification/characterization steps, equipment used Number of examples depends on scope of claims and predictability (or lack thereof) of the chemistry Prospective examples can be included

33. Enablement How to use a chemical composition Include data in the working examples showing that the compounds possess the stated utility All compounds claimed need not exhibit the same degree of utility

34. Best Mode Failure to disclose the specific supplier and trade name of the inventor’s preferred material violated the “best mode” requirement (Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923 (Fed. Cir. 1990) Claimed grommet was made from a polyvinyl chloride plastisol, and the inventor did not know the formula, composition, or method of manufacture of the plastisol Only one of several polyvinyl chloride plastisols tried by the inventor was effective for obtaining his grommet

35. Claiming a Chemical Invention Compound of formula XRR’R”, wherein R is A, B, or C; R’ is D, E, or F; R” is G or H Compound Y per se (i.e. X, wherein R is A; R’ is D; and R” is G) Compound XRR’R” in combination with desirable functional properties (e.g. Compound XRR’R” which inhibits HIV infectivity) Methods of making compound XRR’R” Methods of using compound XRR’R” Compositions containing compound XRR’R” (e.g. A composition comprising compound XRR’R” and a pharmaceutically acceptable carrier) Kits containing a variety of reagents including compound XRR’R” Composition made by combining L, M, and N

36. Functional Expressions E.g.: Defining a radical on a chemical compound as “incapable of forming a dye with said oxidizing developing agent” Although functional, it set definite boundaries on claim scope Claimed composition must still be novel and not merely a known composition with an as yet unknown property recited in the claims

37. Operability E.g.: A composition comprising a herbicidally active compound of the formula X Does not include nonoperable compounds within its scope, even if the generic formula X includes such compounds

38. Biotechnology Inventions Typically involve the modification of an existing system of living matter into elements that may be difficult to define Often described in functional terms (e.g., describing the biological effects of the invention) rather than the structural elements of the invention Claimed composition must still be novel and not merely a known composition with an as yet unknown property recited in the claims

39. Utility Use of a nucleic acid sequence as a probe to obtain the full length gene is not sufficient General research purpose Method of treating X in humans comprising administering Y Utility rejections because application only discloses results obtained in vitro Use “art-recognized” model systems Utility can be shown if there is a “reasonable” correlation between activity and asserted utility In vivo animal data, if possible Treatments need not be 100% effective (need not “cure” a disease) Drugs (“Y”) need not meet FDA standards of safety and efficacy

40. Novelty/Inherency Claimed invention is a metabolite resulting from an administered drug Claim a substantially pure metabolite Claim metabolite as a part of a pharmaceutical composition Claim a method of administering the metabolite

41. Obviousness A pharmaceutical composition comprising: an effective amount of amlodipine and an effective amount of a substantially pure form of hydroxylated atorvastatin metabolite Unexpected results synergistically inhibit lipid peroxidation in human low density lipoprotein or lipid membrane

42. Written Description Rapidly evolving “state of the art” “Experimental” and “unpredictable” procedures becoming “standard” and “well- known” E.g., depositing an antigen in a public depository and claiming an antibody by its binding affinity to the deposited antigen vs. providing the amino acid and/or nucleotide sequence of an antibody

43. Biological Deposits Where words alone cannot sufficiently describe how to make and use the invention, deposit of biomaterials may be necessary (not a substitute for written description) Cell lines Deposit before filing or during pendency of application Must be made for at least 30 years Depository recognized by the Budapest Treaty (e.g. ATCC)

44. Nucleotide and Amino Acid Sequence Listings Requires use of standard symbols and a standard format Requires submission in a computer readable form 1996 guideline permitting examination of up to ten, independent and distinct molecules described by their nucleotide sequence in a single patent application has been rescinded as of February 22, 2007 Claims to polynucleotide molecules will be considered for independence, relatedness, distinction and burden as for any other molecule Unity of invention will exist when polynucleotide molecules share a general inventive concept (i.e. share a technical feature which makes a contribution over the prior art)

45. Claiming a Biotechnology Invention Proteins Purified or isolated protein Protein coupled to another molecule Processed forms of the protein DNA encoding the protein (isolated, purified, in a vector) Expression systems (i.e. DNA linked to control sequences such as promoters) Recombinant host cells containing the encoding DNA or expression system Method to produce the protein recombinantly

46. Claiming a Biotechnology Invention Proteins (cont’d.) Recombinant protein Methods of treatment or diagnosis using the protein Pharmaceutical compositions containing the protein DNA encoding the protein conjugated to another molecule Methods of using the DNA in diagnosis or as a probe Antibodies reactive with the protein Methods to purify the protein from native or recombinant sources Methods to assay for the presence or activity of the protein

47. Some Claim Categories for Biotechnology Inventions Proteins, polypeptides (fragments) cDNA or recombinant DNA (fragments) SNPs (diagnosis) Monoclonal Antibodies (MAbs) Engineered MAbs (e.g. Fabs, humanized antibodies) Anti-sense RNAs, siRNAs Recombinant vectors Transformed cell lines Stem cell lines Transgenic animals Methods of producing a protein, an antibody, a polynucleotide Methods of using a protein, an antibody, a polynucleotide Diagnostics (kits, methods/assays, DNA chips/microarrays) Vaccines Asexually-produced plants, genetically engineered plants