United States Patent Law and Polymorphs

1. United States Patent Law and Polymorphs

2. Overview of Presentation • Overview of U.S. Patent Law • What is a patent? • What is required to get a patent? • Why are polymorphs patentable? • Infringement of Patents • Cases relating to polymorphs • District court’s decision in SB v. Apotex • The Appellate decision in SB v. Apotex

3. UNITED STATES PATENT No. 6,999,999 To John Q. Public What is a Patent? • A Patent Is a Contract Between the Patent Holder and the Government. • A patent provides the government, and thus the general public, with a detailed disclosure of the “invention.” • In return for this disclosure, the patent holder receives a 20 year monopoly.

4. What is a Patent? A Patent Does Not Give Anyone (even the Patent Owner!) the Right to “Practice” the Invention.

5. What is a Patent? Rather, a Patent Gives the Right to Exclude Others from: • making • using • offering for sale • selling, or • importing the patented invention

6. What is a Patent? • Patents are provided for in the U.S. Constitution. • “The Congress shall have power….to promote the progress of…[the] useful arts, by securing for limited times to…inventors the exclusive right to their…discoveries.” • Laws governing the issuance of patents are in U.S.C. Title 35.

7. What is a Patent? • Title 35 U.S.C. Creates Rules for What is a Patentable Invention

8. What is a Patent? U.S. Patent 6,293,874 USER-OPERATED AMUSEMENT APPARATUS FOR KICKING THE USER’S BUTTOCKS

9. What is a Patent? U.S. Patent 3,538,508 COMBINATION PILLOW AND CRASH HELMET

10. What is a Patent? U.S. Patent Des. 302,693 INTEGRAL HANDSET TELEPHONE AND FLIP-TOP SHOE

11. What is a Patent? U.S. Patent 4,995,379 INSTANT FACE LIFT

12. What is a Patent? U.S. Patent 5,708,983 INFLATABLE CHEESE WEDGE HAT

13. What is a Patent? U.S. Patent 912,152 FIRE-ESCAPE

14. What is a Patent? • Requirements for patent: • Utility (35 U.S.C. § 101) • Novelty (35 U.S.C. § 102) • Nonobviousness (35 U.S.C. § 103)

15. Requirements for Obtaining a Patent • 35 U.S.C. § 101 (Utility) • “Whoever invents or discovers any new and useful process, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent thereof, subject to the conditions and requirements of this title.”

16. Requirements for Obtaining a Patent • Utility • Example of Inventions that are Patentable: • Processes • Machines • Manufacture • Compositions of matter (Polymorphs)

17. Requirements for Obtaining a Patent • Utility • Example of Inventions That Are Not Patentable: • Products naturally occurring in nature • Scientific principles • Laws of nature • Mental processes

18. Polymorphs and § 101: SB v. Apotex SmithKline Beecham v. Apotex, Nos. 03-1285, 2004 WL 868425 (Fed. Cir. April 25, 2004). • Case Involved Different Crystalline Forms of Paroxetine Hydrochloride • SB demonstrated that one crystal form converted to a more stable crystal form in the presence of seeds and sufficient water.

19. Polymorphs and § 101: SB v. Apotex • Appellate judge expressed the view that the claim covered subject matter that was unpatentable under section 101, because one crystal form converted to a more stable crystal form, without human intervention. • A “naturally occurring process”

20. Polymorphs and § 101: SB v. Apotex • However, the majority of judges hearing the case dismissed this view, because the crystal compound was a synthetic, man-made compound, and thus a “composition of matter” eligible for patent protection.

21. Requirements for Obtaining a Patent • Novelty (35 U.S.C. § 102) • Seven subsections • Focus on 102(a) and 102(b).

22. Requirements for Obtaining a Patent • 35 U.S.C. § 102(a) & (b) • Control whether an event or document qualifies as a potentially patent-defeating activity. • Potentially patent-defeating activities are described as “prior art.” • For “prior art” to invalidate a patent, it must describe every “element” of the claimed invention.

23. A A B B C C Requirements for Obtaining a Patent

24. Requirements for Obtaining a Patent • What is the difference between 35 U.S.C. § 102(a) and 35 U.S.C. § 102(b)?

25. Requirements for Obtaining a Patent • 35 U.S.C. § 102(a) states: • “A person shall be entitled to a patent unless-(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant.”

26. Requirements for Obtaining a Patent • 35 U.S.C. § 102(b) states: • “A person shall be entitled to a patent unless-(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date the application for patent in the United States.”

27. Requirements for Obtaining a Patent • 35 U.S.C. § 102(a): • Defines prior work by others that may prevent an inventor from obtaining a patent. • Such prior art includes: • If the invention was used by others in the US, or • If the invention was already patented or described in a printed publication in the US or another country. • Use of an invention in Europe will not be prior art under §102(a) unless the use was described in a printed publication or patented.

28. Requirements for Obtaining a Patent • 35 U.S.C. § 102(b) • Defines what activities by the inventor himself may invalidate a patent. • An invention cannot be • patented or described in a printed publication in the United States or foreign country • used in public or offered for sale in the United States • More than one year before filing the patent application IN THE UNTIED STATES • This one year period is called the “critical period.”

29. Requirements for Obtaining a Patent • 35 U.S.C. § 103 (Non-obviousness) • “A patent may not be obtained…if the differences between the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” • Question is how closely the invention as a whole resembles the prior art.

30. Requirements for Obtaining a Patent • Non-obviousness • Structurally similar chemical compounds held non- obvious if the compound has “unexpected results.” • Novel polymorphs can be patented without showing unexpected properties • Reason: one of ordinary skill cannot predict the structures, properties, or how to make a novel crystal form.

31. Polymorphs and §103: In re Irani In re Irani, 427 F.2d 806 (C.C.P.A. 1970) • Patent Office rejected a claim to crystalline anhydrous ATMP as obvious over a reference that disclosed amorphous ATMP. • Patent Office: “no patentably significant change in properties or utility.” • C.C.P.A. reversed: “[W]e are not convinced that the references . . . would lead one of ordinary skill . . . to expect that ATMP could exist in a crystalline, anhydrous form . . . ."

32. Polymorphs and §103: In re Cofer In re Cofer, 354 F.2d 664, 668 (C.C.P.A. 1966) "We think the board failed to address itself to other factors which must be given weight in determining whether the subject matter as a whole would have been obvious, namely, whether the prior art suggests the particular structure or form of the compound or composition as well as suitable methods of obtaining that structure or form."

33. Polymorphs and §103: Zenith Zenith Labs., Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1422 (Fed. Cir. 1994) • The patentability of a claim directed to a chemical compound "derives from the structure of the claimed compound in relation to prior compounds.” • “The relevance to patentability of the properties . . . exhibited by the compound is limited to assessing the significance of the structural distinctions of the claimed compound over the prior art."

34. Requirements for Obtaining a Patent • 35 U.S.C § 112 • What must be included in the patent itself: • Specification • Claims

35. 35 U.S.C. §112: Specification • The Specification Must Contain: • “a written description of the invention • . . . in such full, clear, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the [invention], and • shall set forth the best mode contemplated by the inventor of carrying out his invention.”

36. 35 U.S.C. §112: Claims • The Claims • Applicant “shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”

37. 35 U.S.C. §112: Claims • The Claims • Similar to a fence around a piece of property. • Claim defines the metes and bounds of a patent holder’s property.

38. Claim 35 U.S.C. §112: Claims Intellectual Property

39. Claim Infringer 35 U.S.C. §112: Claims Intellectual Property

40. Claim FHFG&D Infringer 35 U.S.C. §112: Claims Intellectual Property

41. 35 U.S.C. §112: Claims • Polymorphs • Claims often Limited by Analytical Data. • X-ray powder Diffraction Patterns, • Infrared Spectra • DSC • Be Wary of How Much Data to Include in a Claim.

42. 35 U.S.C. §112: Claims Zenith Labs., Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1422 (Fed. Cir. 1994) • Claim was directed to a “Monohydrate Compound” • Defined by a X-ray Powder Diffractogram, that incorporated into the claim 37 relative intensities.

43. 35 U.S.C. §112: Claims

44. 35 U.S.C. §112: Claims

45. 35 U.S.C. §112: Claims

46. Zenith Labs. v. Bristol-Myers Squibb Co., 19 F.3d 1418 (Fed. Cir. 1994) Infringement • Federal Circuit found no infringement • BMS's reference sample possessed a different X-ray diffraction pattern than that claimed in the patent. • Only 22 lines corresponded to the lines of the patent claim: "15 of the lines recited in the claim (representing about 40% of the total) were not considered by the [district] court in its comparison."

47. Infringement • Thus, it is Critically Important to Consider Issues of Infringement When Drafting Claims. • The more detailed the claim, the less property your fence covers and the easier it becomes for other companies to avoid infringement.

48. Infringement: SB v. Apotex

49. Infringement: SB v. Apotex

50. Infringement: SB v. Apotex • “Crystalline Paroxetine HCl Hemihydrate” • New crystalline form of paroxetine hydrochloride • Contains a 2:1 ratio of paroxetine hydrochloride to water bound in the crystalline structure • “We can’t predict the existence of paroxetine hydrochloride hemihydrate . . . or even if we could, how to make it or what its properties would be.” Testimony of Professor Joel Bernstein.