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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Howard W. Levine Jennifer S. Swan The purpose of these slides is to raise issues for academic discussion.

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Presentation on theme: "Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Howard W. Levine Jennifer S. Swan The purpose of these slides is to raise issues for academic discussion."— Presentation transcript:

1 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Howard W. Levine Jennifer S. Swan The purpose of these slides is to raise issues for academic discussion in a developing area of the law. They do not make definitive statements on the current status of the law and do not represent the views of FHFGD or any of its past, present, or future clients. United States Patent Law and Polymorphs

2 Page 2  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 Overview of Presentation

3 Page 3  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. What is a Patent? UNITED STATES PATENT No. 6,999,999 To John Q. Public

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

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

6 Page 6  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. What is a Patent?

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


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

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

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

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

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

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

15 Page 15  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.” Requirements for Obtaining a Patent

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

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

18 Page 18 Polymorphs and § 101: SB v. Apotex  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. SmithKline Beecham v. Apotex, Nos. 03-1285, 2004 WL 868425 (Fed. Cir. April 25, 2004).

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

22 Page 22  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. Requirements for Obtaining a Patent

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

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

25 Page 25  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.” Requirements for Obtaining a Patent

26 Page 26  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.” Requirements for Obtaining a Patent

27 Page 27  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. Requirements for Obtaining a Patent

28 Page 28  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.” Requirements for Obtaining a Patent

29 Page 29  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. Requirements for Obtaining a Patent

30 Page 30  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. Requirements for Obtaining a Patent

31 Page 31  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...." In re Irani, 427 F.2d 806 (C.C.P.A. 1970) Polymorphs and §103: In re Irani

32 Page 32 "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." In re Cofer, 354 F.2d 664, 668 (C.C.P.A. 1966) Polymorphs and §103: In re Cofer

33 Page 33  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." Zenith Labs., Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 1422 (Fed. Cir. 1994) Polymorphs and §103: Zenith

34 Page 34  35 U.S.C § 112 What must be included in the patent itself: 1) Specification 2) Claims Requirements for Obtaining a Patent

35 Page 35  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.” 35 U.S.C. §112: Specification

36 Page 36  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.” 35 U.S.C. §112: Claims

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

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

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

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

41 Page 41  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. 35 U.S.C. §112: Claims

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

43 Page 43 35 U.S.C. §112: Claims

44 Page 44 35 U.S.C. §112: Claims

45 Page 45 35 U.S.C. §112: Claims

46 Page 46 Zenith Labs. v. Bristol-Myers Squibb Co., 19 F.3d 1418 (Fed. Cir. 1994)  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." Infringement

47 Page 47  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. Infringement

48 Page 48 Infringement: SB v. Apotex

49 Page 49 Infringement: SB v. Apotex

50 Page 50  “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. Infringement: SB v. Apotex

51 Page 51 SmithKline Beecham Corp. v. Apotex Corp., 247 F.Supp.2d 1011 (N.D.Ill. 2003)  Apotex filed an ANDA for approval to market paroxetine hydrochloride anhydrate  SB argued that Apotex’s anhydrate converts to paroxetine hydrochloride hemihydrate Infringement: SB v. Apotex

52 Page 52 Factors Causing Conversion  Water  Seeds of Hemihydrate  Heat  Force Infringement: SB v. Apotex

53 Page 53  "Solid-State forms of paroxetine hydrochloride,” Int’l J. of Pharm. 42 (1988) “ ... a batch of Form II [anhydrate] which was stable at all conditions showed rapid and complete conversion when 'spiked' with levels from 1% to 5% of Form I [hemihydrate] and stored at 37ºC / 75% RH for 7 days."  experiments with paroxetine HCl tablets demonstrating conversion of anhydrate to hemihydrate Infringement: SB v. Apotex

54 Page 54  Anhydrate Hygroscopic  "HYGROSCOPIC MATERIAL STORE UNDER NITROGEN IN SEALED CONTAINERS AND AVOID EXPOSURE TO MOISTURE."  Laboratory Studies  Samples of anhydrate converted to high percentages of hemihydrate overnight  Stability Studies  Batches of anhydrate converted to almost entirely hemihydrate when stored at 40ºC and 75% humidity within one month Evidence from Apotex Documents Infringement: SB v. Apotex

55 Page 55  Polymorphic Study of batches used to make Defendants' ANDA tablets  Batches stored at 25°C, 60±5% RH Initial9 months Batch 1Anhydrate 100% Water content.96% Hemihydrate 3% Water content 3.87% Batch 2Anhydrate 100% Water content.70% Hemihydrate 6% Water content 4.06% Batch 3Anhydrate 100% Water content.63% Hemihydrate 28% Water content 4.26% Infringement: SB v. Apotex

56 Page 56 Apotex Arguments  Seeding is “Junk Science”  Mechanism not understood  Not widely accepted Infringement: SB v. Apotex

57 Page 57 “Well, I submit that if one believes in Santa Claus we might believe in these seed crystals....” Counsel For NovoPharm, Inc. Glaxo v. NovoPharm Trial August 9, 1993 Infringement: SB v. Apotex

58 Page 58  Bulk Supplier improved process  Manufacturing steps  Improved storage bags less permeable to water  But, tablet manufacturer...  Tablets at normal humidity  Sprays tablets with aqueous coating (88% water) Apotex Arguments (cont.) Infringement: SB v. Apotex

59 Page 59  District Court rejected Apotex’s attacks on seeding  Apotex's contention "that there is no scientific basis for believing that seeding occurs... is obviously wrong."  "Many scientific phenomena are identified before their causal mechanism is understood." Infringement: SB v. Apotex

60 Page 60  District Court finds that anhydrate converts to hemihydrate  “[T]he greater the heat... and the humidity, the likelier is conversion....”  “[T]he presence of hemihydrate seeds in a batch of anhydrate is likely, provided [normal humidity and temperature], to produce conversion within a short time"  “[G]reater humidity, temperature, or pressure" can convert anhydrate to hemihydrate in amounts greater than a few percent  “[G]iven enough humidity, heat, etc., conversion [to the hemihydrate form] may continue until it reaches 100 percent" Infringement: SB v. Apotex

61 Page 61  District Court’s Conclusions  Apotex “probably will be 'making' at least some hemihydrate crystals and therefore infringing, at least prima facie, patent 723...."  “Some conversion from anhydrate to hemihydrate is likely to occur in a seeded facility in which the anhydrate is exposed to air; BCI's plant is seeded; and the anhydrate manufactured there is exposed to nondehumidified air before it leaves the plant.” Infringement: SB v. Apotex

62 Page 62  District Court still Ruled Against SB  The ‘723 patent notes that hemihydrate is not hygroscopic and thus has certain manufacturing benefits  District court limited claim 1 to only “commercially significant” amounts of hemihydrate  “High double digits to contribute any commercial value”  SB did not establish Apotex will make “high double digits” amounts Infringement: SB v. Apotex

63 Page 63 Equitable Defense of Seeding?  District Court found that SB was responsible for seeds of hemihydrate  Thus, district court found that Apotex was not responsible for the hemihydrate in its product Infringement: SB v. Apotex

64 Page 64 SB’s Position on Appeal  Claim 1 contains only four words: “Crystalline Paroxetine Hydrochloride Hemihydrate”  Claim not limited to “high double digit” amounts of hemihydrate  District court found Apotex will likely market “some” hemihydrate  SB should win Infringement: SB v. Apotex

65 Page 65 Apotex Position on Appeal  District Court’s claim construction correct  Attacks District Court’s findings concerning conversion as clearly erroneous  “In sum, the district court’s apparent fascination with the seeding theory led it to a finding that smacks of alchemy, not chemistry.” Infringement: SB v. Apotex

66 Page 66 The Federal Circuit Agreed with SB’s Claim Construction  “[T]he specification discusses the superior handling properties of the hemihydrate form that improve the manufacture of PHC. Those references, however, do not redefine the compound in terms of commercial properties, but emphasize that the new compound exhibits favorable characteristics.” Infringement: SB v. Apotex

67 Page 67 The Federal Circuit Agreed with SB’s Claim Construction  “[N]othing in the ‘723 patent limits that structural compound to its commercial embodiments.” Infringement: SB v. Apotex

68 Page 68 The Federal Circuit Agreed with SB’s Claim Construction  “Thus, reading claim 1 in the context of the intrinsic evidence, the conclusion is inescapable that the claim encompasses, without limitation, PHC hemihydrate―a crystal form of paroxetine hydrochloride that contains one molecule of bound water for every two molecules of paroxetine hydrochloride in the crystal structure.” Infringement: SB v. Apotex

69 Page 69 The Federal Circuit Agreed with SB that Apotex will infringe  “SmithKline's Experts Applied the Disappearing Polymorph Theory to Show that Apotex’s PHC anhydrate tablets inevitably convert to hemihydrate when combined with moisture, pressure, and practically ubiquitous PHC seeds.” Infringement: SB v. Apotex

70 Page 70 THE END

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