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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Howard W. LevineJennifer 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
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
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 PATENTNo. 6,999,999
To
John Q. Public
Page 4
A Patent Does Not Give Anyone (even the Patent Owner!) the Right to “Practice” the Invention.
What is a Patent?
Page 5
Rather, a Patent Gives the Right to Exclude Others from:
makingusingoffering for saleselling, orimporting
the patented invention
What is a Patent?
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?
Page 7
Title 35 U.S.C. Creates Rules for What is a Patentable Invention
What is a Patent?
Page 8
U.S. Patent 6,293,874
USER-OPERATED AMUSEMENT APPARATUS FOR KICKING THE USER’S BUTTOCKS
What is a Patent?
Page 9
U.S. Patent 3,538,508
COMBINATION PILLOW AND CRASH HELMET
What is a Patent?
Page 10
U.S. Patent Des. 302,693
INTEGRAL HANDSET TELEPHONE AND
FLIP-TOP SHOE
What is a Patent?
Page 11
U.S. Patent 4,995,379
INSTANT FACE LIFT
What is a Patent?
Page 12
U.S. Patent 5,708,983
INFLATABLE CHEESE WEDGE HAT
What is a Patent?
Page 13
U.S. Patent 912,152
FIRE-ESCAPE
What is a Patent?
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?
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
Page 16
UtilityExample of Inventions that are Patentable:
– Processes– Machines– Manufacture– Compositions of matter (Polymorphs)
Requirements for Obtaining a Patent
Page 17
UtilityExample of Inventions That Are Not Patentable:
– Products naturally occurring in nature– Scientific principles– Laws of nature– Mental processes
Requirements for Obtaining a Patent
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).
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”
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.
Page 21
Novelty (35 U.S.C. § 102)Seven subsections
Focus on 102(a) and 102(b).
Requirements for Obtaining a Patent
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
Page 23
Requirements for Obtaining a Patent
A A
B B
C C
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
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
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
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
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
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
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
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
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
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 SquibbCo., 19 F.3d 1418, 1422 (Fed. Cir. 1994)
Polymorphs and §103: Zenith
Page 34
35 U.S.C § 112
What must be included in the patent itself:
1) Specification2) Claims
Requirements for Obtaining a Patent
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
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
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
Page 38
Intellectual
Property
Claim
35 U.S.C. §112: Claims
Page 39
Intellectual Property
Claim
Infringer
35 U.S.C. §112: Claims
Page 40
Intellectual Property
Claim
InfringerFHFG&D
35 U.S.C. §112: Claims
Page 41
PolymorphsClaims 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
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 SquibbCo., 19 F.3d 1418, 1422 (Fed. Cir. 1994)
35 U.S.C. §112: Claims
Page 43
35 U.S.C. §112: Claims
Page 44
35 U.S.C. §112: Claims
Page 45
35 U.S.C. §112: Claims
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
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
Page 48
Infringement: SB v. Apotex
Page 49
Infringement: SB v. Apotex
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
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
Page 52
Factors Causing Conversion
Water
Seeds of Hemihydrate
Heat
Force
Infringement: SB v. Apotex
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
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
Page 55
Polymorphic Study of batches used to make Defendants' ANDA tablets
Batches stored at 25°C, 60±5% RH
Initial 9 months
Batch 1 Anhydrate 100%
Water content .96%
Hemihydrate 3%
Water content 3.87%
Batch 2 Anhydrate 100%
Water content .70%
Hemihydrate 6%
Water content 4.06%
Batch 3 Anhydrate 100%
Water content .63%
Hemihydrate 28%
Water content 4.26%
Infringement: SB v. Apotex
Page 56
Apotex Arguments
Seeding is “Junk Science” Mechanism not understood
Not widely accepted
Infringement: SB v. Apotex
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
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
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
Page 60
District Court finds that anhydrateconverts 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
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
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
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
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
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
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
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
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
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
Page 70
THE END