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Recent Developments in Patent Law W. Murray Spruill.

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1 Recent Developments in Patent Law W. Murray Spruill

2 Question … Allowance rates have drastically dropped at USPTO … WHY??? From: “Trust and Faith: The Credibility of a Patent System Depends on the Output” John Doll, Commissioner for Patents, October 8, 2008.

3 Patentability What is a patent? –A grant (from US or other govt. to patent owner) to exclude others from: making; using; selling; offering for sale; or importing claimed invention

4 Patentability An invention must meet the following patentability requirements: –Statutory subject matter** (§ 101) –Utility (§ 101) –Novelty** (§ 102) –Obviousness** (§ 103) –Written Description, Enablement and Best Mode (§ 112) ** Areas of focus for presentation

5 Patentability – Subject Matter 35 U.S.C. § 101: Patentable subject matter includes any new and useful process (i.e., method), machine, manufacture or composition of matter, or any new and useful improvement thereof. Unpatentable subject matter includes laws of nature, natural phenomena and abstract ideas. First requirement that the USPTO assesses for patentability.

6 Patentability – Subject Matter In re Bilski, 545 F.3d 943 (Fed. Cir., October 30, 2008). –About patenting business methods. Methods of hedging risks in commodities trading. For example, intermediate buys coal and sells to consumers at a fixed price.

7 Patentability – Subject Matter –Court noted that patentable methods do not include “laws of nature, natural phenomena, [or] abstract ideas.” –Court re-established a “machine-or-transformation test” as the test for all patent-eligible methods.

8 Patentability – Subject Matter Court noted: –“A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” –Use of specific machine or transformation of article must impose meaningful limits. –An application of a law of nature or math formula to a known structure or process may be patentable (ex. curing rubber)

9 Patentability – Subject Matter The purpose of the machine or transformation test is to prevent the preemption of fundamental principles. Fundamental principles = laws of nature, natural phenomena, and abstract ideas. Adding data gathering step to algorithm – not enough to make it patent eligible. Merely displaying on a machine not enough.

10 Patentability – Subject Matter Any method claims should either recite a nexus between the method and a machine, or emphasize a transformation step leading to a useful, concrete and tangible result. Bilski has been rigorously applied by the USPTO and courts. Fate of Bilski uncertain as the Supreme Court granted certiorari on June 1, 2009. The case is set for oral argument on November 9, 2009.

11 Patentability – Subject Matter Classen Immunotherapies, Inc. v. Biogen IDEC, No. 2006-1634, -1649 (Fed. Cir., December 8, 2008). –A method of determining whether an immunization schedule affects incidence or severity of a chronic immune-related disorder comprising immunizing mammals with one or more doses of one or more immunogens according to the immunization schedule, and comparing prevalence, frequency or severity of disorder in treatment group and control group.

12 Patentability – Subject Matter –Interestingly, the court’s decision was shorter than the claim at issue: “In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither ‘tied to a particular machine or apparatus’ nor do they ‘transform[] a particular article into a different state or thing.’ Bilski, 545 F.3d at 954. Therefore we affirm.”

13 Patentability – Subject Matter Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403 (Fed. Cir., September 16, 2009). –Method claims for calibrating the proper dosage of thiopurine drugs used to treat various gastrointestinal disorders such as Crohn’s disease and ulcerative colitis.

14 Patentability – Subject Matter –“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject; and (b) determining the level of 6-thioguanine in said subject, wherein the level of 6-thioguanine less than about 230 pmol per 8 x 10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.”

15 Patentability – Subject Matter Invention offers an iterative approach to dosing: –Administer drug. –Determine level of drug in subject. –Decide whether next dose should be the same, higher, or lower.

16 Patentability – Subject Matter Invention involves a mental step. –The claim identifies the threshold that is important. –Process of comparing the drug level to threshold is in mind of physician.

17 Patentability – Subject Matter –District court found that the administering and determining steps were merely necessary “data- gathering” steps for any use of the correlations.

18 Patentability – Subject Matter –Federal Circuit reversed and held that the administering and determining steps were transformative and thus satisfy the transformation prong of the machine-or- transformation test. –Court was clear to distinguish Prometheus claims from diagnosis claims that merely require data gathering and correlation. –Claims are transformative when a drug is administered.

19 Patentability – Subject Matter Petition for cert filed with Supreme Court. Supreme Court granted cert in Laboratory Corp. of America Holdings v. Metabolite.

20 Patentability – Subject Matter Metabolite’s claims –A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and Correlating an elevated level of total homocystein in said body fluid with a deficiency of cobalamin or folate.

21 Patentability – Subject Matter See U.S. Pat. No. 5,443,036: –1. A method of inducing aerobic exercise in an unrestrained cat comprising the steps of: (a) directing an intense coherent beam of invisible light produced by a hand-held laser apparatus to produce a bright highly-focused pattern of light at the intersection of the beam and an opaque surface, said pattern being of visual interest to a cat; and (b) selectively redirecting said beam out of the cat’s immediate reach to induce said cat to run and chase said beam and pattern of light around an exercise area.

22 Patentability – Subject Matter –What can you do to minimize non-statutory subject matter rejections in view of these cases when claiming and describing an invention in an application?

23 Patentability – Novelty Governed by 35 U.S.C. § 102: An invention is not patentable if it was disclosed before the date of filing, or before the date of priority if a priority is claimed, of a patent application, or if statutorily barred.

24 Patentability – Novelty Under US patent law, an invention lacks novelty when one prior art reference or event discloses all the elements or limitations of a claim and enables one of skill in the art to make and use the claimed invention.

25 Patentability – Novelty Sanofi-Synthelabo v. Apotex, Inc., No. 2007-1438 (Fed. Cir., December 12, 2008). –About a denial of a validity challenge by generic pharmaceutical company Apotex of Sanofi’s patent for the dextrorotary isomer of methyl alpha-5(4,5,6,7- tetrahydro-(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate (i.e., Plavix ® ; US Patent No. 4,847,265).

26 Patentability – Novelty Claim: –“Hydrogen sulfate of the dextro-rotatory isomer of methyl alpha-5(4,5,6,7-tetrahydro(3,2-c)thienopyridyl)(2- chlorophenyl)-acetate methyl alpha-5(4,5,6,7- tetrahydro(3,2-c)thienopyridyl)(2-chlorophenyl)-acetate substantially separated from the levo-rotatory isomer.”

27 Patentability – Novelty –Sanofi separated the enantiomers of MATTPCA and found that L-form had virtually all the neurotoxicity and that the R-form had the biological activity (anti-platelet activity) and filed the application that became the ‘256 patent. Parties agreed that generally known in the art that enantiomers can have different biological activities, but that it was rare to have such polar activities in enantiomers. Sanofi earlier patent to racemic mixture cited as prior art.

28 Patentability – Novelty Sanofi presented evidence: –Hundreds of derivatives that were synthesized and tested. –First compound approved had serious side effect. –Second series of compounds synthesized still with serious side effects (21 examples in patent). –Plavix enantiomer displayed absolute stereoselectivity.

29 Patentability – Novelty Additional considerations: –Separating enantiomers difficult and unpredictable both in terms of the process of separation and the properties. –Absolute stereoselectivity displayed by Plavix rare, unexpected, and unpredictable.

30 Patentability – Novelty –Apotex argued that separation of enantiomers routine and that properties of enantiomers inherent and necessarily present in the racemate. –Count found that “the knowledge that enantiomers may be separated is not ‘anticipation’ of a specific enantiomer that has not been separated, identified and characterized.” –Court also found that the prior art did not enable one of skill in the art to make the claimed enantiomer.

31 Patentability – Novelty In re Gleave, No. 2008-1453 (Fed. Cir., March 26, 2009). –About USPTO rejection of claims directed toward antisense oligonucleotides for Insulin-Dependent Growth Factor Binding Proteins (“IGFBP”). –Looked at whether a prior art document disclosing sense nucleic acid molecules with unknown utility can anticipate antisense nucleic acid molecules.

32 Patentability – Novelty Claim: –“A bispecific antisense oligodeoxynucleotide, wherein substantially all of the oligodeoxynucleotide is complementary to a portion of a gene encoding human IGFBP-2 and substantially all of the oligodeoxynucleotide is also complementary to a gene encoding human IGFBP-5, and wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5.”

33 Patentability – Novelty –Prior art reference disclosed a list of all 15-mer sense oligonucleotides (>1400 sequences) from a (publicly- available) full-length IGFBP-2 sequence. –Disclosed that antisense oligonucleotides could comprise any oligonucleotides that specifically bind to (i.e., hybridize with) any of the disclosed 15-mer sense oligonucleotides.

34 Patentability – Novelty –For a reference to anticipate under § 102, it needs to satisfy two (2) requirements: (1) it must disclose each and every element of the claimed invention (explicitly or implicitly as “arranged or combined in the same way as in the claim”); and (2) it must enable one of skill in the art to make and use the invention without undue experimentation.

35 Patentability – Novelty –The court held that anticipation required merely that the oligonucleotide sequence was in the prior art. Anticipation found even though no antisense oligonucleotide disclosed. –Court suggested that method of using the antisense compounds may be patentable.

36 Patentability – Obviousness Governed by 35 U.S.C. § 103: An invention is not patentable if it would have been obvious to one of ordinary skill in the art. –Distinguished from novelty in that each and every element or limitation of the claimed invention does not need to be contained in a single reference or event.

37 Patentability – Obviousness KSR Intl v. Teleflex, Inc., 550 U.S. 398 (2007). –About patent infringement of an adjustable vehicle control pedal connected to an electronic throttle control. –Supreme Court case addressing obviousness.

38 Patentability – Obviousness Sensors –Car engines without computer-controlled throttles – the accelerator interacts with throttle via mechanical link/cable. –’90’s computers installed in cars to control engine operation – open and close valves in response to electronic signals. –Computer-control throttle uses electronic sensor.

39 Patentability – Obviousness Pedals –Traditionally a pedal could not have its position in footwell adjusted by sliding pedal back and forth. –70’s – pedals designed that could be adjusted to change their location in footwell.

40 Patentability – Obviousness Prior art also disclosed placement of sensors on adjustable pedals. Sensor located in pedal footpad – suffered from wire chafing.

41 Patentability – Obviousness KSR patent –Adjustable pedal with an electronic sensor attached to support member allowing sensor to remain in a fixed position while driver adjusts pedal. –Prior art showed a support structure for an adjustable pedal where one of the pedal’s pivot points remains fixed.

42 Patentability – Obviousness District Court – obvious Federal Circuit – not obvious –Obvious to try does not constitute obviousness. –Teaching, motivation, suggestion test.

43 Patentability – Obviousness Supreme Court – obvious –The combination of familiar elements according to known methods – obvious – when it yields predictable results –Rejected TMS test. –Relied on 1966 Graham v. John Deere Co.

44 Patentability – Obviousness Graham Factors: –Determine the scope and content of the prior art; –Determine the level of ordinary skill in the art; –Determine the differences between the claimed invention and the prior art; and –Consider objective evidence of nonobviousness. e.g., commercial success, long-felt but unsolved needs and/or failure of others.

45 Patentability – Obviousness When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has a good reason to pursue known options. In that instance, the fact that a combination was obvious to try → obvious.

46 Patentability – Obviousness A person of ordinary skill often will be able to fit teachings of multiple patents together like pieces of a puzzle.

47 Patentability – Obviousness Mechanical invention → application to chemistry and biotechnology (unpredictable arts).

48 Patentability – Obviousness Impax Laboratories, Inc. v. Aventis Pharmaceuticals, Inc. –Prior art reference must be enabling Aventis patent to the use of riluzole to treat ALS.

49 Patentability – Obviousness –Previous patent by Aventis disclosed class of compounds and indicated that they were useful for treatment of variety of diseases including ALS. –Some dosage information provided.

50 Patentability – Obviousness The court reasoned: Not an enabling reference since –Riluzole is one of hundreds of compounds. –Did not teach that riluzole per se could be used to treat ALS. –Dosage information was broad and not specific to any particular compound.

51 Patentability – Obviousness Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. – In addition to structural similarity, prima facie obviousness requires some reason or motivation for making the changes to a known compound: unpredictability of the art must be considered. –Patent drawn to risedronate, the active ingredient in Actonel. – Teva asserted P&G’s patent claims were invalid as having been obvious in light of an expired P&G patent disclosing structural similar compounds.

52 Background –Risedronate was a member of a group of compounds known as biphosphonates which were active in inhibiting bone resorption. –The ‘406 patent listed thirty-six polyphosphonate molecules as treatment candidates for intermittent dosing, including 2-pyr etidronate (EHDP). –Risedronate (3-pyr EHDP) and 2-pyr EHDP were positional isomers.

53 Patentability – Obviousness –In finding claims not obvious, court considered: P&G experts testified that as of the filing date, a person of ordinary skill in the art would have understood that the properties of bisphosphonates could not be anticipated based on their structure. In 1984 – every bisphosphonate compound exhibits its own physical- chemical, biological and therapeutic characteristics, that each bisphosphonate has to be considered on its own. P&G had synthesized and tested 2-pyr EHDP, risedronate (3-pyr EHDP) and 4-pyr EHDP, and had confirmed that unpredictability of bisphosphonates – test results for 4-pyr EHDP indicated that it was not active in inhibiting bone resportion.

54 Patentability – Obviousness Ritchie v. Vast Resources, Inc. –Sex aid made from Borosilicate glass obvious where properties are known and borosilicate glass used to make Pyrex glassware. –Patent claimed a “sexual aid *** fabricated of a generally lubricious glass-based material containing an appreciable amount of an oxide of boron to render it lubricious and resistant to heat, chemicals, electricity and bacterial absorptions.”

55 Patentability - Obviousness –Glass that contains boron oxide is called “borosilicate glass.” –In prior art, glass sexual devices were made out of soda-lime glass. –Federal Circuit fund that the claimed invention would have been obvious under § 103.

56 Patentability – Obviousness The court noted that “lubricious” in the context of the patent-in-suit meant “slippery” (although adding the primary meaning of the word was “lecherous”).

57 Patentability – Obviousness Factors: –Pyrex glassware was originally made from borosilicate glass by Corning, Inc. –Borosilicate glass was known to be “lubricious.”

58 Patentability – Obviousness The Court reasoned that since borosilicate glass is a standard product with well-known properties – including the properties listed in the patent – to experiment with substituting borosilicate glass for ordinary glass in a sexual device was not a venture into the unknown.

59 Patentability – Obviousness –In re Bell and In re Deuel, two Federal Circuit decisions from the 1990's, established an early standard for obviousness with respect to biotechnological inventions. Natural Killer Cell Activation Inducing Ligand (“NAIL”).

60 Patentability - Obviousness In re Bell, 991 F.2d 781 (Fed. Cir. 1993) –Claim 15. Purified nucleic acid molecules containing a human sequence encoding insulin-like growth factors I and II (“IGF”).

61 Patentability – Obviousness Bell: Prior Art –Amino acid sequences for IGF-I and -II; –General method for isolating a gene that encodes a particular protein where at least a short amino acid sequence of the encoded protein is known; and –General method employing a probe specifically corresponding to the known amino acid sequence for the protein. –Discloses that it is advantageous to design the probe based on amino acids specified by unique codons.

62 Patentability - Obviousness Bell: Board Decision –Board found that the claimed sequences would have been obvious because the DNA and protein are linked via the genetic code, even though they are not structurally similar, given: Disclosure of the partial structure for the protein; and General cloning methods.

63 Patentability - Obviousness Bell: CAFC –CAFC acknowledged one could hypothesize the possible structures for a gene if the structure of the protein is known based on the genetic code. –But CAFC observed that a vast number of nucleotide sequences might code for a specific protein given the degeneracy of the genetic code. Undisputed that 1036 different nucleotide sequences could code for IGF amino acid sequence. –CAFC thus concluded that the claimed nucleic acid molecules would not have been obvious in light of: Nearly infinite number of possible nucleotide sequences; and Failure of prior art to suggest which of these possibilities is the claimed human sequence.

64 Patentability - Obviousness Bell: Limitations –CAFC limited Bell’s reach: “This is not to say that a gene is never rendered obvious when the amino acid sequence of its coded protein is known. Bell concedes that in a case in which a known amino acid sequence is specified exclusively by unique codons, the gene might have been obvious.”

65 Patentability – Obviousness In re Deuel 51 F.3d 1552 (Fed. Cir. 1995) Claimed invention directed to isolated and purified DNA and cDNA molecules encoding heparin-binding growth factors (“HBGF”) –Claim 4. All possible isolated/purified DNAs encoding HBGF –Claim 5. Specific DNA encoding HBGF

66 Patentability - Obviousness Deuel: CAFC –CAFC rejected the use of a prior art method as a basis for finding a claimed composition obvious: “We today reaffirm the principle, stated in Bell, that the existence of a general method of isolating cDNA or DNA molecules is essentially irrelevant to the question of whether the specific molecules themselves would have been obvious, in the absence of other art that suggests the claimed DNAs.

67 Patentability - Obviousness –CAFC emphasized that a prima facie case of unpatentability of a chemical compound is based on the structural similarity of the claimed compound to a prior art compound (“Structural Similarity Test”) –CAFC reasoned that the structural relationship between the claimed compound and the prior art compound may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds

68 Patentability - Obviousness Deuel: CAFC –Even if disclosure of a protein structure and general cloning techniques might have given a skilled artisan the motivation to make a cDNA, that does not render the claimed cDNA obvious.

69 Patentability - Obviousness In re Kubin Effectively Overturned by KSR: Nucleic acid sequence obvious where protein is known and technique for cloning is known –Claim An isolated nucleic acid molecule comprising a polynucleotide encoding a polypeptide at least 80% identical to amino acids 22-221 of SEQ ID NO:2, wherein the polypeptide binds CD48. Claims were drawn to polynucleotides that encoded a polypeptide known as the Natural Killer Cell Activation Inducing Ligand (“NAIL”). NAIL is a specific receptor protein on the cell surface that plays a role in activating NK cells.

70 Patentability - Obviousness Rejection: –The primary reference was a patent to Valiante that disclosed a receptor protein called “p38”, which was the same protein as NAIL. –Valiante also disclosed: A monoclonal antibody specific for p38 The DNA and protein sequences for the receptor p38 may be obtained by resort to conventional methodologies –Sambrook et al., Molecular Cloning, A Laboratory Manual, was the second reference the board had relied upon.

71 Patentability - Obviousness Valiante did not disclose either the amino acid sequence for p38 or the sequence for the DNA molecule that encodes p38. Sambrook disclosed method for molecular cloning, but did not discuss how to clone any particular gene.

72 Patentability - Obviousness The board reasoned that Valiante’s disclosure of the existence of p38 and a method of isolating its DNA, including disclosure of a monoclonal antibody to do so, established that Valiante had possession of the amino acid sequence for p38 and that there was a reasonable expectation of success in obtaining a polynucleotide. Because of the importance of NAIL in the human immune response system, one of ordinary skill in the art would have been motivated to use conventional techniques, such as disclosed in Sambrook and used by Valiante, to obtain such a polynucleotide

73 Patentability - Obviousness On appeal, the Federal Circuit affirmed. KSR had cast doubt on the continued viability of Deuel. The court relied on the Supreme Court’s statement in KSR that where a skilled artisan merely pursues “known options” from a “finite number of identified, predictable solutions”, obviousness under §103 arises. The Federal Circuit also refused to limit KSR to “predictable arts”.

74 –What can you do to minimize obviousness rejections for molecular biology-related inventions in view of these cases when claiming an invention: Importance of building record –Note the variety of attempts to perform what may be considered a simple experiment –Keep track of your successes as well as the failures (not only the failures of others) –Shift of focus to the predictability of the prior art methods rather than predictability of a claimed structure (although predictability of the structure is still important) –Note improvements to unsuccessful prior art methods –Avoid characterizing methods as standard

75 Patentability - Obviousness Balance with Enablement –Beware of building too strong a case for enablement. »The Court seized on the fact that Sambrook was incorporated by reference in Kubin’s application as well as the prior art Valiante patent. »The likely reason Sambrook was incorporated by reference in both instances was to support the case for enablement of the respective inventions. »Of course, this is easier said than done. The Examiner rejected Kubin’s application for lack of enablement as well as lack of adequate written description, and obviousness.

76 Questions Thank you!

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