#ACIPIV
11th Annual Paragraph IV Disputes
Moderator –
Martin B. Pavane
Shareholder
Cozen O’Connor
Understanding the Continuing Impact of
101 on Orange Book Listed-Method Claims
April 24-26, 2017
Speaker 4 –
Jason A. Wietjes
Shareholder
Polsinelli PC (Dallas, TX)
Speaker 5 -
Peter Waibel
Head, US Patent Litigation
Novartis Pharmaceuticals
Corporation (East
Hanover, NJ)
Tweeting about this conference?
Speaker 1 –
Bruce M. Wexler
Partner
Paul Hastings LLP (New
York, NY)
Speaker 3 –
Paul B. Sudentas
Attorney
Locke Lord LLP (New
York, NY)
Speaker 2 –
Dominic A. Conde
Partner
Fitzpatrick, Cella, Harper
& Scinto (New York, NY)
RECENT DECISIONS ON PATENT ELIGIBLE SUBJECT
MATTER
Bruce M. Wexler
David Chen
3THE § 101 TWO STEP
Two-step test for distinguishing claims to patent-ineligible concepts from claims to
patent-eligible applications
Step 1: Is the claim directed to a patent-ineligible concept?
Laws of nature, natural phenomena, and abstract ideas
Step 2: Do the additional elements, considered individually and as an ordered
combination, transform the claim into a patent-eligible application?
More is required than well-understood, routine, conventional activity already engaged in
by the scientific community
Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed. Cir. 2016)
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375-76 (Fed. Cir. 2015)
4ARIOSA DIAGNOSTICS V. SEQUENOM
Claim 1: “A method for detecting a paternally inherited nucleic acid of fetal origin performed on a
maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.”
Sequenom, 788 F.3d at 1373-74.
Undisputed that existence of cffDNA in maternal blood is a natural phenomenon, none of the genetic code
of the cffDNA was created or altered, location of the nucleic acids existed in nature, and paternally
inherited cffDNA is a natural phenomenon.
Id. at 1376.
Methods of amplifying and detecting the cffDNA were “well-understood, routine, and conventional activity.”
Id. at 1377.
Held: Ineligible. “[T]he claims are directed to matter that is naturally occurring,” and the use of “known
laboratory techniques” fails to transform the claims into a patent-eligible application.
Id. at 1373, 1376, 1378.
5SEQUENOM’S RELIANCE ON MAYO
Mayo Claim 1 Sequenom Claim 1
“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 having said immune-
mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in
said subject having said immune-mediated
gastrointestinal disorder,
wherein [certain concentrations indicate a
need to increase or decrease the amount of
drug subsequently administered].”
Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 74-75 (2012).
“A method for detecting a paternally inherited
nucleic acid of fetal origin performed on a
maternal serum or plasma sample from a
pregnant female, which method comprises
amplifying a paternally inherited nucleic acid
from the serum or plasma sample and
detecting the presence of a paternally
inherited nucleic acid of fetal origin in the
sample.”
Sequenom, 788 F.3d at 1373-74.
“Like the patentee in Mayo, Sequenom contends that the claimed methods are patent
eligible applications of a natural phenomenon, specifically a method for detecting
paternally inherited cffDNA. Using methods like PCR to amplify and detect cffDNA was
well-understood, routine, and conventional activity in 1997. The method at issue here
amounts to a general instruction to doctors to apply routine, conventional techniques
when seeking to detect cffDNA. Because the method steps were well understood,
conventional and routine, the method of detecting paternally inherited cffDNA is not new
and useful.”
Sequenom, 788 F.3d at 1377.
6RAPID LITIGATION V. CELLZDIRECT
Claim 1: “A method of producing a desired preparation of multi-cryopreserved hepatocytes . . . said
method comprising: (A) subjecting hepatocytes that have been frozen and thawed to density gradient
fractionation to separate viable hepatocytes from non-viable hepatocytes, (B) recovering the separated
viable hepatocytes, and (C) cryopreserving the recovered viable hepatocytes . . . “
Claim 5: “The method of claim 1, wherein said preparation comprises a pooled preparation of hepatocytes of
multiple sources.”
CellzDirect, 827 F.3d at 1046.
Prior art taught away from multiply freezing hepatocytes because of cell damage. Inventors discovered
that some fraction of hepatocytes were capable of surviving multiple freeze-thaw cycles. They developed
a multiple-freeze method that simplified preparation of pooled hepatocyte preparations and allowed
preserved hepatocyte preparations to be thawed and used later without unacceptable loss of viability.
Id. at 1045.
Held: Eligible. Claims are not directed to an ineligible law of nature, but are “directed to a new and useful
laboratory technique for preserving hepatocytes.”
If reached Step 2, would have been patent eligible despite the claims’ individual steps being known independently in
the art because “a process of preserving hepatocytes by repeating those steps was itself far from routine and
conventional” particularly in light of the prior art teaching away from repeating those steps.
Id. at 1048, 1050-51.
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MacroPoint v. Fourkites
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 10
• MacroPoint’s patents covered:
“a system for providing location information of a vehicle [that] includes a
communications interface and a correlation logic that correlates location information
of a communications device to location of the vehicle.”
• Basically a freight tracking system
• FourKites moved to dismiss
• Argued, based on Alice, patents invalid because they were drawn to an abstract idea.
MacroPoint v. Fourkites, No. 1:15 cv 1002 (N.D. Ohio Nov. 6, 2015)
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 11
• Court found claims directed to “abstract ideas tracking freight”:
“the claim discloses nothing more than a process for tracking freight, including
monitoring, locating and communicating regarding the location of the freight. These
ideas are all abstract in and of themselves.” (Id. at 6)
• Court distinguished other cases because MarcoPoint’s computer related claims were not
“rooted in computer technology to overcome a problem specifically arising in the realm
of computer networks.” (Id. at 7)
MacroPoint – Patent Ineligible?
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 12
• Claims covered “correlating the location information of a communications device with the
location of freight or a vehicle”
• MacroPoint asserted
• Claims solve the problem of “how to monitor the location of freight or vehicle by
technical means …”
• Claims allowed “tracking of freight without the use of a dedicated GPS receiver and
instead discerns the location through a location information provider”
MacroPoint – Inventive Concept?
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 13
• Court disagreed, alleged “inventive concepts” did not transform abstract ideas into
patent-eligible claims (Id. at 11)
• Claims instruct a computer to use preexisting technology to implement the correlation:
“transmitting and receiving data are basic and generic computer functions and these
claims do not solve any problem tethered to [computers.]” (Id.)
• Alleged technological improvement was lacking in the claim language itself. (Id.)
MacroPoint – Inventive Concept?
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 14
• Using the PTO Guidelines is not determinative:
“the fact that the PTO may have considered Alice-based guidelines before issuing the
patents-in-suit does not mandate a finding that the patents are valid.” (Id. at 7)
“Nor is the guidance put forth by the PTO conclusive on the issue of patent-eligible
subject matter. Regardless, other than a blanket statement that the Examiner
presumably applied the guidance, plaintiff offers no analysis on the issue.” (Id. n. 3).
• Claims invalid under§101; CAFC affirmed per curium
MacroPoint – PTO Guidelines
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 15
• Federal Circuit generally has not relied on the PTO Subject Matter Eligibility guidelines in
deciding patent eligibility
• Since 2014, CAFC decided 47 patent eligibility cases
• Only 2 mentioned the guidelines
• Neither case gave much, if any weight, to the PTO’s use of the guidelines
PTO Guidelines: Does the CAFC Care?
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 16
• Federal Circuit has stated that PTO rules are not binding:
As the Interim Eligibility Guidance itself states, it is not intended to create any right
or benefit, substantive or procedural, enforceable by any party against the Office.
Rejections will continue to be based upon the substantive law, and it is these
rejections that are appealable. … [W]e have previously determined that such
Guidance is not binding on this Court.
In re Smith (Fed. Circ. 2016) (emphasis added)
PTO Guidelines: Does the CAFC Care?
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com PAGE 17
• In a concurrence, Judge Mayer stated no presumption of validity should apply:
The rationale for the presumption of validity is that the [PTO], “in its expertise, has
approved the claim…” That rationale, however, is “much diminished” in situations in
which the PTO has not properly considered an issue… Because the PTO has for
many years applied an insufficiently rigorous subject matter eligibility standard,
no presumption of eligibility should attach when assessing whether claims meet the
demands of section 101.
Ultramercial, Inc. v. Hulu, LLC, (Fed. Circ. 2014)(emphasis added)
PTO Guidelines: Does the CAFC Care?
FITZPATRICK, CELLA, HARPER & SCINTO © 2017 | www.f i tzpa tr ickcel la .com
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Boehringer Ingelheim Pharms., Inc., et al.
v.
HEC Pharm Co., Ltd., et al.,
Paul B. Sudentas
April 24, 2017
What’s Happening in D.N.J.?
C.A. No. 15-5982, 2016 WL 7177704
(D.N.J. Dec. 7, 2016) (Sheridan, U.S.D.J.)
20
■ Motion to dismiss (Rule 12(c)) for invalidity under
§ 101
■ Δ’s argument – claims recite a natural law directed to pharmacokinetic observations of
diabetic patients
■ Π’s argument –claims recited methods of using non-naturally existing compounds (DPP-
IV inhibitors), which alter the state of the body in a new and useful way
Boehringer Ingelheim Pharms., Inc., et al. v.
HEC Pharm Co., Ltd., et al.
■ U.S. Patent No. 8,853,156, claim 1:
A method of treating and/or preventing metabolic diseases in a patient for whom metformin therapy is inappropriate due to at least one contraindication against metformin comprising
orally administering to the patient a DPP-IV inhibitor
wherein the contraindication is selected from the group consisting of: renal disease, renal impairment or renal dysfunction, unstable or acute congestive heart failure, acute or chronic metabolic acidosis, and hereditary
galactose intolerance
21
Boehringer Ingelheim Pharms., Inc., et al. v.
HEC Pharm Co., Ltd., et al.
22
Step 1
■ Is the single claimed step (“orally administering”) an abstract idea? YES
■ Single instruction vs. series of steps: Claim 1 provides a single instruction- “orally administering”
a DPP-IV inhibitor to a targeted patient population rather than a series of steps tied to tangible
embodiments
■ Claim 1 provides “no contribution over conventional knowledge of administering DPP-IV
inhibitors.”
■ Claim1 does not require any prior determination that the natural body levels have changed or
altered before performing the “orally administering step” abstract idea.
Boehringer Ingelheim Pharms., Inc., et al. v.
HEC Pharm Co., Ltd., et al.
23
Step 2
■ Does the claim recite an inventive concept (i.e., add “significantly more” to the abstract idea)? NO
■ The preamble and body are simply “additional features [that] recite well-understood, routine, and
conventional activity.” The ‘156 patent specification indicates that the inventor recognized that
side effect issues with antiglycemic agents “were known and well-understood in the scientific
community.”
■ “[C]laim 1 of the ‘156 patent does not amount to significantly more than an abstract idea of
providing an instruction for a medical care professional who is treating the targeted patient
population. The instruction of claim 1 can be conducted via mental processes, which is not tied to
any tangible embodiment.”
Boehringer Ingelheim Pharms., Inc., et al. v.
HEC Pharm Co., Ltd., et al.
24
■ Summary
■ The claimed methods recite only a single step not tied to a tangible
embodiment
■ Compare with CellzDirect which disclosed series of steps tied to
tangible embodiments
■ There was nothing in the preamble or body that added substantially
more to convert the abstract idea into patent eligible subject
■ Specifying amounts of the DPP-IV inhibitor or a particular DPP-
IV inhibitor also did not amount to substantially more than the
abstract idea
■ If appealed, will it be affirmed?
Boehringer Ingelheim Pharms., Inc., et al. v.
HEC Pharm Co., Ltd., et al.
The View From Delaware
Endo v. Actavis
Endo Pharmaceuticals Inc., et al. v. Actavis Inc., et al., No. 14-1381 (2015)
– Judge Andrews order adopting report of Magistrate Judge Thynge
– Judge Thynge determined that U.S. Pat. No. 8,808,737 was facially invalid under §101
– Her report emphasized the factual similarity between representative claim 1 of the ’737 patent and a representative Mayo claim
Endo v. Actavis
The ’737 patent
– Method of Treating Pain Utilizing Controlled Release Oxymorphone Pharmaceutical Compositions and Instruction on Dosing for Renal Impairment
Endo v. Actavis
The ’737 patent v. Mayo
Mayo patent claim 1
indicates a need to [increase/decrease] the amount of said drug subsequently administered to said subject
’737 patent claim 1
orally administering to said patient, in dependence on which creatinine clearance rate is found, a lower dosage of the dosage form to provide pain relief
Endo v. Actavis
Endo’s arguments
1. The claimed method is directed to a new and useful treatment regimen providing a practical, tangible benefit (pain relief) in a particular patient population.
2. The ’737 claim requires a tangible action or application of the method, i.e. lower dose administration.
Endo v. Actavis
Endo’s arguments
3. Judge Thynge failed to apply the Classen decision.
4. The ’737 patent claims a previously unknown relationship.
5. Policy argument that the report in effect invalidates all pharmaceutical method-of-treatment patents using an existing, well-known compound.
Endo v. Actavis
Judge Andrews’s analysis
– “Plaintiffs’ argument that the ’737 patent does not claim a law of nature, but instead a ‘new and useful process,’ is thoroughly unconvincing.”
– In comparing the representative claims: “[N]either formulation provides any sort of ‘inventive concept’ to suggest that more than just the natural law is being claimed.”
Endo v. Actavis
Judge Andrews’s analysis
– After Mayo, Classen holds no precedential value.
– “This case is hardly the poster child for a policy argument on the wide-ranging implications of a § 101 rejection of a pharmaceutical method patent.”
Vanda v. Roxane
Vanda Pharmaceuticals Inc., et al. v. Roxane Laboratories, Inc., Nos. 13-1973, 14-757 (2016)
– Judge Sleet opinion
– U.S. Pat. No. 8,586,610 found to be patent eligible
Vanda v. Roxane
The ’610 patent
– Methods for the Administration of Iloperidone
– The CYP2D6 Reaction
Vanda v. Roxane
Roxane’s arguments
– The ’610 patent embodies two laws of nature:
1. that mutations in the CYP2D6 genes can alter enzymatic activity; and
2. that a patient’s CYP2D6 enzymatic activity affects metabolism of iloperidone.
Vanda v. Roxane
Roxane’s arguments
– All of the method-of-treatment claims depend on natural processes.
– Vanda merely adds a dose adjustment to reduce the risk of a routine side effect.
– A person of ordinary skill in the art would discover the invention in performing FDA-mandated studies.
Vanda v. Roxane
Judge Sleet’s opinion
– The asserted claims depend on laws of nature.
– Specifically, the claims depend on the relationship between iloperidone, CYP2D6 metabolism, and QTc prolongation.
Vanda v. Roxane
Judge Sleet’s opinion
– Issue:
• Whether the claims incorporate some additional, transformative step sufficient to make them valid.
– The Court found it persuasive that the dosage step doesn’t apply to all patients, but only a specific patient population based on genetic composition based on applying genetic tests in a highly specified way.
#ACIPIV
11th Annual Paragraph IV Disputes
Moderator –
Martin B. Pavane
Shareholder
Cozen O’Connor
Understanding the Continuing Impact of
101 on Orange Book Listed-Method Claims
April 24-26, 2017
Speaker 4 –
Jason A. Wietjes
Shareholder
Polsinelli PC (Dallas, TX)
Speaker 5 -
Peter Waibel
Head, US Patent Litigation
Novartis Pharmaceuticals
Corporation (East
Hanover, NJ)
Tweeting about this conference?
Speaker 1 –
Bruce M. Wexler
Partner
Paul Hastings LLP (New
York, NY)
Speaker 3 –
Paul B. Sudentas
Attorney
Locke Lord LLP (New
York, NY)
Speaker 2 –
Dominic A. Conde
Partner
Fitzpatrick, Cella, Harper
& Scinto (New York, NY)