In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug prices,” he has been busy. Here, I review the patents he has challenged with Inter Partes Review (IPR) petitions, and identify whether there are other Orange Book-listed patents for the pharmaceutical product at issue. 

IPRs Against Ampyra® Patents

In February, the Coalition filed IPRs against two Orange Book-listed patents for Ampyra®: 8,663,685 and 8,007,826.

Claim 1 of the ‘685 patent recites:

1. A method of improving walking in a human multiple sclerosis patient in need thereof comprising orally administering to said patient a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, wherein the sustained release composition further comprises one or more pharmaceutically acceptable excipients.

Claim 1 of the ‘826 patent recites:

1. A method for maintaining a therapeutically effective concentration of 4-aminopyridine in order to improve walking in a human with multiple sclerosis in need thereof, said method comprising: orally administering to the human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a day; and thereafter, maintaining administration of 4-aminopyridine by orally administering to said human a sustained release composition of 10 milligrams of 4-aminopyridine twice daily for a time period of at least two weeks, whereby an in vivo 4-aminopyridine CmaxSS : CminSS ratio of 1.0 to 3.5 and a CavSS of 15 ng/ml to 35 ng/ml are obtained in the human.

(The ‘826 patent includes several other independent claims.)

There are three other Orange Book listed patents for Ampyra®:

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IPRs Against Gattex® Patent 

In April, the Coalition filed two IPR petitions against an Orange Book-listed patent for Gattex®, 7,056,886. Claim 1 of the ‘886 patent recites:

1. A glucagon-like peptide 2 (GLP-2) formulation comprising: (a) a medically useful amount of a naturally occurring GLP-2 or an analog thereof; (b) a phosphate buffer in an amount sufficient to adjust the pH of the formulation to a physiologically tolerable level; (c) L-histidine; and (d) a bulking agent selected from the group consisting of mannitol and sucrose.

There are two other patents listed in the Orange Book for Gattex®:

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IPRs Against Lialda® Patent 

In April, the Coalition filed IPR petitions against the Orange Book-listed patent for Lialda®, 6,773,720. Claim 1 of the ‘720 patent recites:

1. Controlled-release oral pharmaceutical compositions containing as an active ingredient 5-amino-salicylic acid, comprising: a) an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90.degree. C., and wherein the active ingredient is dispersed both in said the lipophilic matrix and in the hydrophilic matrix; b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums; c) optionally other excipients; wherein the active ingredient is present in an amount of 80 to 95% by weight of the total composition, and wherein the active ingredient is dispersed both in the lipophilic matrix and in the hydrophilic matrix.

The ‘720 patent is the only Orange Book-listed patent for Lialda®.

IPR Against Xyrem® Patent

In April, the Coalition filed an IPR against an Orange Book-listed patent for Xyrem®, 7,895,059. Claim 1 of the ‘059 patent recites:

1. A computerized method of distributing a prescription drug under exclusive control of an exclusive central pharmacy, the method comprising: receiving in a computer processor all prescription requests, for any and all patients being prescribed the prescription drug, only at the exclusive central pharmacy from any and all medical doctors allowed to prescribe the prescription drug, the prescription requests containing information identifying patients, the prescription drug, and various credentials of the any and all medical doctors; requiring entering of the information into an exclusive computer database associated with the exclusive central pharmacy for analysis of potential abuse situations, such that all prescriptions for the prescription drug are processed only by the exclusive central pharmacy using only the exclusive computer database; checking with the computer processor the credentials of the any and all doctors to determine the eligibility of the doctors to prescribe the prescription drug; confirming with a patient that educational material has been received and/or read prior to shipping the prescription drug; checking the exclusive computer database for potential abuse of the prescription drug; mailing or sending by courier the prescription drug to the patient only if no potential abuse is found by the patient to whom the prescription drug is prescribed and the doctor prescribing the prescription drug; confirming receipt by the patient of the prescription drug; and generating with the computer processor periodic reports via the exclusive computer database to evaluate potential diversion patterns.

(The ‘059 patent includes several other independent claims.)

There are numerous additional patents listed in the Orange Book for Xyrem®:

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IPR Against Imbruvica® Patent

In April, the Coalition filed an IPR against an Orange Book-listed patent for
Imbruvica® , 8,754,090

Claim 1 of the ‘090 patent recites:

1. A method for treating mantle cell lymphoma in an individual who has already received at least one prior therapy for mantle cell lymphoma comprising administering to the individual once per day between about 420 mg to about 840 mg of an oral dose of an inhibitor of Bruton’s tyrosine kinase (Btk) having the structure: ##STR00047##

There are numerous other patents listed in the Orange Book for Imbruvica®:

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IPRs Against Tecfidera® Patents 

In April, the Coalition filed IPRs against two Orange Book-listed patents for
Tecfidera® : 8,759,393 and 8,399,514.

Claims 1 and 13 of the ‘393 patent recite:

1. A pharmaceutical preparation, comprising dimethyl fumarate, wherein the pharmaceutical preparation is in the form of microtablets.

13. A pharmaceutical preparation consisting essentially of an active ingredient and one or more carriers and excipients, wherein the active ingredient is dimethyl fumarate and the preparation contains 10 mg to 300 mg of dimethyl fumarate, and wherein the pharmaceutical preparation is in the form of microtablets and the mean diameter of the microtablets is about 2,000 µm, exclusive of any coating on the microtablets.

Claim 1 of the ‘514 patent recites:

1. A method of treating a subject in need of treatment for multiple sclerosis comprising orally administering to the subject in need thereof a pharmaceutical composition consisting essentially of (a) a therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof, and (b) one or more pharmaceutically acceptable excipients, wherein the therapeutically effective amount of dimethyl fumarate, monomethyl fumarate, or a combination thereof is about 480 mg per day.

There are several additional patents listed in the Orange Book for Tecfidera®:

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IPRs Against Revlimid® Patents

In April, the Coalition filed IPRs against two Orange Book-listed patents for Revlimid®: 6,045,501and 6,315, 720.

Claim 1 of the ‘501 patent recites:

1. A method for delivering a teratogenic drug to patients in need of the drug while avoiding the delivery of said drug to a foetus comprising:

  1. registering in a computer readable storage medium prescribers who are qualified to prescribe said drug;
  2. registering in said medium pharmacies to fill prescriptions for said drug;
  3. registering said patients in said medium, including information concerning the ability of female patients to become pregnant and the ability of male patients to impregnate females;
  4. retrieving from said medium information identifying a subpopulation of said female patients who are capable of becoming pregnant and male patients who are capable of impregnating females;
  5. providing to the subpopulation, counseling information concerning the risks attendant to fetal exposure to said drug;
  6. determining whether patients comprising said subpopulation are pregnant; and
  7. in response to a determination of non-pregnancy for said patients, authorizing said registered pharmacies to fill prescriptions from said registered prescribers for said non-pregnant registered patients.

Claim 1 of the ‘720 patent recites:

1. In a method for delivering a drug to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by said drug, wherein said method is of the type in which prescriptions for said drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber is registered in said medium and qualified to prescribe said drug, that the pharmacy is registered in said medium and qualified to fill the prescription for said drug, and the patient is registered in said medium and approved to receive said drug, the improvement comprising:

  1. defining a plurality of patient risk groups based upon a predefined set of risk parameters for said drug;
  2. defining a set of information to be obtained from said patient, which information is probative of the risk that said adverse side effect is likely to occur if said drug is taken by said patient;
  3. in response to said information set, assigning said patient to at least one of said risk groups and entering said risk group assignment in said medium;
  4. based upon said information and said risk group assignment, determining whether the risk that said adverse side effect is likely to occur is acceptable; and
  5. upon a determination that said risk is acceptable, generating a prescription approval code to be retrieved by said pharmacy before said prescription is filled.

(The ‘720 patent includes several other independent claims.)

There are numerous additional patents listed in the Orange Book for Revlimid®:

Click here to view the table

What Is Kyle Bass Really After?

If the Coalition for Affordable Drugs were challenging all of the Orange Book-listed patents for a given drug, or at least challenging the ones with the latest expiration dates, its stated purpose of reducing prescription drug costs might be more credible. But, for all but one of the IPRs, they have challenged only one of several (or many) Orange Book-listed patents, and did not even select the latest-expiring ones. Thus, even if the IPR petitions are successful and end up invalidating the patents, would-be generic competitors still will have to address the other Orange Book-listed patents. Indeed, some of the patents he has challenged might not even pose a significant hurdle to generics, since many seem to present design-around or carve-out options. So, what is Kyle Bass really after?