About the PTAB Life Sciences Report:  We will periodically report on developments at the PTAB involving life sciences patents.

Par Pharmaceutical, Inc. v. Horizon Therapeutics, LLC

PTAB Petition:  IPR2018-01550; filed August 21, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,561,197, "Methods of therapeutic monitoring of phenylacetic acid prodrug" describes methods of treating a nitrogen retention disorder by measuring a subject's plasma phenylacetic acid ("PAA") and phenylacetylglutamine ("PAGN") levels, and determining whether the dosage of a nitrogen scavenging drug needs to be adjusted based on whether the plasma PAA:PAGN ratio falls within a target range.

Background:  Petitioner requests institution of inter partes review, seeking cancellation of claims 1 and 2 of the '197 patent as unpatentable under 35 U.S.C. § 103(a).  Petitioner alleges that the challenged claims merely apply known techniques to a known method of using glyceryl tri-[4-phenylbutyrate] (GPB) to treat urea cycle disorders.  Petitioner notes that in patients with urea cycle disorders, the clinical benefit of GPB derives from the ability of GPB to metabolize into PAA1, which conjugates with nitrogen to form PAGN and replace urea as a vehicle for carrying waste nitrogen out of the body.  This conjugation avoids the buildup of toxic ammonia in patients with defective urea cycle functionality.  Petitioner notes that the challenged claims generally recite methods of administering a dose of GPB in an amount effective to achieve a specific ratio of PAA to PAGN in the subject's plasma, in subjects whose PAA:PAGN plasma ratio is outside a specific range.

Becton, Dickinson and Company v. bioMérieux SA

PTAB Petition:  IPR2018-01566; filed August 21, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 8,367,337, "Detection of methicillin-resistant Staphylococcus aureus" is directed at improved tests for the detection of methicillin-resistant Staphylococcus aureus.  The patent provides a method of detecting in a sample a methicillin-resistant Staphylococcus aureus (MRSA) having an insertion of a SCCmec cassette within Staphylococcus aureus chromosomal DNA.  The patent claims methods for an amplification and detection reaction utilizing a first and second primer and a probe that hybridizes when a sample contains MRSA.

Background:  Petitioner challenges claims 15 and 29-31 of the '337 patent and requested institution of inter partes review.  The claims are directed to methods of detecting methicillin-resistant Staphylococcus aureus (MRSA), a deadly antibiotic-resistant bacteria strain.  Petitioner alleges that the claimed methods utilize the known technique of multiplex DNA amplification to detect the presence or absence of two distinct DNA segments of the MRSA genome: (1) the junction between two pieces of DNA found in the MRSA genome, referred to herein as the "SCCmec junction" and (2) a region of the methicillin resistance gene, the mecA gene, wherein the presence of both DNA segments in a sample confirms that MRSA is present in the sample.  Petitioner further asserts that an important prior art reference was not of record during prosecution.

Grunenthal GmbH v. Antecip Bioventures II LLC

PTAB Petition:  PGR2018-00092; filed August 21, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,820,999, "Neridronic acid for treating complex regional pain syndrome" is directed at osteoclast inhibitors, such as neridronic acid, in an acid or salt form that can be used to treat or alleviate pain or related conditions, such as complex regional pain syndrome.

Background:  The '999 patent covers methods of treating pain associated with complex regional pain syndrome (CRPS).  Petitioner alleges that before any of the '999 patent's priority applications were filed, it was well-known that bisphosphonate drugs, like neridronic acid, could be used to treat pain associated with CRPS.  Petitioner claims that because of this knowledge, the patent owner directed the '999 patent claims to effective treatment of pain associated with CRPS specifically triggered by fracture.  Petitioner further alleges that the use of neridronic acid to treat pain associated with CRPS triggered by fracture was already known in the art.  Petitioner states that data that Patent Owner used to purportedly support the '999 patent and its parent's claims allegedly came from a much earlier randomized, double-blind, placebo-controlled clinical trial published in 2012.  As a result, Petitioner requests post grant review and cancellation of '999 patent claims 1-30 as unpatentable under 35 U.S.C. §§ 112, 102, and/or 103.

Related Matters:
• Petitioner filed PGR against U.S. Patent No. 9,283,239, "Compositions for oral administration of zoledronic acid or related compounds for treating complex regional pain syndrome" on December 14, 2016 (PGR2017-00008).
• Petitioner filed PGR against U.S. Patent No. 9,408,862, "Therapeutic compositions comprising imidazole and imidazolium compounds" on May 8, 2017 (PGR2017-00022).
• Petitioner filed PGR against U.S. Patent No. 9,539,268, "Therapeutic compositions comprising imidazole and imidazolium compounds" on October 10, 2017 (PGR2018-00001).
• Petitioner filed a PGR against U.S. Patent No. 9,707,245, "Neridronic acid for treating complex regional pain syndrome" on April 18, 2018 (PGR2018-00062).
• The '999, '245, and '239 patents are all part of the same patent family.  Post-grant review was instituted against the ′239 patent.  The Board issued a final written decision finding all challenged claims unpatentable for lack of written description.  An institution decision is forthcoming in PGR2018-00062, against the '245 patent.
• The '862 and '268 patents belong to a different patent family than the '999 patent, but share the same inventor and also cover methods of treating pain conditions with bisphosphonate drugs.  Post grant review was instituted against the '862 patent and the Board heard oral arguments on July 24, 2018.  Post grant review was instituted against the '268 patent PGR2018-00001 in May 2018.

Luitpold Pharmaceuticals, Inc. v. Apicore US LLC

PTAB Petition:  IPR2018-01640; filed August 31, 2018.  View Petition here.

Patent at Issue:  U.S. Patent No. 9,353,050, "A process for the preparation of isosulfan blue" describes a process for preparation of an active pharmaceutical ingredient.  A process is also provided for preparation of the intermediate, 2-chlorobenzaldehyde-5-sulfonic acid, sodium salt of formula, used in the preparation thereof and a procedure for the isolation of benzaldehyde-2,5-disulfonic acid, di-sodium salt of the formula.  Also provided is a process for the preparation of an isoleuco acid of formula, which upon mild oxidation gives rise to isosulfan blue of pharmaceutical grade which can be used for preparation of pharmaceutical formulations.

Background:  Petitioner seeks IPR against claims 1–18 of the '050 patent as unpatentable.  Petitioner claims that an isosulfan blue sodium salt ("ISB") product was FDA-approved and in pharmaceutical use since the early 1980s, long before the priority date of the '050 patent.  Petitioner claims that the only allegedly novel aspect of the challenged claims is the purity level and claims that no secondary considerations outweigh obviousness.