Tag Archives: IPR

Gilead Wins Another Sofosbuvir Challenge: U. Minnesota v. Gilead

Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023)

The Court of Appeals for the Federal Circuit (CAFC) analyzed whether the written description found in UMN’s priority applications supported the claims in the resulting patent # US 8,815,830. The CAFC said no.

While the ‘830 patent claims covered sofosbuvir, The CAFC affirmed an IPR’s invalidation of U. Minnesota’s claims because they could not properly claim priority to its provisional application. The reasoning was that the provisional with its nebulous multiple dependent claims, that were themselves dependent on further multiple dependent claims, did not adequately describe the subgenus eventually claimed in the non-provisional application.

See Patently-O’s posts for more:

March 7, 2023 — Laundry Lists of Components are Insufficient Written Description for a Particular Combination | Patently-O (patentlyo.com)

March 9, 2023 — Multiple dependent claims, blaze marks, and ipsis verbis support | Patently-O (patentlyo.com)

SOVALDI® (soh-VAHL-dee) (sofosbuvir)



Pemetrexed (ALIMTA®) Patent Survives an IPR Obviousness Challenge

December 12, 2017

Eli Lilly’s patent (US Patent No. 7,772,209 claiming methods for administering pemetrexed) survived an IPR Challenge on obviousness (IPR2016-00237).

Recall back in January, the patent made headlines when Eli Lilly won in court with an opinion that Teva was liable for induced infringement of the patent’s methods of administering pemetrexed.

Teva Liable for Induced Infringement of Eli Lilly’s Methods of Administering Pemetrexed (ALIMTA®)

 

 

Onglyza® and Kombiglyze® XR (saxagliptin) Patent Survives Challenge from Mylan

September 12, 2017

Mylan and other generic manufacturers petitioned the Patent Trial and Appeal Board (PTAB) to institute an inter partes review of AstraZeneca’s patent claiming compositions including saxagliptin. AstraZeneca markets saxagliptin as Onglyza® and Kombiglyze® XR for diabetes.

Case IPR2015-01340 / Patent RE44,186 E

The PTAB’s Administrative Patent Judges (APJ) decided that the petitioners did not show with preponderance of the evidence that the claims of Reissue RE44,186 of U.S. Patent No. 6,395,767 would have been obvious to a skilled artisan.  Particularly, saxagliptin was not obvious over “compound 25.”

Saxagliptin:

Saxagliptin Structure

Saxagliptin Structure

Prior art: “Compound 25”

Structure of Prior Art "Compound-25"

Structure of “Compound-25”

State of the Art:

Experienced medicinal chemists (Persons of Ordinary Skill in the Art [PHOSITA]) knew saxagliptin bound to DP 4.  But they did not have detailed knowledge of DP 4’s active site for guidance in designing inhibitors because DP 4’s crystalline structure was unknown. At the time of invention, knowledge of DP 4’s binding requirements came from structure-activity relationship (“SAR”) studies.

Lead Compound Analysis:

Petitioners cited a publication by Ashworth containing Compound-25, which they argued would have been selected as a lead compound. (Ashworth et al., 2-“Cyanopyrrolidides as Potent, Stable Inhibitors of Dipeptidyl Peptidase IV,” 6(10) Bioorganic &Med. Chem. Lett., 1163–66 (1996)).

“Compound-25” would not have been selected as a lead compound

The PTAB reasoned that a medicinal chemist would not have selected compound 25 as a lead compound because, among other reasons, (i) Compound 25 was only one of several other similar compounds (ii) Compound 25 only had in vitro data obtained using non-physiological conditions, (ii) there were two much more advanced compounds in clinical trials (i.e., NVP-DPP728 & P32/98) and (iii) Ashworth’s subsequent publication focused on different series of compounds.

NVP-DPP728 & P32/98

Clinical Compounds NVP-DPP728 & P32/98

The PTAB’s analysis could have ended there. But even accepting Petitioners’ assertion that a skilled artisan would have chosen compound 25 as a lead compound, the PTAB determined that the Petitioners didn’t demonstrate that a skilled artisan would have had reason to modify compound 25 with a reasonable expectation of success to arrive at the claimed saxagliptin.

Check out PatentDocs’s Post for further discussion:

http://www.patentdocs.org/2017/09/mylan-pharm-v-astrazeneca-ab-ptab-2017.html

 

 

Steadymed wins IPR Challenge of United Therapeutics’s Remodulin® Product-by-Process Patent Claims

Final Decision – March 31, 2017

IPR2016-00006

STEADYMED LTD., (Petitioner)  v. UNITED THERAPEUTICS CORPORATION, (Patent Owner)

U.S. Patent No. 8,497,393 B2 “Process to Prepare Treprostinil, the Active Ingredient in Remodulin®”

Link to PDF: https://ptabdata.uspto.gov/ptab-api/documents/663936/native

Juxtapid® Patents Survive IPR Challenge

March 6, 2017

Coalition for Affordable Drugs VIII LLC v. The Trustees of The University of Pennsylvania, IPR2015-01835 &  IPR2015-01836

 

 

Petitioner Must Prove Injury to Have Standing to Appeal an IPR Decision

January 11, 2017

Phigenix v. ImmunoGen (Fed. Cir. 2017) (Wallach, J)

  • Even though § 141(c) allows a party to appeal a PTAB’s IPR decision, the statute does not necessarily establish Article III standing.
    • One of Article III’s requirements is proving Injury-in-Fact.
  • Even if a petitioner loses an IPR challenge (i.e., Patent is still valid), the Petitioner may still not have standing if the petitioner has not suffered any damages yet. (For Example, the patent owner hasn’t sued the petitioner yet for infringement.)
  • Here, Phigenix [petitioner] lost an IPR (i.e., Immunogen [patent owner] won with a ruling of non-obviousness). But Phigenix did not have standing to appeal the IPR loss to the Federal Circuit because Phigenix did not have standing in part because they have not suffered any injury/damages yet.
    • Phigenix did not argue that it risked infringing ImmunoGen’s patent.  Phigenix argued instead that it suffered “actual economic injury” because the mere existence of ImmunoGen’s patent increased competition between itself and ImmunoGen. The Federal Circuit did not find Phigenix’s argument persuasive.

Claims:

Claim 1:  An immunoconjugate comprising an anti-ErbB2 antibody conjugated to a maytansinoid, wherein the antibody is huMAb4D5-8.

Claim 2:  The immunoconjugate of claim 1, wherein the maytansinoid is DM1 having the structure:
US08337856-Image

Related Blog Posts:

Patently-O Blog Post on Phigenix v. ImmunoGen (Fed. Cir. 2017)

PatentDocs Blog Post on Phigenix v. ImmunoGen (Fed. Cir. 2017)

For Fellow Coffee Lovers: PTAB Denies Keurig’s IPR Petition Against Touch Coffee

January 5, 2017

KEURIG GREEN MOUNTAIN, INC., Petitioner, v.
TOUCH COFFEE & BEVERAGES, LLC, Patent Owner.

Case IPR2016-01390; Patent 9,144,343 B2

According to the PTAB, Keurig did not provide adequate “articulated reasoning,” for establishing a reasonable likelihood of prevailing. Expert witnesses cannot merely say something is obvious. They need to explain why it’s obvious.

https://ptabdata.uspto.gov/ptab-api/documents/600671/native

Bristol-Myers Squibb’s CTLA4Ig Formulation Patent Survives IPR Obviousness Challenge from Momenta Pharmaceuticals

Momenta v. BMS

January 3, 2016

MOMENTA PHARMACEUTICALS, INC. (Petitioner)
v.
BRISTOL-MYERS SQUIBB COMPANY (Patent Owner)

Case IPR2015-01537
Patent 8,476,239
FINAL WRITTEN DECISION
December 22, 2016

The PTAB concluded that the preponderance of the evidence did not support Momenta’s argument that the challenged claims would have been obvious.

The claims of Patent US 8,476,239 are directed to stable liquid formulations of the therapeutic molecule CTLA4Ig.  CTLA4Ig is a protein molecule that is used to treat immune system diseases and disorders such as rheumatoid arthritis and adverse transplant reactions.

Claim1:  A stable formulation suitable for subcutaneous administration comprising:
[1]  at least 100mg/ml CTLA4Ig molecule,
[2]  a sugar selected from the group consisting of sucrose, lactose, maltose, mannitol and trehalose and mixtures thereof and
[3]  a pharmaceutically acceptable aqueous carrier, wherein the formulation has a
[4]  pH range of from 6 to 8 and
[5]  a viscosity of from 9 to 20 cps, and
[6]  the weight ratio of sugar:protein is 1.1:1 or higher.
(Bracketed numbers added)

Momenta argued that the inventors did “nothing more than the efforts of a skilled formulator choosing from a limited set of known formulations to subcutaneous liquid formulations.” Momenta further argued that “the inventors went to the formulator’s toolbox and tried the first line of excipients and formulation parameters.  And they worked.” The PTAB agreed that the prior art references provided general guidance for formulating proteins as stable liquids and that BMS followed certain aspects of those general teachings when creating its stable liquid formulation comprising CLTA4Ig, a known protein.  Momenta’s cited evidence, however, did not persuade the PTAB that an ordinarily skilled artisan would have reasonably expected to be successful in achieving the claimed formulations. The evidence was not persuasive because, despite the prior art teaching of general guidance for formulating proteins as stable liquids, the prior art also taught that maintaining physical and chemical stabilities for most proteins in aqueous solution for an extended period is extremely difficult. Expert testimony about testimony about routine trial-and-error optimization did not overcome the statements of difficulty. Such statements of difficulty in the art indicated to the PTAB that there would not have been a reasonable expectation of success in achieving the claimed formulations.

The PTAB highlighted in the importance of anticipated success and predictable results in determining obviousness. Citing the U.S. Supreme Court:

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 good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (emphasis added); compare Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989) (“Reached by means of routine procedures, and producing only predictable results, the recited dosages therefore do not distinguish the claims of the ’430 patent from the amiloride/hydrochlorothiazide combination that the district court properly found was disclosed in the ’813 patent.” (emphasis added)).

Links:

PDF of Final Decision (IPR2015-01537)

Update 1/9/2017 – Link to Jones Day Blog:
“Routine Trial-and-Error Approach to Protein Formulation Is Not Sufficient to Establish Obviousness Absent a Reasonable Expectation of Success in Achieving the Claimed Formulation”

Amerigen and Alembic petition to join Mylan’s IPR arguing that patent claims covering Toviaz® are obvious over Detrol®

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Amerigen Pharmaceuticals, Ltd and Alembic Pharmaceuticals Limited are challenging the claims of U.S. Patent No. 6,858,650 as being obviousness under 35 U.S.C. § 103(a).  Amerigen and Alembic each filed their own petition and seek to join in the IPR of Mylan Pharmaceuticals, Inc.et al. v. UCB Pharma GmbH, Case IPR2016-00510, which the Patent Trial and Appeal Board (PTAB) has already issued its Decision instituting Inter Partes Review (IPR) in January, 2016. The PTAB said in its decision that UCB Pharma GmbH’s patents, licensed to Pfizer for Toviaz, are likely obvious because the compounds used are too similar to Pfizer’s drug Detrol. TOVIAZ® (fesoterodine fumarate) succeeded DETROL ® (tolterodine tartrate) as the company’s branded incontinence treatment.

Patent at Issue:

U.S. Patent No. 6,858,650 (“Stable salts of novel derivatives of 3,3-diphenylpropylamines,” issued February 22, 2005).

Claim 1: Generic structure for the covered molecules: derivatives of 3,3-diphenylpropylamines

Claims 2-5: Specify the type of compatible acid, specify chirality, and specify substitutions and salt forms.

Claim 5: R-(+)-2-(3-(diisopropylamino- 1-phenylpropyl)-4-hydroxymethyl-phenyliobutyrate ester hydrogen fumarate (commonly referred to as fesoterodine fumarate).

Claims 21-24: recite methods of use.

http://www.patentdocs.org/2016/09/ptab-life-sciences-report-1.html

http://www.law360.com/articles/820997/mylan-wins-ptab-review-of-pfizer-s-toviaz-patents