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Ali Berkin, Ph.D. Associate

Dr. Berkin has been with the firm since 2002 and provides clients with his expertise in pharmaceutical sciences and patent/literature searching on litigation, due diligence, and prosecution matters. Having worked for both brand and generic pharmaceutical clients, Dr. Berkin has a unique expertise of having a dual approach to any issue and the ability to consider a subject through a mutual understanding of competing strategies, such as anticipating arguments of opposing counsel.

LOCATION

New York City

+1.212.588.0800

745 5th Avenue Floor 10
New York, NY 10151

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OVERVIEW

Ali Berkin, Ph.D., is an associate who has been with the firm since 2002, focusing on pharmaceutical clients. During this time he has worked extensively on both litigation and prosecution matters for brand and generic pharmaceutical clients. With more than a decade of experience, Dr. Berkin has a unique expertise of having a dual approach to any issue and the ability to consider a subject through a mutual understanding of competing strategies, such as anticipating arguments of opposing counsel.

Dr. Berkin has worked with a vast range of pharmaceutical products and dosage forms, giving him a deep knowledge base in the pharmaceutical industry. He understands and easily recognizes the function that excipients have in pharmaceutical formulations. This ability is valuable to the firm’s clients as pharmaceutical formulations become more complex and the ability to protect intellectual property becomes more intricate.

Dr. Berkin is also an expert in patent and literature searching, saving clients time and money, and served on the Scientific Advisory Board of the Science and Technical Network (STN) of the Chemical Abstracts Service, a division of the American Chemical Society.

  • Shire LLC et al. v. Travis C. Mickle PhD et al., Civil No. 7:10-cv-00434 (SGW) (PMS)
  • Shire LLC et al. v. Teva Pharmaceuticals USA, Inc. et al., Actavis Elizabeth LLC et al., Anchen Pharmaceuticals, Inc. et al., Civil No. 1:10-cv-00329 (SD)
  • Shire Development LLC et al. v. Osmotica Pharmaceutical Corp., Civil No. 1:12-cv-00904 (AT)
  • Shire Pharmaceutical Development Inc., et al. v. Amneal Pharmaceuticals LLC, et al.,
  • Civil No.1:15-cv-2865 (RBK) (JS)
  • Shire Pharmaceutical Development Inc., et al v. Lupin Limited et al., Civil No. 8:15-cv-03437 (GJH)
  • The Medicines Company:
  • U.S. Patent No. 7,582,727: Pharmaceutical Formulations of Bivalirudin and Processes of Making the Same
  • U.S. Patent No. 7,598,343: Pharmaceutical Formulations of Bivalirudin and Processes of Making the Same
  • U.S. Patent No. 7,713,928: Ready-to-use Bivalirudin Compositions
  • U.S. Patent No. 7,803,762: Ready-to-use Bivalirudin Compositions
  • U.S. Patent No. 7,985,733: Buffer-based Method for Preparing Bivalirudin Drug Product
  • QRxPharma:
  • U.S. Patent No. 7,923,453: Methods of Converting A Patient's Treatment Regimen from Intravenous Administration of An Opioid to Oral Co-administration of Morphine and Oxycodone Using A Dosing Algorithm to Provide Analgesia
  • U.S. Patent No. 8,012,990: Methods of Converting A Patient's Treatment Regimen from Intravenous Administration of An Opioid to Oral Co-administration of Morphine and Oxycodone Using A Dosing Algorithm to Provide Analgesia
  • U.S. Patent No. 8,182,837: Methods and Compositions for Reducing the Risk Associated with the Administration of Opioid Analgesics in Patients with Diagnosed or Undiagnosed Respiratory Illness
  • U.S. Patent No. 8,222,267: Methods of Converting A Patient's Treatment Regimen from Intravenous Administration of An Opioid to Oral Co-administration of Morphine and Oxycodone Using A Dosing Algorithm to Provide Analgesia
  • Sephton, Gregory B., and Ali Berkin. “Belcher Pharmaceuticals’ Patent Held Unenforceable by the Federal Circuit.” Haug Partners, 10 Sept. 2021, https://www.haugpartners.com/article/belcher-pharmaceuticals-patent-held-unenforceable-by-the-federal-circuit/.
  • Kurz, Rich, and Ali Berkin, Ph.D. “USPTO Updates Indefiniteness Standard in AIA Post-Grant Proceedings to Match Those of the District Court Under Nautilus.” Haug Partners, 8 Jan. 2021, www.haugpartners.com/article/uspto-updates-indefiniteness-standard-in-aia-post-grant-proceedings-to-match-those-of-the-district-court-under-nautilus/.
  • Roper, Andrew, and Ali Berkin, Ph.D. “How Different Claim Construction Standards Can Ultimately Determine the Validity of a Patent.” Haug Partners, 24 Nov. 2020, www.haugpartners.com/article/how-different-claim-construction-standards-can-ultimately-determine-the-validity-of-a-patent/.
  • Berkin, Ali; Szarek, Walter A.; Kisilevsky, Robert, Biological Evaluation of a Series of 2-Acetamido-2-Deoxy-D-Glucose Analogs Towards Cellular Glycosaminoglycan and Protein Synthesis In Vitro, Glycoconjugate Journal 2005 22 (7/8/9) 443-451
  • Kisilevsky, Robert; Szarek, Walter A.; Ancsin, John B.; Elimova, Elena; Marone, Sandra; Bhat, Shridhar; Berkin, Ali, Inhibition of Amyloid A Amyloidogenesis In Vivo and in Tissue Culture by 4-Deoxy Analogues of Peracetylated 2-Acetamido-2-Deoxy-α- and β-D-Glucose: Implications for the Treatment of Various Amyloidoses, American Journal of Pathology 2004 164 (6) 2127-2137
  • Berkin, Ali; Coxon, Bruce; Pozsgay, Vince, Towards a Synthetic Glycoconjugate Vaccine Against Neisseria Meningitidis A, Chemistry--A European Journal 2002 8 (19) 4424-4433
  • Berkin, Ali; Szarek, Walter A.; Kisilevsky, Robert, Synthesis and Biological Evaluation of a Radiolabeled Analog of Methyl 2-Acetamido-2,4-Dideoxy-β-D-Xylo-Hexopyranoside Directed Towards Influencing Cellular Glycosaminoglycan Biosynthesis, Carbohydrate Research 2002 337 (1) 37-44
  • Berkin, Ali, Synthesis and Biological Evaluation of Monosaccharides Directed Towards Influencing Glycoconjugate Biosynthesis in Culture, Diss. Abstr. Int., B 2000 61 (1) 216, 264
  • Berkin, A.; Szarek, W. A.; Kisilevsky, R., Synthesis of 4-Deoxy-4-Fluoro Analogues of 2-Acetamido-2-Deoxy-d-Glucose and 2-Acetamido-2-Deoxy-d-Galactose and Their Effects on Cellular Glycosaminoglycan Biosynthesis, Carbohydrate Research 2000 326 (4) 250-263
  • Berkin, A.; Szarek, M. A.; Plenkiewicz, J.; Szarek, W. A.; Kisilevsky, R., Synthesis of 4-Deoxy Analogues of 2-Acetamido-2-Deoxy-D-Glucose and 2-Acetamido-2-Deoxy-D-Xylose and Their Effects on Glycoconjugate Biosynthesis, Carbohydrate Research 2000 325 (1) 30-45
  • Berkin, Ali; Coxon, Bruce; Robbins, J. B.; Schneerson, R.; Pozsgay, Vince, Toward a Synthetic Glycoconjugate Vaccine Against Meningitis Caused by Neisseria Meningitidis A, Abstracts of Papers, 222nd ACS National Meeting, Chicago, IL, United States, August 26-30, 2001 2001 CARB-099pp.
  • Pozsgay, Vince; Berkin, Ali, Lipophilic Benzyl Ether-Type Protecting Groups in Oligosaccharide Synthesis, Abstracts of Papers, 222nd ACS National Meeting, Chicago, IL, United States, August 26-30, 2001 CARB-070.
  • National Science and Engineering Research Council (NSERC) Undergraduate Scholarship, 1989-1993
  • McLaughlin Fellowship (awarded to first class doctoral students), 1993-1999
  • National Institute of Health Postdoctoral Fellowship in the National Institute of Child Health and Human Development (NICHD), 2000-2002
  • Concordia University, (B.S., Chemistry, 1993)
  • Queens University, (Ph.D., Organic Chemistry, 1999)
  • Seton Hall Law, (J.D., 2018)
  • New York
  • New Jersey
  • American Chemical Society
  • Patent Information User Group (PIUG)
  • NY State Bar Association
  • NJ State Bar Association
  • Appellate Litigation
  • Biotechnology Litigation
  • Consumer Products Litigation
  • Due Diligence & Investigations
  • FDA
  • Hatch-Waxman Litigation
  • Intellectual Property Litigation
  • Licensing & Transactions
  • Life Sciences Litigation
  • Patent Prosecution
  • PTAB Post-Issuance Proceedings

+1.212.863.2164
aberkin@haugpartners.com

Related Services

  • Appellate Litigation
  • Biotechnology Litigation
  • Consumer Products Litigation
  • Due Diligence & Investigations
  • FDA
  • Hatch-Waxman Litigation
  • Intellectual Property Litigation
  • Licensing & Transactions
  • Life Sciences Litigation
  • Patent Prosecution
  • PTAB Post-Issuance Proceedings

BAR ADMISSIONS

  • New York
  • New Jersey

Haug Partners LLP
745 5th Avenue Floor 10
New York, NY 10151
+1.212.588.0800
haugpartners.com

Ali Berkin, Ph.D.

Associate

HIGHLIGHT

Dr. Berkin has been with the firm since 2002 and provides clients with his expertise in pharmaceutical sciences and patent/literature searching on litigation, due diligence, and prosecution matters. Having worked for both brand and generic pharmaceutical clients, Dr. Berkin has a unique expertise of having a dual approach to any issue and the ability to consider a subject through a mutual understanding of competing strategies, such as anticipating arguments of opposing counsel.

OVERVIEW

Ali Berkin, Ph.D., is an associate who has been with the firm since 2002, focusing on pharmaceutical clients. During this time he has worked extensively on both litigation and prosecution matters for brand and generic pharmaceutical clients. With more than a decade of experience, Dr. Berkin has a unique expertise of having a dual approach to any issue and the ability to consider a subject through a mutual understanding of competing strategies, such as anticipating arguments of opposing counsel.

Dr. Berkin has worked with a vast range of pharmaceutical products and dosage forms, giving him a deep knowledge base in the pharmaceutical industry. He understands and easily recognizes the function that excipients have in pharmaceutical formulations. This ability is valuable to the firm’s clients as pharmaceutical formulations become more complex and the ability to protect intellectual property becomes more intricate.

Dr. Berkin is also an expert in patent and literature searching, saving clients time and money, and served on the Scientific Advisory Board of the Science and Technical Network (STN) of the Chemical Abstracts Service, a division of the American Chemical Society.

REPRESENTATIVE CASES

  • Shire LLC et al. v. Travis C. Mickle PhD et al., Civil No. 7:10-cv-00434 (SGW) (PMS)
  • Shire LLC et al. v. Teva Pharmaceuticals USA, Inc. et al., Actavis Elizabeth LLC et al., Anchen Pharmaceuticals, Inc. et al., Civil No. 1:10-cv-00329 (SD)
  • Shire Development LLC et al. v. Osmotica Pharmaceutical Corp., Civil No. 1:12-cv-00904 (AT)
  • Shire Pharmaceutical Development Inc., et al. v. Amneal Pharmaceuticals LLC, et al.,
  • Civil No.1:15-cv-2865 (RBK) (JS)
  • Shire Pharmaceutical Development Inc., et al v. Lupin Limited et al., Civil No. 8:15-cv-03437 (GJH)

REPRESENTATIVE PATENTS

  • The Medicines Company:
  • U.S. Patent No. 7,582,727: Pharmaceutical Formulations of Bivalirudin and Processes of Making the Same
  • U.S. Patent No. 7,598,343: Pharmaceutical Formulations of Bivalirudin and Processes of Making the Same
  • U.S. Patent No. 7,713,928: Ready-to-use Bivalirudin Compositions
  • U.S. Patent No. 7,803,762: Ready-to-use Bivalirudin Compositions
  • U.S. Patent No. 7,985,733: Buffer-based Method for Preparing Bivalirudin Drug Product
  • QRxPharma:
  • U.S. Patent No. 7,923,453: Methods of Converting A Patient's Treatment Regimen from Intravenous Administration of An Opioid to Oral Co-administration of Morphine and Oxycodone Using A Dosing Algorithm to Provide Analgesia
  • U.S. Patent No. 8,012,990: Methods of Converting A Patient's Treatment Regimen from Intravenous Administration of An Opioid to Oral Co-administration of Morphine and Oxycodone Using A Dosing Algorithm to Provide Analgesia
  • U.S. Patent No. 8,182,837: Methods and Compositions for Reducing the Risk Associated with the Administration of Opioid Analgesics in Patients with Diagnosed or Undiagnosed Respiratory Illness
  • U.S. Patent No. 8,222,267: Methods of Converting A Patient's Treatment Regimen from Intravenous Administration of An Opioid to Oral Co-administration of Morphine and Oxycodone Using A Dosing Algorithm to Provide Analgesia

PUBLICATIONS

  • Sephton, Gregory B., and Ali Berkin. “Belcher Pharmaceuticals’ Patent Held Unenforceable by the Federal Circuit.” Haug Partners, 10 Sept. 2021, https://www.haugpartners.com/article/belcher-pharmaceuticals-patent-held-unenforceable-by-the-federal-circuit/.
  • Kurz, Rich, and Ali Berkin, Ph.D. “USPTO Updates Indefiniteness Standard in AIA Post-Grant Proceedings to Match Those of the District Court Under Nautilus.” Haug Partners, 8 Jan. 2021, www.haugpartners.com/article/uspto-updates-indefiniteness-standard-in-aia-post-grant-proceedings-to-match-those-of-the-district-court-under-nautilus/.
  • Roper, Andrew, and Ali Berkin, Ph.D. “How Different Claim Construction Standards Can Ultimately Determine the Validity of a Patent.” Haug Partners, 24 Nov. 2020, www.haugpartners.com/article/how-different-claim-construction-standards-can-ultimately-determine-the-validity-of-a-patent/.
  • Berkin, Ali; Szarek, Walter A.; Kisilevsky, Robert, Biological Evaluation of a Series of 2-Acetamido-2-Deoxy-D-Glucose Analogs Towards Cellular Glycosaminoglycan and Protein Synthesis In Vitro, Glycoconjugate Journal 2005 22 (7/8/9) 443-451
  • Kisilevsky, Robert; Szarek, Walter A.; Ancsin, John B.; Elimova, Elena; Marone, Sandra; Bhat, Shridhar; Berkin, Ali, Inhibition of Amyloid A Amyloidogenesis In Vivo and in Tissue Culture by 4-Deoxy Analogues of Peracetylated 2-Acetamido-2-Deoxy-α- and β-D-Glucose: Implications for the Treatment of Various Amyloidoses, American Journal of Pathology 2004 164 (6) 2127-2137
  • Berkin, Ali; Coxon, Bruce; Pozsgay, Vince, Towards a Synthetic Glycoconjugate Vaccine Against Neisseria Meningitidis A, Chemistry--A European Journal 2002 8 (19) 4424-4433
  • Berkin, Ali; Szarek, Walter A.; Kisilevsky, Robert, Synthesis and Biological Evaluation of a Radiolabeled Analog of Methyl 2-Acetamido-2,4-Dideoxy-β-D-Xylo-Hexopyranoside Directed Towards Influencing Cellular Glycosaminoglycan Biosynthesis, Carbohydrate Research 2002 337 (1) 37-44
  • Berkin, Ali, Synthesis and Biological Evaluation of Monosaccharides Directed Towards Influencing Glycoconjugate Biosynthesis in Culture, Diss. Abstr. Int., B 2000 61 (1) 216, 264
  • Berkin, A.; Szarek, W. A.; Kisilevsky, R., Synthesis of 4-Deoxy-4-Fluoro Analogues of 2-Acetamido-2-Deoxy-d-Glucose and 2-Acetamido-2-Deoxy-d-Galactose and Their Effects on Cellular Glycosaminoglycan Biosynthesis, Carbohydrate Research 2000 326 (4) 250-263
  • Berkin, A.; Szarek, M. A.; Plenkiewicz, J.; Szarek, W. A.; Kisilevsky, R., Synthesis of 4-Deoxy Analogues of 2-Acetamido-2-Deoxy-D-Glucose and 2-Acetamido-2-Deoxy-D-Xylose and Their Effects on Glycoconjugate Biosynthesis, Carbohydrate Research 2000 325 (1) 30-45

SPEAKING ENGAGEMENTS

  • Berkin, Ali; Coxon, Bruce; Robbins, J. B.; Schneerson, R.; Pozsgay, Vince, Toward a Synthetic Glycoconjugate Vaccine Against Meningitis Caused by Neisseria Meningitidis A, Abstracts of Papers, 222nd ACS National Meeting, Chicago, IL, United States, August 26-30, 2001 2001 CARB-099pp.
  • Pozsgay, Vince; Berkin, Ali, Lipophilic Benzyl Ether-Type Protecting Groups in Oligosaccharide Synthesis, Abstracts of Papers, 222nd ACS National Meeting, Chicago, IL, United States, August 26-30, 2001 CARB-070.

AWARDS

  • National Science and Engineering Research Council (NSERC) Undergraduate Scholarship, 1989-1993
  • McLaughlin Fellowship (awarded to first class doctoral students), 1993-1999
  • National Institute of Health Postdoctoral Fellowship in the National Institute of Child Health and Human Development (NICHD), 2000-2002

EDUCATION

  • Concordia University, (B.S., Chemistry, 1993)
  • Queens University, (Ph.D., Organic Chemistry, 1999)
  • Seton Hall Law, (J.D., 2018)

BAR ADMISSIONS

  • New York
  • New Jersey

MEMBERSHIPS

  • American Chemical Society
  • Patent Information User Group (PIUG)
  • NY State Bar Association
  • NJ State Bar Association

LANGUAGES

  • French