Watson Infringes Bayer’s Natazia Patent; Bayer Pharma v. Watson Laboratories

On December 28, 2016, Leonard P. Stark Judge of United states district court For the district of Delaware has ordered in favor of Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc. (collectively “Plaintiffs”) and against Defendant Watson Laboratories, Inc. (“Watson”) on the claim in Plaintiffs’ Complaint dated December 18, 2012, that the commercial manufacture, use, offer for sale, sale, and/or importation into the United States of the proposed generic version of Bayer HealthCare’s Natazia® combined oral contraceptive that is the subject of Watson’s Abbreviated New Drug Application (“ANDA”) No. 202349 would infringe Claims 1-3 of U.S. Patent No. 8,071,577 (“the ‘5 77 patent”).

Further, the judge also ordered in favor of Plaintiffs and against Watson on the counterclaim of invalidity in Watson’s Answer and Counterclaim dated January 9, 2013. Specifically, that Claims 1-3 of the ‘577 patent are not invalid under any provision of 35 U.S.C. §§ 101, 102, 103, or 112, or any other judicially-created bases for invalidation.


FDA approved Natazia which contains Dienogest; Estradiol Valerate as active ingredients to prevent pregnancy in women who elect to use an oral contraceptive, and to treat heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.

The following patents were listed in OB for Natazia

U.S. Patent Number Expiration Date
6,133,251 (the ‘251 patent) Expired (October 25, 2016)
6,884,793 (the ‘793 patent) Expired (October 25, 2016)
8,071,577 (the ‘577 patent) May 13, 2026
8,153,616 (the ‘616 patent) January 30, 2028

Watson has filed an ANDA  contains paragraph IV certifications under section 505(j)(2)(A)(vii)(IV) with respect to US ‘251, ‘793, and ‘577 patents, stating that each patent is invalid, unenforceable, or will not be infringed by your manufacture, use, or sale of Estradiol Valerate Tablets, 1 mg and 3 mg, Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg, under this ANDA.

Bayer has not initiated any action for infringement of the US ‘251 and ‘793 against Watson within the statutory 45- day period. Bayer only brought the lawsuit under the infringment of US ‘577 patent.

Watson ANDA  contains a statement under section 505(j)(2)(A)(viii)  with respect to US ‘616 patent which claims MOT and it is irrelevant to Watson ANDA.

As per the final judgment given by judge P. Stark the Food and Drug Administration(“FDA”) shall reset the effective date of the approval of Watson’s ANDA No. 202349 to be a date that is not earlier than the date of expiration of the ‘577 patent inclusive of the patent term adjustment awarded to Plaintiffs under 35 U.S.C. § 154(b) (May 13, 2026).

Pfizer sued Indian companies@Bosutinib Monohydrate

Wyeth LLC, Wyeth Pharmaceuticals Inc. (“Wyeth Inc.”) and PF PRISM C.V., (collectively, “Plaintiffs” or “Pfizer”), lodged a complaint against Alembic Pharmaceuticals, Ltd., Alembic Pharmaceuticals, Inc. (collectively “Alembic”), and Sun Pharmaceutical Industries, Inc. (“Sun”), for infringement of United States Patent No. 7,417,148 (the “’148 patent”) and United States Patent No. 7,767,678 (the “’678 patent”), and against Sun for infringement of the ’678 patent. Case 1:16-cv-01305-UNA

Bosutinib monohydrate 

Background :

Alembic Pharmaceuticals, Ltd.’s filed an Abbreviated New Drug Application (“ANDA”) No. 209543 seeking approval by the United States Food and Drug Administration (“FDA”) to sell generic copies of Pfizer’s drug Bosulif® prior to the expiration of the ’678 and ’148 patents, and Sun’s filing of ANDA No. 209577 seeking approval by the FDA to sell generic copies of Bosulif prior to the expiration of the ’678 patent.

US ‘148 claims :

MOT  chronic myelogenous leukemia (CML) using Bosutinib. US ‘148 covers and approved indication. US ‘148 is set to expire on Jan 23, 2026

US ‘678 claims :

Crystalline forms of Bosutinib monohydrate and methods of preparing the same. US ‘678 is set to expire on Nov 23, 2026.

There are total 5 patents listed in OB for Bosulif, which includes US 6,002,008 (expiring March 27, 2018); US 7,919,625 (expiring December 11, 2025); and US RE42376 (expiring September 24, 2019; reissued of US 6,297,258).

In December 2016, U.S. Reissue Patent No. RE42376 received a patent term extension of 1,663 days, which extends its expiration date until April 13, 2024. The paragraph IV notices of Alembic and Sun do not address these three patents. Alembic owns DMF 30552 for Bosutinib.

FDA grants accelerated approval to Rubraca (rucaparib)

On December 19, 2016 the U.S. Food and Drug Administration granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.

The structure of Rucaparib is given below:


Rubraca is marketed by Clovis Oncology, Inc. based in Boulder, Colorado. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine, Inc. of Cambridge, Massachusetts.

Rucaparib is claimed as a product in US 6,495,541 B1 which is set to expire in January 2020. However, the patent may get patent term extension.

US ‘541 issued to Agouron Pharmaceuticals which was acquired by Warner-Lambert. Later, in June 2000, Warner-Lambert merged with Pfizer.

Clovis Oncology entered into an agreement with Pfizer for the development and commercialisation of Rucaparib. Under the terms of the agreement, Clovis is responsible for global development and commercialisation of Rucaparib.

Federal Jury Awards $2.5B of Royalty to Merck: Gilead Sciences Inc. v. Merck & Co@Sofosbuvir

On December 15, 2016 federal jury finds patent infringement of Merck’s US 7,608,597 B2 and awarded $2.54 billion royalty to Merck against Gilead for using patented invention as the basis for its blockbuster drug Sofosbuvir. The jury said that Gilead owed 10 percent royalties on $25.4 billion in total sales for the two drugs.

Sofosbuvir is chemically known as 2′-deoxy-2′-α-fluoro-β-C-methyluridine-5′-triphosphate and structurally represented as


US 7,608,597 B2 (issued to Idenix) claims a method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine β-D-2′-methyl-ribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.

US ‘597 filed as a continuation application from US 6,914,054 which claims priority of May 23, 2000. Sofosbuvir claimed as a product in US 7,964,580 B2 which claims priority of 30 Mar 2007.

The claims of US ‘597 are broad, any pyrimidine β-D-2′-methyl-ribofuranosyl nucleoside or a phosphate compounds for the treatment of HCV infection falls within the scope of US ‘597. US ‘597 neither discloses nor enables Sofosbuvir specifically.

Gilead Arguments for invalidity of US ‘597

Gilead’s argued that Merck patent is invalid as the specification of the US ‘597 patent does not enable the asserted claims (or) as the specification of the US ‘597 patent does not contain an adequate written description of the asserted claims (or) as the for anticipation based on prior invention (or) the claimed subject matter would have been obvious to a person of ordinary skill in the art at the time of the claimed invention. The jury rejected Gilead’s arguments that Merck’s patent is invalid.

The verdict  doesn’t affect Gilead to sell its products. The sales of Gilead’s Sovaldi and Harvoni (developed by pharmasset; later acquired by Gilead) accounts for more than half the Gilead’s revenue.

This is the second trial between the two companies. The first, over different patents, ended in a disaster for Merck. A jury in California said that Gilead should pay $200 million in royalties, but that was thrown out because the judge said a key Merck witness lied. In that case, Merck may have to pay Gilead’s legal fees.

Paragraph IV Patent Certifications

On December 16, 2016 FDA has announced that it received Abbreviated New Drug Application’s (ANDA; U.S.C. § 355(j)(2)(A)(vii)(IV)) containing a “Paragraph IV” patent certification for the following drugs.

Drug Name  Dosage Form  Strength  RLD  Date of Submission
Aspirin and Omeprazole Delayed-release Tablets 81 mg/40 mg and 325 mg/40 mg Yosprala 10/13/2016
Buprenorphine Hydrochloride Buccal Film 75 mcg and 150 mcg Belbuca 10/24/2016
Difluprednate Ophthalmic Emulsion 0.05% Durezol 5/1/2014
Treprostinil Extended-release Tablets 0.25 mg and 1 mg Orenitram 5/19/2016

FDA Approves Anacor Pharmaceuticals Eucrisa (Crisaborole)

On December 14, 2016, the U.S. Food and Drug Administration approved Eucrisa (Crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. The structure of Crisaborole is given below:


Anacor Pharmaceuticals (acquired by Pfizer) is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics.

Anacor’s first approved product, KERYDIN® (tavaborole) topical solution, 5%, is an oxaborole antifungal approved by the U.S. Food and Drug Administration in July 2014 for the topical treatment of onychomycosis of the toenails. Tavaborole and Crisaborole are structural analogs.

Crisaborole (AN2728) is patented in US 8,039,451 B2 which is set to expire on June 11, 2026 (including PTA). However, the term may extended due to Patent term extension.