Pharmaceutical Patents

News & Analysis as of

FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

Celltrion Begins Shipping Remsima to the U.S.

As we reported last week, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion. The Korea Times reports that Celltrion shipped its...more

Intellectual Property Newsletter -August 2016

Shearman & Sterling’s IP litigation team has published its quarterly newsletter. The newsletter covers a number of current IP topics, including a look at the America Invents Act, five years in; the U.S. International Trade...more

BREAKING NEWS: Summary Judgment, Claim Construction, Consolidation, Bifurcation, and Trial Schedule Order Issued in Janssen v....

Following three days of hearings in Janssen v. Celltrion, the District Court for the District of Massachusetts (J. Wolf) today issued a memorandum order summarizing the Court’s rulings on several pending motions in the case....more

BPCIA Litigation Roundup (Summer 2016)

Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product....more

IPR Petition Filed on Genentech Patent Directed to Method of Producing Polypeptides

On August 16, bioeq filed a petition for inter partes review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to...more

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more

A legal look at Patent Trial and Appeal Board decisions and trends: PTAB Statistics - Then and Now

The Inter Partes Review (IPR) and Covered Business Method (CBM) procedures were enacted on September 16, 2012. Since then, the PTAB has released data on a monthly basis to illustrate the trends in the various petitions and...more

Federal Circuit Patent Updates - August 2016

ScriptPro LLC v. Innovation Associates, Inc. (No. 2015-1565, 8/15/16) (Moore, Taranto, Hughes) - August 15, 2016 10:41 AM - Moore, J. Reversing summary judgment of invalidity of claims for lack of written...more

Celltrion Files Petition for IPR on Biogen’s Rituximab Patent

Yesterday, Celltrion filed a petition for inter partes review of Biogen’s U.S. Patent No. 7,820,161, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on updates...more

Helsinn Healthcare S.A. v. Hospira, Inc.

Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more

Apotex Files Petition for IPR On Amgen’s Neulasta Patent

On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the District Court for the Southern District of Florida, in a case in...more

Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al.

Case Name: Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al., Civil Action Nos. 14-3168 (JBS/KMW), 2016 U.S. Dist. LEXIS 48689 (D.N.J. Apr. 12, 2016) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit:...more

USPTO Offers a Fast Track to Cancer Immunotherapy Patents

The United States Patent Office (USPTO) is implementing a new program that provides prioritized examination of patent applications relating to cancer immunotherapy (Cancer Immunotherapy Pilot Program or Program). The new...more

Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.

Case Name: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 15-cv-1455 (WCB), 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine...more

UPDATE Amgen v. Apotex: Amgen argues they have met their burden to prove infringement

As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds of anticipation, lack of written...more

BPCIA Litigation Updates: Amgen v. Apotex, Immunex v. Sandoz, Janssen v. Celltrion

A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: ..The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the...more

Pfizer Inc. v. Sandoz Inc

Case Name: Pfizer Inc. v. Sandoz Inc., C.A. No. 13-1110-GMS, 2016 U.S. Dist. LEXIS 52762 (D. Del. Apr. 20, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate); U.S. Patents Nos....more

AbbVie Sues Amgen On 10 Of 100 Humira Patents

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more

Bayer Pharma AG v. Watson Labs., Inc

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 55752 (D. Del. Apr. 27, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Staxyn® (vardenafil hydrochloride...more

Big Molecule Watch Page Devoted to Tracking IPRs on Biologic Products

Check out our updated Inter Partes Review page with information about all of the IPRs filed on biologic products, including the patent challenged, product that may be covered by the patent, patent owner, challenger, IPR...more

AbbVie Sues Amgen to Prevent Launch of Humira Biosimilar

As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61...more

Endo Pharm. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharm. Inc. v. Amneal Pharms. LLC, Civil Nos. 12 Civ. 8115 (TPG),12 Civ. 8060 (TPG),12 Civ. 8317 (TPG),12 Civ. 8985 (TPG),13 Civ. 435 (TPG),13 Civ. 436 (TPG),13 Civ. 3288 (TPG),13 Civ. 4343 (TPG),13 Civ. 8597...more

Bayer Pharma AG v. Watson Labs., Inc.

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 57888 (D. Del. May 2, 2016) (Sleet, J.) - Drug Product and U.S. Patent(s)-in-Suit: Staxyn® and Levitra® (vardenafil...more

Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.

Case Name: Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., C.A. No. 13-1506-(GMS), 2016 U.S. Dist. LEXIS 62056 (D. Del. May 11, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Mozobil® (plerixafor solution); U.S. Pat....more

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