Pharmaceutical Patents

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PTAB Institutes Two IPRs in Hospira v. Genentech Avastin Dispute

Bevacizumab (Avastin®) is the subject of the widely watched “patent dance” dispute between Genentech and Amgen regarding Amgen’s proposed biosimilar. Hospira, however, (now owned by Pfizer) has chosen a different path in...more

ANDA Update - March 2017 Volume 3, Number 1

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Including Functional Claim Language Helped Save Pozen’s VIMOVO® Patents

On February 28, 2017, the PTAB held that the petitioner Lupin had not shown that the challenged claims in two of Pozen’s patents were invalid (IPR2015-01773 and IPR2015-01775).  These cases show the advantage of using...more

BPCIA Helps Amgen Gain Dismissal of Genentech Complaint

Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more

Amgen Has Filed for EU Approval for Herceptin® (Trastuzumab) Biosimilar

During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more

Biosimilar Remedies Not Limited Without Full Patent Dance

The judge presiding over the pending biosimilar litigation between Janssen and Celltrion/Hospira has issued guidance regarding the ramifications of a potential standing defect. Judge Wolf opined that Janssen’s biosimilar...more

PTAB Institutes IPR of Genentech’s Bevacizumab Patent

The PTAB has instituted inter partes review of Genentech’s U.S. Patent 7,622,115, granting Hospira’s petition in IPR2016-01771. According to the institution decision, the patent is directed to methods for treating cancer in...more

PTAB Institutes IPR in Hospira’s Challenge to Genentech’s Trastuzumab Patent

The PTAB has instituted IPR2016-01837, in which Hospira challenges Genentech’s U.S. Patent 7,807,799. The institution decision extends to all challenged claims, claims 1-3 and 5-11. ...more

Celltrion Files Petitions for IPR of Three Rituximab Patents

Celltrion has filed three petitions for IPR of Biogen’s patents related to rituximab: IPR2017-01093, challenging U.S. Patent 8,329,172; IPR2017-01094 challenging U.S. Patent 8,557,244; and IPR2017-01095 challenging U.S....more

Celltrion Files Response Brief in Infliximab Appeal

As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also...more

PTAB Life Sciences Report -- Part II - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents....more

Mylan and Genentech Reach Settlement on Cabilly Patent IPR

As we reported yesterday, Mylan announced that it has reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. relating to trastuzumab, which extended to Mylan agreeing to withdraw its IPR challenge to U.S. Pat....more

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Pharmaceuticals in South East Asia

1. Are methods of medical treatment patentable? 2. Is extension of patent term possible? 3. Is there a data exclusivity period?...more

Importance of patents in Chinese pharmaceutical tendering

China has a complicated and unique tendering system for drugs – and patents play an important role in almost every tender. What adds to the complexity is that tendering rules vary between provinces. Providing necessary patent...more

Summary of Amgen’s Opening and Responsive Brief in Sandoz v. Amgen

On Friday, March 10, Amgen filed its consolidated opening and responsive brief to the Supreme Court in Sandoz v. Amgen. As we covered in a previous post, Sandoz filed its opening brief in the case last month, addressing the...more

The University of Pennsylvania Overcomes Kyle Bass’s Obviousness Challenge to Juxtapid® Patent Claims Using Commercial Success

The PTAB issued two final written decisions upholding The University of Pennsylvania’s claims to methods of treating high cholesterol based, in part, on commercial success and the meaning of a “printed publication” in...more

Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more

Federal Circuit Review | February 2017

“Common Sense” Alone Is Not a Sufficient Motivation to Combine References - In In Re: Van Os, Appeal No. 2015-1975, the Federal Circuit held that the Patent Trial and Appeal Board’s reliance on intuition or common sense...more

Federal Circuit Vacates PTAB Claim Construction and Obviousness Conclusion in Eli Lilly’s IPR against LA BioMed

The Federal Circuit held that a rat study in a provisional application and a conversion method in an uncited reference did not support the claimed human dosage form in Los Angeles Biomed. Research Inst. v. Eli Lilly & Co.,...more

PTAB Denies Institution of IPR Proceedings Against Bayer’s Patent Covering STIVARGA®

On February 8, 2017, the PTAB denied Fustibal LLC’s (“Fustibal”) petition to institute inter partes review of U.S. Patent 8,637,553 B2 (“the ’553 patent”) owned by Bayer HealthCare LLC (“Bayer”) (IPR2016-01490). The 553...more

UK Court Invalidates AbbVie HUMIRA Patents

On Friday March 3, 2016, in a decision in cases brought by Samsung Bioepsis UK Ltd. and Fujifilm Kyowa Kirin Biologics Co. Ltd., a U.K. court held invalid two European patents owned by Abbvie that purportedly cover Humira®...more

Update: JANSSEN v. CELLTRION – Damages in Biosimilar Cases

The court has issued a memorandum and order reflecting the guidance it provided during the Feb. 23 and 24, 2017 hearing concerning the standards for determining damages in the litigation. The guidance is here....more

PTAB Life Sciences Report -- Part I - March 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. McKesson Corp. v. My Health, Inc. - PTAB Petition: IPR2017-00312; filed November 29,...more

Coherus Files Two More Petitions for IPR of Abbvie’s ‘619 Humira Patent

Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619. (IPR2017-01008 and IPR2017-01009). Coherus recently filed four other petitions for inter partes review of the ‘619...more

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