Log in
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Dynamic quotes 

MarketScreener Homepage  >  Equities  >  Tokyo Stock Exchange  >  Astellas Pharma Inc.    4503   JP3942400007


SummaryMost relevantAll NewsPress ReleasesOfficial PublicationsSector news

Astellas Pharma : Federal Circuit Reverses PTAB Finding Tarceva® Method Of Treatment Claims Invalid For Lack Of Reasonable Expectation Of Success Based On Over 99.5% Failure Rate Among Treatment Candidates

06/03/2020 | 06:15am EST

In a precedential opinion on October 4, 2019, the United States Court of Appeals for the Federal Circuit, in OSI Pharmaceuticals v. Apotex, No. 2018-1925, reversed the Board's Final Written Decision in an inter partes review ("IPR") finding that claims of United States Patent No. 6,900,221 (the "'221 patent") were invalid as obvious. The Federal Circuit panel held on appeal that the prior art relied upon by the Patent Trial and Appeal Board ("PTAB") failed to sufficiently support its finding that a person of ordinary skill in the art would have had a reasonable likelihood of success of achieving the claimed invention - a method of using erlotinib (marketed by OSI under the name Tarceva®) to treat non-small cell lung cancer ("NSCLC") in a mammal. In so ruling, the court relied on the highly unpredictable nature of NSCLC cancer treatment and a failure rate of over 99.5% for NSCLC treatments entering Phase II clinical trials at the time of invention.

On September 2, 2015, OSI had filed a Hatch-Waxman patent infringement suit against Apotex, alleging that Apotex's generic version of Tarceva® will infringe one or more claims of the '221 patent. OSI Pharmaceuticals v. Apotex, No. 15-cv-00772 (D. Del.). On June 28, 2016, Apotex filed a petition for IPR (IPR2016-01284) asserting that claims 44-47 and 53 of the '221 patent are invalid as being obvious or anticipated by the prior art. The Delaware action was stayed pending resolution of the IPR proceeding. The PTAB instituted review and, in January 2018, the Board found the challenged claims invalid as obvious over a prior art combination of a patent for treatment of hyperproliferative diseases, such as cancers ("Schnur"), a review article on anticancer drugs and growth factor signaling ("Gibbs"), and OSI's 1998 10-K filing. The PTAB based its finding on Schnur disclosing all claimed elements except the treatment of NSCLC and that Gibbs and the 10-K filing provided a reasonable expectation of success in using erlotinib to treat NSCLC.

First, the Court found that the PTAB erroneously read the Gibbs reference as supporting erlotinib's anti-cancer activity. As a review article, Gibbs did not include first-hand research and instead relied on previously cited references to frame its conclusions. But the two references cited in the portion of Gibbs that the PTAB relied on made no reference to using erlotinib to treat NSCLC. Moreover, the PTAB improperly disregarded a declaration submitted by the author, Dr. Gibbs, stating that he was unaware of any publication demonstrating erlotinib's effect on NSCLC at the time he wrote the article. Thus, the Court found that the PTAB erred by failing to consider both Dr. Gibbs' declaration and the lack of support within the references Gibbs relied on.

Second, the Federal Circuit held that the PTAB's finding of a reasonable expectation of success was not supported by substantial evidence in light of the highly unpredictable field of NSCLC treatment. None of the cited references contained any data or promising information regarding erlotinib's efficacy in treating NSCLC. The Court found the lack of any efficacy data critical in light of the unpredictable nature of treating NSCLC. Specifically, the Court relied on the fact that over 99.5% of drugs for treatment of NSCLC failed Phase II clinical trials between 1990 and 2005, a period including the time of '221 patent invention. And that failure rate did not even include the drug candidates that failed before or during preclinical or Phase I testing. Based on these data, the Court concluded that "the only reasonable expectation at the time of the invention was failure, not success."

While the Federal Circuit made clear that efficacy data is not always required to establish a reasonable expectation of success nor is an "absolute predictability of success," the opinion provides a reminder against applying hindsight to frame a reasonable expectation of success in a highly unpredictable field with a high failure rate, like the NSCLC treatment at issue.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mr Peter Cuomo
One Financial Center
MA 02111
Tel: 6175426000
Fax: 6175422241
E-mail: www.mintz.com
URL: www.mintz.com

© Mondaq Ltd, 2020 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com, source Business Briefing

01/14ACTINIUM PHARMACEUTICALS : and Astellas Announce Research Collaboration Focused ..
01/06ASTELLAS PHARMA INC. : - FDA Accepts for Priority Review the New Drug Applicatio..
2020ASTELLAS PHARMA : FDA Lifts Clinical Hold for Audentes Therapeutics' AT132 Trial
2020ASTELLAS PHARMA : Reports XOSPATA in Combination with Azacitidine Did Not Meet E..
2020ASTELLAS PHARMA : Supports Recommendations of Task Force on Climate-related Fina..
2020ASTELLAS PHARMA INC. : - Expansion of the Domestic Logistics Platform for Pharma..
2020VIATRIS : Astellas and Viatris Announce Termination of Co-promotion, Succession ..
2020Japan shares slip for third day; all eyes on U.S. stimulus debate
2020Japanese shares slip back as investors look to U.S. stimulus debate
2020Astellas Pharma, Viatris Pharmaceuticals Japan to End Joint Sales Promotion o..
More news
Sales 2021 1 269 B 12 216 M 12 216 M
Net income 2021 185 B 1 776 M 1 776 M
Net cash 2021 440 B 4 234 M 4 234 M
P/E ratio 2021 16,5x
Yield 2021 2,53%
Capitalization 3 087 B 29 742 M 29 710 M
EV / Sales 2021 2,09x
EV / Sales 2022 1,90x
Nbr of Employees 15 883
Free-Float 99,2%
Duration : Period :
Astellas Pharma Inc. Technical Analysis Chart | 4503 | JP3942400007 | MarketScreener
Technical analysis trends ASTELLAS PHARMA INC.
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus OUTPERFORM
Number of Analysts 11
Average target price 2 268,18 JPY
Last Close Price 1 662,00 JPY
Spread / Highest target 117%
Spread / Average Target 36,5%
Spread / Lowest Target -0,72%
EPS Revisions
Managers and Directors
Kenji Yasukawa President, CEO & Representative Director
Yoshihiko Hatanaka Chairman
Naoki Okamura Representative Director & Vice President
Tomokazu Fujisawa Director
Hiroko Sakai Director
Sector and Competitors
1st jan.Capitalization (M$)
JOHNSON & JOHNSON1.86%421 997
ROCHE HOLDING AG2.48%305 385
NOVARTIS AG1.97%218 041
MERCK & CO., INC.1.93%210 954
PFIZER INC.-0.30%203 993