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Patents Pharmaceutical Industry

Global Patent Prosecution Newsletter - September 2017

Worldwide Doctrine of Equivalents and Prosecution History Estoppel - The doctrine of equivalents (DOE) arises in the context of a patent infringement action where the accused product or process does not literally infringe...more

Recent IPR Updates

by Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

Pharmaceutical Company Seeks to Use Tribal Sovereign Immunity to Avoid Inter Partes Review

by Snell & Wilmer on

Allergan announced on September 8, 2017, that it had transferred its patents covering the drug Restasis to the Saint Regis Mohawk Tribe and will pay the tribe $13.75 million. The tribe is also eligible to receive $15 million...more

Framework for Swiss-form claim construction in Australia: Is it really about objective intent?

by FPA Patent Attorneys on

This article looks at the current status of construction of Swiss-style claims in Australia, provides a framework by which construction of Swiss-style claims can be assessed, and concludes that although the position is not...more

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

BI Files Answer to AbbVie’s Complaint in Adalimumab Litigation

by Goodwin on

As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira...more

U.S. - What does the Impression Products v. Lexmark decision mean for drug companies? 5 takeaways

by Hogan Lovells on

Last May, the U.S. Supreme Court issued a highly-anticipated decision in Impression Products, Inc. v. Lexmark Int’l, Inc., reversing the Federal Circuit and holding that, when a patent holder sells a product, it exhausts all...more

Publication of Final Regulations on Patent Linkage and Term Restoration

by Smart & Biggar on

On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

Mylan Pharm. v. AstraZeneca AB (PTAB 2017)

The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office recently issued a Final Written Decision in an inter partes review styled Mylan Pharm. v. AstraZeneca AB affirming the patentability of all challenged...more

News from Abroad -- No Pharmaceutical Extension of Patent Term for Swiss Type Claims in Australia

The Australian Full Federal Court's recent decision in Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 confirms that an extension of patent term for pharmaceutical substances does not extend to Swiss type...more

BPCIA Litigation Roundup (Summer 2017)

by Goodwin on

Below is our summer update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates...more

August 2017: Life Sciences Litigation Update

Mylan Institutional LLC v. Aurobindo Pharma Ltd., No. 2017-1645, 2017 WL 2192945 (Fed. Cir. May 19, 2017). On May 19, 2017, the Federal Circuit issued a precedential opinion in Mylan Institutional LLC v. Aurobindo Pharma Ltd....more

It’s Not Always Obvious What’s Obvious

by Faegre Baker Daniels on

If you think it’s easy to determine what’s obvious and what’s not, take a look at the recent Federal Circuit decision in Millennium Pharmaceuticals v. Sandoz. The lower court had determined that a process was obvious. The...more

Samsung Bioepis Files for Joinder With Hospira Petitions Against Genentech Patents

by Goodwin on

Samsung Bioepis has filed three petitions for IPR challenging Genentech patents related to the use of Herceptin® (trastuzumab): IPR2017-01958, challenging U.S. Patent 6,627,196; IPR2017-01959 challenging U.S. Patent...more

Obviousness Reversed for Clear Error in Factual Findings on Combination of References

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed a district court’s judgment that the challenged claims were invalid for obviousness. The Court also vacated judgments in separate actions that had been entered based on...more

FDA Approves Boehringer Ingelheim’s Adalimumab Biosimilar

by Goodwin on

Today, Boehringer Ingelheim received FDA approval for Cyltezo®, its biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic...more

Counsel’s Actions Support Inference of Intent to Deceive PTO

by McDermott Will & Emery on

In a decision clarifying the analysis for inequitable conduct, a split panel of the US Court of Appeals for the Federal Circuit affirmed a district court finding of specific intent to deceive the US Patent and Trademark...more

Amgen v. Sandoz: Pegfilgrastim Litigation Update

by Goodwin on

On July 17, 2017, in the ongoing Amgen v. Sandoz litigation regarding Sandoz’s proposed biosimilar of Neulasta® (pegfilgrastim), the magistrate judge ordered, among other things, that Amgen is entitled to discovery from...more

A loophole allowing patent term extensions in Australia for certain Swiss-style claims has been closed

by FPA Patent Attorneys on

The Australian Administrative Appeals Tribunal opened the door for patent term extensions based on a Swiss-form claim which enlarged the scope of applications of patent term extensions considerably. Recently, the Full Federal...more

Sandoz Files Petitions for IPR on Two Abbvie Adalimumab Patents

by Goodwin on

Sandoz has filed two petitions for IPR challenging Abbvie patents related to use of an antibody identified in the petitions as Humira® (adalimumab): IPR2017-01987 challenging U.S. Patent 8,911,737, directed to methods of...more

Judge Carter Rules “Customers” Don’t Fit Within the “Customer Exception”

RegenLab USA LLC (“RegenLab”) is the exclusive licensee of U.S. Patent 8,529,957 (“the ’957 patent”) entitled “Cell Preparations for Extemporaneous Use, Useful for Healing and Rejuvenation In Vivo.” RegenLab , who markets and...more

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

by Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Amgen v. Coherus: Coherus Files Reply in Support of Motion to Stay

by Goodwin on

As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on...more

Alza Corp. v. Amneal Pharmaceuticals of New York, LLC

by Robins Kaplan LLP on

Case Name: Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, Civ. No. 16-cv-914-RGA, 2017 U.S. Dist. LEXIS 53551 (D. Del. Apr. 7, 2017) (Andrews, J.)....more

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