Pharmaceutical Industry Patents

News & Analysis as of

Issue Three: Keeping Tabs on the PTAB

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...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

2016 – a year at a glance

What is a human? When is your best method not good enough? When is an inventor not an inventor? What happens when your patent application fails to deliver on its promise? These are just a few of the questions that the...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

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

Section 337 Actions at the ITC: another forum for pharma and biosimilars litigation?

With the growing volume of biosimilar and pharma litigation in district courts and before the PTAB, the U.S. International Trade Commission may emerge as another forum for patent holders against imported biosimilars. Section...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

In re Depomed, Inc. (Fed. Cir. 2017)

Last month, in In re Depomed, Inc., the Federal Circuit affirmed the determination by the U.S. Patent and Trademark Office Patent Trial and Appeal Board that two instituted grounds in an inter partes review rendered claims 1,...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

Preparing Biotech Patent Applications - Ten Strategies for Success

Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...more

Can Swiss-style claims go off-piste in Australia?

Swiss-style claims are a very particular form of claim developed to circumvent the exclusion of methods of medical treatment from patentability in Europe. They are second medical use claims in that the compound used in the...more

Chemistry & Nanotechnology Developments to Watch in 2017

As cases and outcomes make their way into the news this year, we will be watching the following developments closely and sharing them with the IP community....more

Delaware District Court Dismisses Genentech v. Amgen

As we previously reported, yesterday Judge Sleet, United States District Court for the District of Delaware, heard arguments on Amgen’s motion to dismiss in Genentech v. Sandoz. The court orally granted Amgen’s motion under...more

Wrong Inventor Defense Fails in Pharmaceutical Litigation

Addressing derivation and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s denial of a generic drug manufacturer’s attempt to invalidate a patent based on the theory that the...more

"He Ain't Heavy, He's My Brother" - Patents directed to deuterium modified drugs

In this the fourth instalment of our series of articles looking at the hot topic of the patenting of radiopharmaceuticals, we are taking a small side-step away from the radioactive isotopes to look at the area of deuterated...more

Multiple Actors May Perform Steps in Method Claims for Purposes of Inducement

Addressing the issue of divided infringement, the US Court of Appeals for the Federal Circuit affirmed the district court’s finding of induced infringement even though no single actor performed all steps of the asserted...more

News from Abroad -- Swiss-style Patent Claims Can Be Very Valuable in Australia

The scope for enforcement of Swiss-style claims may be broader in Australia than for method of medical treatment claims. Second medical use inventions can be claimed in an ever increasing number of claim formats depending on...more

Shire Development LLC v. Watson Pharmaceuticals Inc. (Fed. Cir. 2017)

The Federal Circuit, in its third opinion involving ANDA litigation between these parties over Shire's LIALDA® (mesalamine) product, has apparently brought this case to a close in generic drug maker Watson's favor, in a...more

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more

How Addressing 'The Triumvirate of Patent Risks' Can Enhance Your IP Portfolio Value

Why investors and patent owners should carefully consider the Patent Triumvirate throughout the commercial development process and beyond....more

Court Rejects Theory Of Derivation Based On FDA Requirement

The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ Nos. 14-1382-RGA, 14-1389-RGA, 2016 U.S. Dist. LEXIS 140112 (D. Del. Oct. 7, 2016) (Andrews, J.). Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone...more

RX IP Update - January 2017

Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

Supreme Court Grants Certiorari in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

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