News & Analysis as of

Pharmaceutical Patents

Allergan Successfully Invalidates Claims Relating to Using Botox to Treat Back Pain

by Jones Day on

Allergan is typically the patent holder in these types of disputes, however, it recently successfully played the role of petitioner in an IPR against 1474791 Ontario Ltd.’s U.S. Patent No. 6,806,251 covering the use of...more

Novartis AG, LTS et al. v. Noven Pharmaceuticals, Inc. – Prior Judicial Opinions Don’t Bind the PTAB

After Novartis’ patents were found nonobvious by the Fed. Cir., affirming the Delaware District Court, defendant Noven filed for inter partes review (IPR) of U.S. Pat. Nos. 6316023 and 6335031, on rivastigmine and an...more

PTAB Life Sciences Report -- Part II - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Actavis Laboratories FL, Inc. et al. v Janssen Oncology, Inc. PTAB Petition: IPR2017-00853;...more

Just How Predictable Must the Invention Be to Lose Patent Protection? Depends on the Inventive Concept

by Bennett Jones LLP on

Only a true invention can be patented; a patent claim to an invention is not valid if the invention was obvious. Assessing obviousness can be thought of as bridging the gap between two cliffs: on one side is the existing...more

Angiomax Patents Limited To Example

by Foley & Lardner LLP on

In The Medicines Co. v. Mylan, Inc., the Federal Circuit construed composition claims of two Angiomax patents as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the...more

Amgen Files Reply Brief in Sandoz v. Amgen

by Goodwin on

On April 14, Amgen filed its reply brief in Sandoz v. Amgen. We have previously reported on Sandoz’s response and reply brief, Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. As we have...more

Federal Circuit Affirms PTAB’s Obviousness Holding for Novartis’s Dementia Drug Patents

The Federal Circuit affirmed the PTAB’s final written decisions holding that claims directed to Novartis’s dementia drug compositions containing Exelon were obvious in Novartis AG v. Noven Pharm. Inc., No. 2016-1679 (Fed....more

Delaware Court Declines to Enter “Judgment” in Genentech v. Amgen

by Goodwin on

We have previously reported on letters submitted by Genentech and Amgen to the District of Delaware regarding Genentech’s decision not to file an amended complaint. In its letter, Genentech requested entry of judgment without...more

Generic consistency evaluation in China: the coming paradigm shift in drug pricing and patent cliff

by Allen & Overy LLP on

China is one of the largest generic drug markets in the world. As part of the drug approval reform, the ongoing generic consistency evaluation (GCE) is likely to have significant, long-lasting impacts on the market landscape,...more

PTAB Life Sciences Report -- Part I - April 2017#2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Reckitt Benckiser LLC v. Ansell Healthcare Products LLC - PTAB Petition: IPR2017-00063; filed...more

Amgen Responds to Genentech’s Letter in Bevacizumab Case

by Goodwin on

As we reported on Friday, Genentech has informed the District of Delaware that it will not file an amended complaint in its declaratory judgment action against Amgen regarding Amgen’s application to market a biosimilar of...more

Federal Circuit Affirms Obviousness of Novartis’s Patent for Multiple Sclerosis Drug

The Federal Circuit affirmed the PTAB’s final written decision holding that claims directed to Novartis’s multiple sclerosis drug Gilenya were obvious in Novartis AG v. Torrent Pharmaceuticals. Ltd., No. 2016-1352 (Fed. Cir....more

Genentech Will Not File Amended Complaint in Case Against Amgen

by Goodwin on

As we previously reported, the District of Delaware granted a motion to dismiss by Amgen in Genentech v. Amgen, finding a lack of subject matter jurisdiction over Genentech’s declaratory judgment complaint under the Federal...more

Summary of Sandoz’s Response and Reply Brief in Sandoz v. Amgen

by Goodwin on

On March 31, Sandoz filed its consolidated response and reply brief in Sandoz v. Amgen. We have previously covered Amgen’s consolidated opening and responsive brief and Sandoz’s opening brief. Amgen’s final reply brief is due...more

The Importance of Aligning Your Regulatory and IP Strategies

by Mark Mansour on

One of the least discussed but potentially most important part of the drug and device approval process is the smooth functioning of the IP and the regulatory strategies. It is natural to focus first on the IP issues,...more

How Soon Can A Biosimilar Applicant Be Sued for Patent Infringement?

by Fish & Richardson on

Biosimilar manufacturers proceeding under the abbreviated approval pathway laid out in the Biologics Price Competition and Innovation Act (“BPCIA”) open themselves up to patent infringement litigation. But how soon can a...more

Aragen Bioscience Files Three Petitions for IPR on Cell-Line Patents

by Goodwin on

Aragen Bioscience, Inc. and Transposagen Biopharmaceuticals, Inc. have filed three petitions for IPR of Kyowa Hakko Kirin Co., Ltd.’s patents: IPR2017-01262 on U.S. Patent 7,425,446; IPR2017-01252 on U.S. Patent 6,946,292;...more

Federal Circuit Patent Updates - April 2017

by WilmerHale on

Affirming judgment of noninfringement of one patent and reversing judgment of infringement of another patent. All asserted claims required a particular process step, construed as defined by one example in the specification,...more

Evidence of Priority to Provisional Application and that Prior Art Was Not Work of Another Defeated Obviousness Challenge in IPR

The Patent Trial and Appeal Board (the “Board”) issued a final written decision determining that the Coalition for Affordable Drugs (ADROCA), LLC (“Petitioner”) failed to prove unpatentable claims 1-52 of U.S. Patent No....more

Federal Circuit Limits Claim to Single Embodiment Because Only Enabling Description Provided in the Patent

On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit. See The...more

PTAB Life Sciences Report -- Part IV

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Smith & Nephew, Inc. v. ConforMIS, Inc. PTAB Petition: IPR2017-00778; filed January 26,...more

Courts' Findings of No Invalidity Are Not Binding on the Patent Office in Inter Partes Reviews

The US Circuit Court for the Federal Circuit issued an important decision last week regarding the interplay of court litigation and inter partes reviews (IPRs) at the US Patent and Trademark Appeals Board (PTAB) on the issue...more

PTAB Update -- Shire Has Rare Motion to Amend Granted

On March 31, 2017, the Patent Trial and Appeals Board ("PTAB" or "Board") granted a motion to amend claims in Amerigen Pharmaceuticals Ltd. v. Shire LLC (IPR2015-02009). This is, of course, an uncommon event. Depending on...more

Amgen v. Hospira: Federal Circuit Oral Argument Held

by Goodwin on

On April 3, 2017, the Federal Circuit heard oral argument concerning the discovery dispute between Amgen and Hospira in their litigation concerning Hospira’s proposed biosimilar of Amgen’s product Epogen®/ Procrit® (epoetin...more

The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017)

The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin...more

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