News & Analysis as of

Pharmaceutical Industry Patents

Allergan, Inc. v. Sandoz, Inc.

by Robins Kaplan LLP on

Case Name: Allergan, Inc. v. Sandoz, Inc., Nos. 2016-1085, -1160, 2017 U.S. App. LEXIS 4733 (Fed. Cir. Mar. 17, 2017) (Circuit Judges Reyna, Wallach, and Chen presiding; Opinion by Wallach, J.) (Appeal from M.D.N.C., Eagles,...more

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc.

On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be...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

Is there a legislative fix for biotech patents?

by Morrison & Foerster LLP on

By some accounts, we have entered a golden age for innovation in personalised medicine. Through scientific advancements in the study of genetic coding and molecular analysis, it is now possible to screen an individual for...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

Pharmaceutical Compound Nonobvious Absent Evidence Suggesting Specific Modification to Prior Art Compound

by Jones Day on

The PTAB issued a final written decision in IPR2016-00204, upholding the validity of claims 1–13 of Patent RE38,551 E (“the ’551 patent”), which covers the antiepileptic drug VIMPAT® (lacosamide)....more

Novartis AG v. Torrent Pharmaceuticals Ltd. (Fed. Cir. 2017)

Can a prior art reference that does not contain a teaching sufficient enough to allow it to be used in an obviousness combination nevertheless be used as a background reference for evidence of motivation to combine? ...more

Fed Circ Affirms Conflicting Invalidity Determinations from District Court and PTAB

by Jones Day on

As we have previously discussed on this blog, when considering an issue of patentability such as definiteness under section 112, the PTAB and a district court may properly reach opposite conclusions. In Tinnus Enterprises LLC...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

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

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

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

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

Protective Agreements Before and During BPCIA Litigation: Prosecution and Regulatory Bars

by Fish & Richardson on

Protective orders that regulate the disclosure and use of confidential information exchanged during patent litigations are commonplace. However, the patent dispute resolution procedures under the Biologics Price Competition...more

PTAB Grants Motion to Amend Claims, Kind Of

by Jones Day on

In Amerigen Pharmaceuticals Limited v. Shire LLC, IPR2015-02009 (March 31, 2017), the PTAB granted Shire’s Motion to Amend the claims in U.S. Reissued Patent RE 42,096, listed in the FDA’s Orange Book as covering Shire’s...more

Novartis v. Noven: The PTAB is not Bound by Prior Decisions of District Courts

Novartis, together with LTS Lohmann Therapie-Systeme, owns a pair of patents covering rivastigmine transdermal patches. These patches are useful for treating Alzheimer’s disease. Noven Pharmaceuticals filed an abbreviated new...more

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

Practice Tips for Patentees Asserting Method-of-Treatment Claims Involving Divided Infringement

by WilmerHale on

Do physicians ‘‘condition participation’’ of drug therapy based on patients’ compliance with drug manufacturer instructions regarding how to take drugs? Do physicians withhold medically necessary drug therapy from patients...more

PTAB Life Sciences Report -- Part II - April 2017

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Teva Pharmaceuticals USA, Inc. v. Allergan, Inc. - PTAB Petition: IPR2017-00576; filed...more

Federal Court of Appeal dismisses Teva’s appeal relating to utility and sufficiency

by Smart & Biggar on

On March 14, 2017, the Federal Court of Appeal (FCA) dismissed Teva’s appeal of Locke J.’s Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva in respect of its calcipotriol and...more

Judge Sweet Holds Invalidity and Non-Infringement Defenses Cannot Shield a Licensee’s Breach of a Patent License

On March 17, 2017, District Judge Robert Sweet (S.D.N.Y.) granted plaintiff Icahn School of Medicine at Mount Sinai's ("Mt. Sinai") motion to strike defendant Neurocrine Biosciences ("Neurocrine") affirmative defenses of...more

Europe: Combatting illegal pharma trade

by Hogan Lovells on

We are delighted to announce the launch of our Combatting illegal pharma trade enforcement guide. This publication is a pharmaceutical industry-specific brochure which complements our suite of brand and trademark protection...more

Issue Three: Keeping Tabs on the PTAB

by Goodwin on

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

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