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Is The Real IPR Institution Rate Higher When Petitioner Errors &...

We have previously noted that the increasing rate of pre-institution settlement may in part be responsible for the declining institution rate in IPR proceedings because stronger petitions may drive...

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Key Trends In Pharmaceutical IPRs Filed By Generic Petitioners

We reviewed a sub-group of two hundred and four (204) IPRs filed by generic drug companies against pharmaceutical patents to assess PTAB outcomes and key trends in dealing with this technology field....

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Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review

As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution...

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CAFC Eases Amendment Process In IPR Proceedings

Today in Aqua Products, Inc. v. Matal, a fractured Court of Appeals for the Federal Circuit (CAFC) sitting en banc decided to flip the burden of persuasion onto petitioners in IPR proceedings to show...

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PTAB Grants Rare Request for Additional Discovery In IPR

In Mylan v. Allergan (IPR2016-00127, Paper No. 73), the PTAB granted a rare request for discovery filed be Petitioner in response to summaries of data presented in a Patent Owner Response used to rebut...

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Expanded PTAB Panel Finds Sovereign Immunity Waived By Patent Enforcement

In a case of first impression, an expanded PTAB panel (including Chief APJ Ruschke) found that a parallel enforcement action by a patent owner waives its sovereign immunity defense against under the...

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Supreme Court Upholds Constitutionality Of IPRs In Oil States

Today in Oil States v. Greene’s Energy, the Supreme Court upheld the constitutionality of IPR proceedings, finding that they are a permissible second review of patents conducted by the administrative...

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Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA...

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge...

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Federal Circuit Affirms PTAB Ruling That Tribal Immunity Does Not Apply To IPRs

On July 20, 2018, the Federal Circuit held in St. Regis Mohawk Tribe v. Mylan Pharmaceuticals that tribal sovereign immunity does not prevent IPR on a patent assigned to a tribe asserting such...

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Revamped PTAB Trial Practice Guide Holds Surprises

The Patent Trial and Appeal Board (“PTAB”) issued its initial Trial Practice Guide in August 2012, shortly before America Invents Act (“AIA”) post-grant proceedings became available. That Guide had not...

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New Estoppel Concern For Petitioners Raised In BTG v. Amneal

The Court of Appeals for the Federal Circuit is poised to decide a case which may create new estoppel concerns for AIA petitioners under 35 USC § 315(e)(2). The appeal resulted from a Hatch-Waxman...

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District Court Sheds Light on Scope of IPR Estoppel

One area of estoppel arising from an unsuccessful AIA petition that remains poorly understood relates to prior art that is described both in a printed publication or patent and also was in use by...

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PTAB - 2019 Year in Review

To wrap up 2019 and usher in 2020 for practitioners who handle Patent Trial and Appeal Board (PTAB) matters, Foley partners Jeanne Gills, Steve Maebius, and George Quillin discussed 2019’s major...

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New USPTO Pilot Program to Expedite Grant of Small Entity COVID-19 Patents

In an effort to help independent inventors and small businesses bring “important and possibly life-saving treatments” to market more quickly, the United States Patent and Trademark Office (USPTO) is...

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INSIGHT: Biogen Decision Shows Need for Clinical, Legal Collaboration

In Biogen International GmbH v. Banner Life Sciences LLC, a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) held that the scope of a patent term restoration under 35 U.S.C. §156 only...

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PTAB’s Motion to Amend Pilot Program: Review of Initial Results

Since the inception of inter partes reviews (IPRs) and post grant reviews (PGRs) under the America Invents Act, the option for a patent owner to file a motion to amend its claims was always present,...

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Wondering if Your Digital Health Product or Service is Subject to FDA...

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel...

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Revisiting FDA’s Original Guidance on Orange Book Listability in Light of...

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product...

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Leveraging USPTO Delays To Maximize Patent Term

Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of...

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