Pharmaceutical Patents

News & Analysis as of

Janssen v. Celltrion: Janssen Appeals Judgment Invalidating the ’471 Patent

As we previously reported, on September 26, 2016, the district court in Janssen v. Celltrion entered partial final judgment that the ’471 patent, asserted by Janssen, was invalid. Today, Janssen filed a notice that they are...more

Kyle Bass Wins at the PTAB

On October 21, 2016, the PTAB issued two final written decisions invalidating claims of U.S. Patent No. 7,056,886 (“the ’886 patent”), covering Shire’s drug Gattex® which were challenged by Kyle Bass last year. Although Bass...more

Life Sciences Spotlight - Asia Pacific Issue 7, 2016

Welcome to the seventh edition of Life Sciences Spotlight, and our very first AusBiotech/Biofest conference edition. We are very pleased to provide updates on a number of developments in the life sciences sector across...more

Substantial Evidence Supports Determination of Reasonable Expectation of Success

In In re Efthymiopoulos, [2016-1003] (October 18, 2016) the Federal Circuit affirmed the PTAB decision that the claimed invention relating to the administration or an anti-influeza drug “by inhalation through the mouth alone”...more

UPDATE: Mylan Files Amicus Brief in Support of Apotex’s Petition in Amgen v. Apotex

Earlier this week, we reported on the amicus curiae brief filed by the Biosimilars Council in support of Apotex’s petition in Amgen v. Apotex. Mylan Pharmaceuticals Inc. has also filed an amicus brief in support of...more

PTAB Denies Institution on Biogen’s Tysabri® Patent

On October 17, the PTAB denied institution of IPR2016-000912, IPR2016-00915, IPR2016-00916. The Petitions in these cases were filed by Swiss Pharma International AG on U.S. Patent Nos. 8,815,236; 8,349,321; and 8,900,577,...more

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more

The Supreme Court’s Decisions Not to Hear Patent Cases Leaves Federal Circuit Decisions on Key Questions Intact

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods...more

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

Janssen v. Celltrion: District Court Schedules Hearing on Motion to Dismiss

As we previously reported, Celltrion has moved to dismiss Janssen’s claim of infringement of the ’083 patent, the sole remaining patent in the case since the district court entered partial final judgment with respect to the...more

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

Amgen v. Hospira (epoetin alfa): District Court Lets in New Infringement Theories, Not New Defendants

As we previously reported, Amgen has sought to amend its complaint regarding Hospira’s planned epoetin alfa biosimilar to add three new defendants and two theories of infringement. On October 3, 2016, Judge Andrews...more

Litigation Update in Abbvie v. Amgen: AbbVie’s Answer Filed in Response to Amgen’s Counterclaims

Last Friday, AbbVie filed its Answer and Defenses to Amgen’s counterclaims of invalidity and noninfringement for each of the patents-in-suit. Of note, AbbVie stated that it lacked “sufficient knowledge and information to...more

Know the Rules! FDA’s New Regulations Change Responsibilities For ANDA Filers

On October 6, 2016, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal...more

In a Groundbreaking Decision, Third Circuit Provides Framework for Evaluating Numerosity

One of the least disputed elements of class certification is Rule 23(a)(1) numerosity, and so there is relatively little analysis from the courts about it. Last month, however, a divided panel of the Third Circuit provided a...more

Amgen v. Apotex: Amgen Appeals Non-Infringement Judgment in Filgrastim/Pegfilgrastim Dispute

Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in...more

Bass IPR Petition Against Shire Fails

On October 5, the PTAB ruled against Petitioner Coalition for Affordable Drugs II LLC, an organization formed by hedge fund manager Kyle Bass, holding that the petitioner had not shown by a preponderance of the evidence that...more

FDA Issues Final Rule on Abbreviated New Drug and 505(b)(2) Applications

New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016. On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule...more

Amgen Appeals Loss of Neulasta® and Neupogen® Litigation

On October 3, 2016, Amgen filed a Notice of Appeal in the U.S. District Court for the Southern District of Florida and thereby laid the groundwork for its next move in the ongoing Amgen v. Apotex dispute. (D.I. 272.)...more

Third Circuit Upholds Dismissal of Doryx ‘Product Hopping’ Suit

On September 28, 2016, the Third Circuit issued an opinion in Mylan v. Warner Chilcott, upholding the Eastern District of Pennsylvania’s holding on summary judgement that Defendants’ “product hopping” conduct did not violate...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Bass’s First IPR Decision Rendered – Victory for Patent Owner, Shire Lpc

If Kyle Bass’s Coalition for Affordable Drugs Series II hedge fund was hoping to reap a windfall from short positions in Shire Plc’s stock this week, it was dealt a major setback by a Patent Trial and Appeal Board (PTAB)...more

Supreme Court Declines to Review Scope of Section 271(e)(1) Safe-Harbor

Earlier this week, the United States Supreme Court denied Amphastar Pharmaceutical’s petition for certiorari regarding the scope of the safe-harbor of 35 U.S.C. § 271(e)(1), a provision that generic drug and biosimilar makers...more

Subject Matter Jurisdiction Remains in Hatch-Waxman Patent Infringement Action after ANDA Filer Changes from Paragraph IV to...

The District Court of Delaware denied defendant Wockhardt’s motion to dismiss a patent infringement action based on the reasonable inference that plaintiff AstraZeneca may need to assert its patent rights in the future. On...more

Litigation Update: Answer Filed in AbbVie v. Amgen

Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501). Amgen asserts...more

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