Note 8 - Commitments and Contingencies	3 Months Ended
Mar. 31, 2018
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	Note 8 . Commitments and Contingencies We are or may be involved in disputes, governmental and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows. While it is not possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in one or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position, or cash flows. Abbreviated New Drug Application Litigations On October 7, 2015 Progenics, Valeant and Wyeth LLC (Valeant’s predecessor as licensee of RELISTOR) received notification of a Paragraph IV certification for certain patents for RELISTOR (methylnaltrexone bromide) subcutaneous injection, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Mylan Pharmaceuticals, Inc. of an Abbreviated New Drug Application (“ANDA”) with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire. On October 28, 2015, Progenics, Valeant and Wyeth LLC received a second notification of a Paragraph IV certification with respect to the same patents for RELISTOR subcutaneous injection from Actavis LLC as a result of Actavis LLC’s filing of an ANDA with the FDA, also challenging these patents and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire. On October 25, 2016, Progenics, Valeant, and Wyeth LLC received a notification of a Paragraph IV certification with respect to certain patents for RELISTOR Tablets. The certification accompanied the filing by Actavis LLC of an ANDA challenging such patents for RELISTOR Tablets and seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire. On May 3, 2017, ANDA filer, Mylan Pharmaceuticals received a tentative approval letter from the FDA for Methylnaltrexone Bromide Subcutaneous Injection, 12 mg/0.6 mL single-dose vial. In accordance with the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act), Progenics, Valeant, and Wyeth (collectively “Plaintiffs”) timely commenced litigation against each of these ANDA filers (collectively “Defendants”) in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i) 30 months from receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed. The 30 -month stays will begin expiring in the second quarter of 2018. On February 9, 2018, Plaintiffs, including Progenics, Salix Pharmaceuticals, Inc, Valeant and Wyeth, LLC, filed a Motion And Brief For Partial Summary Judgment on the validity of claim 8 of U.S. Patent 8,552,025 (the “025 Patent”) with the United States District Court of New Jersey. On February 16, 2018, the Court denied Defendant’s motion to strike the Summary Judgment motion, ordering Defendant to respond by February 20, 2018, with an extension available. On May 1, 2018, the US District Court of New Jersey granted the motion for partial summary judgement of validity of the 025 Patent, a formulation patent for RELISTOR (methylnaltrexone bromide) Injection. Defendants in the case, including Mylan Inc, Mylan Laboratories LTD, Mylan Pharmaceuticals Inc., and Actavis LLC, had previously stipulated to infringement of claim 8 and have no remaining invalidity defenses. The ruling prevents generic competition in the United States until 2024. In the upcoming trial on June 4, 2018, the court is expected to decide the infringement and validity of other patents that could prevent generic RELISTOR vials until 2029 and generic RELISTOR syringes until 2030. In July 2017, we received notification of a Paragraph IV certification from Par Pharmaceuticals with respect to Orange Book listed patents for RELISTOR subcutaneous injection. Valeant timely filed suit against Par. In addition to the above described ANDA notifications, in October 2015 Progenics received notices of opposition to three European patents relating to methylnaltrexone. The oppositions were filed separately by each of Actavis Group PTC ehf. and Fresenius Kabi Deutschland GmbH. The matters are on appeal with the European Patent Office. In each of the above-described proceedings, Progenics and Valeant continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between Progenics and Valeant, Valeant has the first right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement.

Note

. Commitments and Contingencies

We are or

may

be involved in disputes, governmental and/or regulatory inspections, inquiries, investigations, and proceedings that could result in litigation, and other litigation matters that arise from time to time. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect us, our results of operations, financial condition, and cash flows. While it is

not

possible to accurately predict or determine the eventual outcomes of these items, an adverse determination in

one

or more of these items currently pending could have a material adverse effect on our consolidated results of operations, financial position, or cash flows.

Abbreviated New Drug Application Litigations

October 7, 2015

Progenics, Valeant and Wyeth LLC (Valeant’s predecessor as licensee of RELISTOR) received notification of a Paragraph IV certification for certain patents for RELISTOR (methylnaltrexone bromide) subcutaneous injection, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. The certification resulted from the filing by Mylan Pharmaceuticals, Inc. of an Abbreviated New Drug Application (“ANDA”) with the FDA, challenging such patents for RELISTOR subcutaneous injection and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

October 28, 2015,

Progenics, Valeant and Wyeth LLC received a

second

notification of a Paragraph IV certification with respect to the same patents for RELISTOR subcutaneous injection from Actavis LLC as a result of Actavis LLC’s filing of an ANDA with the FDA, also challenging these patents and seeking to obtain approval to market a generic version of RELISTOR subcutaneous injection before some or all of these patents expire.

October 25, 2016,

Progenics, Valeant, and Wyeth LLC received a notification of a Paragraph IV certification with respect to certain patents for RELISTOR Tablets. The certification accompanied the filing by Actavis LLC of an ANDA challenging such patents for RELISTOR Tablets and seeking to obtain approval to market a generic version of RELISTOR tablets before some or all of these patents expire.

May 3, 2017,

ANDA filer, Mylan Pharmaceuticals received a tentative approval letter from the FDA for Methylnaltrexone Bromide Subcutaneous Injection,

mg/0.6

mL single-dose vial. In accordance with the Drug Price Competition and Patent Term Restoration Act (commonly referred to as the Hatch-Waxman Act), Progenics, Valeant, and Wyeth (collectively “Plaintiffs”) timely commenced litigation against each of these ANDA filers (collectively “Defendants”) in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i)

months from receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or

not

infringed. The

-month stays will begin expiring in the

second

quarter of

2018.

February 9, 2018,

Plaintiffs, including Progenics, Salix Pharmaceuticals, Inc, Valeant and Wyeth, LLC, filed a Motion And Brief For Partial Summary Judgment on the validity of claim

of U.S. Patent

8,552,025

(the

“025

Patent”) with the United States District Court of New Jersey. On

February 16, 2018,

the Court denied Defendant’s motion to strike the Summary Judgment motion, ordering Defendant to respond by

February 20, 2018,

with an extension available. On

May 1, 2018,

the US District Court of New Jersey granted the motion for partial summary judgement of validity of the

025

Patent, a formulation patent for RELISTOR (methylnaltrexone bromide) Injection. Defendants in the case, including Mylan Inc, Mylan Laboratories LTD, Mylan Pharmaceuticals Inc., and Actavis LLC, had previously stipulated to infringement of claim

and have

remaining invalidity defenses. The ruling prevents generic competition in the United States until

2024.

In the upcoming trial on

June 4, 2018,

the court is expected to decide the infringement and validity of other patents that could prevent generic RELISTOR vials until

2029

and generic RELISTOR syringes until

2030.

July 2017,

we received notification of a Paragraph IV certification from Par Pharmaceuticals with respect to Orange Book listed patents for RELISTOR subcutaneous injection. Valeant timely filed suit against Par.

In addition to the above described ANDA notifications, in

October 2015

Progenics received notices of opposition to

three

European patents relating to methylnaltrexone. The oppositions were filed separately by each of Actavis Group PTC ehf. and Fresenius Kabi Deutschland GmbH. The matters are on appeal with the European Patent Office.

In each of the above-described proceedings, Progenics and Valeant continue to cooperate closely to vigorously defend and enforce RELISTOR intellectual property rights. Pursuant to the RELISTOR license agreement between Progenics and Valeant, Valeant has the

first

right to enforce the intellectual property rights at issue and is responsible for the costs of such enforcement.