Pharmaceutical Patents

News & Analysis as of

Court Report - August 2014 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Aptalis Pharmatech Inc. et al. v. Apotex Inc. et al. 1:14-cv-01038; filed August 11, 2014 in the District Court of...more

A second patent in a chain falls to obviousness-type double patenting challenge

The court had previously determined that The Kennedy Trust’s U.S. Patent No. 7,846,442 (the “parent patent”) was invalid for obviousness-type double patenting (“ODP”) to U.S. Patent No. 6,270,766 (“the grandparent“). At issue...more

Prior claiming in Australia…has news of its demise been greatly exaggerated? Is prior claiming still applicable to the remaining...

Prior claiming was a ground of invalidity under the Patents Act 1952 (1952 Act). It prevented grant of a patent claiming subject matter already claimed by another patent. Prior claiming was superseded by the broader concept...more

FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more

Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)

Last week, the Federal Circuit affirmed a finding of inequitable conduct in Apotex v. USB, a relatively rare occurrence in the years after the Federal Circuit's decision in Therasense v. Becton, Dickenson. In the Therasense...more

Court Report - August 2014 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Perrigo Co. et al. 1:14-cv-01004; filed July 31, 2014 in the District Court of...more

Purdue Pharm. Products, L.P. v. Actavis Elizabeth, LLC (D.N.J.)

Plaintiffs hold an NDA covering tablets containing two strengths of zolpidem tartrate, which is used in the treatment of middle-of-the-night insomnia. In July 2013, TWi Pharms., Inc. (“TWi”) submitted an ANDA containing a...more

India Enters "Pay-for-Delay" Fray: CCI Investigating Pharmaceutical Patent Settlements

India's competition authority, the Competition Commission of India (CCI), has begun scrutinizing and investigating pharmaceutical patent settlement agreements between brand and generic firms for potential anticompetitive...more

United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/9/14)

This matter arises from a motion for summary judgment by Sandoz alleging that the ’117 patent is invalid since it was previously disclosed in the prior art U.S. Patent No. 4,668,814 (“the ’814 patent”). More specifically,...more

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Court Report - August 2014 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Glycobiosciences Inc. v. Dara Biosciences, Inc. et al. 1:14-cv-01281; filed July 28, 2014 in the District Court of the...more

IP Newsflash - August 2014 #2

Federal Circuit Reverses ScriptPro Invalidity Ruling - On Wednesday, a lawsuit between ScriptPro LLC and competitor, Innovation Associates, Inc., was sent back to the U.S. District Court of Kansas after a three-judge...more

New IP Enforcement Policy in the EU

Given that strategic importance of IP-sensitive industries for the EU economy, the European Commission (Commission) has introduced a new initiative with a view to strengthen the protection of EU-based IP rights by working...more

United Therapeutics Corp. v. Sandoz, Inc. (D.N.J.) (4/16/14)

The ’007 patent covers pharmaceutical preparations in which treprostinil or treprostinil sodium is diluted with a high pH glycine buffer, and the methods of using those preparations in order to facilitate safer intravenous...more

Court Report -- Part II: August 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicines Company v. Accord Healthcare, Inc. et al. 1:14-cv-00626; filed July 24, 2014 in the Middle District of North...more

Avanir Pharms., Inc. v. Actavis South Atlantic LLC (D. Del.)

The ’115 patent relates to formulations containing dextromethorphan and quinidine for the treatment of chronic or intractable pain. The ’282 and ’484 patents relate to the use of dextromethorphan and quinidine for the...more

Reckitt Benckiser Pharms., Inc. v. Biodelivery Services Ltd. (E.D.N.C.)

The issues presented were whether defendant’s actions were sufficient to support declaratory judgment jurisdiction and whether defendant’s conduct supports a claim for patent infringement under 35 U.S.C. §...more

Court Report - August 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Roche Molecular Systems, Inc. v. Cepheid 3:14-cv-03228; filed July 16, 2014 in the Northern District of...more

Prometheus Labs., Inc. v. Roxane Labs., Inc. (D.N.J.)

Lotronex was initially launched in 2000, but was subsequently removed from the market in light of serious side effects attributed to the drug. It was re-launched in 2002 with a new label. At the time, the ’770 patent was...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

A Compound Is Obvious Where Only Minor Changes to a Prior Art “Lead Compound” Are Required to Make the Claimed Compound

Bristol-Myers Squibb Co. v. Teva Pharms USA, Inc. - Addressing the obviousness of a claimed compound where a person of skill would need to make only minor changes to a lead compound to arrive at the claimed invention,...more

Obviousness Only Requires Reasonable Expectation of Success of One Compound Encompassed by Broad Genus Claims

Allergan, Inc. v. Apotex Inc. - Addressing the issue of showing a reasonable expectation of success when making obviousness combinations in the context of broad genus claims, the U.S. Court of Appeals for the Federal...more

Novartis Pharms. Corp. v. Par Pharm., Inc. (D. Del.)

Nature of the Case and Issue(s) Presented: Novartis sued Watson and Par alleging infringement of the patents-in-suit. Both patents share the same specification. The ’031 and ’023 patents claim pharmaceutical compositions,...more

Court Report -- Part III

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Cubist Pharmaceuticals Inc. v. Fresenius Kabi USA LLC 1:14-cv-00914; filed July 11, 2014 in the District Court of...more

Contractual Duty to Deal Does Not Equal Antitrust Duty to Deal

Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust...more

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