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Practical Perspectives on Intellectual Property Legal Developments

Category Archives: Pharmaceuticals

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Brexit Raises Questions About the Future of the Unitary Patent and Unified Patent Court

Posted in Patent, Pharmaceuticals
Recently, the UK voted to leave the EU. However, that has not happened yet for several reasons. The first reason is that the referendum actually needs to be voted on by Parliament, adopting the results of the referendum vote. A second reason is that withdrawal from the EU occurs when Article 50 of the Lisbon Treaty is enacted. Neither one of these two items has occurred. If Parliament agrees to follow the referendum outcome and votes to leave the EU, and if the UK gives notice under Article 50, then many trade agreements and treaties will need to be negotiated in a two-year period from date of notification.… Continue Reading

Federal Circuit Overturns Supplemental Jurisdiction Over Claims of Breach of Fiduciary Duty

Posted in Patent, Pharmaceuticals
In a recent decision from the Federal Circuit in AngioScore, Inc. v. TriREME Medical LLC et al. the court found that a plaintiff’s claim for patent infringement and breach of fiduciary duty did not have the requisite “common nucleus of operative fact” for the district court to maintain supplemental jurisdiction over breach of fiduciary duty claims. In particular, this decision provided the Federal Circuit a rare opportunity to review the jurisdiction limits of a district court in a case involving federal patent infringement claims and state law claims for breach of fiduciary duty aiding and abetting and unfair competition by an independent director and companies he co-founded which developed a competitive product to a product marketed by the plaintiff corporation AngioScore, Inc.… Continue Reading

New Jersey Follows Federal Circuit in Finding Jurisdiction Over Hatch-Waxman Defendants

Posted in Patent, Pharmaceuticals
We recently reported on the Federal Circuit’s holdings in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. and AstraZeneca AB v. Mylan Pharm., Inc., where it held that Mylan was subject to jurisdiction in Delaware because “Mylan’s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs.” Earlier this month, the first decision from the District of New Jersey District applying the Federal Circuits ruling was rendered. In Helsinn Healthcare S.A., et al. v. Hospira, Inc., No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. April 5, 2016), Judge Mary L. Cooper held that sufficient minimum contacts is to find specific jurisdiction is established by the fact that Hospira filed an ANDA seeking to market a generic version of Helsinn’s Aloxi® product that if approved, the marketing of will take place in New Jersey.… Continue Reading

Interesting Trends in Establishing Personal Jurisdiction in Hatch-Waxman/ANDA Litigations

Posted in Patent, Pharmaceuticals
Last week the Federal Circuit handed down one of its more anticipated decisions regarding jurisdiction in cases brought under 35 U.S.C. § 271(e)(2) (aka Hatch-Waxman or ANDA litigation). In its holding, the Federal Circuit stated that a “[defendant’s] ANDA filings and its distribution channels” are enough to “establish that [the defendant’s] plans to market its proposed [ANDA product in the forum state]” are enough to meet the minimum-contacts requirement to establish jurisdiction. It further held “there is no substantial argument that considerations of unfairness override the minimum-contacts basis for [the forum state’s] exercise of specific personal jurisdiction over” the defendants. This holding is much broader than the underlying district court rulings and limited the analysis to specific jurisdiction without addressing the underlying general jurisdictional questions.… Continue Reading

Need to Construe “Plain and Ordinary Meaning”?

Posted in Patent, Pharmaceuticals
In 2005, the Federal Circuit established the framework for the construction of patent claim terms. In its landmark holding in Philips v. AWH Corp., the Federal Circuit stated that “words of a claim ‘are generally given their ordinary and customary meaning . . . [and] that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art . . . ."… Continue Reading

Offering Compassionate Care While Alleviating Ethical Concerns: How Some Pharmaceutical Companies Are Meeting Both Demands

Posted in Pharmaceuticals
In recent years, families and friends of terminally ill patients have launched highly visible social media campaigns to secure access to potentially life-saving medicine, before those experimental drugs are approved. Pharmaceutical companies that are developing these investigational medicines often face difficult ethical and business relations dilemmas: there are limited exceptions for non-approved drug dissemination and the costs and consequences attendant on the exceptions can make either choice unpalatable. Companies and caregivers alike have struggled with how to fairly provide access to experimental drugs without negatively impacting long term drug development or approval.… Continue Reading

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity

Posted in Pharmaceuticals
In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..… Continue Reading

It Ain’t that Obvious to Try

Posted in Patent, Pharmaceuticals
In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.… Continue Reading

Takeda Part Two: Destroy Evidence, Pay the Price — Eli Lilly and Takeda Pharmaceutical Co. Get Hit For $9 Billion Punitive Damages Verdict

Posted in Pharmaceuticals
Recently, in In re Actos (Pioglitazone) Products Liability Litigation, MDL No. 11-2299, a Louisiana federal jury awarded $9 billion in punitive damages against Takeda Pharmaceutical Co. (“Takeda”) and Eli Lilly & Co. (“Lilly”). The verdict was delivered on the heels of Judge Rebecca Doherty’s January opinion, which lambasted Takeda for failing to (1) enforce its own litigation hold and (2) follow its document retention procedures, which led to the destruction of relevant evidence that Judge Doherty found would have likely been beneficial for the plaintiffs’ case.… Continue Reading

Takeda Part One: Prelude To Disaster? — Takeda Can’t Narrow Its Broadly-Written Litigation Hold

Posted in Pharmaceuticals
An opinion from Judge Rebecca Doherty in In re Actos (Pioglitazone) Products Liability Litigation, MDL No. 11-2299, provides valuable lessons on the consequences of drafting overly-broad litigation hold notices, as well as the importance of providing evidence from knowledgeable witnesses in defense of document retention procedures.… Continue Reading

Mutual Pharmaceutical Co., Inc. v. Bartlett

Posted in Pharmaceuticals
The generic pharmaceutical industry faced a Catch-22 when a serious adverse reaction arose from use of a generic drug product, and the manufacturer was restrained from unilaterally amending the product label to conform to state requirements, due to the Supreme Court's decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). PLIVA held that state requirements to change a label are pre-empted by the Federal Food, Drug and Cosmetic Act's prohibition of changing labeling without authorization by the FDA.… Continue Reading

Counterfeit Drugs – The Challenges of a Deadly Global Epidemic

Posted in Pharmaceuticals
For years, the average person who heard the phrase "knock offs" would immediately think of counterfeit versions of brand name luxury goods. While counterfeiters continue to target those types of goods, they are by no means the most nefarious or sophisticated category of counterfeiters. Counterfeiters have effectively targeted almost every type of consumer product imaginable, including the drugs and medical diagnostic devices that consumers rely on for their health and safety.… Continue Reading

Gibbons Institute of Law, Science & Technology Files Amicus Brief in “Pay-for-Delay” Case Before Supreme Court

Posted in Pharmaceuticals
We previously reported on the battle over so-called "pay-for-delay" settlements, which puts the pharmaceutical industry versus the Federal Trade Commission ("FTC") before the Supreme Court, to decide the legality of reverse payments in Hatch-Waxman cases. The case is FTC v. Actavis, Inc., et al.… Continue Reading

Proposed Bill Seeks to Answer the Pay for Delay Debate

Posted in Pharmaceuticals
As the so-called pay for-delay case is ripening for Supreme Court oral argument on March 25, 2013, on Tuesday a bi-partisan group of senators introduced legislation meant to strongly deter such arrangements. The introduction of the bill, known as the "Preserve Access to Affordable Generics Act," follows an annual FTC report disclosing 40 potential pay-for-delay deals struck in the 2012 fiscal year -- a jump from 28 such deals in 2011. The goal of the bill is "to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market." Such reverse payments (payments made by branded pharmaceutical patent holders to generic challengers to postpone market entry) are considered lawful by some, and anti-competitive by others, including the FTC.… Continue Reading

U.S. Supreme Court Will Not Review Lead Compound Test for Obviousness Analysis

Posted in Pharmaceuticals
On Monday, the Supreme Court denied the petition for writ of certiorari filed by Apotex seeking review of the Federal Circuit's May 7, 2012, ruling that affirmed the District Court of New Jersey's judgment that Otsuka's patents covering its blockbuster drug Abilify© are valid and not obvious.… Continue Reading

PhRMA Opposes FTC’s Proposed Rules for Reporting Certain Pharmaceutical Licensing Transactions

Posted in Pharmaceuticals
We recently reported that during the August doldrums the Federal Trade Commission (FTC) proposed for comment amendments to the Hart-Scott-Rodino rules that would require reporting of licensing agreements under which a patent holder grants an "exclusive" license, but retains the limited right to manufacture solely for the recipient of the patent rights, or a right to assist in developing and commercializing the product covered by the patent ("co-rights") and the value of the license exceeds the HSR minimum (currently $68.2 million).… Continue Reading

Reckitt Benckiser v. Tris Pharma — New Jersey Magistrate Finds No Trade Secret Misappropriation

Posted in Pharmaceuticals
In a recent "not for publication" Memorandum Opinion and Order relating to Reckitt Benckiser's ("RB") over-the-counter cough syrup, Delsym® (dextromethorphan polistirex), United States Magistrate Judge Douglas E. Arpert of the District of New Jersey found that RB failed to establish trade secret misappropriation, unfair competition, and tortious interference with business expectations claimed against Tris Pharma, following a four-day bench trial.… Continue Reading

FTC Proposes Rules to Codify Reporting of Exclusive Patent Right Transfers in the Pharmaceutical Industry

Posted in Patent, Pharmaceuticals
Is the sale or assignment of a patent reportable? The Hart-Scott Rodino Antitrust Improvements Act of 1976 ("HSR") and related rules require that all acquisitions of voting securities or assets exceeding a threshold amount be reported to the Federal Trade Commission ("FTC"), as well as the Antitrust Division of the Department of Justice. The current threshold is $68.2 million.… Continue Reading

Save the Date: Rutgers Pharmaceutical Management Program, July 19-20, 2012

Posted in Pharmaceuticals
Gibbons P.C. is again proud to announce a two-day program for Pharmaceutical Management at the Rutgers University Blanche and Irwin Lerner Center for Pharmaceutical Studies in Newark, NJ. The program, which is open to the public, includes in-depth presentations relating to topics including intellectual property, regulatory, financial and marketing issues relating to the pharmaceutical industry, as well as drug development and the role of biotechnology in pharmaceutical development.… Continue Reading

Astra v. Apotex: CAFC Affirms Non-infringement of Method of Use Claims

Posted in Pharmaceuticals
In AstraZeneca Pharms. LP. v. Apotex Corp., the Federal Circuit ruled that an Abbreviated New Drug Application ("ANDA"), filed under § 355(j)(2)(B)(ii) and limited to FDA approved, but unpatented uses of a medication, is not an act of infringement of Orange Book-listed patents covering approved but different uses of the same medication. The Court did find that Plaintiff's allegation that its listed patents are infringed was sufficient to establish subject matter jurisdiction over the generic Defendants.… Continue Reading
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