The U.S. Food and Drug Administration on Tuesday delivered on a promise to better explain its policies for refusing to accept generic-drug applications for review, revising and clarifying a number of proposals issued last year.
Endo International PLC on Tuesday offered to buy men's health products company Auxilium Pharmaceuticals Inc. for $2.2 billion in cash and stock, offering $28.10 per share at a 40 percent premium to Auxilium's average closing price over the previous 30 days, Endo said.
New York’s lawsuit this week accusing Actavis PLC and Forest Laboratories LLC of discontinuing a popular dementia drug’s original version in order to switch patients to a newer version with extended patent protection will be a major test of whether that strategy of "product hopping” is anti-competitive, attorneys say.
Computer Sciences Corp. subsidiary DynPort Vaccine Co., which develops vaccines for the military, sued Lonza Biologics Inc. in Maryland federal court Monday, alleging the company backed out of a subcontract to manufacture a vaccine and made off with $18.9 million.
Boston Scientific Corp. will face a trial in a doctor's suit seeking royalties under a license agreement for coronary stent patents, since the Federal Circuit on Tuesday refused to consider the company's interlocutory appeal of a decision keeping the case alive after the patents were canceled in re-examination.
One of Florida's leading plant growers on Monday formally challenged the state Department of Health's proposed rules for selecting official medical marijuana dispensers, saying several provisions, including a lottery to choose among qualified applicants, do not comply with the law passed earlier this year.
Magna-Rx Inc. was slapped with a proposed class action Monday in California federal court alleging that the labeling on its male strength and performance enhancement supplement misleads consumers by implying it is an effective aphrodisiac.
Shire LLC has fired off a lawsuit against CorePharma LLC in New Jersey federal court, alleging the company will infringe a pair of patents that cover its widely used attention deficit drug Adderall XL by selling a generic version.
Defense contractor Siga Technologies Inc. filed for bankruptcy in New York court Tuesday, saying a potential $232 million judgment owed to rival PharmAthene Inc. stemming from a failed merger and subsequent licensing litigation would hamper its ability to manufacture smallpox drug Tecovirimat for the nation's stockpile.
This week is off to an auspicious start after deal makers introduced a slew of multibillion-dollar transactions that fan out over a range of industries, proving the summer lull is officially over and M&A prospects remain solid heading into fall.
Novartis Pharmaceuticals Corp. hit Roxane Laboratories Inc. with a patent infringement suit in Delaware federal court Tuesday in an effort to block a generic version of Zortress, a medication used to treat organ transplant recipients.
Teva Pharmaceuticals USA Inc. has urged the U.S. Supreme Court to ignore Sandoz Inc. and Mylan Inc.'s argument to uphold a ruling that found several patents for Teva's multiple sclerosis drug Copaxone invalid, saying that the Federal Circuit’s practice of reviewing claim constructions fresh on appeal is incorrect.
Allergan Inc. has settled pending litigation in Delaware with suitors Valeant Pharmaceuticals International Inc. and activist investor Bill Ackman, and agreed to hold a meeting on Dec. 18 for its shareholders to vote on a controversial board overhaul plan, the parties confirmed Tuesday.
The New York attorney general hit Actavis PLC with an antitrust suit in New York federal court Monday to stop the pharmaceutical company from halting sales of its widely used dementia drug Namenda and forcing patients to switch medications all in an effort to eliminate competition.
The pelvic mesh trial that unleashed a $73 million verdict against Boston Scientific Corp. stood out in one crucial way from two similar bellwethers won by the device maker: It dredged up an internal company email about a study advising doctors not to use its Obtryx sling device, just the sort of internal communication attorneys say can drastically sway a jury.
A Florida federal judge ruled Monday that she had no authority under the Stark Law or the Anti-Kickback Statute to issue a permanent injunction preventing Millennium Laboratories Inc. from giving doctors free drug-test cups, a practice for which it was hit with a $15 million jury verdict last June.
Drugmakers Teva Pharmaceutical Industries Ltd. and AstraZeneca PLC on Friday asked a Massachusetts federal judge to bar a pharmaceutical expert from testifying at an upcoming pay-for-delay antitrust class action trial over Nexium, saying the witness' calculation of reasonable royalty rates was unreliable.
The New Jersey Supreme Court has approved the transfer of a half-dozen mass tort cases against Johnson & Johnson, Merck & Co. Inc. and other drug and medical device makers out of Atlantic County, according to a letter sent on Monday to attorneys involved in the suits.
The Federal Circuit on Friday refused to reconsider its decision to lift an injunction on generic versions of Allergan Inc.'s eyelash growth stimulant Latisse after previously ruling that two patents covering the drug were obvious in light of prior art.
A Canadian and Israeli businessman was cleared Monday of charges relating to allegations that his online payment processing company was tied to a scheme to sell invalid prescription drugs through an Internet pharmacy, after a California federal judge vacated his guilty plea.
Since the U.S. Supreme Court issued Nautilus Inc. v. Biosig Instruments Inc. and adopted the new “reasonable certainty” standard for finding patent claim terms indefinite, courts have found the vast majority of claim terms to be sufficiently definite — whether viewed on a case-by-case or term-by-term basis, the vast majority of indefiniteness challenges have failed, say attorneys at Hiscock & Barclay LLP.
The U.S. Supreme Court’s replacement of a “rigid” circuit court rule in Highmark Inc. v. Allcare Health Management System Inc. and Octane Fitness LLC v. Icon Health & Fitness Inc. with a more flexible standard has ample precedent, thus although fee-shifting awards as an equitable remedy should still be the exception we anticipate their frequency to increase, say attorneys at Wilson Sonsini Goodrich & Rosati PC.
Given the price of defeat and the strength of the government’s evidence, why didn’t former Virginia Governor Robert McDonnell plead guilty when he had the chance? There are three common reasons why white collar criminal defendants choose to fight instead of admit guilt, says Daniel Suleiman, special counsel at Covington & Burling LLP and a former senior official in the U.S. Department of Justice Criminal Division.
A recent Law360 article about the perennial BigLaw concern over how to recruit and retain female and ethnically diverse attorneys addressed a new approach being taken by some law firms — going beyond traditional mentoring programs by creating a sponsorship relationship. Pro bono can also play a part, say David Lash and Merle Vaughn of the Association of Pro Bono Counsel.
In the recent Adderall XR case, a Second Circuit panel ruled that an alleged monopolist patent-holding drug manufacturer’s alleged breach of an agreement to supply a patented drug to competing manufacturers did not violate the Sherman Act. This decision provides yet another illustration of the limits of the U.S. Supreme Court's decision in Aspen Skiing, say John Elliott and Irving Scher of Greenberg Traurig LLP.
For a law firm, excess time dedicated to legal research generates waste, either in the form of artificially reduced billable hours or, particularly in flat or contingency fee projects, as overhead eroding the profitability of legal work. By measuring five factors, firms will begin to understand their own opportunities for improving profits, says David Houlihan of Blue Hill Research Inc.
The Federal Trade Commission’s complaint in FTC v. AbbVie Inc. marks a key development because it is the first FTC reverse-payment case to be filed in the wake of Actavis. It also represents a departure from the FTC’s approach in these cases in that it alleges that the underlying patent infringement litigation was baseless and motivated by anti-competitive purposes, say attorneys with Skadden Arps Slate Meagher & Flom LLP.
The Federal Circuit's recent decision in Align Technology Inc. v. U.S. International Trade Commission highlights a loophole in current ITC rules — limitations on the ITC’s ability to review the denial of summary determination motions on threshold issues — that the commission is likely to consider closing, says Christopher May of McDermott Will & Emery LLP.
Each lawyer's practice is a self-run business, even within the platform of a firm, and yet the level of entrepreneurialism within the practice of law is oftentimes marginalized, says legal industry business development specialist Jenn Topper.
The Second Circuit's decision in Merck Eprova AG v. Gnosis SPA may ease some plaintiffs’ evidentiary burdens with respect to proving liability and recovering damages and auger an increase in Lanham Act false advertising suits, say attorneys at Kramer Levin Naftalis & Frankel LLP.