News & Analysis as of

Pharmaceutical Industry

Shortage of Relief: Recent Disasters Highlight Multifaceted Drug Shortage Problem

by Holland & Knight LLP on

• Nearly a month after Hurricane Maria swept through Puerto Rico, roughly 80 percent of the U.S. territory is still without electrical power. • The island is home to multiple drug manufacturing facilities that are directly...more

Reaping the Jurisdictional Whirlwind

by Reed Smith on

Literally for decades plaintiffs in mass torts have employed the business model of flooding jurisdictions seen as friendly to them with more solicited plaintiffs than any court system can possibly handle. They have employed...more

[Webinar] Selected Issues Impacting Biopharma and Medical Device Patent Post-Grant Review Proceedings - November 9th, 12:00pm CT

by Brinks Gilson & Lione on

Join members of Brinks Gilson & Lione's Post-Grant Patent and Medical Device practice groups as they present the webinar, "Selected Issues Impacting Biopharma and Medical Device Patent Post-Grant Review Proceedings." Some of...more

Missouri Appeals Court Vacates $72 Million Verdict For Lack Of Personal Jurisdiction

by Rumberger Kirk & Caldwell on

In a significant defense win applying recent U.S. Supreme Court precedent, a Missouri appeals court reversed and vacated a $72 million judgment for lack of personal jurisdiction. Estate of Jacqueline Fox v. Johnson & Johnson,...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Allegan’s Restasis Patents Invalidated By A Federal District Court Even After Transfer To Native American Tribe And Sovereign...

by Weintraub Tobin on

In Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al, Case No. 2:15-cv-1455-WCB (EDTX October 16, 2017 Order), a Federal District Court recently invalidated several patents covering Allergan’s dry-eye drug Restasis. The...more

FDA Approves Companion Dx for PD-1 Inhibitor

by Foley & Lardner LLP on

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung...more

Pro Te: Solutio - Vol. 10 No. 3 – Summer 2017

by Butler Snow LLP on

Every summer vacation (or, at least, the ability to take the weekend off!) should include a good read. Whether your preference runs toward a memoir with words of wisdom, a review of new technical advancements, issues of...more

Compulsory Licensing of Biopharmaceutical Inventions

Very few topics in international intellectual property have been as controversial as compulsory licenses. While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets minimum standards for...more

Uncle Sam should be wary in partnering with Big Pharma on cancer treatments

Is Uncle Sam launching a way to speed and improve cancer treatments so they get to patients sooner—or is Big Pharma about to fleece taxpayers, yet again? The National Institutes of Health should carefully consider its just...more

Product Liability Update: October 2017

by Foley Hoag LLP on

Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more

Senators and court complain of ‘anti-competitive’ transfer of patent rights to American Indian tribe

We have previously discussed antitrust implications of pharmaceutical companies’ efforts to maximize patent protection for their drugs. Consumers and generic drug makers, for instance, have alleged antitrust violations based...more

The Federal Circuit Explains Admissibility of Post-Priority Date Evidence Regarding Written Description and Enablement Proofs

by Locke Lord LLP on

Is post-priority date evidence admissible as relevant to determining whether a patentee has complied with the written description requirement? What about for enablement? Recently, the Federal Circuit answered those...more

Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits

by Reed Smith on

If you want to insult and annoy someone, consider suing them under the Racketeering Influenced and Corrupt Organizations Act, 18 U.S.C. section 1964. That law is charmingly known as RICO, in an allusion to the big bad in the...more

Intas Launches Bevatas (bevacizumab) in India

by Goodwin on

Intas, an Indian pharmaceutical company based in Ahmedabad, has launched BEVATAS (bevacizumab), a biosimilar to Roche’s AVASTIN, in India. Bevacizumab is used to treat colorectal cancer, ovarian cancer, cervical cancer, lung...more

Alert: China Issues New Policy for Drug and Medical Device Approvals

by Cooley LLP on

On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect

by Arnall Golden Gregory LLP on

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back...more

Patents for Billion Dollar Restasis Drug Under Siege

Using an innovative strategy, pharmaceutical company Allergan recently transferred the patents associated with the eye drug, Restasis, to the Saint Regis Mohawk Tribe, in exchange for an exclusive license back. The tribe...more

District Court Allows Mohawk Tribe to Join ANDA Litigation, Finds Patents at Issue Invalid

In something of an anticlimax, Federal Circuit Judge William Bryson, sitting by designation on the bench of the U.S. District Court for the Eastern District of Texas, granted Allergan's motion to join the St. Regis Mohawk...more

Upcoming FTC Workshop: Understanding Competition in Prescription Drug Markets

by Goodwin on

The Federal Trade Commission (FTC) is hosting a workshop on November 8, 2017 at the Constitution Center in Washington, DC entitled: “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” ...more

U.S. watchdogs tally $1.5 billion cost for one type of defective medical device

Big medical device makers, like Big Pharma, have complained Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents...more

California Enacts Bill on Drug Pricing Transparency

by Ropes & Gray LLP on

On October 9, 2017, California Governor Jerry Brown (D) signed into law what may be the most comprehensive prescription drug pricing transparency bill in the country. The bill, SB-17, is intended to foster transparency in...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

by Hogan Lovells on

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more

Judge Andrews Finds Plaintiff Proved Infringement Of Asserted Claims of Patents-In-Suit Following Three-Day Bench Trial In...

by Fox Rothschild LLP on

Following a three-day bench trial in the matter on June 5-7, 2017 and after having considered the entire record in the case and the applicable law, the Court, through Trial Opinion, entered by The Honorable Richard G. Andrews...more

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