Generic Drugs Manufacturers

News & Analysis as of

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

BioPharma Patents Quick Tips & News – July 2016

U.S. FDA Orange Book Refresher Edition - What types of patents can be listed on the FDA’s Orange Book? Listable = Pharmaceutical-related patents are allowed in the FDA’s Orange Book only if they’re “composition” or...more

Lowered Risk for Inventors Who Use Contract Product Development or Manufacturing

On July 11, in The Medicines Company v. Hospira, Inc., the Federal Circuit held that a contract manufacturer's sale of manufacturing services to an inventor did not constitute a commercial sale of the patented invention for...more

FDA Offers Draft Guidance for Generic Drug Label Updates

In July 2016, the U.S. Food and Drug Administration (FDA) published draft guidance outlining when drug companies should update a generic drug’s label after the brand name drug on which the generic is based has been withdrawn...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more

Senators Introduce the CREATES Act

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more

Calif. Asks Innovator Drug Brands to Do the Impossible

Eight years ago, in Conte v. Wyeth, the California Court of Appeals shocked brand prescription drug manufacturers when it held that they could be liable for injuries caused by generic versions of their medications — an...more

Breaking News – California Supreme Court To Consider Innovator Liability

We’ve always hated Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), and the whole concept of innovator liability (imposing liability on the original innovator drug manufacturer for injuries allegedly caused by a generic...more

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Generic vs. Branded Liability: Mensing Holds Sway Until FDA Completes Rulemaking

FDA’s delay on the final version of generic labelling rules until April 2017 means both branded and generic drug manufacturers face continued uncertainty. The U.S. Food and Drug Administration (FDA) recently announced it...more

EU Parliament Takes Steps to Increase Manufacture and Export of European Generics and Biosimilars During Protected Period

The Committee on Internal Market and Consumer Protection of the European Parliament has adopted its report on the “Single Market Strategy” – a strategy that aims to consolidate industries in European countries under one...more

Are Drug Prices Really Too High?

Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning: - By even greater force of logic; even more so it follows. We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567...more

TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really...more

FDA Biosimilars Guidance Not Conducive To Preemption

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for...more

Another Outlier From California On Innovator Liability

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in...more

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school. Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at...more

Alabama No Longer An Outlier State: Legislature Says “No” To Innovator Liability

I. Introduction - Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic...more

Contract Manufacturing Makes Angiomax Patents Invalid Under On Sale Bar

In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more

Antitrust Update: The Aggressive Global Enforcement Network

Companies face lots of risks – the soup du jour has been anti-corruption enforcement and compliance. Like any consistent restaurant you might visit regularly, one risk continues to grow, quietly and significantly –...more

Alabama Governor Signs Bill Quashing Innovator Liability Claims

On May 1, 2015, Alabama Governor Robert Bentley signed SB80, which expressly bars liability claims against manufacturers that did not design or make the product that a plaintiff actually ingested or used. While at first...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

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