Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Federal Circuit Provides Clarity For Contract Manufacturing On-Sale Invalidity Claims
In The Medicines Company v. Hospira, Inc., App. No. 14-1469, 14-1504 (Fed. Cir. July 11, 2016) (slip op.) (en banc), the Federal Circuit provided clarity and guidance to companies that rely on contract manufacturing, holding that “to be 'on sale' under '102(b), a product must be the subject of a commercial sale or offer for sale, and that a commercial sale is one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.” Id. at 3.
The case arose in the context of Hospira's Abbreviated New Drug Application (ANDA) submissions seeking FDA approval to sell generic versions of The Medicines Company's (TMC) Angiomax', an anticoagulant used in heart surgery. In the ensuing litigation, alleging that Hospira's ANDA submissions infringed two of TMC's patents, Hospira raised several grounds of invalidity, including that TMC's inventions were sold or offered for sale before the critical date under '102(b).
TMC is a specialty pharmaceutical company that does not have its own manufacturing facilities. Therefore, it contracted with a third-party provider, Ben Venue Laboratories (Ben Venue), to manufacture commercial quantities of Angiomax'. The active pharmaceutical ingredient in Angiomax', bivalirudin, is an acidic compound that requires processing before it can be injected into patients. A potential adverse effect of the compounding process used to adjust bivalirudin's pH is the formation of certain impurities such as Asp9-bivalirudin. Id. at 4-5. In June 2005, Ben Venue manufactured a batch of bivalirudin with an Asp9 level that exceeded the FDA's allowable limit. In 2006, another batch was manufactured that again had an unacceptable level of Asp9. TMC's subsequent investigation to resolve the issue led to the development of a new compounding process. U.S. Patent Nos. 7,582,727 (the '727 patent) and 7,598,343 (the '343 patent) contain product and product-by-process claims for pharmaceutical batches of the improved drug product with a maximum Asp9 impurity level of 0.6%. The applications for the '727 and '343 patents were filed on July 27, 2008. Thus, the critical date for purposes of the on-sale bar of '102(b) is July 27, 2007. Id. at 5-6.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Stranger to the Deed Rule
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.