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No intellectual property rights impact society more forcefully than patents on pharmaceuticals. But as a practical matter, only a handful of jurists resolve disputes involving them. Two neighboring federal districts, Delaware and New Jersey, adjudicate the vast majority of patent contests between brand-name drug companies and generic manufacturers. And in contrast to Eastern Texas, which has been persistently derided as a renegade jurisdiction, the authority of the mid-Atlantic courts has seldom been questioned. The complex workings of the Hatch-Waxman Act, the compromise legislation that governs pharmaceutical patent litigation, go a long way to explaining such distinct shareholder reactions to highly similar judicial behaviors. Yet the dominance of Delaware and New Jersey in pharmaceutical patent litigation may have come to an end. A recent decision of the U.S. Court of Appeals for the Federal Circuit, Valeant v. Mylan, has narrowed the rules for venue in Hatch-Waxman cases. We are now poised to see multiple, parallel trials involving the same patented pharmaceutical proceeding in courts across the country. The new order of pharmaceutical patent litigation affords an opportunity to reconsider an intellectual property environment that aims to promote pharmaceutical innovation but also increase public access to medications. Venue determinations are puzzling in pharmaceutical patent cases due to a concept originating within the Hatch-Waxman Act, the tort of "artificial" infringement. Artificial infringement occurs when a manufacturer petitions the federal government to obtain permission to market a generic drug. But the federal government both issues patents, and awards regulatory approval to sell a drug, with effect across the entire nation. Congress gave no thought towards situating artificial infringement at a certain place, and judicial efforts to do so have amounted to a facile and strained exercise. Venue is not artificial infringement's only problem. Artificial infringement also creates disconnects with personal jurisdiction principles, incorporates obsolete remedial provisions, and fails to comply with the international commitments of the United States. Courts should instead recognize their authority to accept declaratory judgment actions to resolve pharmaceutical patent infringement cases, with legislative abolition of artificial infringement presenting another, preferred possibility. [ABSTRACT FROM AUTHOR]

Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. Yet prior scholarship has seldom acknowledged current statutory mechanisms to improve the notice function of patents after they issue. This Article endeavors to fill that gap. Congress has long encouraged intellectual property rights holders to identify their patents on the products they sell. Patent marking has traditionally occurred on physical products or their packaging, although it has been recently extended to Internet-based virtual marking. The marking statute stipulates that patent proprietors that fail to mark face severe remedial restrictions when challenging infringers. Congress has assigned the Food & Drug Administration (FDA) a part in providing patent notice as well. In keeping with federal legislation, the agency maintains two publications, commonly known as the Orange and Purple Books, that act as a patent clearinghouse for approved drugs and licensed biologics. The role of a patent within the marketplace provides perhaps the most valuable form of notice that that instrument may offer. Yet the marking statute and FDA publications suffer from some apparent flaws. In combination they project a failure to identify all patents that are relevant to the product, favor patent trolls, involve dubious practical workings, promote misleading advertising, and impose punitive sanctions in comparison to the notice requirements of peer intellectual property rights. For its part, the FDA has proven an untutored and unreliable patent publicist for the past four decades. This Article offers specific suggestions to improve the notice functions of patents after they issue. It calls for the USPTO to develop and populate its own virtual marking database that correlates individual patents with the marketplace. It also encourages the FDA to take further steps to counter abuses of the Orange and Purple Books and to accelerate their patent notice functions. Finally, this Article takes broader lessons from this effort, offering pathways for policymakers to look beyond the patent instrument as they endeavor to improve the patent system's notice functions. [ABSTRACT FROM AUTHOR]

Claim drafters tend to thwart congressional intent and judicial reasoning by skillful claim drafting linking the scope of proprietary patent rights with the format of the claim. and the format of a patent claim should play a significant part in determining the proprietor's substantive rights. The courts should use phenomenological techniques in determining whether the ontic dimension of a technology lies in technique or artifact. Nonobviousness should also be a requirement for patentability, and this would be an additional reason to reject Beauregard-style claims.

The force of the contemporary patent instrument cannot be confined to the territorial setting of its origin. Although issued exclusively by individual national or regional patent offices, the information these [...]