BIO Chimes In: TC Heartland LLC v. Kraft Food Brands Group LLC (Supreme Court)

This is part two of a three part series on BIO’s recently submitted amicus briefs in cases before the Supreme Court as well as the U.S. Court of Appeals for the Federal Circuit.

Spring kicked off yesterday, and with it was the beginning of the confirmation process for U.S. Supreme Court nominee Judge Neil M. Gorsuch. Empty seat or not, SCOTUS has a full plate of decisions to reach this term, patent cases among them.

We’ve already talked about BIO’s position on Impression Products v. Lexmark International (oral arguments begin today), so let’s take a look at another important patent case headed to the Supreme Court next week.

At issue in this case is the determination of venue for patentees and the interpretation of Congress’s venue statute. The court is being asked “whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) limits the venue of patent cases to 1) the judicial district where he defendant resides, or 2) where the defendant has committed acts of infringement and has a regular and established place of business.

28 U.S.C. § 1391(c) broadens the definition of residence for venue to be any judicial district where the defendant is subject to the court’s personal jurisdiction. Since patent defendants are generally subject to nationwide personal jurisdiction, venue would be in any jurisdiction.

Given the broad interpretation of 28 U.S.C. § 1391(c), there has been a significant concentration of patent-infringement suits in the Eastern District of Texas, where more than 40% of patent cases are litigated.

BIO and the Association of University Technology Managers (AUTM) submitted an amicus brief supporting Kraft Food Group (the respondent).

In the brief, BIO argues that while it is not good for the patent system to have a concentration of patent cases come up through a single district, “attempting to resolve [these] issues through this case would do significantly more harm than good.”

If the Supreme Court decides in favor of TC Heartland, the venue regime that prevailed prior to 1988 would return, severely inconveniencing patent owners (particularly small businesses) and increase the amount of patent litigation, “forcing patent holders to brin related claims in multiple separate actions, and would skew litigation in favor of accused infringers.”

BIO’s brief further argues that Congressional reform efforts have “recognized the importance of including venue options tied to locations where the patent owner is or was engaged in activities related to the patent.”

BIO and AUTM argue that reform efforts to combat issues with patent venue should be left to Congress, “rather than legislating an obsolete approach to venue that Congress has not endorsed.”

Oral arguments in this case will take place next Monday, March 27, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , ,

BIO Chimes In: TC Heartland LLC v. Kraft Food Brands Group LLC (Supreme Court)

This is part two of a three part series on BIO’s recently submitted amicus briefs in cases before the Supreme Court as well as the U.S. Court of Appeals for the Federal Circuit.

Spring kicked off yesterday, and with it was the beginning of the confirmation process for U.S. Supreme Court nominee Judge Neil M. Gorsuch. Empty seat or not, SCOTUS has a full plate of decisions to reach this term, patent cases among them.

We’ve already talked about BIO’s position on Impression Products v. Lexmark International (oral arguments begin today), so let’s take a look at another important patent case headed to the Supreme Court next week.

At issue in this case is the determination of venue for patentees and the interpretation of Congress’s venue statute. The court is being asked “whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) limits the venue of patent cases to 1) the judicial district where he defendant resides, or 2) where the defendant has committed acts of infringement and has a regular and established place of business.

28 U.S.C. § 1391(c) broadens the definition of residence for venue to be any judicial district where the defendant is subject to the court’s personal jurisdiction. Since patent defendants are generally subject to nationwide personal jurisdiction, venue would be in any jurisdiction.

Given the broad interpretation of 28 U.S.C. § 1391(c), there has been a significant concentration of patent-infringement suits in the Eastern District of Texas, where more than 40% of patent cases are litigated.

BIO and the Association of University Technology Managers (AUTM) submitted an amicus brief supporting Kraft Food Group (the respondent).

In the brief, BIO argues that while it is not good for the patent system to have a concentration of patent cases come up through a single district, “attempting to resolve [these] issues through this case would do significantly more harm than good.”

If the Supreme Court decides in favor of TC Heartland, the venue regime that prevailed prior to 1988 would return, severely inconveniencing patent owners (particularly small businesses) and increase the amount of patent litigation, “forcing patent holders to brin related claims in multiple separate actions, and would skew litigation in favor of accused infringers.”

BIO’s brief further argues that Congressional reform efforts have “recognized the importance of including venue options tied to locations where the patent owner is or was engaged in activities related to the patent.”

BIO and AUTM argue that reform efforts to combat issues with patent venue should be left to Congress, “rather than legislating an obsolete approach to venue that Congress has not endorsed.”

Oral arguments in this case will take place next Monday, March 27, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , ,

Four Former FDA Commissioners Warn About Drug Importation Dangers

Last week, four former FDA Commissioners – Robert M. Califf, Margaret B. Hamburg, Mark B. McClellan, and Andrew Von Eschenbach – wrote an open letter to members of Congress warning them about the risk of legalizing importation of drugs. The Washington Post outlines how these former FDA heads – who served in both Democrat and Republican administrations – advise against proposals to expose U.S. consumers to foreign medicines. The Commissioners write that a broad-based importation scheme would:

Harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.

Robert Califf, in an interview with the Post, expressed concern that consumers would have no dependable way of knowing where drugs are coming from, what’s in them, or their safety overall. The letter warns that:

Global experience confirms that illicit, ineffective, or adulterated products are readily available on the open market and represent one of the most lucrative avenues of organized crime.

If the FDA were required to oversee this process, as proposed, a significant regulatory oversight system would be required. The former Commissioners question the likelihood of the agency getting the resources it would need to fulfill such a monumental task:

Obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.

Studies on importation have forecasted the effects on access and savings in the U.S. to be small – potentially too small to ever reach the patient. The Commissioners write:

Any improved access and cost savings resulting from importation are likely to be minimal. Studies examining this issue have estimated that importation would likely have only a small, incremental effect on cost and access for drugs in the U.S. market; further, these small savings might not be passed on to patients, even if consumers are able to obtain a legitimate imported drug.

The letter also notes:

The current U.S. drug distribution system, as overseen by the FDA, ensures good manufacturing practices and the quality and security of an increasingly complex supply chain.

Read the full letter here.