PharmaPatents

Timely Insight on Emerging Legal Developments

In Re Montgomery: Inherently Therapeutic

Posted by Courtenay Brinckerhoff on Posted in 102; Federal Circuit Decisions

In In re Montgomery, the Federal Circuit addressed the issue of anticipation by inherency in the therapeutic context. This case illustrates the difficult doctrine of inherency and the potential importance of claim language—and claim construction—to an inherency analysis.Continue reading this entry

Federal Circuit Upholds Declaratory Judgment Jurisdiction Over Subsequent ANDA Litigation

Posted by Courtenay Brinckerhoff on Posted in Federal Circuit Decisions

In Dey Pharma, LP v. Sunovion Pharmaceuticals, Inc., the Federal Circuit affirmed the district court’s determination that it could exercise jurisdiction over a declaratory judgment action brought by a subsequent ANDA filer. This case follows earlier decisions in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. and Janssen Pharmaceutica, N.V. v. Apotex, Inc., which I discussed in this article, and addresses the circumstances under which a subsequent ANDA filer can bring a declaratory judgment action to challenge Orange Book listed patents when the first ANDA filer has not yet entered the market.Continue reading this entry

USPTO Announces QPIDS Pilot Program For Post-Issue Fee Information Disclosure Statements

Posted by Courtenay Brinckerhoff on Posted in Duty of Disclosure; Patent Office Practice; USPTO Proposed Rule Changes

The USPTO has announced a new pilot program to permit Applicants to obtain consideration of certain Information Disclosure Statements (IDSs) after the Issue Fee has been paid without having to reopen prosecution. The “Quick Path Information Disclosure Statement (QPIDS) Pilot Program” takes effect May 16, 2012 and will run through September 30, 2012 unless it is extended. 

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Should “Economically Significant” Inventions Be Subject To Secrecy Orders?

Posted by Courtenay Brinckerhoff on Posted in Patent Office Practice

As set forth in a Federal Register Notice issued April 20, 2012, Congress has asked the USPTO to consider whether it should take steps “to protect economically significant patents from discovery by foreign entities” by extending the current national security screening program to encompass patent applications that may be important to the “economic security” of the United States. The USPTO has asked for public input on thirteen specific questions relating to economic security-based secrecy orders and three specific questions relating to national security-based secrecy orders. Written comments should be submitted by June 19, 2012.Continue reading this entry

Public Comments Criticize USPTO’s Proposed Rules For “Routine Discovery,” “Patentee Estoppel,” and Amendments in Board Trial Proceedings

Posted by Andrew Baluch on Posted in Duty of Disclosure; Patent Reform; USPTO Proposed Rule Changes

As I previously pointed out, there are three proposed rules in the USPTO’s patent trial proceedings rules package that raise concerns and should be dropped.  Public comments on these proposed rules were due April 9-10, 2012.  Now that the public has spoken, let’s take a look at what people had to say about these three specific proposals.Continue reading this entry

Federal Circuit Sets Briefing Deadline, Oral Argument Date For Myriad Isolated DNA Case

Posted by Courtenay Brinckerhoff on Posted in 101; Federal Circuit Decisions; Personalized Medicine; Prometheus

Pursuant to the Supreme Court’s March 26, 2012 order remanding Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), the Federal Circuit has issued an order requesting supplemental briefing to be filed by June 15, 2012.  Biotechnology companies interested in the patent-eligibility of  newly discovered, biologically relevant DNA sequences (and other similar compounds) should consider filing amicus briefs to explain their views and concerns to the court.

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Help The USPTO Reduce The Paperwork Burdens Of Patent Prosecution

Posted by Courtenay Brinckerhoff on Posted in Duty of Disclosure; USPTO Proposed Rule Changes

As announced in a recent Federal Register Notice, the USPTO is soliciting public comments on its information collection requirements, in accordance with the Paperwork Reduction Act. This is an important opportunity to highlight requirements that are unnecessarily burdensome and that may go beyond requirements authorized by statute. While my main paperwork concerns relate to the IDS rules, the Notice highlights other areas where the USPTO may be underestimating the burdens of its regulations. The USPTO will consider written comments received by May 21, 2012. Continue reading this entry

Vlog: Why Prometheus Doesn’t Govern Myriad But Might Impact It Anyway

Posted by Courtenay Brinckerhoff on Posted in 101; Personalized Medicine; Prometheus

I was honored to be invited by the Washington Legal Foundation to prepare a video commentary on the recent Supreme Court decision in Prometheus and its possible impact on the Myriad isolated DNA case for their Legally Brief series.  

Here’s what I had to say:

WLF Legally Brief: Supreme Court Prometheus Patent Decision

Federal Circuit Clears Way For Generic Yasmin

Posted by Courtenay Brinckerhoff on Posted in Federal Circuit Decisions

In Bayer Schering Pharma AG v. Lupin, Ltd., the Federal Circuit upheld the district court’s determination that the Abbreviated New Drug Applications at issue did not infringe the asserted patent related to Yasmin. In particular, the Federal Circuit agreed that the FDA had not approved Yasmin for the method of use claimed in the patent, and so filing the ANDAs could not amount to infringement of the patent.

While this case is similar to Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, in that it relates to a method of use patent in the ANDA framework, it raises different issues than those decided by the Supreme Court a day after this Federal Circuit decision was issued. (Please see this article for a discussion of Caraco.)

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Supreme Court Reverses Caraco, Finds Right To Challenge Orange Book Use Code

Posted by Courtenay Brinckerhoff on Posted in Supreme Court Decisions

On April 17, 2012 the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Labs., Ltd. v. Novo Nordisk A/S, reversing the Federal Circuit decision and finding that 21 USC § 355(j)(5)(C)(ii)(I) provides a mechanism for a generic drug manufacturer to challenge the accuracy of a use code associated with an Orange Book listed patent. This decision may permit generic manufacturers to obtain earlier FDA approval for certain generic drugs, but may not solve all of the problems that can arise from an overly broad use code. Continue reading this entry