Patent Law Practice Center

Implementing the Biologics Price Competition and Innovation Act?

Alexandra McTague, of DLA Piper, sent in this article discussing whether the final rules the FDA implements for follow-on biologics will actually end the debate surrounding the Biologics Price Competition and Innovation ACT (BPCIA).

The vigorous debate over the Biologics Price Competition and Innovation Act (BPCIA), which aims to provide an expedited approval framework for follow-on biologics, will likely inform the final rules the FDA implements, and those rules will determine the business strategies of innovator companies and the extent to which generic companies use the BPCIA.

Biosimilars vs. interchangeable biologics

Under the BPCIA, generic biologics can be characterized as “biosimilar” to or “interchangeable” with innovator products. Both require clinical studies for approval, with interchangeability requiring a higher showing. Only those follow-on biologics designated as “interchangeable” can be automatically substituted by a pharmacy for the innovator’s product. As a result, generic companies will have to market biosimilars to boost prescriptions and sales. Thus, when seeking approval, generic companies will weigh the cost of marketing biosimilars against the cost of the yet-to-be-determined clinical testing requirements for interchangeables. If those requirements are too onerous, the generic company may instead choose to pursue a Biologic License Application (BLA), which has the benefit of circumventing the innovator company’s marketing exclusivity. (more…)

Birch Stewart on the McKesson Tech v. Epic Systems Decision

Leonard R. Svensson, Partner at Birch Stewart Kolasch & Birch, sent in this post discussing the recent McKesson Technologis v. Epic Systems decision and how it may impact those in the medical diagnostic or treatment fields.

On April 12^th the Federal Circuit issued another decision related to joint infringement situations. This should be another warning to those drafting method claims, particularly in the medical diagnostic or treatment fields. The decision perhaps also portends a future en banc review of the issue. This follows the pattern of several decisions discussed by my partner, Jerry Murphy (Practice Center Contributor), and I at PLI’s 5th Annual Patent Law Institute during our lecture on Federal Circuit decisions in 2010 in the life sciences field.  (Click on the link to view Mr. Svensson and Mr. Murphy’s presentation “All Things Chemical & Biotechnical At The PTO“).

In the April 12^th case of McKesson Technologies v. Epic Systems, the patent owner McKesson tried to enforce a patent on a method of electronically communicating between health care providers and patients. Epic Systems developed software and licensed it to heath care providers who used the software to communicate with patients. But since the steps of the method claims were performed by a combination of the patients and the health care providers, the Federal Circuit agreed with the District Court’s finding on summary judgment of no infringement by Epic Systems. (more…)

AMP v. U.S.P.T.O.: Oral Argument at the Federal Circuit

Yesterday, the much anticipated oral argument in the AMP v. USPTO aka the Myriad Case took place at the Court of Appeals for the Federal Circuit.  Fortunately for us, Ryan B. Chirnomas, Partner at Westerman, Hattori, Daniels & Adrian attended the argument and has passed along this article summarizing the day’s events.

On April 4, 2011, the Appellant, Appellee and the U.S. Government presented oral argument before the Court of Appeals for the Federal Circuit in AMP v. USPTO, which deals with gene patenting.  The parties in this case are the Association for Molecular Pathology, along with many other medical organizations, doctors and patients on one side, and the U.S.P.T.O., Myriad Genetics, Inc., and the University of Utah Research Foundation on the other side.  Many amicus briefs have been filed as well.  The argument was heard by a panel consisting of Judges Bryson, Lourie and Moore, and was attended by approximately 200 people.   Due to the complexity of the subject matter and the presence of Government, the Court granted each side approximately 30 minutes of argument, instead of the usual 15 minutes.

Interestingly, although the parties seemed eager to discuss the merits, approximately half of the time for the Appellant and Appellee was spent discussing the issue of jurisdiction and standing.  In particular, Judge Moore seemed very interested in this issue.  The Appellants, led by Myriad, argued that there was no immediate controversy between the parties, since Myriad had not contacted any of the parties in over ten years.  However, Judge Moore questioned whether those parties previously threatened by Myriad were still refraining from making and using the claimed subject matter due to a continuing fear of litigation over the past decade.  (more…)

Centocor v. Abbott Labs: When Is A Biotech Invention Complete And Ready For Filing?

The following post was written by Gerald M. Murphy, Partner at Birch, Stewart, Kolasch & Birch, LLP and Practice Center Contributor.

On February 23, 2011, the Court of Appeals for the Federal Circuit in Centocor v. Abbott Labs set aside a $1.7 billion jury verdict in favor of the patentee (Centocor) and held the patent claims at issue were invalid for lack of written description.  This decision reflects a trend of the Federal Circuit in recent years to invalidate patents for lack of written description and offers little guidance as to what is necessary to actually comply with the written description requirements. This case dealt with a somewhat “unpredictable” biotech invention, where there was not an actual reduction to practice of the claimed invention.  In the pharmaceutical fields, it is very common to have method claims directed to treatment of humans and it is very unusual to have had an actual reduction to practice of the method prior to filing the patent application.  However, in this case, the claims were not directed to a method of use, but rather, a new product (antibody).  Based on this and other cases, it appears that the trend of finding lack of written description may become more common in so-called “predictable technologies.” (more…)

The Gold Seal of Ownership: Stanford v. Roche and Ownership of Federally Funded Research

Mary Hess Eliason, an Associate of Birch, Stewart, Kolasch an Birch, sent in this article she wrote discussing the Stanford v. Roche case.  Eliason highlights the issues being brought before the Supreme Court and the possible effects of this case if Stanford prevails.

When an invention is conceived, it is generally presumed to be owned by the inventor under U.S. patent law. [1] The case of Stanford v. Roche demonstrates that this may not be true in the context of federally funded research.  The issue being brought before the Supreme Court is whether, in the context of federally funded research, the ownership of the invention first arises with the federal contractor (i.e., Stanford) or with the inventor under the Bayh-Dole Act 35 U.S.C. §§ 200-212 and whether the inventor can interfere with that right by assigning the invention to a third party.[2]                                                    

The facts of Stanford v. Roche show a commonly occurring relationship between inventors, research institutions and collaborators, especially in the biotechnological field. [3]In 1988, inventor Holodniy joined a laboratory at Stanford University as a research fellow.  Upon joining the laboratory, Holodniy signed an agreement stating “I agree to assignor confirm in writing to Stanford . . . right, title and interest in . . . such inventions as required by Contracts or Grants”.  (more…)