A Scheme For Maximizing The Benefits Available Under The Patent Prosecution Highway (PPH)

Posted on March 1, 2011 by Warren Woessner

This post is from Mark Horsburgh of Fisher Adams Kelly in Australia.

Summary

  • File in Australia first;
  • Request expedited examination (report issues within 3 months);
  • Address objections and obtain acceptance;
  • File in USA and request entry to PPH (faster and fewer office actions);
  • File PCT designating EPO as ISA;
  • Amend claims for best possible prosecution based on results from AU, US and EP.

Explanation

The PPH aims to accelerate examination in an office of second filing (OSF) based on the outcome of examination in an office of first filing (OFF). To take maximum advantage of PPH an allowance should be obtained as early as possible in the OFF and then a request to use the PPH made in the OSF, together with a claim table showing correlation between the OSF claims and the allowed claims.

The PPH has best advantage when a quick allowance is possible in the OFF. Australia affords this opportunity through the expedited examination procedure. At the time of filing an Australian patent application it is permissible to voluntarily request examination and pay the examination fee. At the same time the examination can be expedited by a request with a simple justifying reason. A suitable reason may be, “The Applicant is entering a competitive market and seeks early determination of validity”. If expedited examination is granted (and it almost always is) an examination report will issue within three months. A diligent and comprehensive response can lead to allowance of the application within 6 months of filing.

Once allowance is obtained a corresponding application can be made in USA together with a request to use the PPH. The main requirement is that the claims in the US application correlate with the allowed claims from Australia. Statistics show that the first office action on a PPH case issues up to a year earlier than a non-PPH cases and on average a PPH case receives about one less office action than a non-PPH case.

If the Applicant is seeking protection in a number of countries it is sensible to use the PCT system. The PCT application could designate the EPO as the searching authority, thus providing a third independent view on the validity of the claims. Article 34 claim amendments can be made to obtain a clear IPRP. This would virtually guarantee the patent issuing in Europe, together with the patent having issued in Australia and probably being close to issuance in USA. With this level of testing of the claims it can be reasonably expected that the claims are valid and likely to be defendable in any court action.

Posted in Non-U.S. Practice | Tagged , , , , , , , , , , | Leave a comment

Centocor v. Abbott: Fed. Cir. Takes New Written Description Requirement Out For A Spin.

Posted on February 25, 2011 by Warren Woessner

In an important post-Ariad decision, the Federal Circuit reversed a district court decision that Abbott’s Humira infringed claims of a Centocor patent that could have cost Abbott $1.67 billion in damages. (A copy of the decision is at the end of this post.) Humira is a fully-humanized antibody against TNF-alpha. While Centocor obtained U.S. Pat. No. 7,070,775 (a copy is available below), that contained claims to such antibodies, it needed to be able to assert the priority of an earlier application in a long chain of CIP filings, in order to pre-date the filing date of Abbott’s patent covering the product. Applying the Ariad v. Lilly written description requirement standards, the Fed. Cir. panel denied Centocor priority, essentially finding no adequate description of a completely humanized antibody in the priority document and thus no description adequate to support the later-issued claims.

Although a number of commentators have already written on this decision, two aspects stand out as deserving attention. The first is how the “new” written description requirement is being used as an “easy button” by the Fed. Cir. to dispose of what, in some cases, are pioneering biotech patents that issue with broad claims. (Apart from Ariad, think back to U. of Rochester v. Searle or even to UC v. Lilly itself). No need to resolve messy and complex factual issues involving enablement issues when, as Judge Prost put it, “A patent also can be held invalid for failure to meet the written description requirement based solely on the face of the patent specification [citing, U of Rochester v. G.D. Searle]…Ultimately, ‘the specification must describe an invention understandable to [a POSA] and show that the inventor actually invented the invention claimed [citing UC v. Lilly].’”

Continue reading →

Posted in Written Description Requirements (WDR) | Tagged , , , , , , , , | Leave a comment

Mumbo Jumbo: The Patentability of Biological Materials In Australia

Posted on February 25, 2011 by Warren Woessner

From Vaughn Barlow of Pizzeys Patent and Trade Mark Attorneys.

1. Introduction

The Patent Amendment (Human Genes and Biological Materials) Bill (2010) is currently being debated before the Australian parliament. The Bill seeks to ban the patenting of all biological material that is “identical or substantially identical to such materials as they exist in nature”. If passed, this legislation would represent a major shift in Australian patent law. It may also significantly jeopardize the biotechnology, pharmaceutical, medical and agricultural industries in Australia.  This article therefore examines the current patentability of biological materials in Australia, charts the evolution of public debate surrounding this issue, sets out the proposed ban on patentable subject matter, and briefly discusses the ramifications of such a ban.

You can download the entire article here.

Patentability of biological materials in AU FINAL VPB

Posted in Non-U.S. Practice | Tagged , , , , , , , , , , , | Leave a comment

AUTM Panel To Address A “Myriad” Of Challenges

Posted on February 24, 2011 by Warren Woessner

Robert S. MacWright, J.D., Ph.D., the new head of tech transfer at the Salk Institute, will moderate a panel at the 2011 Annual Meeting of the Association of University Technology Managers (AUTM) on March 1st in Las Vegas.  The panel, entitled, “The Ever Changing Kaleidoscope of U.S. Patent Law,” will examine what MacWright terms “a decade of meddling by the legislature and the courts.” The “panel of experts” – that will include, Sandra Kuzmich of Frommer Lawrence, Gonzalo Merino, J.D., Ph.D., of Columbia and me – will review the current state of affairs and “with considerable risk of error, [we] will also make predictions about other changes that may lie ahead.”

Apart from encouraging you to attend this session (Tuesday, D1 on the program), the trend of judicial decisions at all levels to weaken patent protection for pharma/biotech inventions is alarming. The big losses like KSR (which eliminated the rigorous TSM test for obviousness), Merck v. Integra (expanded safe harbor for drug research), Ariad (“Yes, Virginia, Section 112 does contain a written description requirement”), and Myriad (No patent protection for DNA or for diagnostics used in personalized medicine) have tended to overshadow smaller but still significant anti-patent decisions like In re Kubin (Deuel reversed), In re Fisher (ESTs and SNPs lack utility) and In re Alonso (good-bye to the “monoclonal antibody exception”).

The Federal Circuit’s holding in Prometheus v. Mayo was one of the few bright spots (methods of screening for drug efficacy and medical treatment are patentable – yea!) but even this decision may be reviewed by the  Supreme Court – again (it granted cert. once). And while it is difficult to see the Supreme Court’s Bilski decision as a good thing, at least an entire category of patentable subject matter was not eliminated. If the “M or T” test had been affirmed, the Federal Circuit would have been required to invalidate most of the Myraid diagnosis claims. Now Judge Rader has to figure out how to support a holding that the Myriad “comparing DNA sequence” claims are less abstract than Bilski’s claims to hedging commodity risk. And he is the judge that the ACLU is trying to recuse as prejudiced in favor of biotech! It’s going to be an interesting year.

Posted in Patent Eligible Subject Matter | Tagged , , , , , , , , , , , , , , , , | Leave a comment