Patents Post Grant Blog

In a teleconference with reporters on Thursday, December 16, 2010, Commerce Secretary Gary Locke – whose department includes the Patent Office – announced that the U.S. Patent and Trademark Office will open its first-ever satellite office in Detroit in the summer of 2011.  Also during this teleconference, it was stated that Detroit will be the first in what could be a few satellite offices scattered around the country (Denver is known to be making a strong push for a satellite office).   The objective of the satellite offices is to increase retention of the examining corps, as well as to increase the number of examiners, as the Office attempts to decrease the ever-increasing backlog of pending patent applications.  According to the Associated Press, officials said Detroit was chosen because of the area’s high percentage of scientists and engineers — many with auto industry background — and the region’s major research universities. Alternatively, PTO insiders indicate that Detroit already has a Department of Commerce facility that helps sidestep congressional red tape. (besides, no point having examiners distracted by competitive baseball and football teams, works in DC after all) Read the rest of this entry »

The recently published Volume 2, Issue 2 of the journal Medical Innovation & Business focused entirely on patent reform’s potential impact on medical innovation.  Special guest editors Renee Kaswan, David Boundy, and Ron Katznelson express particular concern that patent reform will weaken the investment incentive for innovations with high development costs and low production costs, notably including medical innovations.  Numerous articles in this issue discuss the effects that proposed post-grant review might have on the value of smaller companies’ patents and therefore on the incentives to invest in such companies.

The articles in this patent reform issue of Medical Innovation & Business that are relevant to post-grant procedures for assessing validity fall roughly into three categories based on three different perspectives: venture capitalists’ perspective, the perspective of attorneys in private practice, and judicial perspective. Across these categories, post-grant discussions repeatedly highlight several sources of uncertainty that may apply to small companies relying on their intellectual property investments.

We provide the following review of the articles in this issue that pertain to post-grant review.
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In the world of pharmaceuticals, every day counts.  Indeed, when the subject matter is a block-buster drug like Bristol-Myers/Sanofi’s anti-blood clot drug Plavix® every day of U.S. sales averages nearly $15.5 million dollars (reported U.S. sales for 2009 of $5.6 billion).  So, it comes as no surprise that Apotex Inc., a Canadian manufacturer of a generic version of the drug, refuses to sit on the side-lines waiting for the Plavix® patent (U.S. 4,847,265) to expire.  However, the playing field has not been so kind to Apotex. Read the rest of this entry »

In patent application prosecution, patent owners may  file an RCE or continuation to continue prosecution as a matter of right under 37 CFR 1.53(b) or 1.53(d) or 37 CFR 1.114.  However, these mechanisms are not available in patent reexamination.

There may be occasions when additional prosecution may be beneficial in reexamination.  For example, in certain situations special dispatch may be served by the submission of new evidence, prior art,  or amendments. So, is a final action the end of the line?

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On December 15, 2009 the USPTO issued a ‘Notice of Intent to Issue an Ex Parte Reexamination Certificate’ confirming the patentability of Merck’s billion dollar Singulair patent, U.S. 5,565,473.  This development effectively concludes the reexamination of the Singulair patent.  In initiating the reexamination, the USPTO issued a single nonstatutory obviousness-type double patenting reexamination rejection.  Double patenting rejections relate to the ability of a Patent Holder to obtain multiple patents on obvious variations of a single invention.  This rejection, if maintained by the Office would not have invalidated the patent, but instead, could have potentially shortened the term of the Singulair patent.  However, the rejection was withdrawn by the USPTO.

The reexamination was initiated by a third party, Article One.  Article One claimed to have uncovered Read the rest of this entry »

On May 26, 2008, Troll Busters LLC (Troll Busters) filed a request for inter partes reexamination of U. S. Patent No. 6,869,779 (“the ‘799 patent”).  Originally, Troll Busters named itself as both the sole real party in interest and the third party requester.  However, as the PTO became aware of Troll Buster’s website, http://www.troll-busters.com, questions arose as to whether the actual real party in interest was correctly identified as required by 35 U.S.C. § 311(b)(1) and 37 C.F.R. 1.915(b)(8).

On their website, Troll Busters proclaims that “Troll Busters invalidates patents, not just any patents but patents being asserted by patent trolls, those ugly beasts who try to dominate the innovations of others….Troll Busters takes aim and fires in our own name.  The patent Troll will never know who or how many are behind the ‘hit’.” Read the rest of this entry »

Singulair is Merck’s best-selling drug, with sales of nearly $1.1 billion in the third quarter of 2009.  However, Merck’ patent covering Singulair has also been hotly contested in court, at the FDA, and, most recently, at the USPTO.

The Singulair patent, U.S. Patent No. 5,565,473, issued in 1996, covers the basic compound as well as a method of treating asthma.  The ‘473 patent has been the subject of ongoing litigation between Merck and generic manufacturer Teva Pharmaceuticals.  Merck filed three suits against Teva in April of 2007, May of 2007, and January of 2009, all in the U.S. District Court for the District of New Jersey, claiming that Teva infringed the ‘473 patent by filing an ANDA for generic Singulair. Because the suits all asserted infringement of the ‘473 patent, the later two suits were stayed pending a final decision on the merits in the first suit.

On August 19, 2009, Judge Garrett E. Brown of the U.S. District Court for the District of New Jersey ruled that Teva’s generic drug would infringe Merck’s ‘473 patent, and ordered the FDA to stay market approval of the generic version of Singulair pending expiration of the ‘473 patent in 2012.

Unfortunately for Merck, the success in the District Court represents only one front of battle for defending the validity of the ‘473 patent.  On April 27, 2009, four months prior to Judge Brown’s ruling, an ex parte reexamination request was filed for the ‘473 patent by Article One Partners LLC, a global research community which rewards Advisors for finding prior art to invalidate patents. The ex parte examination request was submitted with eight prior art documents in which Article One set forth over 276 pages of obviousness arguments.  The request was granted by the USPTO on May 28, 2009. Read the rest of this entry »