By Donald Zuhn —

Reflecting upon the events
of the past twelve months, Patent Docs
presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that
were covered on Patent Docs last year
that we believe had (or are likely to have) the greatest impact on
biotech/pharma patent practitioners and applicants.  Yesterday, we counted down stories #15 to
#12, and today we count down stories #11 to #8 as we work our way towards the
top three stories of 2012.  As with our
other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these
stories (as well as a few links to articles on related topics) have been
provided in case you missed the articles the first time around or wish to go
back and have another look.  As always,
we love to hear from Patent Docs
readers, so if you think we left something off the list or disagree with
anything we included, please let us know.

11.  Patent Law Changes Abroad

In December, the European
Parliament adopted two draft regulations on the creation of the unitary patent,
and an agreement establishing the Unified Patent Court (UPC), a specialized
court having exclusive jurisdiction over infringement and validity questions
related to unitary patents, is expected to be signed next month.  The European Union, however, was not the only
governing body making patent news abroad. 
In Australia, significant amendments were made to that
country's patent laws through enactment of the Intellectual Property Laws
Amendment (Raising the Bar) Act 2012, with the new provisions scheduled to
take effect on April 15, 2013.  Those
provisions will raise Australia's patentability threshold and specification
requirements, and are intended to raise the quality of granted patents in
Australia to a level that is more consistent with the standards set in the
U.S., Japan, and Europe.  In Israel, the
adoption of a set of amendments to the Israel patent statute establish 18-month
publication, submission of prior art by third parties, and third party requests
for expedited examination of patent applications.

For information regarding
this and other related topics, please see:

• "Parliament Approves
EU Unitary Patent Package," December 17, 2012
• "European Parliament
Adopts Draft Regulations on Unitary Patent," December 12, 2012
• "Unitary Patent
& Unified Patent Court," December 12, 2012
• "Progress for Single
European Patent and Litigation System," November 12, 2012
• "Australia Reforms
Its Patents Act 1990," August 29, 2012
• "Recent Amendments
to the Israel Patent Statute: Pulling the Pace of Prosecution from the Purview
of the Applicant," August 7, 2012
• "EU Patent Is
Finally Born," July 2, 2012

10.  Federal Circuit Issues Fractured En Banc
Decision on Divided Infringement Cases

On August 31, the
Federal Circuit issued its en banc decision in Akamai Technologies,
Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic
Systems Corp., reversing the
District Court in both cases and remanding for reconsideration.  A majority consisting of Chief Judge Rader
and Circuit Judges Lourie, Bryson, Moore, Reyna, and Wallach (with Circuit
Judges Newman, Linn, Dyk, Prost, and O'Malley dissenting) expressly overruled BMC
Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007), which
held that there must be a single actor (or a second actor acting under the
control of another) for infringement to lie. 
According to the majority, all the steps of the claimed method still
need to be performed, but it is not necessary to prove a "single
entity" performed them.  The
majority opinion, if upheld, would be a boon for biotechnology, if only because
it would provide another way for claim drafters to protect diagnostic method
claims.  However, it is unlikely that the
Supreme Court will deny certiorari in a case of statutory construction where
the Federal Circuit is so plainly fractured.  (According to the Supreme Court's
website, the deadline for filing a petition for a writ of certiorari was
December 28, 2012.)

For information regarding
this and other related topics, please see:

• "Akamai
Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc.
v. Epic Systems Corp. (Fed. Cir. 2012) (en banc)," September 4, 2012

9.  More USPTO PTA Interpretations Questioned

In 2012, the District
Courts for the District of Columbia and the Eastern District of Virginia sided
with a number of patentees in determining that certain practices used by the U.S.
Patent and Trademark Office in determining Patent Term Adjustment (PTA) were
improper.  In ArQule, Inc. v. Kappos, the District Court for the District of
Columbia found that the Office's practice of counting weekends and holidays as
applicant delay under 37 C.F.R. § 1.704(b) (while permitting responses filed by
the next business day to be considered timely under 35 U.S.C. § 21(b)) was improper.  In Exelixis, Inc. v. Kappos, the Eastern
District of Virginia disagreed with the Office's practice of negating B delay
in circumstances where an applicant had responded to a final rejection by
filing a request for continued examination (RCE).  According to the District Court, the statute
"makes [it] clear that once the three year clock has run, PTA is to be
awarded on a day for day basis regardless of subsequent events" in the
Court's view.  As a result, RCEs filed
after the three-year date should not toll the amount of B-Delay to be awarded to the patentee.  The District Court for the District of
Columbia adopted the rationale of the Eastern District of Virginia in Novartis AG v. Kappos, finding that PTA
should not be reduced by time attributable to an RCE where the RCE is filed after
the expiration of the three year guarantee period specified in the statute.  The Court in Novartis, however, refused to toll the 180-day after issuance deadline for filing suit
against the USPTO Director to challenge a PTA determination (for one of 23 patents at issue in the case, where the Office had failed to issue a
determination on reconsideration within the 180-day period of 35 U.S.C. §
154(b)(4)(A), but Novartis had filed suit within 180 days of the Office's
determination on reconsideration, the Court did toll the start of the 180-day period).  The
Court issued a warning to patentees that may be dissatisfied with PTA
determinations by the Office that are based on different theories than those
presented in Wyeth, ArQule, or Exelixis, stating that "Novartis was free to raise the same
issues that Wyeth and Abbott Laboratories raised in their lawsuits within the
180 days after their patents were granted."

For information regarding
this and other related topics, please see:

• "Novartis AG v.
Kappos (D.D.C. 2012)," November 27, 2012
• "Exelixis, Inc. v.
Kappos (E.D. Va. 2012)," November 8, 2012
• "ArQule v. Kappos:
Enjoy Your Weekend, or What a Difference a Day (or Two or Three) of PTA Can
Make," October 1, 2012
• "USPTO Proposes
Change to PTA Provisions Regarding Appellate Review," January 9, 2012

8.  Supreme Court to Resolve Circuit Split on
Reverse Payment Settlement (Pay-for-Delay) Agreements

Last month, the Supreme Court
granted certiorari in Federal Trade Commission v. Watson
Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment
settlement (or pay-for-delay) agreements in ANDA litigation under the Hatch
Waxman Act.  The
Court's decision to grant certiorari marks the culmination of almost a
decade of effort by the Federal Trade Commission to get a reverse payment case
before the Court.  What clinched the effort this time was the decision in the K-Dur
case by the Third Circuit in favor of the FTC's position, finding such
settlements to be presumptively anticompetitive and subject to a "rule of
reason" antitrust analysis.  This result was contrary to decisions in
the 11th Circuit (Valley Drug Co.
v. Geneva Pharmaceuticals, Inc., 344 F.3d 1294 (11th Cir. 2003)
and Schering-Plough
Corp. v. Federal Trade Commission, 402 F.3d 1056 (11th Cir.
2005)); 2nd Circuit (In re Tamoxifen
Citrate Antitrust Litigation, 466 F.3d 187 (2d Cir. 2006) and Arkansas
Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98,
105 (2d Cir. 2010)); and the Federal Circuit (In re
Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323
(Fed. Cir. 2008)) that such agreements are legal provided that they stay within
the legitimate bounds of the patent grant (applying the "scope of the
patent" test).  (It should be noted that the lone appellate exception
(before K-Dur), In re Cardizem
CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003), involved
different facts leading to the conclusion that there was anticompetitive
behavior.)

For information regarding
this and other related topics, please see:

• "Supreme Court to
Review Reverse Payment Settlement Agreements," December 9, 2012
• "FTC Moves as Amicus
in Effexor Litigation, and Gets Its (Well-Earned) Comeuppance," October
18, 2012
• "FTC Asks Supreme
Court to Play Favorites in Reverse Payment Settlement Agreement Cases,"
October 16, 2012
• "Amici File Briefs
Supporting Certiorari in K-Dur Case — Part II," October 10, 2012
• "Amici File Briefs
Supporting Certiorari in K-Dur Case," October 8, 2012
• "GPhA Files Amicus
Brief in K-Dur Case," October 3, 2012
• "Bayer Files Amicus
Brief in K-Dur Case," September 27, 2012
• "PhRMA Files Amicus
Brief in K-Dur Case," September 26, 2012
• "Should Presumptions
Be Avoided in the Reverse Payment Debate?" September 21, 2012
• "Generic Defendant
Petitions for Certiorari in K-Dur Litigation," September 17, 2012
• "Merck Asks Supreme
Court to Review Third Circuit K–Dur Decision," August 28, 2012
• "The Federal Trade
Commission Finally Wins One," July 18, 2012
• "Federal Trade
Commission v. Watson Pharmaceuticals, Inc. (11th Cir. 2012)," April 30,
2012
• "Latest Legislative
Attempt on Reverse Payment ANDA Settlements," February 27, 2012

Image of New Year's Eve
ball drop for 2012 in Times Square
(above) by Replytojain, from the Wikipedia Commons under the Creative Commons
Attribution-ShareAlike 3.0 Unported
license.