Patent Docs

AIPLA Annual Meeting

September 2, 2012

The American
Intellectual Property Law Association (AIPLA) will be holding its 2012 annual
meeting on October 25-27, 2012 in Washington, DC. Among the sessions being offered during the
annual meeting will be:

Plenary Session —
The Impact of the AIA Rules

Concurrent Track —
Patent Litigation Under the AIA — including presentations on:

• AIA Effects on
Litigation, Operating Under PGR/IPR and Getting Best Effect/Results
• Discovery
Procedures Under AIA
• Best Practices
for Corporate e-Discovery Under AIA
• Joint
Infringement—Akamai/McKesson Aftermath and Strategies Under AIA

Concurrent Track —
Emerging IP Issues in Emerging Markets — including presentations on:

• If You Can’t Beat 'Em, Can You Join 'Em? Trying to Use Recent Changes in Israel Patent Law to Get
an Early Look Inside Your Competitor's Head
• Tips, Tricks and
Pitfalls in the Brazilian Patent Prosecution System
• South Africa —
An Overview of Important Prosecution and Enforcement Issues in South Africa and
Other African Countries
• Important Aspects
of IP Practice in Russia for Foreign Patent Practitioners
• Strategies for
Foreign Filing
• Export Control
Issues

Concurrent Track —
What In-House Lawyers Need to Know About the AIA and Whether It Will Change
Corporate Practice — including presentations on:

• What In-House
Lawyers Need to Know About the AIA — Focus on Post Grant Reviews
• Third Party
Interactions and the AIA
• Implications and
Considerations for In-House Counsel in the Implementation of AIA First Inventor
to File Provision

Committee
Educational Session — IP Issues in Novel Venture Financing of
Biopharmaceutical Development — including presentations on:

• Overview of Novel
Venture Structures and Financing Arrangements
• Venture Capital
Company Approaches Investing in Clinical Development and Generation of IP
• Big Pharma
Partnerships with Small Biotech/Pharma
• Partnerships with
Government to Commercialize New Technologies

Committee
Educational Session — Declarations and Assignments and Effective Filing Date
of Claims Under the AIA

Concurrent Track —
What’s the Big Diff? — Patent Prosecution Under the AIA — including
presentations on:

• USPTO Perspective
and Developments — Policy, Rules, and Examination Guidelines — to be
presented by USPTO Deputy Director Teresa Stanek Rea
• In-House
Perspectives on the AIA: Strategies for Successful Corporate Outcomes
• International
Perspectives and Developments: One Off, Harmonizing, Progress?
• Changes at the
OED: What Corporations and Practitioners Need to Know and When You Need to Know
It — to be presented by William R. Covey, USPTO Office of Enrollment and
Discipline
• Strategies, Tips,
and Potholes
• Patent System RX:
Pre-issuance Submissions

Concurrent Track —
AIA — Will the New System Work? — Panel discussion to be moderated by AIPLA
Executive Director Q. Todd Dickinson and including Chief Judge Randall Rader of
the U.S. Court of Appeals for the
Federal Circuit; USPTO Director David Kappos; Robert A. Armitage of Eli Lilly
& Company; Aaron Cooper, Senior Counsel, IP and Antitrust, U.S. Senate
Committee on the Judiciary; and W. Todd Baker of Oblon Spivak McClelland Maier
& Neustadt, LLP

Committee
Educational Session — Antibody Patents and Patenting Antibodies — US and EP
Perspectives — including presentations on:

I. Patenting Antibodies — A European
Perspective:
• Antibodies and
the EPO
• International
Antibody Patenting Strategy
• Patenting
Antibodies in Europe

II. Antibody Patents — Written Description
• Written
Description and Predictability — One Corporate View
• Written
Description: Not Required for Antibodies — An Academic View
• Understanding the
Patent Office's "Antibody Exception" to the Requirement for Written Description

On October 26, the
luncheon keynotes will be given by the Hon. Kathleen O’Malley of the U.S. Court
of Appeals for the
Federal Circuit.

A brochure for the
meeting, which includes an agenda, list of speakers, and registration
information can be downloaded here.

The registration
fee for the AIPLA annual meeting is $825 (AIPLA members), $1,280 (non-members),
$55 (AIPLA student members), or $70 (government employees or AIPLA
academic/government members). AIPLA
members or non-members registering by September 27, 2010 will receive a $100
discount off the registration fee. Those
interested in registering for the conference can obtain a registration form
here.
Webinar on Supplemental Examination

August 31, 2012

The
Intellectual Property Owners Association (IPO) will offer a one-hour webinar on
"Supplemental Examination: Rules and Strategy" on September 18, 2012
beginning at 2:00 pm (ET). A panel
consisting of Robert Bahr, Deputy Commissioner for Patent Examination Policy,
USPTO; Courtenay Brinckerhoff of Foley & Lardner LLP; and Kurtis MacFerrin
of Google, Inc. will discuss the final rules and when a patent holder would be
well advised to ask for supplemental examination, balancing the risks and
benefits.

The
registration fee for the webinar is $120 (government and academic rates are
available upon request). Those
interested in registering for the webinar can do so here.
Webinar on Inter Partes Review

August 31, 2012

The
Intellectual Property Owners Association (IPO) will offer a one-hour webinar on
"Inter Partes Review: Rules and
Strategy" on September 5, 2012 beginning at 2:00 pm (ET). A panel consisting of the Hon. Sally Medley,
Administrative Patent Judge, USPTO; Kevin Laurence of Stoel Rives, LLP; and
Scott Markow of Stanley Black & Decker, Inc. will focus on the final rules
and such topics as estoppel, costs, and related stays in litigation. The panel will also discuss when to launch an
inter partes review in light of other
alternatives, the nature of the trial at the PTAB, how to defend the patent,
and how to manage teams that include litigators who have not previously
practiced at the USPTO.

The
registration fee for the webinar is $120 (government and academic rates are
available upon request). Those
interested in registering for the webinar can do so here.
Solicitor General Recommends the Supreme Court Deny Cert in Bowman v. Monsanto

August 30, 2012

By
Kevin E. Noonan —

Earlier
this year, the Supreme Court asked the Solicitor General for his views on
whether the Court should grant certiorari
in Bowman v. Monsanto. The Solicitor has now given the Court his
views, and they are that the Court should not grant cert. Although the Court does not always follow the
Solicitor's recommendations (and sometimes regrets not doing so; see Laboratory
Corp. v. Metabolite Labs., Inc. ("LabCorp")), in this case
the rationales in the Solicitor's brief make it unlikely that the Court will
not agree.

To
recap, the case arose as the result of a farmer replanting Monsanto's patented
Roundup Ready® seed. The patents-in-suit are (as they have been in
other cases) U.S. Patent Nos. 5,352,605 and RE39,247 (a reissue of
5,633,435). Claims 1 and 4 of the '605 patent are representative:

1. A chimeric gene which
is expressed in plant cells comprising a promoter from a cauliflower mosaic
virus, said promoter selected from the group consisting of a CaMV (35S)
promoter isolated from CaMV protein-encoding DNA sequences and a CaMV (19S)
promoter isolated from CaMV protein-encoding DNA sequences, and a structural
sequence which is heterologous with respect to the promoter.

4. A plant cell which comprises a chimeric gene that contains
a promoter from cauliflower mosaic virus . . . .

Claims 103, 116, 122, 128, 129, and
130 of the '247 patent are representative:

103. A recombinant,
double-stranded DNA molecule comprising in
sequence: 
    (a) a promoter which functions in
plant cells to cause the production of an RNA sequence;
    (b) a structural DNA sequence that
causes the production of an RNA sequence which encodes an EPSPS enzyme having
the sequence of SEQ ID NO:70; and 
    (c) a 3' non-translated region that
functions in plant cells to cause the addition of a stretch of polyadenyl
nucleotides to the 3' end of the RNA sequence;
    where the promoter is heterologous with
respect to the structural DNA sequence and adapted to cause sufficient
expression of the encoded EPSPS enzyme to enhance the glyphosate tolerance of a
plant cell transformed with the DNA molecule.

116. A glyphosate-tolerant plant cell comprising a DNA
sequence encoding and EPSPS enzyme having the sequence of SEQ ID NO: 70.

122. A seed of the plant of claim 116, wherein the seed
comprises the DNA sequence encoding an EPSPS enzyme having the sequence of SEQ
ID NO: 70.

128. A glyphosate[-]tolerant plant cell
comprising the recombinant DNA molecule of claim 103.

129. A plant comprising the glyphosate[-]tolerant plant cell of
claim 128.

130. A method for selectively controlling weeds in a field
containing a crop having planted crop seeds or plants comprising the steps
of: 
    (a) planting the crop seeds or plants which
are glyphosate-tolerant as a result of a recombinant double-stranded DNA
molecule being inserted into the crop seed or plant . .
. 
    (b) applying to the crop and weeds in the field
a sufficient amount of glyphosate herbicide to control the weeds without
significantly affecting the crop.

Pioneer Hi-Bred (Pioneer), one of Monsanto's
licensed seed producers, sold seed to Bowman; these sales were subject to a
Technology Agreement similar to the Agreements Monsanto typically requires for
farmers who purchase its seed. Under the Technology Agreement, the
licensed grower agreed: (1) "to use the seed containing Monsanto gene
technologies for planting a commercial crop only in a single season"; (2) "to
not supply any of this seed to any other person or entity for planting";
(3) "to not save any crop produced from this seed for replanting, or
supply saved seed to anyone for replanting"; and (4) "to not use this
seed or provide it to anyone for crop breeding, research, generation of
herbicide registration data, or seed production." It was undisputed
that Bowman complied with these provisions as to its "first planting"
each year. Monsanto's complaint arose from farmer Bowman's "second
planting," which was made using so-called "commodity seed"
obtained from local grain elevators. Farmers under the Technology
Agreement could freely sell seed to grain elevators for commodity use (for
example, as cattle feed), which did not include replanting. However,
since Farmer Bowman's "second planting" was riskier (in terms of
potential yield) he decided to use commodity seed because it was significantly
cheaper than Roundup Ready® seed. After planting this seed, Farmer
Bowman tested this second crop for Roundup® resistance, and finding that
substantial amounts of the seed were resistant, used Roundup® on these
plantings and replanted this seed.

The District Court granted summary
judgment of patent infringement and entered judgment against Farmer Bowman in
the amount of $84,456.20. The Federal Circuit rejected Bowman's arguments
that were predicated directly on the Supreme Court's Quanta
decision. In Quanta, the Supreme Court reiterated its "substantial
embodiment" test to apply the patent exhaustion principle, which applied
to both composition and method claims (reversing the Federal Circuit as to
method claim exhaustion), citing Ethyl
Gasoline Corp. v. United States,
309 U.S. 436 (1940), and United
States v. Univis Lens Co., 316 U. S. 241
(1942). Specifically, the Court stated the standard that sales that "substantially
embody" the patents in suit will be sales that exhaust the patent right to
obtain royalties, citing Univis. The immediately evident
application of this decision to biotechnology patent claims include cases, as
in Monsanto, where a patented article has the biological property of
replication, where the license precludes use of replicates of the article after
purchase. Although critically important economically (since it is clear
that Monsanto would not be in the seed business for very long in the absence of
these restrictions), the rubrics for applying patent exhaustion set forth in
the Court's Quanta decision could be applied to Monsanto's claim, and
Bowman argued that they should be so applied. It is without question that
the seeds "embody" (figuratively and literally) the "essential
features" of the patented invention, and thus the types of limitations
Monsanto (and other seed producers) have placed on replanting of their patented
seeds implicate the application of these standards to Monsanto's claims.

The Federal Circuit did not see it this
way. Farmer Bowman argued that exhaustion applied to all Roundup Ready®
soybean seeds, including those present in grain elevators as undifferentiated
commodity. "Sales of second-generation seeds by growers to grain
elevators, and then from grain elevators to purchasers (like Bowman) are
authorized according to the terms of Monsanto's [T]echnology [A]greement[], and
are thus exhausting sales . . . under the Supreme Court's analysis in Quanta
[Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008)],"
according to Bowman.

In response, Monsanto argued that sale of
soybeans are not "authorized" when those soybeans are replanted (i.e.,
used as seed rather than as commodity grain). Monsanto further argued
that, even if sale to grain elevators resulted in exhaustion, infringement
occurred when the seed was replanted because "patent protection 'is
independently applicable to each generation of soybeans (or other crops)
that contains the patented trait,'" arguments Monsanto had previously
(successfully) made in other infringement actions. Monsanto also urged
that J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.,
534 U.S. 124 (2001), was controlling for patent exhaustion in
seeds, specifically that exhaustion "must be limited to the seeds sold."
In this regard, Monsanto urged the portion of the J.E.M. opinion that
stated that "there are no exemptions for research or saving seed
under a utility patent." Id. at 143 (emphases added).

The Federal Circuit agreed that patent
exhaustion did not apply. Citing the McFarling opinion, the panel
stated that "[t]he 'first sale' doctrine of patent exhaustion . . . [wa]s
not implicated, as the new seeds grown from the original batch had never been
sold. The price paid by the purchaser 'reflects only the value of the 'use'
rights conferred by the patentee.'" Id. at 1299 (citing B. Braun Med., Inc. v. Abbott Labs.,
124 F.3d 1419, 1426 (Fed. Cir. 1997)). Turning to the specific facts in this case,
the Court stated that the important consideration is that "the grower has
created a newly infringing article" when commodity seed was planted by Bowman
and the "next generation" of seeds comprising Monsanto's Roundup
Ready® technology were produced. "The fact that a patented
technology can replicate itself does not give a purchaser the right to use
replicated copies of the technology," according to the opinion, and "[a]pplying
the first sale doctrine to subsequent generations of self-replicating
technology would eviscerate the rights of the patent holder," citing Monsanto Co. v.
Scruggs, 459 F.3d 1328, 1336 (Fed. Cir. 2006), cert.
denied, 549 U.S. 1342 (2007). According to the opinion, the right to use
patented technology upon purchase "do[es] not include the right to
construct an essentially new article on the template of the original, for the
right to make the article remains with the patentee," citing Jazz Photo Corp. v. Int'l Trade Comm'n,
264 F.3d 1094, 1102 (Fed. Cir. 2001), cert. denied, 536 U.S. 950 (2002).
The opinion applied the "substantial embodiment" test with regard to
separate generations of seed, stating that present seed does not "substantially
embody" "all later generation seeds," because with regard to the
commodity seeds "nothing in the record indicates that the 'only reasonable
and intended use' of commodity seeds is for replanting them to create new
seeds, citing Quanta, 553 U.S. at 631 and noting that other uses for
commodity seed existed (such as use as feed). "While farmers, like
Bowman, may have the right to use commodity seeds as feed, or for any other
conceivable use, they cannot 'replicate' Monsanto's patented technology by
planting it in the ground to create newly infringing genetic material, seeds,
and plants. Bowman's certiorari petition
followed the adverse decision by the Federal Circuit.

The
Solicitor's brief acknowledges that the Federal Circuit's treatment of
so-called "conditional" sales has not been entirely consistent with
the Supreme Court's views on patent exhaustion; this contrary jurisprudence was
corrected by the Court in Quanta and
thus does not warrant further correction. More importantly, the Solicitor contends that conditional exhaustion was
not the basis for the Federal Circuit's decision in this case. Rather, the Solicitor's brief quotes the
Federal Circuit as saying that "'[e]ven if
[respondent's] patent rights in the commodity seeds are exhausted, such a
conclusion would be of no consequence because once a grower, like [petitioner],
plants the commodity seeds containing [respondent's] Roundup Ready technology
and the next generation of seed develops, the grower has created a newly
infringing article." In addition, "[t]he
right to use [] do[es] not include the right to construct an essentially new
article on the template of the original, for the right to make the article
remains with the patentee.'" The Solicitor further
notes that the Court rejected the argument that replanting was the only use for
the "commodity seed," noting that the seed was useful, inter alia, as animal feed.

The Solicitor's brief notes
that a majority (pp. 9-16) of petitioner's brief is focused on the Federal
Circuit's "conditional sale" jurisprudence. The brief sets forth these cases, beginning
with Mallinckrodt, Inc. v. Medipart, Inc., 976 F.2d 976 F.2d 700, 706-08 (1992), where the Federal Circuit held that a patent was
not exhausted if the patentee conditioned the sale of a patented article to "unilateral
or bilateral restrictions on the use or resale of the purchased article." The Federal Circuit had justified these
restraints under conditions where the restriction was "within the patent
grant" (i.e., it did not exceed or be unrelated to subject matter
within the scope of the claims) and did not have "anticompetitive effects
extending beyond the patentee's statutory right to exclude" or was in
violation of the antitrust laws. These
line of cases was relevant to the instant case, the Solicitor wrote, because
other cases (significantly, ones for which the Court had denied certiorari) were based (at least in
part) on the conditional sale doctrine, including Monsanto Co. v.
McFarling, 302 F.3d 1291 (2002), cert, denied, 537 U.S.
1232 (2003), and Monsanto Co. v. Scruggs. But these cases were all decided prior to the Supreme Court's Quanta decision; perhaps somewhat tongue
in cheek, the brief states that "[i]t is not clear, however, whether the
Federal Circuit will continue to adhere to the Mallinckrodt line of
cases after Quanta. What is clear
is that the court did not do so here," thus avoiding this issue as a basis
for a certiorari grant (which may
arise by implication if the Federal Circuit does not follow the Court's lead from Quanta).

Here, the Solicitor
affirms that the Federal Circuit rejected the patent exhaustion defense as
point of "no consequence" because "'[e]ven if' exhaustion had
occurred [] petitioner would still be liable because he had 'created a newly
infringing article' when he 'plant[ed] the commodity seeds containing
respondent's Roundup Ready technology and the next generation of seed
develop[ed].'" In other words, even if the petitioner had a "right to
use" the seed for any "conceivable use," the one right that he
did not have was the "'right to
construct an essentially new article on the template of the original.'" The brief casts the issue as one of the patent law
giving a patentee "separate rights" to exclude others from "making, using, offering for sale, and selling [or
importing] a patented invention," rights that can be separately
alienated. Separate from the rights to
use and (re)-sell a patented article (which rights are exhausted upon first
sale) is the right to make a new infringing article, something the Solicitor's
brief contends was never the subject of the patent exhaustion doctrine. Citing Quanta
and other Supreme Court case law (including Mitchell v. Hawley, 83
U.S. (16 Wall.) 544, 547 (1872); United States v. Univis Lens Co., and Aro
Mfg. Co. v. Convertible Top Replacement Co., 365 U.S. 336,346 (1961)), the
Solicitor argues that exhaustion is particular to the article sold. This
issue has arisen in the past when courts have been asked to determine the
distinction between repair of a purchased patented article (which is
permitted) and reconstruction (which is not); this principle is a
long-standing one according to the brief, hieing from cases like Wilson v.
Simpson, 50 U.S. (9 How.) 109, 123-125 (1850), and American Cotton-Tie
Co. v. Simmons, 106 U.S. 89, 93-94 (1882). Quoting the Federal
Circuit, "the rights of ownership do not include the right to construct an
essentially new article on the template of the original, for the right to make
the article remains with the patentee" says the Solicitor, citing Jazz
Photo Corp. v. Int'l Trade Comm'n.

The Solicitor's
brief recognizes that the case presents something of a novelty, because this
invention is capable of making replicas of itself (although later in the brief
the Solicitor rejects petitioner's contention that this self-replicating
property absolves him of infringement liability). The brief rejects petitioner's contention
that planting new seed is a "use" of the seed and does not constitute
"making" new seed, because while planting see is certainly a use, "the planting and harvesting of soybeans also
constitutes the 'making' of newly infringing seed" (emphasis in original). The brief also rejects petitioner's argument that new Roundup Ready
seeds are "made" only "'when they
artificially insert patented germplasm into naturally occurring soybean seeds.'" This is also a making, according to the
brief, but is does not negate that planting and harvesting seed is also a "making"
of seed. (Here, the brief relies on a
dictionary definition of the word "make," in the absence of any
special definition of the word in the Patent Act, unlike, for example, the
definition of the word "process" at 35 U.S.C. § 100(b).) "Petitioner 'cause[d]
[the progeny seed] to exist,'" according to the Solicitor, and it was
immaterial that how that was accomplished differed from how the patentee had
created the recombinant seed in the first place.

Turning to the
argument that seeds "self-replicate without farmer assistance" (and
thus, presumably, somehow absolve the farmer from responsibility for
infringement), the Solicitor states that:

[P]etitioner
did not simply leave the seed "untended on a field." . . . Rather, he
intentionally planted the commodity seed in order to create a new crop of
soybeans; he saved some of that new crop to replant the next growing season; he
continued to plant, harvest, and save seed for eight successive years; and he
exploited the known glyphosate-resistant properties of the progeny seed by
treating his crops with a glyphosate-based herbicide.

All
these are acts presumably raising infringement liability.

The
brief also relied upon the Court's decision in J.E.M.
Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. in support of its argument that
planting seeds constituted "making" under the patent statute. There, the Supreme Court held that the Patent
Act provided utility patent protection (that endowed patent holders with "greater
rights of exclusion" than patents under the Plant Variety Protection
Act). The PVPA provides an affirmative
exemption for farmers to save seed that can be used for replanting, and the J.E.M. Court noted that there was no
such exemption for utility patents. The Solicitor's brief argues that there would be "no practical
significance" for this distinction (between plant and utility patents) "if
the unauthorized creation of new seed was treated as non-infringing under 35 U.S.C. 154 and 271 [] based on
the patent-exhaustion doctrine. Petitioner would effectively read a
seed-saving exemption into the Patent Act." This aspect of the
difference between the extent of the exclusionary right conferred by utility
versus plant patents also distinguished Asgrow Seed Co. v. Winterboer,
513 U.S. 179 (1995), another case involving the seed-saving exemption of the PVPA:

If, as petitioner contends, the authorized
sale of patented seed exhausts a patentee's rights in that seed, as well as in
its progeny, then a grower could save second-generation seed and sell that seed
commercially without infringing the patent. That would, in turn, afford greater
rights of exclusion to holders of a PVPA certificate than to utility patent
holders, contrary to this Court's understanding in J.E.M.

The
Solicitor also notes that recombinant seed are not exempt from the patent
exhaustion doctrine. The question is for
which seed does patent exhaustion
apply, and the Solicitor answers that it is the seed that is sold, and not
progeny seed, that is subject to exhaustion. "But the sale of patented seed never authorizes a purchaser to
create a new generation; the right to make is a distinct, exclusive right that
remains with the patentee," says the brief.

The Solicitor
ends his brief by addressing the policy issues raised by petitioner: "that
the court of appeals' decision will eliminate commodity soybeans as a low-cost
alternative for second-crop plantings, and will otherwise alter traditional
farming practices." These are
decisions best left for Congress, according to the Solicitor. In addition, a decision by the Court on
recombinant seeds "could also affect the
enforcement of patents for man-made cell lines, DNA molecules,
nanotechnologies, organic computers, and other technologies that involve
self-replicating features." Instead
of deciding this issue in this case, "[t]he Court should allow the case
law to develop further before considering whether to adopt a more restrictive
definition of 'making' that could have unforeseen consequences for other
present and future self-replicating technologies, citing the Court's own
cautionary statements in this regard in Bilski v. Kappos, 130 S. Ct. 3218, 3227
(2010).

The
Court will schedule a conference to discuss whether to grant certiorari in due
course after the summer recess.
News from Abroad: Australia Reforms Its Patents Act 1990

August 29, 2012
By Craig Humphris & David McCarthy
—

Australia is attempting to raise its patentability
threshold and specification
requirements. Significant amendments have been made to Australia's
patent laws through enactment of the Intellectual Property Laws Amendment (Raising
the Bar) Act 2012. Most provisions will take effect from 15 April 2013.

The Raising the Bar Act, which was enacted on 15 April 2012, seeks to raise the quality of granted patents to a level that is more
consistent with the standards set with Australia's major trading partners,
including the U.S., Japan, and Europe. Prior to this Act, concerns were expressed
in the 2008 review of the national innovation system (entitled 'Venturous Australia') and the
Government's response to this review (Powering
Ideas: the innovation agenda for the 21st century, 12 May 2009),
that the thresholds set for the grant of a patent in Australia are too low,
patents are granted for inventions that are not sufficiently inventive, and
that the details of inventions are not sufficiently disclosed to the public.

The Raising
the Bar Act intends to raise the requirements for patentability and the
requirements for patent specifications for all applications filed after 15
April 2013, and for patent applications filed prior to that date for which an
examination request has not been filed prior to 15 April 2013.

A number of actions are available to patent applicants
to ensure that the current and perhaps more lenient patentability and
specification requirements apply to their applications and future patent
grants.

• File
patent applications, including national phase applications, and request examination before 15
April 2013.

• If a PCT
application has not been filed, consider filing a Convention application in Australia and request examination before 15
April 2013.

• Instead of filing a
provisional application to obtain a priority date, file a complete application and request examination before 15 April 2013.

• Add all
new subject matter to description/examples before 15 April 2013.

• File divisional
applications and a request for examination before 15 April 2013.

• File divisional
applications from opposed applications before 15 April 2013.
• If desired, convert
pending applications to a divisional application before 15 April 2013

Future granted patents will still be litigated
under the current patentability and specification requirements if the
application was filed and had examination requested before 15 April 2013.

FURTHER INFORMATION

The key amendments made by the Raising the Bar Act are as follows:

Schedule 1 – Raising the quality of granted patents

Inventive Step

Currently, only common general knowledge from
Australia is taken into account in determining what is common general knowledge
for the purposes of assessing inventive step. Under the Raising the Bar Act, common general knowledge from overseas (that
is, without a territorial limitation) can also be taken into account and this
will permit the use of foreign experts who have given evidence in overseas
proceedings.

Previously, only information 'ascertained,
understood and regarded as relevant' was considered in a review of prior art
for the assessment of inventive step. Under the Raising the Bar Act, all information in existence in Australia or
overseas can be considered prior art, provided it is capable of being understood
and regarded as relevant. This should increase the volume of prior art taken
into account when assessing inventive step.

Sufficiency

The level of disclosure required for provisional
applications will be increased and will require a similar level of disclosure
required for complete specifications, although provisional applications need
not disclose the best method of performance of the invention.

Complete applications will have their disclosure
requirements changed. The law will be amended to conform substantially to the
corresponding United Kingdom provision and the new provision states that the
complete specification must "disclose the invention in a manner which is
clear enough and complete enough for an invention to be performed by a person
skilled in the relevant art". The explanatory memorandum to the Raising the Bar Act, indicates that the
subject matter of a claim should be enabled across its "whole width".

Fair Basis

Australia's requirement that a claim needs to be 'fairly
based' on matter disclosed in the specification will be replaced with a 'supported
by' requirement.

Under the new law, there must be basis in the
description for each claim. Further, the scope of the claims must not be
broader than is justified by the extent of the description, drawings, and
contribution to the art. This second aspect of the support requirement appears
to be intended to provide a means for rejecting unduly speculative claims.

Currently, it appears settled by the Australian
High Court (the supreme court in Australia's court hierarchy) following its
decision in Lockwood
Security Products Pty Ltd v Doric Products Pty Ltd (2004)
217 CLR 274, that there
is no link between claim scope and technical contribution in the art. The Raising the Bar Act attempts to change
this and seeks to import a link between these two elements.

Utility

The Raising
the Bar Act introduces a new provision which will require a complete
specification to disclose a "specific, substantial and credible use"
for the invention. This provision was based substantially on the corresponding
US section. This requirement for a specification to disclose a use for the
invention is additional to the requirement for the invention itself to be
useful, in the sense of meeting the promise of the invention as described in
the specification.

Examination

Under the new system, patent examiners will be able to consider utility and prior use at the
examination stage. These grounds are not available to examiners under the
current system.

The standard of proof to be applied by an
examiner for all examination tests will be raised to the civil standard
(balance of probabilities). Currently, an Examiner is required to accept a
patent application 'unless it appears practically certain' or 'clear' that the
patent would be invalid. Under the new laws, the Examiner will need to be satisfied on the balance of probabilities that a patent
would be valid. These changes
will shift more burden on the applicant to show patentability.

Re-Examination

Australia's ex parte re-examination procedure
before the patent office (IP Australia) will be modified. Currently, re-examination only considers the
grounds of novelty and inventive step. However, from 15 April 2013,
re-examination will be extended to include the grounds of best method, clarity,
fair basis, manner of manufacture, and utility.

Amendments

The
amendment provisions will be modified to prevent applicants from adding subject
matter to their applications, except when the amendment is to correct an
obvious mistake or clerical error. Whether subject matter has been added is
made with reference to the complete specification as filed, as well as "other
prescribed documents (if any)".

Schedule 2 – Free access to patented inventions for
regulatory approvals and research

Regulatory Exemption

Under the current system, exemption from patent
infringement is allowed for use of a patented invention solely connected with
generating information for submission to a drug regulation authority for
seeking regulatory approval of a pharmaceutical.

From 15 April 2013, exemptions from patent
infringement will be broadened beyond pharmaceutical products and will be
provided for use solely connected with generating information
for seeking regulatory approval for any product. These changes will be most
relevant to certain medical device products and agricultural products that
require regulatory approval
before market launch.

Experimental use
exemption

Australia has now codified an experimental use
exemption to patent infringement.

The provision was made effective on 15 April 2012
and applies to acts done for experimental purposes
relating to the subject matter of the invention, including:

• Determining the properties of an invention;

• Determining the scope of a claim relating to the invention;

• Improving or modifying the invention;

• Determining the validity of a patent or of a claim relating to the
invention; or
• Determining whether the patent would be/has been infringed by the doing
of an act.

Schedule 3 – Reducing delays in resolution of
patent applications

Divisional Applications

Other significant amendments introduced by the Raising the Bar Act, include changes to
practice on divisional applications (Australian divisional applications are
often seen as equivalent to U.S. continuation applications).

(1)
Under the current system, it is possible to file divisional applications
from applications under opposition (Australia has a post acceptance, pre-grant,
third party opposition procedure). The practice of filing divisionals from
applications under opposition is a useful tactic by patent applicants who want
to maintain a live application in case the parent application is successfully
opposed or substantially narrowed. From 15 April 2013, it will no longer be possible to file divisional applications from applications
under opposition or at the end of the opposition period (3 months from
advertisement of acceptance).

Furthermore, under the current system, it is possible to withdraw an
opposed application at any time and pursue a divisional application. The
applicant can also wait to see the evidence from the opponent before making a
decision to pursue this option and withdraw. However, under the new system,
patent applicants will require the Commissioner's consent to withdraw an
opposed application and consent is likely to be withheld if all other
divisional applications are removed.

(2) From 15 April 2013, it will also no longer be
possible to convert an application to a divisional or
innovation patent off an earlier filed application, e.g., to overcome novelty or
inventive step rejections from own application.

Under the current system, where a novelty objection is raised against an
applicant's invention citing their own earlier application, the applicant could
overcome the objection by converting the later application to make it a
divisional of the earlier application. The Raising
the Bar Act will close this option.

Mr.
Humphris is a Senior Associate with Wrays and team leader of Wrays' Adelaide
office. Dr. McCarthy is an Associate
with Wrays.
Merck Asks Supreme Court to Review Third Circuit K–Dur Decision

August 28, 2012

By Kevin E. Noonan —

Last month, the Federal Trade
Commission accomplished a decade-long goal: getting a Federal Circuit Court of Appeal (the 3rd Circuit) to
support its position that so-called "reverse
payments" (also known as "pay-for-delay" arrangements) between
innovator pharmaceutical companies and generic drugmakers in ANDA litigation
brought under 35 U.S.C. § 271(e)(2) are anticompetitve and barred by Federal
antitrust law, in In re K-Dur Antitrust Litigation. Such a ban on these agreements have been part
of the Obama Administration's budget for the past few years, but neither
Congress nor the courts have been willing to adopt the FTC's stance on their
purported anticompetitiveness. Indeed, most courts that have considered
the issue disagreed with the FTC's position, based on their assessment that, on
average, generic drugs actually come on the market sooner than they would if the patentee retained its exclusivity for
the full scope of the patent term. This rationale has been applied, in
varying degrees, by the Second, Eleventh, and Federal Circuits, in Valley Drug Co. v. Geneva Pharmaceuticals, Inc.,
344 F.3d 1294 (11th Cir. 2003); Schering-Plough Corp. v. Federal Trade Commission,
402 F.3d 1056 (11th Cir. 2005); In re Tamoxifen Citrate Antitrust Litigation,
466 F.3d 187 (2d Cir. 2006), Arkansas Carpenters Health & Welfare Fund v. Bayer AG,
604 F.3d 98, 105 (2d Cir. 2010); and In re Ciprofloxacin Hydrochloride Antitrust Litigation,
544 F.3d 1323 (Fed. Cir. 2008). Where a court has found a reverse
payment agreement to be anticompetitive, In re Cardizem CD Antitrust Litigation,
332 F.3d 896 (6th Cir. 2003), the facts of the case distinguished the behavior
of these parties from the behavior of the other parties involved in such
agreements.

To recap, the K-Dur
case involved the drug K-Dur 20, a specific formulation of potassium chloride
sold by Schering-Plough Co. and protected by a formulation patent, U.S. Patent
No. 4,863,743.
Upsher filed its ANDA as first-filer with a Paragraph IV certification of
non-infringement based on alleged chemical differences between Upsher's generic
drug and Schering's branded drug product. Schering filed suit and settlement
negotiations ultimately resulted in an agreement, entered into on June 18,
1997, wherein Upsher would "refrain from marketing its generic potassium
chloride supplement or any similar product until September 1, 2001."
In return, Schering agreed to grant Upsher a "non-royalty [bearing] non-exclusive
license" and Upsher granted Schering non-exclusive licenses on several of
its products (although Schering never marketed any Upsher products).
Schering agreed to pay Upsher sixty million dollars over three years, plus
additional amounts tied to its marketing of Upsher's products under the
non-exclusive license. Finally, the agreement called for Upsher to
dismiss the patent litigation and not to enter the market with its KCl product
until September 1, 2001, thus forming the predicate for allegations that this
was at heart a "pay for delay" agreement.

A second ANDA filer, ESI Lederle, was also
involved in a separate litigation that was settled (under the supervision of a
magistrate judge) with an agreement wherein ESI agreed not to market its
generic KCl formulation (which, like Upsher, it alleged was not infringing) in
return for a $5 million upfront payment and additional payments depending on
when ESI's ANDA was approved by the FDA (an amount the District Court said
varied from $10 million to $625,000 depending on the ANDA approval date); as it
turns out, ESI obtained FDA approval of its ANDA in sufficient time to be
entitled to $10 million, which it received from Schering.

An FTC action ensued, with the Commission
alleging that the agreements between Schering, Upsher, and ESI amounted to an
unlawful restraint of trade under Section 5 of the FTC act. The
Administrative Law Judge dismissed, based on his determination that the
agreements included separate licensing terms that fell outside a simple "pay
for delay" arrangement. The Commission reversed the ALJ's
determination, finding a "direct nexus between Schering's payment and Upsher's
agreement to delay its competitive entry" and that this agreement "unreasonably
restrain[ed] commerce," and that the Schering-ESI agreement violated the
antitrust laws (wherein the Commission rejected the parties' contention that "judicial
pressure to settle" was involved in their agreement). The Commission
did not review or rule on the merits of the underlying patent suits, creating a
per se rule that:

[W]here a name brand pharmaceutical maker pays a generic manufacturer as
part of a settlement, "[a]bsent proof of other offsetting consideration,
it is logical to conclude that the quid pro quo for the payment was an
agreement by the generic to defer entry beyond the date that represents an
otherwise reasonable litigation compromise."

Under a "rule of reason"
analysis, the Commission found that "the possible existence of a reverse
payment raises a red flag and can give rise to a prima facie case that an
agreement was anticompetitive." Schering appealed in the Eleventh
Circuit, which overturned the FTC.

This action named as plaintiffs drug
wholesalers (Louisiana Wholesale Drug Co.) and retailers (CVS Pharmacy, Rite
Aid, Walgreens, Eckerd, Safeway, Kroger, Albertson's, Hy-Vee and Maxi Drug)
against Merck & Co. (the successor-in-interest to Schering-Plough) and
Upsher-Smith Laboratories. Characterized as "separate from the FTCs
challenge" (but no doubt motivated by it), the plaintiffs here filed
various lawsuits that were consolidated in the District of New Jersey by the
Judicial Panel on Multidistrict Litigation (fortuitously for plaintiffs and the
FTC, in an appellate circuit that had not ruled on the reverse payment practice).
A Special Master appointed by the Court filed a Report and Recommendation that
the lawsuits be dismissed, based on Schering's right under the patents to "exclude
infringing products until the end of [the patent's] term," and that
reverse payment agreements warrant antitrust scrutiny only if they either
exceeded the scope of the underlying patents or if the patent infringement
lawsuits brought under the authority of the patents were objectively baseless
(grounds that other appellate circuits had also considered in assessing the
legality of reverse payment agreements).

The Third Circuit rejected the precedent
of its sister circuits, finding reverse payment agreements to be presumptively
illegal. The opinion sets forth its view
of antitrust law and its application to the reverse payment agreements before
it. The Court set forth its opinion that the proper approach is to
evaluate any agreement alleged to be one that restrains trade by the "rule
of reason," following its appreciation of applicable Supreme Court
precedents. In doing so, the opinion states that "the finder of fact
must decide whether the questioned practice imposes an unreasonable restraint
on competition, taking into account a variety of factors, including specific
information about the relevant business, its condition before and after the
restraint was imposed, and the restraint's history, nature, and effect,"
citing State Oil Co. v. Khan, 522 U.S. 3, 10 (1997). This inquiry
has three parts, according to the Third Circuit: there must be a showing
of an anticompetitive effect on the market, which (if established) "shifts
the burden to the defendant to show that the challenged conduct promotes a
sufficiently pro-competitive effect." The antitrust plaintiff can
rebut this showing if it can establish that the restraint on trade is not "reasonably
necessary to achieve the [purportedly] pro-competitive objective" asserted
by the antitrust defendant. The opinion also notes that there is a class
of activities that have been deemed "unlawful per se" that
includes "horizontal price fixing, output limitations, market allocation,
and group boycotts," citing Copperweld Corp. v. Independence Tube
Corp., 467 U.S. 752, 768 (1984).

The opinion rejected what it termed "precedent
from other Circuits," namely the cases noted above that have almost
unanimously found reverse payment agreements to be lawful. The opinion
noted that in each case, the appellate court found the reverse payments to be
lawful based on the patent's presumption of validity and the patentee's right
to exclude, and that the agreements did not involve an improper extension of
that exclusionary right (as well as the policy considerations involving
favoring settlements). The panel opinion termed these considerations the "scope
of the patent" test, which it identified from the Second Circuit's In
re Tamoxifen Antitrust Litigation decision. In a footnote, the panel acknowledged
these decisions but, finding that they are persuasive and not binding authority
and that the panel does not find the arguments persuasive, they "decline
to follow [them]."

The panel then explained its analysis of
this case law and why it is unpersuaded. Put simply, the panel does not
believe that the "scope of the patent" test is the appropriate test
and should not entitle reverse payments to avoid antitrust scrutiny. The
opinion forms this conclusion because "that test [in the panel's view] improperly
restricts the application of antitrust law and is contrary to the policies
underlying the Hatch-Waxman Act and a long line of Supreme Court precedent on
patent litigation and competition." The opinion provides three
grounds for this conclusion. First, the opinion stated that it creates "an
almost unrebuttable presumption of patent validity," due to the fact that
the settlement "forces a presumption that the patent holder would have
prevailed" in the underlying (and settled) ANDA litigation. This
presumption has (or should have) no substantive vitality, according to the
panel, because it is merely 'a procedural device and is not a substantive right
of the patent holder," citing Stratoflex, Inc. v.
Aeroquip Corp., 713
F.2d 1530, 1534 (Fed. Cir. 1983). The opinion also believed using the
presumption of validity to uphold reverse payment agreements was "particularly
misguided" when the basis for the underlying patent infringement defense
is non-infringement (as it was in this case), because the burden is properly on
the patentee, not the challenger, to prove infringement. The panel
opinion also "question[ed] the assumption" that subsequent ANDA
filers will come forward to challenge "weak" patents.

The Third Circuit panel considered perceived
pernicious effects on reverse settlements as being directed to first ANDA
filers, which it asserts are the "most motivated" due to the promise
of 180 days of market exclusivity. The panel also cites several Supreme
Court cases for the proposition that patent rights are "a limited
exception to a general rule of the free exploitation of ideas" that
indicate that "the public interest supports judicial testing and
elimination of weak patents" (this in contrast to the 11th Circuit's
recognition that:

No matter how valid a patent is — no matter how often it has been
upheld in other litigation or successfully reexamined — it is still a gamble
to place a technology case in the hands of a lay judge or jury. Even the
confident patent owner knows that the chances of prevailing in patent
litigation rarely exceed seventy percent. Thus, there are risks involved
even in that rare case with great prospects.

The panel explicitly limited the scope of
its decision to "reverse payments between patent holders and would be
generic competitors in the pharmaceutical industry." It is clear that the
panel was motivated at least in part by its perception, as argued by the FTC,
that reverse payment settlement agreements were contrary to and in
contravention of Congressional goals of "increase[ing] the availability of
low cost generic drugs" (despite findings in other circuits that in some
circumstances reverse payment settlements do just that). Nevertheless,
the panel found that "[t]he line that Congress drew between these
competing objectives [of stimulating innovation and furthering the public
interest] strongly supports the application of rule of reason scrutiny of
reverse payment settlements in the pharmaceutical industry." And the
panel limits the scope of its decision only to settlements that involve
payments from the patentee to the putative generic competitor: "[n]othing
in the rule of reason test that we adopt here limits the ability of the parties
to reach settlements based on a negotiated entry date for marketing of the
generic drug: the only settlements subject to antitrust scrutiny are
those involving a reverse payment from the name brand manufacturer to the
generic challenger." According to the Court, "the vast majority
of pharmaceutical patent settlement [will be] unaffected" by its ruling.

The proper procedure under Third Circuit
law is thus to use a "quick look" rule of reason analysis "based
on the economic realities of the reverse payment settlement rather than the
labels applied by the settling parties" and that "any payment from a
patent holder to a generic patent challenger who agrees to delay entry into the
market as prima facie evidence of an unreasonable restraint of trade."
In doing so, the Court also "agrees [] with the FTC that there is no need
to consider the merits of the underlying patent suit because '[a]bsent proof of
other offsetting consideration, it is logical to conclude that the quid pro
quo for the payment was an agreement by the generic to defer entry beyond
the date that represents an otherwise reasonable litigation compromise,'"
citing the Commission's Final Order in this matter that was overturned by the 11th
Circuit.

Merck has now petitioned for
certiorari; the Question Presented is:

Whether the federal antitrust laws permit a
brandname manufacturer that holds the patent for a drug to enter into a
settlement of patent litigation with a prospective generic manufacturer, where
the settlement includes a payment from the brand manufacturer to the generic
manufacturer but does not exclude competition beyond the scope of the patent.

According to the petition, there
are three reasons why certiorari should be granted. First, the Third Circuit's decision creates a
"circuit split" below regarding the "appropriate standard"
to be applied in assessing antitrust liability for settlements of ANDA
litigation between branded and generic drug makers. Second, this case is an "ideal vehicle"
for the Court to consider the question.
The "divergent legal standard" applied by the Third and
Eleventh Circuits were applied "in
reviewing the very settlements at issue [in this case]" (emphasis in petition), a circumstance
where "the Court can be not only confident, but certain, that a circuit
conflict concerning the appropriate legal standard is squarely implicated,
because two courts of appeals have applied different legal standards to the same
facts," citing United States v. American Can Co., 280 U.S.
412, 415-16 (1930). In addition, in
this case the Court would have the benefits of an extensive record, including
the proceedings before the FTC, the District Court and two appellate
courts. Finally, the petition asserts
that the Court will hear from all interested parties — branded and generic drug
makers, private plaintiffs including wholesale and retail drug stores, and the
government. Third, the petition
characterizes the Question Presented as "an exceptionally important and
recurring one" with great "legal and practical significance." Moreover, "[f]urther percolation []
would serve no useful purpose." And, "if
left undisturbed, the decision of the Third Circuit — a circuit with jurisdiction
over many of the Nation's major pharmaceutical companies — promises to have a
chilling effect on patent settlements between brand manufacturers and generic
manufacturers." But while the Third
Circuit's decision may appear to be limited to settlements where there is an
actual payment from the branded drug maker to one or more generic companies,
the petition notes that, "[s]eemingly emboldened by the Third Circuit's decision,
however, the FTC has recently taken the position in litigation that 'payments' include terms of settlements that cannot
meaningfully be characterized as payments at all, such as terms concerning the
entry of brand manufacturers' own generic versions, citing the FTC Brief in In
re Effexor XR Antitrust Litig., Civ. No. 11-5479 (D.N.J.) (filed Aug. 10,
2012).

It is unlikely that any of the
parties — or the government — will oppose this petition, making it likely for
that reason alone that the Court will grant cert. And insofar as this is in many respects a "patent"
case, it seems even less likely that the Court will resist the siren call of
another opportunity to consider this area of the law.
USPTO News Briefs

August 27, 2012

By Donald Zuhn —

USPTO to Hold Roundtable on
AIA First Inventor to File Provisions

Earlier this month, the
U.S. Patent and Trademark Office published a notice in the Federal Register (77
Fed. Reg. 49427)
announcing that the Office will be hosting a roundtable on September 6, 2012 to
obtain public input from organizations and individuals on issues relating to
the USPTO's proposed implementation of the first-inventor-to-file provisions of
the AIA. On July 26, the Office
published a notice of proposed rulemaking regarding "Changes to Implement
the First Inventor to File Provisions of the Leahy-Smith America Invents
Act" (77 Fed. Reg. 43742)
and a request for comments regarding "Examination Guidelines for
Implementing the First-Inventor-to-File Provisions of the Leahy-Smith America
Invents Act" (77 Fed. Reg. 43759). The roundtable will focus on the above
documents.

The roundtable will be held
from 1:30 to 4:30 (EDT) in the Madison Auditorium at 600 Dulany Street in Alexandria,
Virginia, and is open to the public. The Office indicated that it plans to invite a number of roundtable
participants from among patent user groups, practitioners, industry,
independent inventor organizations, academia, and the government. An agenda for the roundtable can be found
here. The roundtable will be available via WebEx
webinar
(event number: 997 151 983; password: 123456) or teleconference at +1-408-600-3600 (access
code: 997 151 983).

USPTO to Hold Eight AIA
Roadshows on Final Rules

The U.S. Patent and
Trademark Office has announced that it will be hosting eight roadshows in
September to share information about the new final rules for implementing the
provisions of the Leahy-Smith America Invents Act that take effect on September
16, 2012. The final rules to be covered
at the roadshows relate to the inventor's oath/declaration, preissuance
submissions, citation of patent owner statements, supplemental examination, inter partes review, post grant review,
and covered business method review provisions of the AIA. The roadshows will be free and open to the
public. While pre-registration is not
required, seating will be available on a first-come, first-served basis. The Office notes that the roadshows in
Minneapolis, Alexandria, and Los Angeles will be webcast. The eight roadshows include:

Monday, September 10
Hennepin County Library
Minneapolis, MN

Wednesday, September 12
USPTO Campus
Alexandria, VA

Friday, September 14
Los Angeles Public Library
Los Angeles, CA

Monday, September 17
Denver Public Library
Denver, CO

Thursday, September 20
Detroit Public Library
Detroit, MI

Monday, September 24
Georgia Institute of
Technology Library
Atlanta, GA

Wednesday, September 26
Rice University Fondren
Library
Houston, TX

Friday, September 28
New York Public Library
New York, NY

According to the USPTO's AIA
Roadshow webpage, the
agenda of the roadshows will be as follows:

10:30 am — Opening Remarks

11:00 am — Patents: Final
Rules for Inventor's Oath/Declaration, Pre-issuance Submission, Miscellaneous
Post Patent Provisions, and Supplemental Examination

12:30 pm — Lunch Break

1:30 pm — Board: Umbrella
Final Rules and Specific Final Rules for Post Grant Review, Inter Partes Review, and Covered Business Method Review

3:15 pm — Break

3:30 pm — Finance:
Proposed Rules for Fees

4:10 pm — Patents:
Proposed Rules for First-Inventor-to-File

4:50 pm — Closing Remarks

USPTO Expands Patent Law
School Clinic Certification Pilot Program

Last month, the U.S. Patent
and Trademark Office announced
the further expansion of the Patent Law School Clinic Certification Pilot
Program to include an additional eleven schools for the upcoming academic
year. Under the pilot program, law
students are permitted to practice patent law before the Office under the
guidance of a law school faculty clinic supervisor. In particular, students in the program can
expect to draft and file a patent application and respond to an office action.

The Patent Law School
Clinic Certification Pilot Program was begun in 2008 with six law schools, was
expanded to include ten more schools in 2010 (some of the participating schools
allow students to practice before the Office in both patents and trademarks and
others allow students to practice before the Office in trademarks only). The eleven new participating schools are
Arizona State University Sandra Day O'Connor College of Law, Case Western
Reserve University School of Law, University of Colorado Law School, Fordham
University School of Law, University of Maryland Francis Carey School of Law,
North Carolina Central University School of Law, University of Notre Dame Law School,
University of Puerto Rico Law School, Thomas Jefferson School of Law,
University of Washington School of Law, and Wayne State University Law
School. The above schools join the
sixteen prior participating law schools — University of Akron School of Law;
American University, Washington College of Law; University of Connecticut
School of Law; The George Washington University School of Law; Howard
University School of Law; The John Marshall School of Law; University of Maine
School of Law; University of Maryland School of Law; University of New
Hampshire School of Law; North Carolina Central University School of Law;
University of Puerto Rico School of Law; University of Richmond – Richmond
School of Law; Rutgers Law School – Newark Vanderbilt College of Law; West
Virginia University School of Law; and William Mitchell College of Law.
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2012)

August 26, 2012

By
Kevin E. Noonan —

A
three judge Federal Circuit panel went a long way towards disentangling its
jurisprudence on the question of obviousness-type double patenting, in
affirming a District Court finding that the doctrine did not apply to the
patent claims at issue in Eli Lilly &
Co. v. Teva. In what seems to
becoming a penchant of this Court (see
"Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals,
Inc.: 'The Rest of the Story'"), the panel distinguished its decision rather
than simply finding the Court's most recent spate of decisions to have gone
astray (see "Cert. Denied in Eli Lilly v. Sun
Pharmaceuticals").

The present case concerns pemetrexed, a folate
metabolism inhibitor synthesized by Professor Ed Taylor at Princeton University
and developed by Eli Lilly & Co., sold as the anticancer drug Alimta®
for treating mesothelioma and small cell lung cancer. Pemetrexed's biological activity, as with
earlier folate inhibitors like methotrexate, is understood to result from its
structural similarity to naturally occurring folic acid, which is needed for
DNA and RNA synthesis:

Earlier embodiments of folate inhibitors, like
methotrexate, were disadvantageous because their effects on nucleic acid
metabolism were felt by non-cancerous as well as cancer cells, due to their ability to
inhibit cellular enzymes like dihydrofolate reductase (DHFR) that were needed
for both DNA and RNA production. Pemetrexed was able to specifically inhibit DNA synthesis by virtue of its specificity for enzymes such as thymidylate synthetase (because the nucleotide
thymidine is incorporated into DNA but not RNA).

Princeton University obtained (and Eli Lilly
licensed) three patents related to pemetrexed: U.S. Patent No. 5,344,932 (the patent-in-suit); U.S. Patent No.
5,028,608 and U.S. Patent No. 5,248,775. The '608 patent disclosed and claimed a related but structurally distinct
antifolate compound, and the '775 patent disclosed a "family of chemical
intermediates that can be used to make a variety of antifolates"; important for the
issues on appeal, the '775 patent disclosed an intermediate in antifolate
synthesis that can be used to make pemetrexed (along with a variety of other
antifolate molecules). The '608 and '775 patents expired prior to the instant
suit, while expiration of the '932 patent was delayed until July 14, 2016
pursuant to patent term extension under 35 U.S.C. § 156.

Eli Lilly sued Teva, Barr Laboratories and APP
Pharmaceuticals after each filed an ANDA, pursuant to 35 U.S.C. § 271(e)(2),
asserting claims 1, 2, 3 and 7 of the '932 patent. At the district court, the defendants
asserted as a defense that the claims of the '932 patent were invalid under the
judicially established doctrine of obviousness-type double patenting over claim
3 of the '608 patent (claiming a related but structurally distinct antifolate
molecule) and claim 7 of the 775 patent (that claims the intermediate). With regard to the '608 patent, Teva
contended at trial that pemetrexed was related to the compound claimed by claim
3 of the '608 patent by substitution of a thienyl group with a phenyl group,
something Teva asserted was "consistent with 'conventional wisdom' in the
field [of the pharmaceutical arts]" and thus rendered the claims invalid. As for the '775 patent, Teva's argument was that the pemetrexed compounds
claimed in the '932 patent were a "use" of the intermediate compound
disclosed in the '775 patent, and were invalid for double patenting under a
line of Federal Circuit cases, the most recent of which was Sun Pharmaceuticals Industries, Ltd. v. Eli
Lilly & Co. In the
alternative, Teva argued that pemetrexed was merely an obvious end product for
the '775 patent intermediate.

The District Court found none of these arguments
persuasive. The Court rejected Teva's "focus"
on the particular portion of pemetrexed that differed from the compound
disclosed in the '608 patent, saying that the weight of the evidence was that
the skilled worker would have "pursued changes outside of the aryl region
to improve TS inhibition and would have avoided introducing a phenyl group into
the '608 Compound based on previous reports of toxicity with analogous
antifolate structures." The basis
for the District Court's rejection of Teva's obviousness-type double patenting
argument over the disclosure of the '775 patent intermediate was that the
intermediate was not claimed ("so the teachings from the '775 patent's
specification were inapplicable to its obviousness-type double patenting
analysis") and that there were many possible end products that could have
been produced from the '775 patent intermediate and no reasoned basis for the
skilled worker to have produced pemetrexed as the end product.

The Federal Circuit agreed, in an opinion by Judge
Lourie joined by Judges Dyk and Wallach. The panel rejected Teva's argument on appeal, that Federal Circuit
precedent (specifically, Amgen Inc. v. Hoffmann-La Roche Ltd., 580 F.3d
1340 (Fed. Cir. 2009)), mandated that a court look only at the differences
between the claims at issue and the earlier claims, "so that any features
held in common between the claims — in this case, all but the aryl regions of the
'608 Compound and pemetrexed — would be excluded from consideration." The panel acknowledged that Amgen directs a court to identify the
differences, but asserts that Amgen
then requires that the claims at issue be considered "as a whole" and
not "the differences [] in isolation." The basis for this analytical framework is
the rubric reasserted in Amgen that
obviousness-type double patenting is assessed "analogous to an obviousness
analysis under 35 U.S.C. §103." And as in a § 103
analysis, claims must be considered "as a whole" in an obviousness-type double patenting analysis says the panel, citing General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992). "On the merits," the
panel found no basis for finding clear error in the District Court's factual
determinations underlying its judgment, and "absent any motivation to
derive pemetrexed from the '608 Compound or reason to expect success in doing
so," the panel concluded that the District Court had not erred in finding against
Teva that the asserted claims of the '932 patent were not invalid for
obviousness-type double patenting over the claims of the '608 patent.

Turning to Teva's obviousness-type double patenting
arguments based on the teachings of the '775 patent, the panel noted that these
argument's were rooted in earlier precedent, specifically citing In re Byck,
48 F.2d 665 (CCPA 1931), and Sun Pharmaceutical Industries, Ltd. v. Eli
Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010). But the panel found this reliance on these
cases "unsound" and proceeded to distinguish this case from that
precedent. The panel began by citing the
"general rule" that obviousness-type double patenting depends on a
comparison with what is claimed in an earlier patent, "with the earlier
patent's written description considered only to the extent necessary to
construe its claims," citing In re Avery, 518 F.2d 1228, 1232 (CCPA
1975). The panel then further reaffirmed
the fundamental principles that the doctrine of obviousness-type double
patenting is concerned with what is claimed, not what is disclosed, because the
goal of the doctrine is to prevent separate patenting of merely obvious
variants of a previously patented invention.

The opinion then characterized the line of cases
relied upon by Teva as "a limited exception" to this rule. The basis for this exception was set forth in
Byck, wherein:

It would shock one's
sense of justice if an inventor could receive a patent upon a composition of
matter, setting out at length in the specification the useful purposes of such
composition, manufacture and sell it to the public, and then prevent the public
from making any beneficial use of such product by securing patents upon each of
the uses to which it may be adapted.

Next, the Court turned to a "trio" of
recent cases: Sun Pharma, Geneva Pharm., Inc.
v. GlaxoSmithKline PLC, 349 F.3d 1373
(Fed. Cir. 2003), and Pfizer, Inc. v. Teva
Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir.
2008). Each of these cases,
according to the panel, resulted from situations where the second patent
claimed a use of a composition claimed in an earlier patent that disclosed the
later-claimed use. According to the
opinion, these cases each "address the situation in which an earlier
patent claims a compound, disclosing the utility of that compound in the
specification, and a later patent claims a method of using that compound for a
particular use described in the specification of the earlier patent,"
citing Sun Pharma, and that in each case the later
application (or patent) claimed "a, or the" disclosed use of the
composition claimed in the earlier patent. This analysis was enough by itself to distinguish the claims at issue
here, because it was not disputed that the intermediate compound disclosed in
the '775 patent (and the compound claimed in the '608 patent) were not the same
compound claimed in the '932 patent, i.e., pemetrexed. Under these circumstances, "[t]he particular
concerns motivating our prior decisions are [] absent here" because the
claims of the '932 patent were "wholly independent" of the claims of
the '775 patent, according to the opinion. And "[p]utting aside the
teachings in the '775 patent's specification, Teva's double patenting
contentions evaporate." In
addition, the panel noted that it had no basis for finding error in the District Court's conclusion that there was "no reason" the skilled
worker would have chosen to make pemetrexed from the '775 patent intermediate,
noting in passing that while not controlling, this conclusion was consistent
with the provisions of the Manual of Patent Examining Procedure that states
that:

[A]n
intermediate product and a final product can be shown to be distinct inventions
if the intermediate and final products are mutually exclusive inventions (not
overlapping in scope) that are not obvious variants, and the intermediate
product as claimed is useful to make other than the final product as claimed. §806.05(j).

Finally, the
panel found that the District Court had erred by refusing to consider so-called
"secondary" considerations of non-obviousness, on the grounds that
these considerations were not to be applied in an obviousness-type double
patenting assessment (on the contrary, the opinion asserts that they must be considered). But this was
harmless error because the District Court had reached the correct conclusion in
rejecting Teva's invalidity arguments based on obviousness-type double
patenting.

The panel's
opinion and discussion of the reasoning behind it appears to have cabined to a
narrow category of facts the trio of decisions that applied the disclosure, as
opposed to just the claims, of an earlier patent to make an obviousness-type
double patenting determination on later-filed claims. Under the revised interpretation of the
obviousness-type double patenting standard enunciated by the Lilly court here, the claims of an
earlier patent alone are to be considered for determining obviousness-type
double patenting, except insofar as
the disclosure of the earlier patent is necessary to construe the scope of the
earlier claims, or unless the later
application claims a use for a composition claimed in an earlier patent wherein
the use itself is disclosed but not claimed in the earlier patent. If this view is not further distinguished by
a future panel, the Court may have brought some certainty to the application of
the obviousness-type double patenting doctrine, consistent with their mandate
from Congress to harmonize and clarify U.S. patent law.

Eli Lilly & Co. v. Teva
Parenteral Medicines, Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Lourie, Dyk, and Wallach
Opinion by Circuit Judge Lourie
Court Report

August 26, 2012

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Merck Sharp
& Dohme Corp. v. Watson Laboratories, Inc.
3:12-cv-05228;
filed August 20, 2012 in the District Court of New Jersey

Infringement
of U.S. Patent Nos. 5,571,817 ("Methods of Treating Androgenic Alopecia
with Finasteride
[17β-N-mono-substituted-carbamoyl-4-aza-5-α-androst-1-en-ones]," issued
November 5, 1996), 5,547,957 ("Method of Treating Androgenic Alopecia with
5-α Reductase Inhibitors," issued August 20, 1996), and 5,886,184 ("Finasteride
Processes," issued March 23, 1999) following a Paragraph IV certification
as part of Watson's filing of an ANDA to manufacture a generic version of Merck's
Propecia® (finasteride, used to treat androgenic alopecia). View the complaint here. [NB: Merck voluntarily dismissed the case
without prejudice 3 days after filing.]

Santarus,
Inc. et al. v. Dr. Reddy's Laboratories Inc. et al.
3:12-cv-05202;
filed August 15, 2012 in the District Court of New Jersey

• Plaintiffs:
Santarus, Inc.; The Curators of The
University of Missouri
• Defendants:
Dr. Reddy's Laboratories Inc.; Dr. Reddy's
Laboratories, Ltd.

Infringement
of U.S. Patent Nos. 6,699,885 ("Substituted Benzimidazole Dosage Forms and
Methods of Using Same," issued March 2, 2004), 6,489,346 (same title,
issued December 3, 2002), 6,645,988 (same title, issue November 11, 2003), and
7,399,772 (same title, issued July 15, 2008) following a Paragraph IV
certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic
version of Santarus' Zegerid® (omeprazole/sodium bicarbonate, used to treat
heartburn and other symptoms associated with gastroesophageal reflux
disease). View the complaint here.
Conference & CLE Calendar

August 26, 2012

August 27, 2012 – AIA Post-Grant Implementation Begins – Is Your Business Strategy Aligned? (Foley & Lardner) – 3:00 pm (Eastern)

August 30, 2012 – The Written Description Requirement: Are Antibodies Chemicals, Proteins, or Exceptions? (American Bar Association) – 1:00 – 2:30 pm (Eastern)

September 6, 2012 – A Review of the Impact of Recent Supreme Court and Federal Circuit Decisions on Patent Strategy (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am (CT)

September 9-11, 2012 – IPO Annual Meeting (Intellectual Property Owners Association) – San Antonio, TX

September 10-12, 2012 – Business of Biosimilars & Generic Drugs (Institute for International Research) – Boston, MA

September 18,
2012 – New USPTO Rules for Post-Grant Proceedings (Strafford) – 1:00 – 2:30 pm (EDT)

September 19, 2012 – New Post Grant Proceeding Rules: Adjusting to the New Reality (Technology Transfer Tactics) – 1:00 – 2:15 pm (Eastern)

September 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 24-25, 2012 – Biosimilars and Biobetters*** (SMi) – London, UK

September 25-26, 2012 – EU Pharma Regulatory Law*** (C5) – Brussels, Belgium

September 28, 2012 – Focus on Biologics and Biosimilars (Catalyzing Collaboration Between Industry and Academia in the Life Sciences) – Hospira, Inc., Lake Forest, IL

October 10-11, 2012 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) – New York, NY

October 10-11, 2012 – Biotech & Pharmaceutical Patenting*** (C5) – London, UK

October 22-23, 2012 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – John Hopkins University, Montgomery County, MD

October 24-25, 2012 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

October 25-26, 2012 – Life Sciences Congress on
Paragraph IV Disputes (Center for
Business Intelligence) – Washington, DC

***Patent Docs is a media partner of this conference or CLE

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