Patent Docs

Conference & CLE Calendar

July 21, 2013

July 22, 2013 – IP & Diagnostics Symposium (Biotechnology
Industry Organization) – Alexandria, VA

July 22, 2013 – Patent-Eligible Subject Matter After CLS Bank and Ultramercial: Implications
of Two Key Federal Circuit Decisions (Law
Seminars International) – 3:00
to 4:00 pm (Eastern)

July 24, 2013 – AIA and Patent Prosecution: Navigating the
Ethical Grey Areas (Strafford) – 1:00 to 2:30 pm
(EDT)

July 28-30, 2013 – 2013 Annual Meeting & Conference (National Association of Patent Practitioners) – San
Diego, CA

July 30,
2013 – Are We Innovators, or Are We
Trolls: The Slippery Slope of Defining A Patent Troll (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

July 31, 2013 – Battling Patent Trolls: Leveraging New
Executive Orders, AIA and Other Tools (Strafford) – 1:00
to 2:30 pm (EDT)

July 31 to August 2, 2013 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

August 5-7, 2013 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

August 8, 2013 – Analyzing and Adapting to the Supreme Court's
Myriad Ruling (Technology
Transfer Tactics) – 1:00 to 2:00 pm
(Eastern)

August 8-11,
2013 – 2013 Annual Meeting (American Bar
Association) – San Francisco, CA

August 21, 2013 – Inducement to Infringe in Hatch-Waxman Litigation: Lessons from Commil USA v. Cisco Systems and Bayer Schering v. Lupin for Pharma
Patents (Strafford) – 1:00 to 2:30 pm (EDT)

August
22, 2013 – What are the Implications of CLS
Bank Int'l v. Alice Corp. on Computer-Implemented Inventions? (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

September 17-18, 2013 – FDA Boot Camp (American Conference
Institute) – Boston, MA

September 18, 2013 – Conflicts in Patent Prosecution: Avoiding the
Ethical Pitfalls Minimizing Risks of Malpractice Liability and Ethics Sanctions (Strafford) – 1:00 to 2:30 pm (EDT)

***Patent Docs is a media partner of this conference or CLE
Webinar on Battling Patent Trolls

July 19, 2013

Strafford
will be offering a webinar/teleconference entitled "Battling Patent Trolls: Leveraging New
Executive Orders, AIA and Other Tools" on July 31, 2013 from 1:00
to 2:30 pm (EDT). Scott A. McKeown of Oblon Spivak McClelland
Maier & Neustadt and Scott Marks, Senior Intellectual Property Counsel for
St. Jude Medical will discuss recent developments and new tools to battle
so-called patent trolls, including recent executive orders, the America Invents
Act (AIA), and state and congressional action. The panel will discuss the
impact of these efforts and offer best practices for combating patent trolls
before and during litigation. The
webinar will review the following questions:

•
How are the executive orders anticipated to impact patent troll litigation?
•
How can counsel act to proactively minimize the threat of patent troll
litigation?
•
What defense strategies are effective in combatting patent trolls in
litigation?

The
registration fee for the webinar is $297 ($362 for registration and CLE processing). Those interested in registering for the
webinar, can do so here.
CLE on Patent-Eligible Subject Matter After CLS Bank and Ultramercial

July 19, 2013

Law
Seminars International (LSI) will be offering a one-hour telebriefing on "Patent-Eligible Subject Matter After CLS Bank and Ultramercial: Implications
of Two Key Federal Circuit Decisions" on July 22, 2013 from 3:00
to 4:00 pm (Eastern). Eric L. Sophir of Dentons will
moderate a panel that includes Thomas
W. Krause, Special Counsel for Intellectual Property Litigation, Solicitor's
Office, U.S. Patent and Trademark Office; Michael B. Chernoff, Director of
Legal Services, Patent Operations, Accenture; and Benjamin Lee, Legal Counsel,
Twitter. The panel will assess
the implications of the CLS Bank and Ultramercial
decisions and provide practical guidance for assessing patent-eligibility of an
invention, particularly software and business methods patents. Among the topics to be covered are:

•
Impact of the decisions on applications and challenges to software and business
methods patents
•
Current test for assessing patent-eligibility under Section 101
•
When and how the Abstract Idea Exception may apply
•
Strategies for drafting claims for examination at the U.S. Patent &
Trademark Office
•
Predictions on future handling of this issue by the courts

A
Q&A will follow the presentation and last for up to 30 minutes.

The
registration fee is $150 per caller and $100 for each additional person on the
same line who desires continuing education credit. Those interested in registering for the
telebriefing, can do so here.
IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

July 18, 2013

By
Kevin E. Noonan —

Earlier
this month, the Generic Pharmaceutical Association (GPhA) held a press
conference to announce the release of a study of the effects of reverse
payment settlement agreements in ANDA litigation. Such agreements have long been vilified by
the Federal Trade Commission and have been the subject of extensive litigation
that culminated in a decision by the U.S. Supreme Court last month that
mandated these agreements are to be evaluated for antitrust liability under the
"rule of reason" (see "Federal Trade Commission v. Actavis, Inc. (2013)"). In its decision the Supreme Court
rejected the FTC's position that these agreements should be presumptively illegal
or, in the alternative, subject to so-called "quick look" rule of
reason assessment.

The
study, commissioned by the GPhA and performed by the IMS (Intercontinental
Marketing Services) Institute for Healthcare Informatics (an independent
research organization with branches in the U.S., China, and India), should
provide solid support for parties to such agreements should the FTC come
calling with allegations of anticompetitive behavior. (The likelihood of such inquiries is enhanced
by the provisions of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Public Law 108-17) that require parties to ANDA
settlements to submit these settlements to the FTC for review.) The bottom line: settlements of ANDA
litigation in 33 different drug molecules resulted in a savings to consumers of
$25.5 billion from 2005-2012, and are projected to provide an additional $61.7
billion through patent expiry for patents listed in the Orange Book for these
drugs. About one third ($8.3 billion) of
the 2005-2012 total were savings to the Federal government.

The
methodology used by IMS calculated the average brand and generic drug costs
over time from IMS National Sales Perspective, described as the "industry
standard" for pharmaceutical costs that captures 100% of the market; the
volume of brand and generic drug activity was calculated from the National
Prescription Audit, a measure of "dispensed" prescriptions from
retail, long-term care pharmcies and prescription mail services; and dates of
brand patent expiry were obtained from the FDA Orange Book. The GPhA identified 65 molecules subject to
ANDA settlement agreements, and 32 of these molecules were excluded from the
study because the generic had not yet launched, there was insufficient data for
other reasons, or the "calculated" generic price was not less than the branded
drug price.

In
addition to the cost savings, the study found that generic drugs were brought
to market an average of 81 months (6.75 years) before patent expiry (i.e., the
date a branded drug maker could have enjoyed the patent "monopoly rents"
so often disparaged by the FTC in suits and public statements about these
agreements (see "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation").

The
GPhA issued the following statement regarding the results from this study:

"For years, opponents of
pharmaceutical patent settlements with consideration have stated that
settlements create a cost for consumers, the government and others. This new
analysis provides the most current, complete and transparent estimate of the
impact of patent settlements on health costs, and it shows that the opposite is
true," said Ralph G. Neas, President and CEO of the Generic Pharmaceutical
Association. "In particular, the new analysis estimates that patent
settlements — including those with consideration — have led to billions in
savings. For example, the settlement involving Lipitor alone will save $22
billion over the next four years. This is critical for lawmakers to understand,
because any further restrictions on settlements will put these savings at risk."

The
GPhA also noted that Department of Labor statistics show that drug expenditures
have declined for the first time in 55 years during the time that branded and
generic drug makers have entered into reverse payment settlement agreements.

The
IMS Healthcare Institute states that its objectives include "[t]o provide
key policy setters and decision makers in the global health sector with unique
and transformational insights into healthcare dynamics derived from granular
analysis of information." While the
implications of its results may be disputed because the GPhA commissioned the study,
the data speak for themselves. It seems
likely that these statistics will provide objective evidence of pro-competitive
consequences of these settlements that both parties (branded and generic) will be
able to use (persuasively) when and if the FTC challenges these settlements,
either before the Commission or before the courts, or if private parties bring
such challenges. In view of the several
bills introduced in this and other Congresses that would render such
settlements illegal, it can be hoped that the study is presented to
policymakers (in both the legislative and executive branches) so that laws and
policies are developed that account for the facts, rather than the presumptions
and prejudices, that surround such settlement agreements.

For additional information regarding this topic, please see:

• "Impact of Patent Settlements on Drug Costs: Summary of Findings," July 9, 2013
News from Abroad: Second Referral for the “Broccoli” Patent Case to the Enlarged Board of Appeal

July 18, 2013

Following the issuance of decision G2/07 in
connection with the "Broccoli" patent, which discussed whether plant
breeding methods were excluded from patentability as essentially biological
processes for the production of plants, the Technical Board of Appeal in
proceedings T83/05 have now referred further questions to the Enlarged Board of
Appeal, relating to whether the exclusion of Article 53(b) extends to the
products of essentially biological processes.

The issue of whether the exclusion of Article 53(b)
prohibits the allowability of the patent's product claims was only raised during
appeal proceedings and not during opposition proceedings. However, as the
respondent had consented to the examination of the objection and as the
objection was relevant to the maintenance of the patent, the Technical Board of
Appeal decided to consider it. Further, similar questions had been referred to
the Enlarged Board of Appeal regarding the "Tomato" case, which are
currently pending as case G2/12.

The Technical Board of Appeal suggested that the
product claims were not excluded under Article 53(b), as the plants were not
defined by a multitude of characteristics resulting from a given genotype or
combination of genotypes but only by a particular trait, which is not
sufficient to define a plant variety without providing further information
about the genotype.

However, the essentially biological process claims
of the application would cover plants which are produced by the excluded
process. Further, the subject-matter of a product-by-process claim extends to
products which are structurally identical to the products produced by the
process but are produced by a different process, though no alternative processes
are disclosed in the application. A product claim generally provides protection
for the process of making the product and so the product claims discussed in
this case would protect any act of making the claimed plants, including those
processes excluded from patentability.

In response to this argument, the respondent raised
the possibility of including a disclaimer to waive a part of the prerogatives
of the owner of a product patent, namely the essentially biological process for
producing the plant itself. This disclaimer was not deemed to be a usual
disclaimer (which excludes part of the subject-matter defined in the claim) and
the Technical board of Appeal indicated that it was doubtful whether such a disclaimer
would be allowed.

The questions to be referred are:

1. Can the
exclusion of essentially biological processes for the production of plants in
Article 53(b) EPC have a negative effect on the allowability of a product claim
directed to plants or plant material such as plant parts?

2. In
particular:

• (a) Is a product-by-process
claim directed to plants or plant material other than a plant variety allowable
if its process features define an essentially biological process for the
production of plants?

• (b) Is a claim directed to
plants or plant material other than a plant variety allowable even if the only
method available at the filing date for generating the claimed subject-matter
is an essentially biological process for the production of plants disclosed in
the patent application?

3. Is it of
relevance in the context of questions 1 and 2 that the protection conferred by
the product claim encompasses the generation of the claimed product by means of
an essentially biological process for the production of plants excluded as such
under Article 53(b) EPC?

4. If a claim
directed to plants or plant material other than a plant variety is considered
not allowable because the plant product claim encompasses the generation of the
claimed product by means of a process excluded from patentability under Article
53(b) EPC, is it possible to waive the protection for such generation by "disclaiming"
the excluded process?

This
report comes from European Patent Attorneys at WP
Thompson & Co., 55 Drury Lane, London UK. Further details and
commentary can be obtained from Gill Smaggasgale,
a partner at the firm.

Image of Brassica oleracea var. italica, Location: Maui, Foodland Pukalani (above) by Forest & Kim Starr, from the Wikipedia Commons under the Creative Commons Attribution 3.0 Unported license.
Senator Leahy Urges NIH to Use March-In Rights on Myriad BRCA Test

July 17, 2013

By Donald Zuhn —

On Friday, Sen. Patrick
Leahy (D-VT) sent a letter to Dr. Francis Collins, the Director of the
National Institutes of Health (NIH), "to urge [the Director] to consider
using march-in rights under the Bayh-Dole Act to ensure greater access to
genetic testing for breast and ovarian cancer." The Bayh-Dole Act, which was enacted in 1980,
created a uniform patent policy among the many federal agencies that fund
research, enabling small business and non-profit organizations — including
universities — to retain title to inventions made under federally funded
research programs. In commemorating the
Act's 30th anniversary in 2010, the U.S. Patent and Trademark Office noted that
"[t]he legislation is credited with the creation of thousands of new
companies and billions of dollars of direct benefits to the U.S. economy"
(see "USPTO Recognizes 30th Anniversary of Bayh-Dole Act").

As a result of the concern
that U.S. taxpayers should not have to pay businesses for inventions that the
public has already paid for, legislators added a section to the Act that gave
the government "march-in" rights.
Recently, a handful of groups filed a petition with the NIH requesting
the agency to exercise these march-in rights over the anti-AIDS drug ritonavir,
exclusively sold by Abbott Laboratories (see
"Groups Petition for NIH Exercise
of March-in Rights over Abbott Laboratories' Norvir®,"
which includes a discussion of the statute and regulation governing the exercise of
the government's march-in rights under the Bayh-Dole Act, as well as a recent
history of requests that the government exercise such rights).

In
encouraging the NIH to exercise its march-in rights with respect to the
Myriad's BRCA test, Sen. Leahy (above right) indicates that:

Myriad's genetic test, which was developed with federally-funded research, is
truly important for public health. Myriad
is the only provider of this test because it is covered by patent protection. Unfortunately, testimony before the United
States Patent and Trademark (USPTO) revealed that Myriad does all of this
testing in-house, and charges between $3,000 and $4,000.

The
letter notes that while the Supreme Court determined last month in Association
for Molecular Pathology v. Myriad Genetics, Inc.
that a naturally occurring DNA segment is a product of nature and not patent
eligible merely because it has been isolated, the Court also held that cDNA is
patent eligible because it is not naturally occurring (albeit with the caveat,
which the letter does not address, that a "very short series of DNA may
have no intervening introns to remove when creating cDNA," and therefore,
"a short strand of cDNA may be indistinguishable from natural DNA"). "As a result," Sen. Leahy suggests
that "Myriad may continue to be the only company able to provide women
with the genetic testing they need to make important health care decisions."

Sen.
Leahy explains that because "the Bayh-Dole Act . . . gives the government
tools, known as 'march-in rights,' to provide greater access to the subject
invention in appropriate situations," "[t]he government can require
the patent holder to grant a license to the patent on reasonable
terms." He notes that "[i]f
the patent owner refuses, the government can directly license the patent in
limited circumstances, including if it 'is necessary to alleviate health or
safety needs which are not reasonably satisfied' by the patentee." Indicating that "Myriad's patents were based
in part on federally-funded research," and stating that the health
benefits and healthcare cost savings of genetic testing for breast and ovarian
cancer are clear, Sen. Leahy expresses "concern[] that the health needs of
the public are not reasonably satisfied by the patentee in this situation
because testimony presented to the USPTO made clear that many women are not
able to afford the testing provided by Myriad." He therefore encourages the Director to
consider using the government's march-in rights with respect to the Myriad's BRCA test.

Interestingly,
of the ten patents that Myriad recently asserted against Ambry Genetics (see "Myriad Genetics Files Suit
Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes"),
only two (U.S. Patent Nos. 5,747,282 and 5,753,441) are assigned (on their
face) to the U.S. government (as well as to Myriad and the University of Utah
Research Foundation). Of the remaining
patents, one (U.S. Patent No. 5,709,999) is assigned to Myriad, the Centre de
Recherche du Chul (Sainte-Foy, Canada), and the Cancer Institute (Tokyo, Japan);
two (U.S. Patent Nos. 5,837,492 and 6,033,857) are assigned to Myriad, Endo Recherche,
Inc. (Sainte-Foy, Canada), HSC Research & Development Ltd. (Toronto,
Canada), and the Trustees of the University of Pennsylvania; three (U.S. Patent
Nos. 5,654,155, 5,750,400, and 6,051,379) are assigned to OncorMed, Inc.; one
(U.S. Patent No. 6,951,721) is assigned to Gene Logic Inc.; and one (U.S.
Patent No. 7,250,497) is assigned to Myriad alone. A search of the USPTO's Assignments on the
Web for Patents (AOTW-P) database indicates that Myriad assigned the '999,
'492, and '857 patents to the University of Utah Research Foundation, and that
the '155, '400, '379, and '721 patents are assigned to Gene Logic Inc. and
Myriad.

Patent Docs thanks Hal
Wegner for alerting the patent community to Sen. Leahy's letter.
New Patent Litigation Bill Introduced in House

July 16, 2013

By Donald Zuhn —

Last week, Rep. Hakeem
Jeffries (D-NY) introduced the "Patent Litigation and Innovation Act of
2013" (H.R. 2639)
in the House. The bill, which would add procedural
requirements for patent infringement suits, is related to the "Patent
Abuse Reduction Act of 2013" (S. 1013), which was introduced in the Senate
in May (see "Congress Continues Efforts to
"Reform" U.S. Patent Law").

Like
S. 1013, H.R. 2639 would require a party alleging infringement to include in
its complaint, counterclaim, or cross-claim an identification of each patent,
and each claim of each patent, allegedly infringed, as well as a specific
identification of each accused instrumentality alleged to infringe the claim,
the party alleging infringement would also be required to provide "a
description of the principal business of the party alleging infringement"
and to identify co-owners, assignees, and exclusive licensees of the asserted
patent. Unlike the Senate version of the
bill, the House version would not require a party alleging infringement to
include a list of other complaints (of which the party alleging infringement
has knowledge) asserting the same patents; whether the asserted patents are subject
to any licensing term or pricing commitments through any agency, organization,
standard-setting body, or other entity or community; or the identity of any
person having a direct financial interest in the outcome of the action.

In
addition, while S. 1013 would limit discovery prior to claim construction
"to information necessary for the court to determine the meaning of the
terms used in the patent claim, including any interpretation of those terms used
to support the claim of infringement," H.R. 2639 would permit a court to
stay discovery "if the court determines that a ruling relating to the
construction of terms used in a patent claim asserted in the complaint in the
action is required." The House bill
also includes provisions for a stay of action against secondary parties, which
would allow a court to "grant a motion to stay all or part of the action
as to a secondary party with respect to infringement related to a primary party
in the same or another action concerning the same apparatus, product, feature,
device, method, system, process, function, act, service, or other
instrumentality, in whole or in relevant part, of the disputed patent of the
primary party" provided that certain conditions are met.

In
addition, the House bill provides provisions for sanctions for abusive
litigation. In particular, the
legislation would require a court, upon final adjudication of "any civil
action arising under any Act of Congress relating to patents," to "include
in the record specific findings regarding compliance by each party and each
attorney representing any party with each requirement of Rule 11(b) of the
Federal Rules of Civil Procedure as to any complaint, responsive pleading, or
dispositive motion."

A
statement released on Rep. Jeffries' website
noted that the new legislation "represents a bipartisan effort to promote
American innovation and job creation in the technology ecosystem by addressing
the growing problem of abusive patent litigation." Rep. Jeffries (above left) suggested that the legislation
was needed because of "[t]he explosion of patent troll activity [that] diverts
resources away from research and development, hinders innovation and stifles
entrepreneurship." Co-sponsor Rep. Blake Farenthold
(R-TX) stated that "Americans need to know they are safe from abusive
litigation when they buy a product off the shelf and use it for its intended
purpose," adding that "[t]he solutions proposed in [H.R. 2639] will
deter patent trolls without impeding the rights of responsible intellectual
property holders."

After being introduced, the
bill was referred to the House Committee on the Judiciary.
Court Report – Part II

July 16, 2013

By Sherri Oslick —

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

Aptalis Pharma US Inc. et al.
v. Mylan Pharamaceuticals, Inc. et al.
3:13-cv-04158; filed July 5,
2013 in the District Court of New Jersey

• Plaintiffs: Aptalis Pharma US
Inc.; Aptalis Pharma Canada Inc.
• Defendants: Mylan
Pharamaceuticals, Inc.; Mylan Inc.

Infringement of U.S. Patent
Nos. 8,217,083 ("Mesalamine
Suppository," issued July 10,
2012) and 8,436,051 (same title, issued May 7, 2013) following a Paragraph IV
certification as part of Mylan's filing of an ANDA to manufacture a generic
version of Aptalis' Canasa® (mesalamine rectal suppository product, used to
treat active ulcerative proctitis). View
the complaint here.

Novartis AG et al. v. Accord
Healthcare, Inc. USA et al.
1:13-cv-01013; filed July 3,
2013 in the District Court of the District of Columbia

• Plaintiffs: Novartis AG;
Novartis Pharmaceuticals Corp.
• Defendants: Accord
Healthcare, Inc. USA; Intas Pharmaceutical Ltd.

Infringement of U.S. Patent
Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of
Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated
Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same
title, issued October 23, 2001) following a Paragraph IV certification as part
of Accord's filing of an ANDA to manufacture a generic version of Novartis'
Myfortic® (mycophenolate sodium, used for the prophylaxis or prevention of
organ rejection in patients receiving allogeneic renal transplants,
administered in combination with cyclosporine and corticosteroids). View the complaint here.

Purdue Pharma L.P. et al. v.
Teva Pharmaceuticals USA, Inc.
1:13-cv-04606; filed July 2,
2013 in the Southern District of New York

• Plaintiffs: Purdue Pharma
L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Grunenthal GmbH
• Defendant: Teva
Pharmaceuticals USA, Inc.

Infringement of U.S. Patent
Nos. 8,337,888 ("Pharmaceutical Formulation Containing Gelling Agent,"
issued December 25, 2012) and 8,309,060 ("Abuse-Proofed Dosage Form,"
issued November 13, 2012) following a Paragraph IV certification as part of
Teva's filing of an ANDA to manufacture a generic version of Purdue Pharma's
OxyContin® (controlled release oxycodone hydrochloride, used to treat
pain). View the complaint here.

Alpex Pharma, S.A. et al. v.
Zydus Pharmaceuticals USA, Inc. et al.
1:13-cv-04076; filed July 1,
2013 in the District Court of New Jersey

• Plaintiffs: Alpex Pharma,
S.A.; Citius Pharmaceuticals, LLC.; Prenzamax, LLC
• Defendants: Zydus
Pharmaceuticals USA, Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent
No. 6,149,938 ("Process for the Preparation of a Granulate Suitable to the
Preparation of Rapidly Disintegrable Mouth-Soluble Tablets and Compositions
Obtained Thereby," issued November 21, 2000) following a Paragraph IV
certification as part of Zydus' filing of an ANDA to manufacture a generic
version of Alpex's Suprenza® (phentermine hydrochloride, used to treat
obesity). View the complaint here.

Trivitis, Inc. v. Primus
Pharmaceuticals, Inc.
3:13-cv-00352; filed July 1,
2013 in the District Court of Nevada

Infringement of U.S. Patent
No. 6,562,864 ("Catechin Multimers as Therapeutic Drug Delivery Agents,"
issued May 13, 2003) based on Primus' manufacture and sale of its Limbrel
product (flavocoxid and citrated zinc bisglycinate, used for the clinical
dietary management of the metabolic processes of osteoarthritis). View the complaint here.
Smith & Nephew, Inc. v. Rea (Fed. Cir. 2013)

July 15, 2013

By Nicole Reifman
—

Last week, in Smith & Nephew, Inc. v. Rea, the
Federal Circuit reversed a decision of the Patent Trial and Appeal
Board, finding U.S. Patent No. 7,128,744 (the '744
patent), which is owned by Synthes, to be obvious. Smith & Nephew originally
submitted a request for reexamination of the '744 patent, which was granted. Upon review under reexamination, the Examiner
found all of the claims of the patent to be obvious. Synthes appealed the Examiner's decision to the
Patent Trial and Appeal Board, which reversed the Examiner's decision with respect to certain
claims (claims 1-23 and 32). Smith &
Nephew then appealed the Board's decision to the Federal Circuit. Despite the
deferential standard of review (substantial evidence) to be applied for a
Board decision, the Federal Circuit found claims 1-23 and 32 to be
obvious.

Both parties and
the Court treated claim 1 as representative for all claims under appeal. Claim 1 is related to a bone plating system designed
to improve the stability of a bone fracture in a long bone. The claimed system includes a plate with a shaft
portion that runs along the outside of a fractured bone, and a flared head
portion to accommodate the wider portion of the bone near a joint. Predrilled
holes are formed on both the shaft and the head portions of the plate. The dispute in the case focused on the
structure of the holes in the head portion of the plate; in particular, whether it would have
been obvious at the time of the invention to design a bone plate in which all
of the holes in the plate's head portion were conically tapered and at least
partially threaded, as required by claim 1.

A number of prior
art references were applied. First, the
Court found that a prior art Synthes condylar buttress plate disclosed most of
the limitations of claim 1 of the '744 patent, including a head portion of a
plate with at least three screw holes. An
article by Kenneth Koval and an FDA submission by Synthes (dubbed the K982222
reference) each disclosed modifying the Synthes prior art plate to include
partially threaded holes to engage the threads on the head of a locking
screw. A Synthes patent, U.S. Patent No.
5,709,686 (the '686 patent) disclosed anchor holes that were all partially
threaded and intended to accommodate either locking screws or compression
screws. Another article, by N.P. Haas,
disclosed holes in the head portion of a plate that were both conically tapered
and partially threaded; however, unlike the other prior art plates, the Haas
plate merely stabilized the femur and did not contact, let alone, compress,
bone fragments directly.

The Board found
that these prior art references did not teach or suggest the exclusive use of
conical, partially threaded holes in a condylar buttress plate because it was
not believed that conical, partially threaded holes could be used with non-locking
(compression) screws to provide compression against a bone. The Court held that the Board erred in its
analysis, since claim 1 of the '744 patent does not require that the screws
drilled into the head holes provide compression ("the patentability of the
invention . . . turns on the structure of the holes, not the special nature of the
non-locking screw"), and, contrary to Synthes' suggestion that compression is
needed in the head portion of the plate, the specification of the '744 patent
indicated that locking screws are sometimes used in all of the threaded holes
of the head portion of the plate.

The Court also found
the Board erred in determining the prior art showed that using a compression
screw in a conical, partially threaded hole would cause the screw to undesirably
protrude above the line of the plate. The
Court pointed to a chamfer disclosed in the Haas reference that could be used
to countersink a screw head so that it does not sit above the top surface of
the plate. The Board had disregarded
the Haas chamfer because a drawing in Haas showed the chamfer to be too narrow
to prevent protrusion of a compression screw. The Court held that the Board erred in disregarding the Haas chamfer, and that the chamfer should
not be limited to the narrow one shown in the drawing, as chamfers are "conventional features in the art and can be sized to accommodate screw threads
of varying heights." The Court also
reasoned that a person of ordinary skill in the art would not have necessarily
selected a "rounded-bottom head" that would stick out from the plate, but would
have chosen an appropriately shaped screw for the plate holes.

Finally, the Court
held that the Board erred in relying on distinguishing the partially threaded,
partly conical, holes discussed in the '686 patent from the fully conical
threaded holes in the Haas reference for obviousness. The Court noted that the '744 patent discloses
that partially threaded holes, regardless of shape, could provide compression,
and held that "a person of skill could adjust a plate hole's geometry — whether
conical, cylindrical, or otherwise — to fit any standard screw without
sacrificing compression."

Thus, the Court
held that the motivation to combine the holes in the Haas reference with the
prior art condylar plates was there: the use of threads in all of the holes
offers flexibility to the surgeon to choose either locking or non-locking
(compression) screws in any of the holes in the head portion of the plate.

The Court additionally
held that the Board should have considered two other prior art references that the Board had discounted because the Examiner had not relied on the references in making his rejections. The
fact that the Examiner had incorporated Smith & Nephew's arguments by
reference (which included the two references) allowed for Board review of those
references. The Court held that the two
references were "clearly probative" regarding whether it was known at the time
of the invention that non-locking screws could be used in threaded holes.

Thus, the Court,
despite taking a deferential approach to the Board's findings due to the substantial evidence standard of review, concluded that the Board erred in
its decision, and reversed the Board's decision for claims 1-23 and 32. In addressing the deference owed
the Board, The Court noted that it did not dispute the Board's resolution of the factual
questions of the case, and that the Board's decision was "mainly the result of
the [Board's] analytical errors," as discussed above.

Smith &
Nephew, Inc. v. Rea (Fed. Cir. 2013)
Panel: Circuit
Judges Dyk, Bryson, and Wallach
Opinion by Circuit
Judge Bryson
ABA Journal Accepting Nominations for 7th Annual Blawg 100

July 14, 2013

The ABA Journal has begun
work on its 7th annual list of the 100 best legal blogs (or blawgs) and has
announced that it is seeking the advice of its readers, via the ABAJournal.com
website, on which blogs to include on this year's Blawg 100. Last year, Patent Docs was honored to be included among five blogs selected in
the IP Law category of the Blawg 100 (see "ABA Journal Announces 2012 Blawg 100").

Readers interested in
nominating a particular blog for the 7th annual Blawg 100 should use the ABA
Journal's blawg 100 amici form. Additional information about the Blawg 100
can also be found on the blawg 100 amici
form. The form requires that anyone making a
nomination provide a name, employer or law school, city, and e-mail
address. The ABA Journal requires this
information in order to discourage:

• Bloggers who nominate
their own blogs or nominate blogs to which they have previously contributed
posts.
• Wives and husbands who
nominate their spouses' blogs.
• Employees of law firms
who nominate blogs written by their co-workers.
• Public relations
professionals in the employ of lawyers or law firms who nominate their clients'
blogs.
• Pairs of bloggers who
have clearly entered into a gentlemen's agreement to nominate each other.

The ABA Journal, however,
welcomes comments (up to 500 words in length) from readers who do not fall into
the above categories.

Nominations must be
submitted no later than 7:00 pm (ET) on Friday, August 9, 2013.

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