Patent Docs

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

September 16, 2013

By Kevin E. Noonan —

Last
week, the Federal Circuit in a non-precedential opinion, invalidated claims to
Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA. The grounds for reversing the District Court's
finding that the defendant had not established invalidity under the public use
statutory bar under 35 U.S.C. § 102(b) was based on the Court's determination
that Pronova's predecessor in interest had permitted unrestricted use of
formulations falling with the scope of the claims and disregarded Pronova's
argument that public use was negated because there was insufficient evidence
that the use was for the inventions' intended purpose.

The
case concerned U.S. Patents Nos. 5,502,077 and 5,656,667 involved in ANDA
litigation between Pronova and, in separate ANDAs, Teva and Par
Pharmaceuticals, who propounded Paragraph IV letters contending that these
patents were invalid and non-infringed by their generic formulations of the
branded drug Lovaza®. The drug comprised a formulation of certain
omega-3 and omega-6 fatty acids derived from fish oils for prevention of heart
disease and other cardiovascular ailments specifically, hypertriglyceridemia,
based on evidence of native populations with diets high in fish. The District Court found the patents
infringed, not proven invalid by clear and convincing evidence, and not
unenforceable for inequitable conduct.

The
following claims were at issue for the '667 patent:

20. A pharmaceutical mixed-fatty-acids composition in which
    a)
at least 80% by weight of the composition is comprised of a combination of
(all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z
omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of
EPA:DHA of from 1:2 to 2:1 and
    b)
(all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount
of at least one percent by weight, [or] wherein at least 85% by weight of the
composition is comprised of long chain omega-3 fatty acids, [or] wherein the
EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes
25 to 45% by weight of the composition, [or] wherein C 20:4 omega-6 fatty acid
constitutes at least one percent by weight of the composition, [or] wherein C
22:5 omega-3 fatty acid constitutes at least one percent by weight of the
composition, [or] wherein the (all-Z omega-3) -6,9,12,15,18-heneicosapentaenoic
acid is present in an amount of from 1 to 4% by weight, [and]
wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to
2:1.

44.
A pharmaceutical mixed-fatty-acids
composition in which
    a)
at least 80% by weight of the composition is comprised of a combination of
(all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z
omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of
EPA:DHA of from 1:2 to 2:1 and
    b) at least 3% by weight of the composition is comprised of
omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon
atoms, [or] wherein the EPA constitutes 40 to 60% by weight of the composition
and the DHA constitutes 25 to 45% by weight of the composition, [or] wherein
the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1,
and wherein the fatty acids are present in ethyl ester form.

50. A
pharmaceutical mixed-fatty-acids composition in which
    a)
at least 90% by weight of the composition is comprised of long chain,
polyunsaturated, omega-3 fatty acids;
    b)
at least 80% by weight of the composition is comprised of a combination of
(all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z
omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of
EPA:DHA of from 1:1 to 2:1, with the EPA constituting 40 to 60% by weight of
the composition and the DHA constituting 25 to 45% by weight of the
composition;
    c)
at least 4.5% by weight of the composition is comprised of omega-3 fatty acids
other than EPA and DHA that have 20, 21, or 22 carbon atoms;
    d)
from 1 to 4% by weight of the composition is comprised of (all-Z
omega-3)-6,9,12,15,18-heneicosapentaenoic acid; and
    e)
the composition is in oral dosage form and includes an effective amount of a
pharmaceutically acceptable antioxidant, wherein the fatty
acids are present in ethyl ester form.

(where
text in italics was recited in independent claims incorporated into the
dependent claims) (claim 50 was asserted only against Teva). Also in the litigation at the District Court
was claim 9 of the '077 patent; however, this patent expired n March 2013 and
the Federal Circuit thus did not react any issues regarding this patent.

The
facts surrounding defendants' arguments for an invalidating public use involved
transfer of samples of formulations falling within the scope of the asserted
claims by Pronova' predecessor in interest in the patents, all of which
occurred prior to the critical date of the '677 patent. These transfers included samples sent to Dr.
Victor Skrinska, with disclosure of the contents of the formulations, with no
restrictions, confidentiality requirements, or obligations to report the results
of any experiments performed using the formulations. Dr. Skrinska analyzed the contents of the
formulations but did not perform any testing on the clinical use or benefits of
the formulations (although he did administer capsules of the formulation "to
himself and others"). There were
also three other instances of alleged public use: to Dr. Peterson of General
Mills; to Dr. Davis of the University of Colorado; and Dr. Nordoy of the
University of Oregon. The Federal
Circuit's opinion states that "the distributions to Peterson and Davis
were (1) unrestricted; (2) non-experimental; and (3) for purposes of generating
interest in the product" and that Dr. Nordoy actually performed "an
experimental bioavailability study" on the formulation. The District Court held that there was
insufficient evidence to rebut Pronova's argument that Dr. Nordoy's use was an
exempted experimental use and that there was also insufficient evidence that
Drs. Peterson or Davis had used the formulations for their intended purpose and
thus did not constitute an invalidating public use. And the District Court further held that Dr.
Skrinska's use was not invalidating, "apparently [because the District Court agreed
with Pronova] that an invalidating use of a pharmaceutical compound must be for
the purposes identified in the patents-in-suit." The District Court further "discredited"
Dr. Skrinska's testimony in rejecting defendants' public use argument for
invalidity.

In
an opinion by Judge O'Malley, joined by Judges Dyk and Wallach, the Federal Circuit
reversed as to the public use determination, and remanded with instructions
that the District Court enter judgment in favor of defendants. Assessing the Court's public use
jurisprudence in light of relevant Supreme Court precedent, the panel agreed
with defendants that "[a]n invalidating public use need not be the intended
use of the invention disclosed or claimed in the patent as long as the
invention is fully disclosed without restriction." Under this precedent, the Court asserts that "either
public accessibility or commercial exploitation" qualifies as public use,
citing Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379
(Fed. Cir. 2005). The Invitrogen court also held that the Supreme
Court's "ready for patenting" test (Pfaff v. Wells Electronics,
Inc., 525 U.S. 55, 67–68 (1998)) applies to public use as well as the
on-sale bar (and here, the Court says there is no question that the invention
was ready for patenting at the time of the alleged instances of public use).

According
to the panel, the standard for public use is where
"a completed invention is used in public, without restriction," citing Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351, 1355
(Fed. Cir. 2013). Public use can be
negated where there exists disclosure under a confidentiality agreement or "similar
expectations of secrecy," Invitrogen Corp. v. Biocrest Mfg., L.P.,
424 F.3d 1374, 1379 (Fed. Cir. 2005), or where some but not all aspects of an
invention are disclosed, citing W.L. Gore
& Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1549 (Fed. Cir. 1983);
Janssen Pharmaceutica, N.V. v. Eon Labs Mfg., Inc., 134 F. App'x 425,
431 (Fed. Cir. 2005) (all aspects of the invention must be disclosed). The "seminal case" is Egbert v.
Lippmann, 104 U.S. 333, 336 (1881) (the corset case), where the Court posed
the essential question: "[w]as the invention's use public in the sense
that it was made available to others with no limitation or restriction?" One measure of the extent to which the
disclosure is confidential (as opposed to "public") is "the
amount of control which the discloser retains over the invention during the
uses in question," citing Lough v. Brunswick Corp., 86 F.3d 1113,
1121 (Fed. Cir. 1996) (insufficient control); Eolas Technologies Inc. v.
Microsoft Corp., 399 F.3d 1325 (Fed. Cir. 2005) (unrestricted disclosure to
employees); Beachcombers, International, Inc. v. Wildewood Creative
Products, Inc., 31 F.3d 1154 (Fed. Cir. 1994) (unrestricted disclosure to party-goers);
and Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265–67 (Fed.
Cir. 1986) (inventor retained control of puzzle and information). Finally, the panel cited the "sophistication
of those to whom disclosure was made" as a factor in the extent to which a
use is a public use.

Applying
these principles, the panel held that the disclosure (by transfer of samples of
the formulation) constituted an invalidating public use. Factors supporting this determination were
that the transfer contained no evidence of confidentiality restrictions and the
fact that Pronova conceded there was no experimental use involved in this
transfer. The panel concluded that the
transfer was "with no secrecy obligation or limitation for [Dr. Skrinska's]
unfettered use" and that the shipment of the formulations "made
public all aspects of the claimed inventions, since it included a certificate
of analysis revealing the composition of the supplied products." It was also undisputed that Dr. Skrinska was "one
highly skilled in the art, with the full ability to know, understand, and fully
disclose the invention to others" (and that there was evidence at trial
that Dr. Skrinska had disclosed the
information he had on the formulations with colleagues and "other members
of the medical community" without restriction. In sum (particularly with regard to Pronova's
argument that Dr. Skrinska had not used the formulation for its intended use):

Where, as here . . . a compound is provided without restriction to one highly
skilled in the art, that compound's formulation is disclosed in detail, and the
formulation is subject to confirmatory testing, no other activity is needed to
render that use an invalidating one. Once the formulation was disclosed in full
to Skrinska, without any restriction on its use, it had been released into the "public
domain" for purposes of § 102(b).

Pronova
Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)
Nonprecedential
disposition
Panel:
Circuit Judges Dyk, O'Malley, and Wallach
Opinion
by Circuit Judge O'Malley
Court Report

September 15, 2013

By Sherri Oslick —

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

Roche Palo
Alto LLC et al. v. Mylan Pharmaceuticals Inc.
1:13-cv-01532;
filed September 4, 2013 in the District Court of Delaware

• Plaintiffs:
Roche Palo Alto LLC; Genentech Inc.
• Defendant:
Mylan Pharmaceuticals Inc.

Roche Palo
Alto LLC et al. v. Watson Laboratories Inc. – Florida
1:13-cv-01533;
filed September 4, 2013 in the District Court of Delaware

• Plaintiffs:
Roche Palo Alto LLC; Genentech Inc.
• Defendant:
Watson Laboratories Inc. – Florida

The
complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,083,953 ("2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol
Derivative," issued July 4, 2000) following a Paragraph IV certification
as part of defendants' filing of an ANDA to manufacture a generic version of
Roche's Valcyte® (valganciclovir hydrochloride, used to treat cytomegalovirus
retinitis and cytomegalovirus disease).
View the complaint here.

Gilead
Sciences, Inc. v. Merck & Co, Inc. et al.
3:13-cv-04057;
filed August 30, 2013 in the Northern District of California

• Plaintiff:
Gilead Sciences, Inc.
• Defendants:
Merck & Co, Inc.; Merck Sharp and Dohme Corp.; Isis Pharmaceuticals,
Inc.

Declaratory
judgment of non-infringement and invalidity of U.S. Patent Nos. 7,105,499 ("Nucleoside
Derivatives as Inhibitors of RNA-Dependent RNA Viral Polymerase," issued
September 12, 2006) and 8,481,712 (same title, issued July 9, 2013) based on
Gilead's anticipated marketing and sale of its sofosbuvir product for the
treatment of Hepatitis C Virus. View the
complaint here.

Takeda
Pharmaceuticals USA Inc. v. Par Pharmaceutical Companies Inc. et al.
1:13-cv-01524;
filed August 30, 2013 in the District Court of Delaware

• Plaintiff:
Takeda Pharmaceuticals USA Inc.
• Defendants:
Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Infringement
of U.S Patent Nos. 7,906,519 ("Methods for Concomitant Administration of
Colchicine and a Second Active Agent," issued March 15, 2011), 7,935,731 ("Methods
for Concomitant Administration of Colchicine and Macrolide Antibiotics,"
issued May 11, 2011), 8,093,298 (same title, issued January 10, 2012),
7,964,648 ("Methods for Concomitant Administration of Colchicine and a
Second Active Agent," issued June 21, 2011), and 8,093,297 (same title,
issued January 10, 2012) following Par's filing of an ANDA to manufacture a
generic version of Takeda's Colcrys® (single-ingredient colchicine product,
used to treat Familial Mediterranean Fever).
View the complaint here.

Genzyme
Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:13-cv-01506;
filed August 29, 2013 in the District Court of Delaware

• Plaintiffs:
Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendants:
Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Genzyme
Corp. et al. v. Sandoz Inc.
1:13-cv-01507;
filed August 29, 2013 in the District Court of Delaware

• Plaintiffs:
Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendant:
Sandoz Inc.

Genzyme
Corp. et al. v. Teva Pharmaceuticals USA Inc.
1:13-cv-01508;
filed August 29, 2013 in the District Court of Delaware

• Plaintiffs:
Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendant:
Teva Pharmaceuticals USA Inc.

The
complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. RE42,152 ("Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity"
issued February 15, 2011), 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011), and
6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV
certification as part of defendants' filing of an ANDA to manufacture a generic
version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination
with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells
to the peripheral blood for collection and subsequent autologous
transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma). View the Dr.
Reddy's complaint here.

Takeda
Pharmaceutical Co. et al. v. Mylan Pharmaceuticals Inc. et al.
1:13-cv-00197;
filed August 29, 2013 in the Northern District of West Virginia

• Plaintiffs:
Takeda Pharmaceutical Co.; Takeda Pharmaceuticals U.S.A., Inc.;
Takeda Pharmaceuticals America, Inc.
• Defendants:
Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement
of U.S. Patent Nos. U.S. Patent Nos. 6,462,058 ("Benzimidazole Compound
Crystal," issued October 8, 2002), 6,664,276 (same title, issued December
16, 2003), 6,939,971 (same title, issued September 6, 2005), 7,285,668 ("Process
for the Crystallization of (R)- or (S)-Lansoprazole," issued October 23,
2007), 7,790,755 ("Controlled Release Preparation," issued
September 7, 2010), 8,173,158 ("Methods of Treating Gastrointestinal
Disorders Independent of the Intake of Food," issued May 8, 2012), and
8,461,187 ("Multiple PPI Dosage Form," issued June 11, 2013) following
a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture
a generic version of Takeda's Dexilant® (dexlansoprazole, used for the
treatment of all grades of erosive esophagitis, maintaining healing of
esophagitis, and treating heartburn associated with symptomatic non-erosive
gastroesophageal reflux disease). View
the complaint here.
Conference & CLE Calendar

September 15, 2013

September 15-17, 2013 – 41st IPO Annual Meeting (Intellectual
Property Owners Association) – Boston, MA

September 16, 2013 – America Invents Act (AIA)
Second Anniversary Forum (U.S. Patent and Trademark Office) – 1:00 to 5:00 pm (ET)

September 16, 2013 – The European Unitary Patent:
Strategic Considerations for a New Era (McDonnell
Boehnen Hulbert & Berghoff LLP & Nederlandsch Octrooibureau) – Chicago, IL

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)

September
19, 2013 – Biosimilars and
the BPCI Act: Where Are We Now and Where Are We Going? (American Bar
Association (ABA) Section of Science and Technology, Section of Intellectual
Property Law, and Center for Professional Development) – 2:00 to 3:30 pm (Eastern)

September 23-24, 2013 – International Congress on
Paragraph IV Litigation*** (Momentum) – New York, NY

September 26, 2013 – Supreme Court IP Review (IIT Chicago-Kent
College of Law) – Chicago, IL

October 1, 2013 – 2013 Intellectual Property
Continuing Legal Education Seminar (DuPont and the Widener
University School of Law) – Wilmington, DE

October 3,
2013 – Resolving
IP Disputes: Calling for an Alternative Paradigm (University of Missouri School of Law's Center
for the Study of Dispute Resolution and Journal of Dispute Resolution) – University of Missouri
School of Law

October
3-4, 2013 – Paragraph IV Disputes*** (American Conference
Institute) – Chicago, IL

October
9, 2013 – Biosimilars: Navigating FDA's Evolving
Approval Pathway, Protecting Patents and Trade Secrets (Strafford) – 1:00 to 2:30 pm (EDT)

October 10, 2013 – Recent Judicial Decisions
Impacting Technology Licensing (McDonnell
Boehnen Hulbert & Berghoff LLP) – 10:00
to 11:15 am (CT)

October 15-17, 2013 – Business of
Biosimilars*** (Institute for
International Research) – Boston, MA

November 4-5, 2013 – FDA Boot Camp Devices Edition*** (American Conference
Institute) – Chicago, IL

November 4-5, 2013 – Trade Secrets: Protecting Your Intellectual Capital and Confidential
Business Information*** (American Conference
Institute) – Chicago, IL

November 6-8, 2013 – 2013 Fall Intellectual Property
Counsels Committee (IPCC) Conference (Biotechnology
Industry Organization) – Washington, DC

November 17-20, 2013 – Creating and Leveraging Intellectual Property in Developing Countries: A Power Tool for Social and
Economic Growth*** (Companies and IP Commission and National
IP Management Office of South Africa) – Durban, South Africa

December 9-10, 2013 – Patent Infringement Litigation Summit (Legal iQ (IQPC)) – San Francisco, CA

***Patent Docs is a media partner of this conference or CLE
News from Abroad: EPO Proposal Would Remove Time Limit for Divisional Filing

September 13, 2013

Editor's note: The following notice was reprinted
with permission from Forresters.

Our August 2013 News item: "EPO divisional
deadline U-turn in the offing…" seems prescient. We now learn that the EPO has made formal
proposals to remove the current two-year time limit for filing
divisionals.

Instead, the EPO proposes that applicants can file
divisionals (and divisionals from divisionals) for as long as the original
application is pending. The EPO also wants to increase the filing fee for
second and subsequent generation divisionals.

The proposals aim for 1 April 2014 to formulate and
introduce appropriate amended rules. Under the current proposals, applicants
with a pending application (not granted, refused or abandoned) on 1 April 2014,
can use it as the basis for a divisional application, even if the current two
year limit has expired.

We recommend that you identify currently pending European
patent applications where the divisional due date has expired, or will do
before 1 April 2014. If you are still
interested in filing a divisional from any of these, you should slow prosecution
as much as you can. There are techniques
enabling you to draw out EPO procedures, and we would be pleased to advise you
on those.
2013 BIO IPCC Fall Conference

September 13, 2013

The Biotechnology
Industry Organization (BIO) will be holding its 2013 Fall Intellectual Property
Counsels Committee (IPCC) Conference on November 6-8, 2013 in Washington, DC.

The conference will
offer presentations on the following topics:

Wednesday, November
6:

• Inter
Partes Review Strategy After
a Year's Worth of Experience (Pre-Conference Workshop)

Thursday, November
7:

• Biosimilars War Games – Business and
Regulatory Considerations
• Biosimilars War Games – Preparation for
Litigation
• Patent Reform 2.0 — The Next Wave (working
luncheon)
• Cases to Watch
• The Honorable Judge Kathleen M. O'Malley,
Circuit Judge, U.S. Court of Appeals for the Federal Circuit (keynote speaker)

Friday, November 8:

• Does Myriad Matter?
• Is There a New Paradigm for Indirect Infringement?

In addition, there
will be a welcome reception at the Hotel Monaco from 5:30 pm to 7:30 pm on November
6, and an Odyssey Dinner Cruise
from 5:30 pm to 10:00 pm on November 7.

A program agenda for
this conference, including a list of speakers and descriptions of the
presentations and events can be obtained here.

Registration information
can be found here. Additional information regarding the
conference can be found at the conference website.
Patent Infringement Litigation Summit

September 13, 2013

Legal iQ (IQPC)
will be holding a Patent Infringement Litigation Summit on December 9-10, 2013
in San Francisco, CA. IQPC faculty will
help attendees:

• Develop in-house
expertise to facilitate smart decision-making at threshold moments and strong
partnerships with outside counsel;
• Work with outside
counsel in an efficient way to maximize results while minimizing cost;
• Empower your
legal department with proactive strategies to reduce the unexpected workload
burdens that come with patent litigation; and
• Influence and
respond to changes in the patent reform landscape.

In particular, IQPC
faculty will offer presentations on the following topics:

• Organizing the
legal team: Effective strategies for finding the right counsel &
establishing strong, efficient working relationships between in-house &
outside counsel (focus session);
• Helping the judge
& jury navigate complicated, technical cases to make well-informed
decisions;
• Developing a
customized in-house approach to handling patent infringement litigation: One
size does not fit all;
• Negotiating &
using alternative fee arrangements to achieve more cost certainty;
• Making sound
business decisions: Considerations in evaluating whether to litigate or settle;
• Developing clear
expectations & obligations within joint defense groups to maximize value
& reduce redundancy;
• Navigating the
new post-grant review landscape: How to use IPR successfully;
• Using the ITC's
new program for early determination of potentially dispositive issues to limit
unnecessary adjudication in complaints involving standard essential patents or
NPEs;
• Strategies for
early establishment of appropriate discovery limitations to avoid burdensome,
costly, unnecessary discovery;
• Safely navigating
the uncertain damages landscape;
• In-depth review
of recent case law: What new developments mean for patent litigation practice;
• Managing your
patent portfolio & developing an understanding of the patent landscape to
avoid unexpected suits; and
• What you need to
know about defensive patent aggregation & other proactive practices.

Two additional
workshops will also be offered. The
first workshop, entitled "Working the Rules: A Sampling of the Procedures
in the Most Litigated Jurisdiction," will be offered from 7:30 to 9:30 am
on December 9, 2013. The second
workshop, entitled "Efficient Discovery Practices to Make the Process Less
Cumbersome & Manage Costs" will be offered from 7:30 to 9:30 am on
December 10, 2013.

An agenda for the
conference can be found here (Day 1)
and here (Day 2). A complete brochure for this conference,
including an agenda, detailed descriptions of conference sessions, list of
speakers, and registration form can be obtained here.

The registration
fee is $1,399 (conference alone), $549 (either workshop), or $1,899 (conference
and both workshops). Those registering
by October 4, 2013 will receive a $400 discount off the conference alone or
conference and both workshops, and those registering by November 8, 2013 will
receive a $200 discount off the conference alone or conference and both
workshops. Those interested in
registering for the conference can do so here.

Patent Docs is a media partner of the IQPC Patent Infringement Litigation Summit.
St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)

September 12, 2013

By
Kevin E. Noonan —

The
Federal Circuit revisited the extent of the safe harbor from the judicially
created doctrine of obviousness-type double patenting carved out by 35 U.S.C.
§ 121 in St. Jude Medical, Inc. v. Access
Closure Inc. Unlike earlier
decisions regarding whether continuation or continuation-in-part applications
could benefit from the safe harbor, here the Court considered the effects of election-of-species
requirements on whether there is consonance between claims in one patent over
those on a related patent in which such a requirement is imposed.

The
patents in suit, U.S. Patent No. 7,008,439 (Janzen patent; claims 7, 8 and 9);
5,275,616, and 5,716,375 (Fowler patents, claim 14 and claim 21, respectively), were directed to apparatus, methods, or both for sealing vascular puncture that
arises, inter alia, when a vein or
artery is punctured as part of a medical procedure, and provides an alternative
to applying direct pressure to seal the wound. Regarding the Janzen patent, three claims were asserted below and
considered by the Court in its opinion:

U.S.
Patent No. 7,008,439:

7. A
device for closing a puncture in a wall of an artery comprising: an elongated
member having a distal end, said elongated member sized to be fitted through a
passageway leading to said puncture so that said distal end is disposed near
said puncture in said artery, separable plug means for plugging said puncture
being disposed in said elongated member, movable guide means extending
longitudinally through said elongated member and said plug means for extension
through said puncture for guiding said plug means to said puncture, and means
for ejecting said plug means from said distal end of said elongated member so
as to place said plug means in blocking relation with said puncture, so as to
seal said puncture [A device as claimed in claim 1], wherein said plug
means includes an orifice therethrough, said guide means being disposed through
said orifice, said orifice automatically closing when said guide means is
removed therefrom.

8. A device for closing a puncture in a wall of an
artery comprising: an elongated member having a distal end, said elongated
member sized to be fitted through a passageway leading to said puncture so that
said distal end is disposed near said puncture in said artery, a separable plug
member for plugging said puncture being disposed in said elongated member, a
movable guide element extending longitudinally through said elongated member
and said plug member for extension through said puncture for guiding said plug
member to said puncture, and an ejecting mechanism for ejecting said plug
member from said distal end of said elongated member so as to place said plug
member in blocking relation with said puncture, so as to seal said puncture.

9. A method of closing a puncture in a wall of an
artery made for the purpose of moving an elongated cardiac catheter into the
artery in which an exterior guide tube is extended through a passage leading to
the puncture and through the puncture in the wall of the artery and into the
artery so a to enable the catheter to be guidingly moved through the guide tube
and into the artery, the method comprising the steps of: withdrawing the
cardiac catheter and moving the guide tube outwardly so that it no longer
extends within the puncture, extending a plug having a removable guide wire
extending longitudinally therethrough so that the guide wire extends from the
plug through said puncture, moving the plug inwardly along the guide wire into
blocking relation with said puncture, and withdrawing the guide wire from the
plug so as to leave the plug sealed in blocking relation with said puncture.

(where
the italicized portion of claim 7 recites the limitations of claim 1 from which
claim 7 is a dependent claim).

The
following related patents are relevant to the double patenting issues before
the Court:

• Grandparent application,
USSN 07/746,339, now U.S. Patent No. 5,391,183
• Divisional
application USSN 08/318,380, now U.S. Patent No. 5,830,130
• Continuation
granted as Janzen patent, second continuation U.S. Patent 5,725,498

The
U.S. Patent and Trademark Office imposed a restriction requirement in the '339
application ("the grandparent application), wherein Group I was directed
to apparatus claims and Group II directed to method claims. The Office also imposed an election-of-species
requirement between Species A, B, and C:

• Species
A: Claims relating to the apparatus
comprising a solid tissue dilator;
• Species B: Claims relating to the apparatus
comprising a hollow dilator and guidewire;
• Species C: Claims relating to the apparatus comprising a guidewire and no
dilator.

In
the '339 application, the Applicant elected Group I, Species B, and claims to
these embodiments granted in the '183 patent. In the first divisional application (the '380 application), the examiner
imposed a similar restriction requirement and applicant elected claims of Group
I, Species B that granted in the '130 patent. The '439 patent-in-suit (the Janzen application) contains claims to both
Group I and Group II, each electing Species C. And a second continuation (that granted as the '498 patent) contained
claims to Group II but without election of any particular species.

The District Court held that the safe harbor provisions of 35 U.S.C. § 121 protected the claims of
the Janzen patent from invalidity under obviousness-type double patenting. The Federal Circuit reversed, in an opinion by
Judge Plager, joined by Judges Lourie and Wallach, with a concurring opinion by
Judge Lourie.

The
Court reiterated its interpretation of the statute:

A patent
issuing on an application with respect to which a requirement for restriction
under this section has been made, or on an application filed as a result of
such a requirement, shall not be used as a reference either in the Patent and
Trademark Office or in the courts against a divisional application or against
the original application or any patent issued on either of them if the
divisional application is filed before the issuance of the patent on the other
application.

(which
it opined is "not a model of clarity") that what is required is "consonance,"
i.e., later-filed applications must
conform to the "lines of demarcation" set up by a restriction
requirement, citing Gerber Garment Tech., Inc. v. Lectra
Sys., Inc., 916 F.2d 683, 688 (Fed. Cir.
1990). It is not a violation of
consonance if two or more non-elected inventions are pursued in a subsequent
application, the Court noted, citing Boehringer Ingelheim Int'l GmbH v. Barr
Labs, Inc., 592 F.3d 1340, 1350 (Fed. Cir. 2010), but "a divisional
application filed as a result of a restriction requirement may not contain
claims drawn to the invention set forth in the claims elected and prosecuted to
patent in the parent application."

As the opinion sets out, the consonance requirement
is applied to the patent "challenged for double patenting" as well as
the reference patent. And here, the
panel states that consonance "requires
that the challenged (Janzen) patent, the reference patent, and the
patent in which the restriction requirement was imposed (the restricted patent,
i.e. the '183 grandparent patent) do
not claim any of the same inventions identified by the examiner. In this case, the question of whether the
requirement is fulfilled depends on the effect of the election of species
requirement. ACI contended below that the
election was irrelevant to the consonance question, while St. Jude argued that
the election of species must be considered in determining whether consonance
was satisfied. The Court held that not
only was the election of species relevant but that the result of the combination
of restriction and election was the identification of six separate, patentably
distinct inventions: Group I, Species A; Group I, Species B; Group I, Species
C; Group II, Species A; Group II, Species B; and Group II, Species C. Under this standard, the grandparent patent
contained claims to one invention (Group I, Species C) and the Janzen patent
contained claims to two other inventions (Group I, Species B and Group II,
Species B).

The opinion notes the basis in the regulations for
election of species requirements (37 C.F.R.
§ 1.146):

In the
first action on an application containing a generic claim to a generic
invention (genus) and claims to more than one patentably distinct species
embraced thereby, the examiner may require the applicant in the reply to that action
to elect a species of his or her invention to which his or her claim will be
restricted if no claim to the genus is
found to be allowable.

(emphasis
added).

The key to the Court's decision in applying the
statute in this instance is the italicized phrase "if
no claim to the genus is found to be allowable," i.e., there is no generic
claim in the grandparent application. That is the case here, which results in the election of species being a
restriction of the claims in the grandparent application for purposes of
applying Section 121. (The opinion notes that the restriction requirement in
the grandparent application expressly stated the rule.) This outcome is a rational one, according to
the Court:

It makes
logical sense that the election of species affected the line of demarcation
when no claim was generic. If the election of species did not affect the line,
double patenting would have prevented the Janzen applicant from obtaining valid
claims directed to non-elected species. This result would be unfair since it
was the examiner, not the applicant, who created the further division of the
application with the election of species, and the examiner already stated on
the record that the non-elected species were patentably distinct from the
elected species. The unfairness of the result would violate the purpose of the
safe harbor.

Having established the parameters of
the restriction the Court then assessed whether there was consonance. While the difference in elected species
distinguished the Janzen patent from the grandparent '339 application, the
panel found no such distinction with the claims of the second continuation (the
'498 patent), which contained claims directed to Group II without any limitations as to species. Accordingly, the claims of this second
continuation were not consonant with the claims of the Janzen patent, which are
directed, inter alia, to inventions
of Group II, Species C. The claims of
the Janzen patent were thus not patentably distinct from the claims of the
second continuation and the Court found them invalid for obviousness-type
double patenting.

ACI also appealed the District Court's
determination that the claims of the Fowler patents were not obvious. The following are the claims that were at
issue:

U.S.
Patent No. 5,275,616:

14. A
method of sealing an incision formed in the body of a patient wherein the
incision extends generally from the skin of the patient; through the lumen of a
blood vessel and into the blood vessel of a patient, the method including the
steps of:
    forming
a vessel plug of a material which is absorbable in the body of the patient and
wherein the vessel plug is formed to include distal and proximal ends therein
and is dimensioned to be received in the incision; and
    positioning
the vessel plug in the incision such that the distal end of the vessel plug is
located proximally of the blood vessel to seal the incision from the flow of
blood passing through the blood vessel, [The method of claim
9] further including the step of inflating a member on an insertion member to
identify the location of the blood vessel adjacent to the incision.

(where
the italicized portion of claim 14 recites the limitations of claim 9 from
which claim 14 is a dependent claim); and,

U.S.
Patent No. 5,716,375:

21. An insertion assembly for sealing an
incision in the body of a patient wherein the incision extends from the skin of
the patient into a blood vessel of the patient, said insertion assembly
comprising in combination:
    a vessel plug which is constructed of a material
that is absorbable within the body of a patient and which seals the incision
from the flow of blood therethrough; and
    an elongate positioning member having a passage way
therein for the receipt of said vessel plug therein, and at least a portion of
said positioning member is expandable so that it has an outer diameter in use
which is greater than the diameter of the incision to position said vessel plug
in the incision proximally of the blood vessel such that said vessel plug
obstructs the flow of blood through the incision without extending into the
blood vessel.

ACI
argued that these claims were obvious over two prior art references: a 1988
scientific journal article to Takayasu, which disclosed a method and apparatus
for sealing punctures in a liver vein using "a compressed 'gelfoam stick'";
and a 1971 scientific journal article to Smiley, which disclosed using a
balloon catheter. ACI argued that these
references demonstrated that the problem the Fowler's patents addressed — how
to restore hemostatis to a punctured blood vessel — was known and that these references
disclosed methods for solving the problem. The skilled worker would have had a reasonable expectation of achieving
the claimed invention by combining the Takayasu and Smiley references and thus
were obvious under 35 U.S.C. § 103.

The Federal Circuit agreed with St.
Jude's argument that their claimed invention contained limitations and features
not disclosed in the cited prior art that distinguished their claims from the
hypothetical combination of the teachings of the Takayasu and Smiley
references. Rather than combining the
references, the Court held that the disclosed elements useful for stemming
blood flow from a puncture -– a gelfoam stick or a balloon -– would be considered
alternatives and the skilled worker would not combine the references. Nor was the panel convinced that the skilled
worker would use an "invasive" balloon rather than non-invasive
methods (x-ray or ultrasound) used in the art to check the position of the
gelfoam in the wound. The Court
characterized as "a logical chasm" the differences between the art
and the invention, and further noted that "[e]ven under our "expansive
and flexible" obviousness analysis (see KSR Int'l Co. v. Teleflex Inc.,
550 U.S. 398, 415, (2007)), we must guard against "hindsight bias"
and "ex post reasoning," which "compels [the Court] to
reject ACI's argument."

Judge Lourie provided a concurring
opinion, which agreed with the result but rejected the panel's analysis
elevating the election of species requirement to a formal restriction. In Judge
Lourie's view:

In a
nutshell, this case is resolved by the failure of the granted Janzen and '498
(sibling) patents to maintain consonance with the original restriction
requirement. The accompanying requirement for election of species, which
perhaps raises an issue of first impression, is a complication that should not
come into play in deciding the appeal.

According to Judge Lourie, the
presence of both method and apparatus claims in the Janzen patent is enough to
vitiate consonance with the grandparent application, which contains claims to
apparatus ("It is the opposite of consonant.") That is enough to reach the conclusion
announced in the panel decision, and thus while Judge Lourie believed that "the
majority opinion overcomplicates the analysis of this appeal and improperly
commingles restriction practice with election of species practice," he
concurred with the decision.

St. Jude Medical, Inc. v.
Access Closure, Inc. (Fed.
Cir. 2013)
Panel: Circuit Judges Lourie, Plager, and Wallach
Opinion by Circuit Judge Plager; concurring opinion by Circuit Judge Lourie
Acting Director Rea to Leave U.S. Patent and Trademark Office

September 12, 2013

By
Kevin E. Noonan —

Acting Director
Teresa Stanek Rea (at right) has notified her colleagues that she will be leaving the
agency "in the near future." The text of her announcement reads as follows:

Dear
Colleagues,

It has been a tremendous honor and a true pleasure
to serve with you as Deputy Director and Acting Director of the USPTO, America's
own "innovation agency." It is with deep appreciation and
gratitude that I inform you that I have decided to leave the agency in the near
future.

I joined the United States Patent and Trademark
Office in March of 2011 as Deputy Director and have been privileged to serve at
an historic time for this agency. As deputy to Dave Kappos I was fortunate
enough to participate as our agency implemented historic patent reforms, as
well as our ongoing efforts to modernize our entire way of serving and engaging
our stakeholders and the public in all areas of our operations. Since I
became Acting Director we have together endured the difficulties of sequestration,
but we are weathering that financial storm with clear thinking and bold
determination.

My fondest memories of my time with this agency
will be all of those moments I engaged with each of you on matters large and
small. You are some of the most hard-working and dedicated individuals I have
ever had the privilege of working with, and our stakeholders and the American
public are better off for your service. You have exercised true vision in
ensuring we set the standard for excellence in government, and that is
reflected in our rapid rise in the rankings of one of the top places to work in
the federal government.

It is my anticipation that we will soon welcome a
new Director who will continue guiding the excellent work of the agency. Until
then, I will do everything I can to ensure a smooth transition.

Thank you for the privilege of serving with you.

Terry

Teresa Stanek Rea
Deputy
Under Secretary of Commerce for Intellectual Property &
Deputy
Director of the United States Patent and Trademark Office
Department
of Commerce
Email:
Teresa.Rea@uspto.gov
Phone:
571-272-8700

Acting Director
Rea has led the Patent Office since former Director David Kappos left last
year, and worked closely with him during his tenure. She is widely respected for having done an
excellent job leading the agency, and will be missed.
A Reply to the New England Journal of Medicine

September 11, 2013

Editor's
Note: Yesterday, we reported
on a perspective, entitled "Patents,
Profits, and the American People — The Bayh–Dole Act of 1980,"
that was published in the August 29 issue of the New England Journal of
Medicine. Earlier today, we received an e-mail from
Joseph Allen, who noted that he had authored a reply to the NEJM
article. His response was originally
published on IPWatchdog,
and is being republished here with the permission of IPWatchdog founder
Gene Quinn. Patent Docs thanks
Mr. Allen and Mr. Quinn for allowing us to republish Mr. Allen's response.

By Joseph Allen
—

In its August 29, 2013
edition, the New England Journal of Medicine saw fit to print two "perspective"
pieces attacking the Bayh-Dole Act. The primary article is by Dr. Howard
Markel entitled "Patents,
Profits, and the American People — The Bayh–Dole Act of 1980." It repeats previously refuted charges that patenting and licensing federally
funded inventions harms the public interest. To give the author due "credit,"
Dr. Markel does invent some new allegations as well which simply cannot go
unanswered.

The Bayh-Dole Act was
passed because Congress was rightly concerned that potential benefits from
billions of dollars of federally funded research were lying dormant on the
shelves of government. Government funded inventions tend to be very early stage
discoveries — more like ideas than products — requiring considerable private sector
risk and investment to turn them into products that can be used by the public.

Under prior patent polices,
government agencies took such inventions away from their creators and offered
them non-exclusively for development. There were no incentives for the
inventors to remain engaged in product development. Not surprisingly, few such
inventions were ever commercialized even though billions of dollars were being
spent annually on government R&D. This failure spurred two Senators
from opposing sides of the aisle, Birch Bayh of Indiana and Bob Dole of Kansas,
to form a remarkable partnership seeking a remedy.

But here's how Dr. Markel
characterizes the impetus for Senator Bayh's involvement:

In 1978, a group of constituents representing Purdue University lobbied Bayh to
seek ways of reaping profits from government allocations for university-based
research, arguing that although the United States spent billions of dollars
annually funding more than half of all academic research and owned 28,000 patents,
it had little to show for the investment.

Unlike Dr. Markel, I was
actually in that meeting. Ralph Davis, who then ran Purdue's technology
transfer office, is no longer with us to defend himself. Neither Ralph nor
anyone else present was looking for "ways of reaping profits from
government allocations for university-based research." Quite the
contrary, Ralph said that Purdue had made several promising inventions under
Dept. of Energy grants which would never benefit U.S. taxpayers unless they
were effectively licensed and developed.

This motivation was
reflected in Senator Bayh's statement on introducing the bill:

The bill
addresses a serious and growing problem: hundreds of valuable medical, energy
and other technological discoveries are sitting unused under government
control, because the government, which sponsored the research that led to the
discoveries, lacks the resources necessary for development and marketing
purposes, yet is unwilling to relinquish patent rights that would encourage and
stimulate private industry to develop discoveries into products available to
the public.

The cost of
product development exceeds the funds contributed by the government toward the
initial research by a factor of at least 10 to 1. This, together with the
known failure rate for new products, makes the private development process an
extremely risky venture, which industry is unwilling to undertake unless
sufficient incentives are provided.

The
consequences of our inadequate government patent policy have not gone
unnoticed. In the energy area, bureaucratic delays caused by case-by-case
review of each patent application are now running behind by almost two years. . . .

But nowhere is
the patent situation more disturbing than in biomedical research
programs. Many people have been condemned to needless suffering because
of the refusal of agencies to allow universities and small businesses
sufficient rights to bring new drugs and medical instrumentation to the
marketplace. The exact magnitude of this situation is unknown, but we are
certain that the cases we have uncovered to date are but a small sample of the
total damage that has been done and will continue to be done if Congress does
not act.

Dear
Colleague letter from Senator Birch Bayh on the introduction of Bayh-Dole,
Sept. 6, 1978.

Senator Bayh's wife was
then suffering from a cancer which would later take her life. Senator Bayh was
very grateful for the help she received from the doctors at the National
Institutes of Health. His determination to enact Bayh-Dole to ensure that new
treatments for relieving human suffering were being developed was driven by a
passionate concern for patients, not "reaping profits."

Markel repeats the
discredited allegation that technology licensing was more successful before
Bayh-Dole than claimed by proponents of the law. This charge used to be widely
circulated leading my colleagues Norman Latker and Howard Bremer to look up the
actual source materials the critics cited. Perhaps not surprisingly, they
found the critics were misreading the data. See "The Bayh-Dole Act and Revisionism Redux," pp.
9-10.

Dr. Markel lightly
dismisses as "[m]ore difficult to confirm" the meticulous work that
Lori Pressman and her team (which included economists at the Department of
Commerce) put into a ground breaking study estimating the significant economic
impact of university patent licensing on the U.S economy. Lori documented
the methodology behind the study which until now, no one has challenged. Perhaps Dr. Markel's "difficulty" would be solved if he actually read
the paper. To make it easy, here's the link: "The Economic Contribution of University/Nonprofit
Inventions in the United States: 1996-2010."

Adding insult to injury,
Markel continues: "Indeed, the law's many critics question how much it has
actually benefited the economy (as opposed to individuals and stakeholders)
and the extent of its social costs."

Here's some data that may
help Dr. Markel and the other critics:

• Since 1980
more than 9,000 new firms have been created around university inventions, more
than 4,000 of which are still in business. These companies tend to locate in
the same state as the university, spurring economic growth.

• 705 new companies were
created by university patented inventions in FY 2012 alone, along with 591 new
commercial products introduced for consumers to use. Not a bad
performance in an economy otherwise stuck in the doldrums.

• There are now more than
40,000 active licenses and options in place on university inventions, the
majority of which are with small businesses.

• No new drugs were
commercialized when the government took inventions away from universities
before Bayh-Dole. Since then at least 153 are now on the market fighting the scourge of disease
world-wide according to a study published in the New England Journal of
Medicine. See "The Role of Public-Sector Research in the Discovery of
Drugs and Vaccines."

A new Forbes magazine analysis calculates
that it now costs $5 billion to develop a new drug — expenses that are borne by
the private sector. If the critics ever get their way and succeed in
undermining Bayh-Dole, we could return to the days when we again pull the plug
on drugs developed from federally funded research. One has to wonder
where those suffering will then turn for relief. It's unlikely the critics will
be able to offer them much solace.

While not in Dr. Markel's
article, publications covering it surmised from his characterization of its
legislative history that enactment of Bayh-Dole was "fluke ridden"
(University of Michigan Health.org) or a "rocky and somewhat inglorious
road to passage by a lame duck Congress" (Tech Transfer News blog). Such language reflects a fundamental lack of understanding of the legislative
process. Bayh-Dole passed on its merits in the full light of day, not
through any legislative sleight of hand.

The bill not only went
through all of the steps for passing a new law that you read about in civics
class, it was subjected to additional scrutiny not normally required for
legislation: it needed a unanimous vote of approval in the closing days of the
Congress. Bayh-Dole was even attacked by its bureaucratic opponents after
enactment who sought to undermine the new law by wrecking the regulations
needed for its implementation. See "The Enactment of Bayh-Dole, An Inside Perspective."

Dr. Markel saves his "best"
for last:

It's time for
Congress to recalibrate Bayh-Dole. Profits and patents can be powerful
incentives for scientists, businesspeople, and universities, but new and
ongoing risks — including high prices that limit access to lifesaving
technologies, reduced sharing of scientific data, marked shifts of focus from
basic to applied research, and conflicts of interest for doctors and academic
medical centers — should be mitigated or averted through revisions of the
law. All Americans should be able to share in the bounties of federally
funded research.

Oh my, where to
begin? Would Dr. Markel feel better knowing that a survey of academic
researchers concluded that "patenting does not seem to limit research
activity significantly, particularly among those doing basic research,"
with only 1% of their random sample of 398 academic respondents reporting a
project delay of more than a month due to patents on knowledge inputs necessary
for their research, and none reporting abandoning of a research project due to
the existence of patents? See Final Report to the National
Academy of Sciences' Committee Intellectual Property Rights in Genomic and
Protein-Related Inventions: Patents, Material Transfers and Access to Research
Inputs in Biomedical Research (Sept. 20, 2005).

Would he feel better
knowing that Bayh-Dole has not shifted the focus of federal R&D from basic
to applied research? See "The Bayh-Dole Act and Revisionism Redux," pp.
11-12. This is hardly surprising as federal agencies fund research either in
pursuit of expanding the frontiers of knowledge or to meet their mission
needs. With industry abandoning basic research, being able to partner
with our unparalleled public research institutions is a tremendous competitive
advantage for the United States. Bayh-Dole makes this possible.

Perhaps Dr. Markel will
feel better knowing that all Americans can only share in the bounty of
federally funded research when embryonic ideas are taken from the lab and
turned into new products they can actually use, while creating new jobs and
companies where they can work. The United States is leading the world in
this regard — thanks to the Bayh-Dole Act.

About
the Author

Joesph Allen is a 30-year veteran of national efforts to
foster public/private sector commercialization partnerships, and author of
numerous articles on technology management for national publications. Mr. Allen
served as a Professional Staff Member on the U.S. Senate Judiciary Committee
with former Senator Birch Bayh (D-IN), and was instrumental in working behind
the scenes to ensure passage of the historic Bayh-Dole Act. Mr. Allen has served as
the Executive Director of Intellectual Property Owners, Inc., a trade
association representing major R&D companies, he was involved in the
creation of the Court of Appeals for the Federal Circuit, and he also served at
the U.S. Department of Commerce as the Director of the Office of Technology
Commercialization. From 1992 until 2004, Mr. Allen was with the National Technology
Transfer Center (NTTC), becoming President in 1997. Clients included NASA, the
Department of Defense, EPA, the Department of Veterans Affairs, and the
Department of Commerce. Between 2004 until 2007, Mr. Allen was the Vice President
and General Manager of the West Virginia High Technology Consortium Foundation. In 2008, he founded Allen &
Associates to continue to facilitate public/private partnerships
between universities, federal laboratories, and industry.

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

• "NEJM Perspective Calls for Recalibration
of Bayh-Dole Act," September 10, 2013
• "Senator Leahy Urges
NIH to Use March-In Rights on Myriad BRCA Test," July 17, 2013
• "Patent Docs Author Testifies at Genetic
Diagnostic Testing Hearing," February 16, 2012
• "AUTM Survey Shows Significant Increases in University Patent Filings and Issuances in FY2010," October 5, 2011
• "USPTO Recognizes
30th Anniversary of Bayh-Dole Act," December 9, 2010
• "University Start-ups and Licensing Activity Held Steady During Recession," October 7, 2010
• "AUTM Survey Shows Drop in Issued Patents," March 9, 2010
• "BIO Comes out
Swinging against SACGHS Report," February 4, 2010

• "Patent Haters Take
Notice! University Innovation Fuels Robust Economic Activity," IPWatchdog, August 7, 2013
• "Intellectual
Dishonesty About Bayh-Dole Consequences," IPWatchdog, May 10, 2013
• "The Good Steward —
Turning Federal R&D into Economic Growth," IPWatchdog, August 2, 2012
• "University Tech
Licensing Has Substantial Impact on Economy," IPWatchdog, December 10, 2012
• "AUTM Survey:
University Licensing Strong Despite Economy," IPWatchdog, December 17, 2010
• "Statement of
Senator Birch Bayh on the 30th Anniversary of the Bayh-Dole Act," IPWatchdog, December 5, 2010
NEJM Perspective Calls for Recalibration of Bayh-Dole Act

September 10, 2013

By Donald Zuhn —

In a perspective published
in the August 29 issue of the New England Journal of Medicine, Dr. Howard
Markel outlines the events leading up to the enactment of the Bayh-Dole Act and
states that "a review of [the Act's] origins and consequences supports the
idea that policies governing the fast-changing worlds of medicine and
biotechnology merit frequent reappraisal and reform." In the article, entitled "Patents, Profits,
and the American People — The Bayh–Dole Act of 1980,"
Dr. Markel,
the George E. Wantz Distinguished Professor of the History of Medicine, and
Director for the Center for the History of Medicine at the University of
Michigan, notes that "Bayh–Dole's inspiration was not a perceived need to
transform the conduct of research but the economic doldrums of the 1970s." Following a helpful summary of the history of
the Act, Dr. Markel explains that "[w]hen the Bayh–Dole Act was written,
its aim was primarily to stimulate economic growth by more efficiently mining
the untapped scientific riches of hospitals, laboratories, and universities." He argues, however, that "[m]uch has changed since then."

While Dr. Markel provides
no proposed changes to the Act, he contends that "some of the most vexing
quandaries weren't fully addressed in the original legislation." As for examples of such
"quandaries," he suggests that revised legislation should address several
questions:

Who should benefit from discoveries pertaining
to nature or the human body? . . . [W]hat conflicts of interest must be
identified and contained in order to protect patients? How can scientific discovery proceed if all
innovations and research tools are patented and the discoverers control access
to them?

Dr. Markel (at left) concludes his article by
declaring that "[i]t's time for Congress to recalibrate Bayh–Dole,"
adding that "[p]rofits and patents can be powerful incentives for scientists,
businesspeople, and universities, but new and ongoing risks — including high
prices that limit access to lifesaving technologies, reduced sharing of
scientific data, marked shifts of focus from basic to applied research, and
conflicts of interests for doctors and academic medical centers — should be
mitigated or averted through revisions of the law."

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