[Ip-health] Contrary to IFPMA press spin on vaccine patents, there is plently of litigation over vaccine patents

James Love james.love at keionline.org
Fri May 29 04:44:21 PDT 2020


These are just a few examples of patent disputes involving vaccines, from
this document (the Google doc includes some links), and is still being
worked on.

I would appreciate Thomas Cueni explaining how he can assert in public
events (including at least twice yesterday in the context of the WHO
COVID-19 technology pool) that patents are a non-issue for the
manufacturing of and access to vaccines, when companies and patent holders
are constantly suing each other over patent claims.

Jamie

https://docs.google.com/document/d/1ZjbqjvmhuhbChikfJIkFsq1TWwkH6wDE2lxh6EPMSr4/edit?usp=sharing

1934 June 30. Jensen-Salsbery Labs. v. O.M. Franklin Blackleg Serum Co.
The Circuit Court of Appeals for the Tenth Circuit issues an order in
Jensen-Salsbery Labs. v. O.M. Franklin Blackleg Serum Co., 72 F.2d 15 (10th
Cir.), adhered to on reh'g, 74 F.2d 501 (10th Cir. 1934), in which Franklin
Company alleged that Jensen-Salsbery infringed on a patent related to a
“vaccine used to immunize against symptomatic anthrax or blackleg, a
disease to which herbivorous animals, chiefly cattle and sheep, are
subject.” Id. at 15.

1989. Oct 6. Intervet Am., Inc. v. Kee-Vet Labs., Inc.
The United States Court of Appeals, Federal Circuit, issues an order in
Intervet Am., Inc. v. Kee-Vet Labs., Inc., 887 F.2d 1050 (Fed. Cir. 1989),
in which Intervet alleges  “infringement of its patent No. 4,530,831 ('831
patent), entitled ‘Infectious Bursal Disease Vaccine.’” Id. at 1051.

1993 Oct. 6. Vaccine, Inc. v. Am. Cyanamid Co.
The United States Court of Appeals for the Federal Circuit issues an order
in N. Am. Vaccine, Inc. v. Am. Cyanamid Co., 7 F.3d 1571 (Fed. Cir. 1993),
in which North American Vaccine alleged that American Cyanamid Company and
Praxis Biologics, Inc. infringed on patents related to “human infant
vaccines against bacterial infections such as meningitis.” Id. at 1573. The
lawsuit was brought in 1991, but after judgment was entered for the
defendants, the plaintiffs appealed. Id. The appeals court affirmed in part
and reversed in part. Id.


1995. October 9. Compulsory license in Israel over Biogen’s HBV vaccine
patent
https://www.sec.gov/Archives/edgar/data/722104/000091205701505751/a2043448z10-k.txt
In January 1992, BTG-Israel filed an application in the Israeli Patent
Office for a compulsory license to manufacture BTG's BIO-HEP-B vaccine
under Biogen's Israeli patent. The Registrar ruled in an interlocutory
decision that BTG-Israel is entitled to a compulsory license to the Biogen
patent. Biogen's appeal of the interlocutory decision was rejected. In
November 1996, the Registrar set the terms of the license, including
royalties to be paid by BTG to Biogen.

1998. April 27. Boehringer Ingelheim Animal Health, Inc. v. Schering-Plough
Corp.
The United States District Court for the District of New Jersey issues an
order denying a motion for summary judgment and a motion for a preliminary
injunction in Boehringer Ingelheim Animal Health, Inc. v. Schering-Plough
Corp., 6 F. Supp. 2d 324 (D.N.J. 1998), in which Boehringer Ingelheim
Animal Health alleges that Schering-Plough Corp infringed on a patent that
Boehringer alleged was “instrumental to the development of a PRRS vaccine.”
Id. at 326.

1998. June 10. Evans Med. Ltd. v. Am. Cyanamid Co.
The United States District Court for the Southern District of New York
issues an order in Evans Med. Ltd. v. Am. Cyanamid Co., 11 F. Supp. 2d 338
(S.D.N.Y. 1998), aff'd, 215 F.3d 1347 (Fed. Cir. 1999), in which plaintiffs
Medeva PLC and Evans Medical Ltd. alleged that “patents on acellular
antigens and vaccines for pertussis, or whooping cough,” were infringed
upon by defendant American Cyanamid Company and American Home Products
Corp. Id. at 341–42.

2000.  June 28.  EMBREX, INC., Plaintiff-Appellee, v. SERVICE ENGINEERING
CORP. and Edward G. Bounds, Jr., Defendants-Appellants.

>From the opinion
Embrex is the exclusive licensee of the '630 patent from the United States
Government under the Bayh-Dole Act. A scientist at the U.S. Department of
Agriculture developed the patented technology. The '630 patent claims
methods for inoculating birds against disease by injecting vaccines into a
specified region of the egg before hatching.  In its commercial
application, the claimed invention immunizes chickens in ovo, i.e., while
they are still in the egg. Thus, the claimed method reduces the risk that
chickens will succumb to infections that often infect an entire flock. This
method represents an advance over the prior art method, which inoculated
several days after hatching, leaving the chicks unprotected.  The '630
patent contains 13 claims, 12 of which the jury found SEC had infringed.

2000. March 8 Salvatore CATAPANO, Plaintiff, v. WYETH AYERST
PHARMACEUTICALS, INC. and American Home Products Corp., Defendants.
Catapano alleges that the Defendants “are the sole manufacturer of typhoid
vaccine in the United States,” and that “the Defendants distribute the
vaccine knowing that it is widely being used by doctors, hospitals and
others in the medical field for the specific purposes of immune stimulation
that clearly violates Plaintiff new (sic) patents.” Curiously, Catapano
seeks an injunction preventing the Defendants, the only manufacturers of
the typhoid vaccine used in his treatment, from selling or distributing the
vaccine. He also requests royalties in the amount of $50 per dose of the
vaccine administered since 1987. Defendants moved to dismiss the case for
failure to state a claim under Fed. R. Civ. P. 12(b)(6). The court held 35
U.S.C.S. § 271 identified three kinds of actionable patent infringements,
direct infringement, inducement of infringement, and contributory
infringement. The court held plaintiff failed to prove direct infringement,
as plaintiff failed to show defendants used or sold his particular method
of treating immune deficient patients. Plaintiff failed to prove inducement
of infringement, as he did not show defendants specifically intended to
encourage other doctors to use plaintiff's patented treatment. The court
held plaintiff failed to show contributory infringement, as plaintiff
failed to show defendants manufactured the vaccine especially for use in
plaintiff's patented treatment.

2001. Sept. 21. Boehringer Ingelheim Vetmedica, Inc. v. Schering Plough
Corp.
The United States District Court for the District of New Jersey issues an
order in Boehringer Ingelheim Vetmedica, Inc. v. Schering Plough Corp., 166
F. Supp. 2d 19 (D.N.J. 2001), aff'd, 320 F.3d 1339 (Fed. Cir. 2003), in
which the plaintiff alleged that defendant Schering Plough Corp.’s sale of
a pig vaccine infringed on its patent. Id. at 22.

2005. February. Merck v. GlaxoSmithKline
GSK and Merck settle litigation over HVP patent claims, with cross license
of certain patents. GSK, Merck Reach Deal on HPV Vaccine Patent Rights

2005. July. Classen Immunotherapies, Inc. v. Biogen IDEC
The United States District Court for the District of Maryland, Northern
Division, issues an order granting a motion to dismiss in Classen
Immunotherapies, Inc. v. Biogen Idec, 381 F. Supp. 2d 452 (D. Md. 2005), in
which Classen argues that Biogen, GSK, Chiron Corporation, Merck, Kaiser
Foundation Health Plan, and other defendants infringed on patents
“involv[ing] a mechanism for evaluating the safety of vaccine
administration schedules by comparing or identifying the adverse events
associated with various vaccine schedules.” Id. at 453–54.

2006.  March 15.  Modified Vaccinia Ankara, (MVA)
From: Mula Moran, Intellectual Property: Patent war over smallpox vaccine.
March 15, 2006.  Science Business.Net.
The MVA vaccine is a highly attenuated strain that cannot replicate in
human cells. It is intended to protect people with weakened immune systems
or skin conditions such as dermatitis, who cannot tolerate the full
strength vaccine. This includes babies, old people, those with immune
system diseases such as AIDS. In the US this is estimated this is estimated
to cover 20 percent of the population. .

Last week saw the first detailed rebuttal from the UK company Acambis to
three lawsuits filed by Bavarian Nordic of Kistgard, Denmark, with Acambis
saying it was confident of defending the freedom to operate. Gordon
Cameron, CEO of Acambis, said the charges concerning its vaccine, MVA3000
are “without foundation” as he outlined his company’s detailed response at
an analysts’ meeting in London. “We have always believed and continue to
believe that any patents awarded or pending do not restrict our freedom to
operate in the field of MVA,” he said. He expects the cases to cost Acambis
£3 million over the next year. And Cameron accused Bavarian Nodic of trying
to disrupt and frustrate competition in the MVA procurement process, both
in the US and elsewhere. The most recent lawsuit, filed in the Commercial
Court in Vienna, Austria, follows the granting of a European patent to
Bavarian Nordic in December 2005. In two suits under way in the US, Acambis
is accused of stealing trade secrets at the US Federal District Court in
Delaware, and of patent infringement at the US International Trade
commission in Washington, DC. In addition to two US patents and one
European one, Bavarian Nordic has licensed rights from Mayr. Commenting on
the need for legal action Peter Wulff, President and CEO of Bavarian Nordic
noted the company has made a substantial investment in developing its
MVA-BN vaccines. “This legal action [in Europe], along with those we have
instituted in the U.S., is being taken to protect our assets.”

While Bavarian Nordic claims its technology forms the basis of MVA3000,
Acambis says it got the all important samples and rights through a Material
Transfer Agreement with the US National Institute of Allergy and Infectious
Diseases (NIAID).

2007. May 15. Bavarian Nordic A/S v. Acambis Inc.
United States District Court for the District of Delaware issues an order
in Bavarian Nordic A/S v. Acambis Inc., 486 F. Supp. 2d 354 (D. Del. 2007),
in which Bavarian Nordic alleges that defendant Acambis Inc. engaged in
various torts related to a smallpox vaccine, MVA3000.

2009. Combiotech v Serum Institute of India Ltd., Supreme Arbitration Court
of the Russian Federation
Combiotech brings a patent infringement case in Russia alleging that Serum
Institute of India Ltd. infringed on its patent for a recombinant hepatitis
B vaccine. The lawsuit lasts for almost three years.

2011. March 22 Wyeth, LLC v. Intervet, Inc.
Plaintiff company alleged that defendant corporation infringed seven of its
patents related to porcine circovirus vaccines. The issue was claim
construction. The parties agreed that five terms--porcine circovirus type
B, PCVB, type B porcine circovirus, porcine circovirus-B, and PCV-B
(PCVB)--were used interchangeably throughout the claims and had the same
meaning. PCVB was construed as a porcine circovirus having two genomic
sequences because the specification repeatedly defined PCVB with respect to
the two sequences, and PCVB had a specific genome sequence; it was not a
category of viruses.

2012. January 31.  Combiotech v Serum Institute of India Ltd., Supreme
Arbitration Court of the Russian Federation
The Presidium of the Supreme Arbitration Court of the Russian Federation
rendered a decision that Serum Institute of India Ltd. did not infringe
Combiotech’s patent for a recombinant hepatitis B vaccine. Combiotech sued
in 2009.  PATENTICA provided some commentary on the case here.

2013. August. Classen Immunotherapies, Inc. v. Biogen Idec
The United States District Court for the District of Maryland, Northern
Division issues an order in Classen Immunotherapies, Inc. v. Biogen Idec,
968 F. Supp. 2d 660 (D. Md. 2013), in which Classen alleges that Biogen,
GSK, and GSK’s affiliates infringed on Classen’s patents entitled, “method
and composition for an early vaccine to protect against both common
infectious diseases and chronic immune mediated disorders or their
sequelae” by manufacturing and selling various vaccines. Id. at 667.

2014. October 1. Human papillomavirus vaccines appeal by GSK at the EPO
The EPO Appeals Board issued a decision in T 1493/09, relating to an appeal
filed by GlaxoSmithKline over a decision of the examining division refusing
European patent application No. 03 712 047, which, in the first claim, was
directed to “[a] vaccine composition comprising VLPs containing L1 proteins
or functional L1 protein derivatives from HPV16, HPV18, HPV 31 and HPV 45
genotypes wherein the immune response generated by the vaccine is at a
level in which the protective effect of each VLP type is still seen and
wherein the vaccine composition comprises an adjuvant which is an aluminium
salt.” The appeal was dismissed because the patent application failed to
meet the requirements of Article 56 EPC relating to inventive steps.

2014. October 6.  Biovision life science forum in Lyon.
>From Catherine Saez, “Access To Vaccines, Patents Growing Concerns,
Panellists Say,” IP-Watch, October 6, 2014.

The production of vaccines relies on very sophisticated methods and the
level of knowhow required to manufacture them makes the infringement of
vaccine patents unlikely, according to several sources. However, this
situation is changing, according to Martin Friede, programme leader for the
Technology Transfer Initiative of the World Health Organization. For most
vaccines, intellectual property has not been a challenge he said, but
during the last 20 years some 10,000 patent applications for vaccines have
been submitted. The main owners of these patents are not big industries,
but rather national institutes of health and universities, he said. The
patents mainly concern vaccines against tuberculosis, malaria and HIV. The
bulk of the funding comes from the public sector because there is no market
force driving this, he said.

“In the old days,” he said, companies would go to universities for the
products they wanted, negotiate and pay an upfront cash fee on four or five
patents. Now a large number of patents on tuberculosis, malaria and HIV are
being “held by many different people.” However, “it is not the patents that
are causing the damage, it is the patent management,” he said. The
university technology transfer offices “are saying, you want to use this
technology, we want to see cash on the table,” he said. “We believe that
there is a massive amount of patents out there on these three areas, owned
almost exclusively by the public sector, paid for by taxpayers’ money,” he
said, and “they are being used as commercial leverage,” he said.  “There
are so many [patents] out there, the industry is saying since there is no
market, we are not prepared to make the investment to procure these
licences,” he said. . . .

In response to an audience question, Friede confirmed that knowhow is the
primary barrier to vaccine manufacturing but for some new vaccines, patents
can constitute a barrier, adding as an example the recent patenting by
“some groups” of an entire virus.  [Seth] Berkley concurred and said that
patent thickets are becoming a problem for vaccines, as are patent trolls
(patent assertion entities).

2016. November 7. The Commercial Court in Ireland hears a patent
infringement lawsuit brought by GSK against  Pfizer Ireland Pharmaceuticals
and Pfizer Inc regarding a meningococcal group B vaccine called Trumenba.
https://www.irishtimes.com/business/health-pharma/gsk-takes-case-against-pfizer-over-meningococcal-vaccine-1.2856931

2017. August 24.  India patent office grants Pfizer patent for pneumococcal
vaccine Prevnar 13, over MSF objections
https://www.fiercepharma.com/vaccines/pfizer-gains-indian-patent-to-prevnar-13-draws-monopoly-criticism-from-msf
The Indian patent, originally filed by Wyeth in 2007, would block other
companies from selling cheaper versions of the vaccine in India or
manufacturing one in the country for exports until 2026. “The method Pfizer
is trying to patent is too obvious to deserve a patent under Indian law,
and is just a way to guarantee an extended market monopoly for the
corporation for many years to come,” Leena Menghaney, South Asia head for
MSF’s Access Campaign, said in a statement. Pfizer’s patent involves the
methods of conjugating 13 serotypes of streptococcus pneumoniae into a
single carrier protein. An equivalent patent was revoked by the European
Patent Office in 2014 and is being challenged in South Korea and before the
U.S. Patent Trial and Appeal Board, MSF said.

2018. June 11. Merck Sharp & Dohme Corp vs. GlaxoSmithKline
Merck Sharp & Dohme Corp. filed four IPR petitions (IPR2018-01229,
 IPR2018-01236, IPR2018-01234, and IPR2018-01237) against GlaxoSmithKline
process patents – US Patent Nos. 8,753,645 and 9,265,839.
New IPR Petitions Filed Against GSK Vaccine Process Patents

2019. June 3. Sanofi Pasteur Inc. and SK Chemicals Co v. Pfizer, Inc.,
Patent Tr. & App. Bd.
https://news.bloomberglaw.com/ip-law/pfizer-vaccine-patent-strikes-out-again-at-patent-board

The Patent Trial and Appeal Board issues an order ruling on an appeal to an
inter parties review petitioned for by Sanofi and SK Chemicals regarding
U.S. Patent No. 9,492,559, which involves vaccines for “vaccination of
human subjects, in particular infants and elderly, against pneumoccocal
infections ....” 2019 WL 2352182 (Patent Tr. & App. Bd.), 1.

2019.  November 26.  Merck Sharp & Dohme Corp. v. Wyeth LLC (Fed. Cir. 2019)
>From the Decision
The ’999 patent, owned by Wyeth LLC (“Wyeth”), is directed to formulations
for stabilizing polysaccharide-protein conjugate vaccines.  . . .

On December 1, 2016,  Merck filed two petitions for inter partes review
with the Board, challenging claims 1–6, 10, 11, 14, and 17–20 of the ’999
patent. The Board instituted review of all challenged claims in two
parallel proceedings, IPR2017-00378 (“the 378 IPR”) and IPR2017-00380 (“the
380 IPR”). In each proceeding, the Board found all the challenged claims
except one—claim 18—to be unpatentable as obvious. Claim 18 covers a
13-valent pneumococcal conjugate vaccine.



-- 
James Love.  Knowledge Ecology International
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U.S. office phone +1.202.332.2670
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