ISSUE060
06.01.2016
w w w. i p p r o l i f e s c i e n c e s . c o m
The primary source of global intellectual property life sciences news and analysis
Bayer says Mylan infringes
Nexavar patents
Bayer HealthCare has sued Mylan
Pharmaceuticals for infringement of its
patents for Nexavar (sorafenib tosylate).
Mylan’s Abbreviated New Drug Application
(ANDA), filed at the US Food and Drug
Administration, for the generic version of
Nexavar would lead to infringement of four
of its patents, according to Bayer.
Mylan notified Bayer of its intention to
produce a generic version of the drug via
letter in December 2014.
But Bayer alleged in its complaint, filed at the
US District Court for the District of Delaware
on 17 December 2015, that it would suffer
“irreparable injury” unless Mylan was
enjoined from infringing its patents.
Celgene and Natco make amends
Celgene and Natco Pharma have settled
their patent infringement dispute over
Revlimid (lenalidomide).
producing a generic version of Revlimid,
and sought a ruling to block the approval of
Natco’s ANDA.
The pharma companies agreed to settle the
patent dispute on 22 December, with Celgene
allowing the launch of Natco’s generic
lenalidomide before the April 2027 expiration
of its patents covering Revlimid.
Revlimid had sales of $2.3 billion in 2010, and
is one of Celgene’s most profitable products.
Celgene initially sued Natco in 2010 after the
Indian pharma company filed an Abbreviated
New Drug Application (ANDA) with the US
Food and Drug Administration for a generic
version of Revlimid.
Celgene claimed that Natco would infringe
all 10 of its patents covering the drug by
Under the settlement, Celgene and Natco will
file consent judgements with the US District
Court for the District of New Jersey that enjoin
Natco from marketing generic lenalidomide in
2025, before the expiration of the patents.
Natco will sell an unlimited quantity of generic
lenalidomide in the US as of 31 January 2026
and will receive a volume-limited licence to sell
generic lenalidomide in the US commencing in
March 2022.
Continued on p2
“Mylan has made substantial preparation in
the US to manufacture, use, sell, offer to sell,
and/or import Mylan’s ANDA product with its
proposed labeling prior to the expiration of
the patent.”
Continued on p2
GSK set to acquire
Bristol-Myers R&D assets
GlaxoSmithKline has signed an agreement to
acquire Bristol-Myers Squibb’s research and
development HIV assets in a $317 million deal.
The agreement includes an upfront payment
of $317 million, followed by development
and first commercial sale milestones of up
to $518 million and tiered royalties on sales.
The purchase of preclinical and discovery
stage research assets includes another
upfront payment of $33 million, followed
by development and first commercial sales
milestones of up to $587 million.
Continued on p2
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Celgene and Natco make amends
Continued from p1
licensing and product commercialisation with
the Supreme Court.”
Natco’s ability to market lenalidomide in An oral hearing is set for October 2016.
the US will be contingent on its obtaining
approval of the ANDA.
Bayer and CRISPR Therapeutics
commercialise gene editing
Bob Hugin, chairman and CEO of Celgene,
said: “This settlement provides clarity Bayer and CRISPR Therapeutics have teamed
around the future of Revlimid.”
up to develop breakthrough therapeutics to
cure blood disorders.
“We remain confident in the strength of our
patents, and will continue to vigorously CRISPR will contribute its CRISPR-Cas9
defend them,” he added.
gene editing technology and intellectual
property, while Bayer will offer its protein
GSK set to acquire Bristol-Myers and disease knowledge.
R&D assets
The agreement is thought to be the first of its
kind to make a substantial investment in the
David Redfern, chief strategy officer at GSK, development of target delivery systems in an
said: “These acquisitions strengthen our effort to bring CRISPR gene editing technology
leadership and innovation in HIV, one of our applications to patients.
core areas of scientific research at GSK.”
and
Vertex
Pharmaceuticals
Through the joint venture Bayer will secure Genomics
Licensing society asks SCOTUS rights to use the technology and associated collaborate to develop therapeutic pathways
to reconsider standard
p4
intellectual property.
Continued from p1
Contents
Latest News
The Licensing Executives Society (LES) has Axel Bouchon, head of the Bayer life sciences
asked the US Supreme Court to reconsider the centre, will lead the joint venture on an interim
standard for enhanced patent damages.
basis, while Rodger Novak, CEO of CRISPR,
will serve as the interim chairman of the joint
The LES filed an amicus brief at the Supreme venture board.
Court on 16 December in the Halo Electronics
v Pulse Electronics and Stryker Corporation v Novak called the investment “game-changing”
Zimmer cases.
and said that it will retain full access to target
delivery technologies and IP developed by the
LES proposed a neutral argument in light of the joint venture.
petitioners’ claims that the standard is contrary
to legislative intent and inconsistent with the The joint venture will be based in London with
court’s precedent, referencing the Octane operations in Massachusetts.
Fitness and Highmark decisions.
Latest News
Purdue Pharma hits Mylan Pharmaceuticals
with a complaint over its plans to launch a
generic version of OxyContin
p6
Latest News
Amgen reacquires rights to three drugs
from GlaxoSmithKline
p7
Gastric cancer treatment to
The petitioners claimed the standard of review rocket to $4.4 billion
is “unduly rigid” and “inflexible”, making
enhanced damages nearly impossible to attain. The gastric cancer treatment market will
increase to $4.4 billion by 2024, according to
But the respondents held that changing the GlobalData’s new report.
standard would increase variability in willfulness
judgements and unfairly force parties to settle The PharmaPoint report predicted that the
under the threat of triple damages.
market will rise from $1.3 billion in 2014 to the
reported figures, driven by the introduction
LES argued that if the court adopted a more of premium-priced therapies for advanced
flexible standard for assessing enhanced gastric cancer and, as a consequence, the
damages, the “prospect” of enhanced increased uptake of therapy and a longer
damages would serve as a deterrent to treatment duration.
willful infringement.
The main drivers of the expansion of the
But if the court affirmed a more prescriptive market includes the launch of premium
enhanced damages framework, there might be priced metastatic therapies such as Eli Lilly’s
“certain efficiencies and a likely higher level of Cyramza (ramucirumab) and Merck’s Keytruda
consistency among the district courts would (pembrolizumab), according to GlobalData.
discourage forum shopping”.
The research company expects, by the
Rachel Kreppel, chair of the public policy end of the forecast period, for Cyramza
committee for LES, said: “LES is pleased to dominate the market with an overall
to share its insights into the real-world 37 percent share of the gastric cancer
implications of enhanced damages policy on treatment market.
2
Australia Insight
Australia’s IP system has come under the
spotlight as the government considers
possible reforms
p8
People Moves
Comings and goings at Wynne-Jones, Reising
Ethington and more
p11
Stillwaters Law Firm
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Latest News
The key patent expiry of Herceptin will also lead
to biosimilar entries from 2017.
Genomics and Vertex join forces
over therapeutics
Algorithm company Genomics and Vertex
Pharmaceuticals have collaborated over the
development of therapeutic pathways.
Under the agreement, Vertex Pharmaceuticals
will use Genomics’s analysis tools to inform its
drug R&D activities.
Genomics has developed an analytical platform
for genome analysis and interpretation.
The platform combines proprietary algorithms
and software with the company’s integrated
genome-phenome database and analytical
expertise to learn about human biology.
The tools will provide Vertex with confidence
in the rationale for targeting Vertex’s
pathway for the treatment of diseases and
to identify potential safety concerns and
repositioning opportunities.
John Colenutt, CEO of Genomics, said: “We
are excited that Vertex has chosen to use
Genomics’ proprietary technology, integrated
database and tools to support them in this aim.”
Genomics has existing partnerships with
pharmaceutical companies, and is a platform
partner for Genomics England.
Biosimilar applicants do need to
provide notice, says district court
A biosimilar applicant must notify the patent
owner upon receiving regulatory approval and
wait 180 days before beginning commercial
marketing, a US district court has ruled.
Under the Biologics Price Competition and
Innovation Act (BPCIA), patent owners are
entitled to 180 days of notice before a biosimilar
product is marketed.
notice period would kick in and it could assess Apotex sought the court to limit the Sandoz
whether there would be any infringement of two decision to instances where the applicant did
patents protecting Neulasta.
comply with Section 262. But Judge Cohn said
Apotex’s scenario would result in “confusion
Apotex cited the Court of Appeals for the and uncertainty”.
Federal Circuit decision in Amgen v Sandoz,
which held that a biosimilar applicant does not Granting the injunction, Judge Cohn ruled:
have to comply with the information exchange “Nothing in the statute or the Sandoz decision
and patent dance procedures of the BPCIA, as Ieads to or supports such a result; neither the
proof that it did not have to give Amgen notice statute nor the Sandoz decision condition the
of the FDA’s approval to begin commercial 180 day notice provision of Section 262(/)(8)(A)
marketing of the pegfilgrastim biosimilar.
upon a sub-section (k) applicant’s compliance
with Section 262(9(2).”
Under the BPCIA, a biosimilar applicant submits
an aBLA to the FDA and provides a copy of it to Roche and Glenmark resolve
Tarceva differences
the branded drug manufacturer.
Generic drug manufacturer Apotex is seeking
to produce a biosimilar of Amgen’s Neulasta
(pegfilgrastim) treatment, but it is yet to receive
Food and Drug Administration (FDA) approval Judge James Cohn of the US District Court
to begin commercial marketing.
for the Southern District of Florida said
that the Federal Circuit “addressed the
According to court documents, Apotex meaning of ‘shall’ as used in US Section
complied with the BPCIA and disclosed its 262(/)(8)(A) [of the BPCIA] in the Sandoz
Abbreviated Biologics Licence Application case, but left some ambiguity which this
(ABLA) and information about its manufacturing court must now address”.
process to Amgen, but refused to provide the
patent owner with notice of FDA approval, He explained: “[Because] the situation was
thereby avoiding a 180-day notice period.
not before [the Federal Circuit], the court did
not address whether the notice provision of
This refusal prompted Amgen to seek a Section 262 applies where the applicant, like
preliminary injunction to force Apotex to give Apotex, did share the information required by
notice of the FDA’s approval, so the 180-day Section 262.”
4
Swiss pharmaceutical giant F. Hoffmann-La
Roche and Indian generic manufacturer
Glenmark Pharmaceuticals have settled their
patent dispute over cancer treatment Tarceva
(erlotinib hydrochloride).
The Mumbai-based manufacturer attempted
to produce a generic version of Tarceva,
but Roche responded with a complaint and
subsequent litigation.
Under the agreement, Roche and Glenmark
have decided to toss all patent litigation related
to the drug.
Latest News
In a joint statement, the companies said:
“Glenmark and Roche confirm that they have
reached an agreement regarding ongoing
patent disputes relating to the anti-cancer
medicine erlotinib hydrochloride.”
No further information was provided.
Life Sciences portfolio worth an estimated The company will now trade on Nasdaq the
worth of $70 million.
Global Select Market as IONS.
The portfolio includes 25 products, including 18
generics and four specialised products, among
the anti-allergy and antiviral medicines.
Amgen takes back growth
market drugs
Amgen has reacquired rights to three drugs
The deal is expected to ‘jump start’ from GlaxoSmithKline in Europe, Australia
Glenmark also settled with Forest Laboratories Bionpharma in the generics market, according and South America.
in December 2015 over patent litigation related to the firm’s statement.
to its application for milnacipran hydrochloride,
The agreement will see Amgen reacquire
the generic version of Forest’s Savella.
Over the last 12 months companies have the rights to Proli and Xvega (denosumab)
invested in Bionpharma, with 40 percent of and Vectibix (panitumumab) in Brazil, China,
Purdue bites back with patent the business owned by Signet Healthcare and Colombia, Hong Kong, Israel, Singapore,
infringement complaint
some owned by Pharmascience, Canada’s South Korea, Taiwan and Thailand.
largest drug manufacturer.
Purdue Pharma has hit Mylan Pharmaceuticals
GlaxoSmithKline has held regional rights to
with a complaint about its plans to launch a generic Venkat Krishnan, CEO of Bionpharma, Prolio and Xgeva since 2009 and Vectibix
version of OxyContin (oxycodone hydrochloride). confirmed the closure of the deal.
since 2010, under licence from Amgen.
The patent infringement complaint follows Isis Pharmaceuticals now Ionis
Mylan’s filing of an Abbreviated New Drug
Application (ANDA) for a generic version Isis Pharmaceuticals has changed its name to
of OxyContin in November. It claimed it Ionis Pharmaceuticals.
did not infringe a patent covering the pain
relief drug.
The company chose the new name to represent
its “innovative culture” and “heritage” in the
But in the complaint filed at the US District RNA-targeted therapeutic space, which it has
Court for the District of Delaware, filed on 16 operated in for 26 years.
December, Purdue alleged that it would suffer
“irreparable harm” if the ANDA is granted.
Ionis brings late-stage, third-stage drugs, to the
market, which have the potential to become
Purdue is seeking an order enjoining Mylan best-in-class drugs that treat patients with lifefrom producing oxycodone hydrochloride, threatening or serious diseases.
along with costs.
Lynne Parshal, chief operating officer at
Bionpharma buys portfolio worth Ionis, said: “We decided to change our
$70 million
company name because, when people
see or hear our name, we want them to
Ranbaxy’s New Jersey-based pharmaceutical think about the life-saving medicines we
start up Bionpharma has acquired a Banner are developing.”
6
Amgen said it would make milestone
payments to GlaxoSmithKline for the
transition of the products.
GlaxoSmithKline will continue to hold the
license and sell the products for an interim
transition period, which is expected to last
12 months.
Robert Bradway, CEO of Amgen, said: “This
unique agreement allows Amgen to regain
rights to three important growth products,
and to directly serve more patients in key
expansion markets.”
“The agreement also allows Amgen to build
additional commercial infrastructure in
oncology and bone health, two strategically
important therapeutic areas for Amgen
with emerging late-stage pipeline assets,”
added Bradway.
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Australia Insight
Australia’s IP system has come under the spotlight as the government considers
possible reforms. Naomi Pearce and Nigel Lokan of K&L Gates speak to Tammy Facey
In light of the Australian government calling for an
investigation into the quality and handling of IP in
Australia, how likely is patent reform?
published in May 2013, and in the six months that followed, Australia
changed its prime minister twice.
Nearly three years later, it is great to see the subsequent Australian
government dust off the reports of the previous government and
commission its own inquiry, with a view to taking steps toward a
more balanced IP system in Australia. While we are not holding our
breath, we hope to see further law reform.
Naomi Pearce: It is not unlikely, but it is easy to become cynical
about the fact that earlier inquiries into Australia’s intellectual
property system have not yet resulted in law reform. The Australian
government’s further inquiry is an acknowledgement that we still do
not have the balance right in relation to IP laws in Australia.
In relation to patents, a significant improvement would be made
if the PPR report recommendations regarding manufacture for
export (MFE) were implemented in Australia. This would enable
companies to manufacture pharma/biopharma products in Australia
Some important changes were suggested in the report of the 2013
Pharmaceutical Patent Review (PPR), but they fell by the wayside
due to political changes in Australia at the time. The PPR report was
8
Australia Insight
For smaller companies
or private individuals, the costs
of patent litigation, and the size
of the Australian market, may
result in cases not getting litigated
in Australia
Naomi Pearce, partner, K&L Gates
for export only, during the term of a patent term extension in
Australia. The effect would be that Australia would retain its
pharmaceutical manufacturing capabilities as less pharma/
biopharma manufacturing would be driven offshore. IP Australia
certainly seems to be supporting MFE implementation in Australia
in its latest submission to the Productivity Commission.
There has only been one opposition decision to date since the
Raising the Bar amendments came into force, where an application
was found invalid because of lack of descriptive support. The
pro-applicant stance of the IP Australia may be shifting, but it is
early days.
Post-grant, ex parte re-examination is also available. Given recent
reforms to the opposition system to reduce delays and hear matters
more expeditiously, in our view Australia is unlikely to implement an
inter partes review system like the US in the foreseeable future.
How can patents be challenged pre- and post-grant,
without going to court?
Nigel Lokan: Australia has a pre-grant opposition system in which
any person may oppose the grant of a patent. A demonstration
of standing is not required. An opposition may be filed in the
name of an anonymous third party, or ‘straw man’. If an opponent
wishes to appeal against the IP Australia decision regarding an
opposition, an appeal may be filed in the Federal Court.
Is Australia likely to create a separate route for resolving
patent cases in a time and cost-effective way?
Pearce: There has not been any real discussion in Australia about
law reform introducing a low cost court alternative to resolution of
IP disputes such as the Intellectual Property Enterprise Court (IPEC,
previously the Patents County Court) in London, but we think this
would be a good thing for Australia.
While Australia does not have a patent appeal board, patent
applicants can request a formal hearing before IP Australia at any
time if prosecution of an application reaches an impasse. However,
such requests are rare. These may be become more common in the
future in view of the recent reduction in the time allowed for patent
applications in Australia to be accepted (reduced from 21 months to
12 months from the day of the first report).
Any type of IP protection is only as good as the owner’s ability to
enforce. For smaller companies or private individuals, the costs of
patent litigation, and the size of the Australian market, may result in
cases not getting litigated in Australia.
Until recently, the IP Australia has been pro-applicant for granting
patents. In April 2013, various law reform initiatives were introduced,
including the Raising the Bar Act, which was aimed at bringing
Australia in line with its major trading partners, and at ‘raising the
bar’ for standards of patentability in Australia.
If an efficient low-cost court alternative such as the UK IPEC were
introduced in Australia, some of the legitimate cases could be heard
in a cost- and time-effective manner. We believe an optional low-cost,
fast track would be of great benefit in certain situations. IPPro
Given recent reforms to
the opposition system to reduce delays
and hear matters more expeditiously,
in our view Australia is unlikely
to implement an inter partes review
system like the US
Nigel Lokan, partner, K&L Gates
9
People Moves
Industry appointments
Comings and goings at Wynne-Jones, Reising Ethington and more
Wynne-Jones has appointed James Robertson as partner in its
Cheltenham office.
He has worked across licensing, prosecution and opinion and
offered due diligence for companies in the medical devices industry
and computer software.
He has more than 20 years of experience in the patent sector and
previously served as a partner at Marks & Clerk.
Snow has also been trial counsel for numerous IP cases, Markman
hearings, along with judgements in copyright, trademark and
patent cases.
He is experienced in the registration of UK and Community
designs and specialises in biotechnology, medical devices and
plant variety rights.
“We are thrilled to welcome Snow into the Pryor Cashman fold,
adding strength to our already strong IP practice,” said Ronald
Shechtman, firm managing partner.
“I am incredibly excited about joining Wynne-Jones,” said Robertson.
Ian Lambert, partner at Wynne-Jones, said: “Robertson is one of
the UK’s top life sciences patent attorneys and we look forward to
utilising his knowledge and experience of the field.”
David Ward has been promoted to managing partner of Marks &
Clerk’s UK patent and trademark attorney business.
Maureen Kinsler has also become chairman of Marks &
Clerk International.
Stefan Osterbur has joined Reising Ethington as counsel.
He previously served as partner at Fishman Stewart Yamaguchi.
Their promotions follow predecessors Keith Hodkinson and Bob
Naismith stepping down at the end of 2015.
Osterbur focuses his practice on domestic and foreign patent prosecution, patent infringement and validity issues, trade secrets and
intellectual property litigation.
Ward, based in Birmingham, joined the firm in 1986. He was on the
firm’s UK board for five years.
He primarily counsels clients on a wide variety of IP matters, including
portfolio management, infringement issues and IP transactions.
He specialises in material science and food technologies and his
clients include universities and multinational companies.
Jeffrey Snow has become partner at Pryor Cashman in New York.
Ward said: “I am delighted to be taking on the responsibility of UK
managing partner as we maintain this focus.”
Snow joins the firm from Cooper & Dunham where he was also
a partner.
Kinsler has been at the firm since 2002.
10
People Moves
She oversees the firm’s international marketing and business
development functions and specialises in physics, electronics
and software.
“This is a very exciting time to become chairman of Marks & Clerk’s
international business,” said Kinsler.
“Our clients face an increased need for international, sound IP
advice. It is now my privilege to lead the business as we continue to
work with existing clients and develop and grow our client portfolio,”
she added.
Editor: Mark Dugdale
markdugdale@ipprolifesciences.com
+44 (0)203 750 6022
Alston & Bird has promoted three IP attorneys to partner in its offices
in Atlanta, Georgia, and Charlotte, North Carolina.
Deputy Editor: Stephanie Palmer
stephaniepalmer@blackknightmedialtd.com
+44 (0)203 750 6019
Dane Baltich and Michele Glessner have become partners in the
firm’s patent prosecution, counselling and review group. New partner
David Frist is a member of the firm’s IP litigation group.
Reporter: Tammy Facey
tammyfacey@blackknightmedialtd.com
+44 (0)203 750 6017
Baltich concentrates his practice on patent solicitation in electrical
and computer-related technologies, and counsels clients on patent
portfolio management, infringement, validity and enforcement.
Contributors: Becky Butcher and Drew Nicol
Glessner works on domestic and foreign prosecution. She advises
clients on utility design patent prosecution matter, patentability and
freedom-to-practice investigations.
Marketing Director: Steven Lafferty
design@securitieslendingtimes.com
Frist represents clients in federal district courts in patent infringement cases involving telecommunications, computer software and
mechanical devices.
Marketing Executive: Ayla Uzunhasan
ayla@blackknightmedialtd.com
+44 (0)203 750 6020
Thirteen others partners have also been elected at the firm within the
financial, tax and securities groups.
Designer: John Savage
johnsavage@ipprotheinternet.com
+44 (0)203 750 6021
Richard Hays, managing partner of Alston & Bird, said: “Our new
partners have all shown an outstanding ability to work together
with their colleagues to advise clients on complex legal and
business issues.”
Senior Account Manager: Clinton Hanson
clintonhanson@ipprolifesciences.com
+44 (0)203 750 6026
Associate Publisher: Carlos Northon
carlosnorthon@ipprotheinternet.com
+44 (0)203 750 6023
Kaye Scholer has promoted former counsel Rob Laurenzi to partner
and associates Abigail Langsam and Paul Margulies to counsel.
Laurenzi, based in New York, focuses his practice on patent litigation
and inter partes review proceedings covering computer, software,
internet and telecommunication technologies.
Publisher: Justin Lawson
justinlawson@securitieslendingtimes.com
+44 (0)203 750 6019
New counsel Langsam is based in New York, while Margulies is
located in Washington DC.
Recruitment Manager: Chris Lafferty
chris@assetservicingtimes.com
+44 (0)208 663 9624
Langsam has completed patent due diligence investigations and has
counseled clients in connection with licences and acquisitions. She
focuses on patent matters in biotechnology, pharmaceuticals and
telecommunications.
Office Manager: Chelsea Bowles
accounts@securitieslendingtimes.com
+44 (0)203 750 6020
Marguiles has represented plaintiffs and defendants in a variety of
patent cases involving software and pharmaceuticals at all stages
of litigation.
Office fax: +44 (0)20 8711 5985
Published by Black Knight Media Ltd
“We are proud to recognise the achievements of this talented group
of lawyers and congratulate them on this significant professional
milestone,” said Mike Solow, Kaye Scholer managing partner.
Copyright © 2016 Black Knight Media Ltd.
All rights reserved.
A further 15 members of the firm were promoted across Chicago,
Frankfurt, New York, Washington DC and Shanghai. IPPro
Do you have an appointment to announce?
Let us know: tammyfacey@blackknightmedialtd.com
11
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