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20 March 2014 Issue 492
Arthritis Drugs US Celebrex ruling opens door
A
key US patent protecting Pfizer's Celebrex (celecoxib) blockbuster
until December next year is invalid, a Virginia district court judge has ruled. The summary judgement opens the way for generics firms tosecure approval for, and to launch, the arthritis drug once six-monthpaediatric extensions to two other patents expire in May this year.
Pfizer – which reported US Celebrex sales ahead by 11% to US$1.93billion last year – said it would appeal.
Judge Arenda Wright Allen granted summary judgement to Actavis, Apotex, Lupin, Mylan and Teva, declaring that Pfizer's reissued USmethod-of-use patent RE44,048 was invalid. Pfizer, she said, "could notuse the reissue process to correct its failure to file a divisional application".
Furthermore, Allen added, Pfizer had deliberately filed a continuation- in-part, not a divisional application, of an earlier patent to maximise itsexclusivity for Celebrex. "Because intentional acts are not correctable viareissue, the court finds that the ‘048 patent violates the reissue statuteas a matter of law, and is invalid." And as the ‘048 patent could not beconsidered divisional, it was also invalid due to obviousness-type doublepatenting in light of earlier patents.
The ruling comes 12 months after the US Patent and Trademark Office (PTO) reissued the ‘048 patent, and Pfizer sued the generics firms foralleged infringement.
Actavis said it "may be entitled to 180 days of generic market exclusivity, or shared exclusivity" pending final approval for its 50mg, 100mg, 200mgand 400mg capsules, which the firm expects upon expiry of paediatricextensions to US patents 5,466,823 and 5,563,165 on 30 May this year.
Mylan expects to share exclusivity on the three highest strengths.
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20 March 2014 Issue 492
Unitary Patent Court will face delays
Europe's Unitary Patent Court will not be operational until "the end of
2015 at the earliest", according to Alexander Ramsay, vice-chairman of the court's preparatory committee. Ramsay – who also works for Sweden'sMinistry of Justice – told delegates to the European Generic medicinesAssociation's (EGA's) 10th Legal Affairs Forum this week that his com-mittee's previous prediction of the court starting work in early 2015"cannot be accomplished".
Nevertheless, Ramsay insisted, substantial progress was being made towards setting up the court, which will hear infringement and validitydisputes over unitary patents as well as European patents provided thepatent holder does not opt out. A training centre for judges located in Budapest, Hungary, had been inaugurated last week, he pointed out. And Sweden had recently teamed up with theBaltic States to form a regional division of the court in Stockholm withEnglish as its operating language.
Sun facility suffers an FDA import alert
S
un Pharmaceutical's active pharmaceutical ingredients (APIs) and finished-
dose cephalosporins facility in Karkhadi, near Gujarat, India, has been hit by an import alert issued by the US Food and Drug Administration (FDA).
This followed an inspection at the plant that revealed current good currentmanufacturing practice (cGMP) deficiencies. "The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by theFDA," the Indian firm commented.
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20 March 2014 Issue 492
Biological Drugs/Market Research European doctors report by brand
One in six prescribers in Europe communicates only the international
non-proprietary name (INN) when reporting adverse drug events, according to a survey of 470 doctors carried out by originators' groupthe Alliance for Safe Biologic Medicines (ASBM). More than half ofthe physicians questioned – 54% – cited both the brand and INN name,while 29% reported only the brand name.
Similarly, fewer than one in four doctors used only the INN when prescribing biological medicines, while a third used both the brand andINN name, and 30% prescribed exclusively by brand.
"Although the results showed that physicians prefer to use brand names when prescribing biological medicines and reporting adverseevents," acknowledged the ASBM, "the findings around the use of INNand its meaning in the context of biosimilar products leads us to con-clude that the use of distinguishable INNs for all biologics, includingbiosimilars, is critical to further strengthen and facilitate patient safetythrough effective pharmacovigilance." Pricing & Reimbursement Romania must amend clawback
Romania's government must immediately change the way it calculates
mandatory clawbacks if the country's generics industry is to survive, Romania's generics producers' association, APMGR, has warned.
Introducing a budget-neutral cap for clawbacks on generics and other essential medicines should only be a temporary measure, APMGR insists.
In the medium term, it says, generics producers which supply 70% of
medicines used in Romania should be exempted from paying clawbacks. G
Page 3 of 7
20 March 2014 Issue 492
Canada and Korea strike trade deal
A
free trade agreement struck between Canada and South Korea includes
"no new commitments in the area of pharmaceutical patents", according to a summary released by the Canadian government. Intellectual-property provisions in the Canada-Korea Free Trade Agreement(CKFTA) are "in line with Canada's current regime, including criteriaregarding patentability and exclusions from patentability".
According to the Canadian government, the CKFTA "recognises the importance" for public health of the World Trade Organization's (WTO's)declaration on trade-related aspects of intellectual-property rights (TRIPS). Upon the agreement entering into force, 63% of pharmaceutical tariff lines will be duty-free, the summary states, while all remaining tariffs ofup to 8% will be eliminated within five years. "Products of export interestinclude antibiotics and anti-tuberculosis medications," it adds.
Attention Deficit Hyperactivity Disorder Drugs Actavis strikes Daytrana deal
A
ctavis will be able to launch a US generic version of Noven Pharma-
ceuticals' Daytrana (methylphenidate) transdermal patch from 1 September 2015 under the terms of a patent-litigation settlement agreedbetween the two companies.
"Noven will grant Actavis a non-exclusive, royalty-bearing licence to market its generic Daytrana", Actavis said, adding that the launch dependedon securing approval from the US Food and Drug Administration (FDA)for the generics firm's abbreviated new drug application (ANDA).
Actavis believes it may be entitled to 180-day exclusivity for its versionof the attention deficit hyperactivity disorder treatment as one of the firstto file an ANDA.
Citing IMS Health data, Actavis said Daytrana had US sales of around US$98 million in 2013.
Page 4 of 7
20 March 2014 Issue 492
EGA demands action on SPCs
Urgent action from the European Commission is needed on patent
extensions to allow European producers to compete equally with other manufacturers, according to the European Generic medicines Association(EGA). "The supplementary protection certificate (SPC) unfairly blocksour industry from exporting to the rest of the world and encourages thedelocalisation of our production," the EGA's director-general, Adrian vanden Hoven, told delegates to association's 10th Legal Affairs Forum earlierthis week. The association wants to amend the SPC Regulation to permit"advanced manufacturing" for export during the SPC term. Highlighting efforts to improve a patent's ‘inventive step', the EGA's government affairs and intellectual-property manager, Lidia Mallo, saidthe EGA was "engaged in a constructive dialogue with the EuropeanPatent Office to address deficiencies in the granting of pharmaceuticalpatents that, if abused, can delay competition in the single market".
The EGA also called for "more guidance on what is authorised in a patent settlement" in light of the Commission's actions over certain patent deals. G
Alvotech finesses its biotech production
A
lvogen's newly-formed biosimilars affiliate, Alvotech, has formed a
manufacturing partnership with California-based Finesse Solutions.
The deal will give Alvotech access to "world-class, scalable, flexible andcost-efficient manufacturing and laboratory technology through Finesse'sturnkey SmartFactory good manufacturing practice (GMP) manufacturingplatform suite". Page 5 of 7
20 March 2014 Issue 492
Adcock faces ‘bumpy road ahead'
A
dcock Ingram's sales during its current financial quarter ending 31
March 2014 have "shown no improvement" over the prior-year period as of the end of February, while its generic and OTC portfoliosales "remain of concern" and are "significantly behind those of the cor-responding period", the South African firm has reported to shareholders.
"Gross profit as a percentage of sales remains under extreme pressure,"the firm added, pointing to a combination of an "unfavourable revenuemix, rand depreciation … and certain facilities running significantlybelow capacity, particularly oral liquids".
"The road ahead is likely to be bumpy," predicted Adcock, which revealed costs associated with its failed takeover by Chilean firm CFRPharmaceuticals – called off earlier this year – were expected to reachZAR140 million (US$12.8 million).
Parkinson's Disease Drugs Amerigen celebrates first US approval
A
merigen has secured its first marketing authorisation from the US
Food and Drug Administration (FDA) after the agency approved the firm's abbreviated new drug application (ANDA) for a rival to Valeant'sLodosyn (carbidopa).
Korman to call it a day with Mylan
Mylan's chief operating officer, Harry Korman, will end his 18-year
association with the US firm when he steps down from the role on 1 July. "Harry has been an important part of the leadership team thathelped successfully transform Mylan from a US-based generics businessinto a leading global pharmaceutical company," Mylan commented.
Page 6 of 7
20 March 2014 Issue 492
Strategic Al iances Sandoz expands programme in Africa
S
andoz will this year begin supplying Egypt's Ministry of Health with
an additional "life-saving anti-tuberculosis medicine". The agreement struck by the firm – which already has a portfolio of three tuberculosisdrugs in the country – will run for two years.
Meanwhile, Sandoz' German affiliate – 1A Pharma – has struck a three- year development partnership "aimed at increasing access to high-quality,
affordable medicines" in Ghana. Local firm La Gray Chemical Company
forms part of the venture, and will receive training and support from Sandoz. G
Promotions
Takeda picks Platford for emerging markets
T
akeda will on 1 April promote Giles Platford – who currently leads the
firm's Middle East, Turkey and Africa (META) region – to head the firm's commercial operations and emerging markets business. Last month, the
firm's head of emerging markets, Jostein Davidsen, agreed to join Swiss company
Acino as chief executive officer by 15 May "at the latest" (Generics bul-
letin
, 7 March 2014, page 30).
Genitourinary Drugs Par goes after Hyperion's Ravicti
Par has submitted an abbreviated new drug application (ANDA) containing
a paragraph IV certification for a generic rival to Hyperion Therapeutics' Ravicti (glycerol phenylbutyrate) 1.1g/ml oral liquid. The US firm's ANDAalleges invalidity against two of the urea-cycle disorders treatment's threepatents – US patents 8,642,012 and 8,404,215 – that protect Ravicti untilSeptember 2030 and March 2032 respectively.
Mergers & Acquisitions Mallinckrodt completes Cadence deal
Mallinckrodt has completed its US$1.4 billion acquisition of Cadence
Pharmaceuticals. The deal – which was announced earlier this year (Generics bulletin, 7 March 2014, page 9) – gives Mallinckrodt access to
Cadence's Ofirmev (acetaminophen) injectable, as well as providing the
firm with "an expanded presence in the US hospital channel".
Page 7 of 7

Source: https://safebiologics.org/wp-content/uploads/2014/03/[email protected]

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