The words indented and in itallics comprise The Critque – of the words Remaining which comprise the press release
Samsung brings in the lawyers for biosimilars push
SEOUL | BY SE YOUNG LEE
Samsung Bioepis Co Ltd, which aims to become a force in the fledgling biosimilar drugs industry, has filed a lawsuit against the originator of the world’s best-selling drug, to stop it blocking the launch of its own version.
The pronouns used here (it, its) are confusing. Who is stopping whom from launching? ‘Fledgling industry’ versus ‘world’s best-selling’ – a twisted would-be David and Goliath story perhaps?.
The unit of South Korea’s Samsung Group [SAGR.UL], along with partner and minority shareholder Biogen (BIIB.O), filed suit in Britain on March 24 against AbbVie Inc (ABBV.N), maker of rheumatoid arthritis drug Humira, which generated sales of $14 billion (9.85 billion pounds) last year.
It’s not clear whether Humira generated the money or AbbVie Inc. I am assuming the claim refers to the drug not to the company. The world’s best selling drug generated sale s of $14billion last year. See the figures in the following paragraphs which are projected as their wishlist targets by Samsung, its subsidiaries and competitors in the wider bio drug similars marketplace. These sums are much huger than $14 billion
It is the company’s first suit against a drug originator.
The first suit – and therefore an advance – possibly a new way found to make attempts to muscle in, and to muscle others out The term ‘drug originator’ here used is an emotionally neutral term, a sanitised term, unlike a term such as ‘drug patentee’ or ‘drug owner’ or ‘drug creator’ all of which imply more strongly an ownership of a property. ‘Originator’ on the other hand tends to exclude, or to at least dampen down in its use, any idea of exclusive possession of property rights.
Interest in biosimilars – lower-cost copies of complex biotech drugs – has soared in recent years as copies of some of the world’s best-selling prescription medicines have hit the market.
‘Interest in’ might be a euphemism for muscling in and muscling others out so as to make a land grab; one which at present is within the law to attempt, and so to aim to poach business and revenues from other companies? ‘Lower-cost copies’ is a term which also neutralises any hint of an attempted rip-off. As for ‘complex bio drugs’ – does the word ‘complex’ add anything other than to fabricate a mystique surrounding the science of bio drugs? They must be good!
Unlike generic versions of simple chemical medicines, biotech drugs are made from living cells, so it is impossible to manufacture exact copies.
A fallacy: The statement concluding impossibility just does not follow from the premises. The statement seems to be a backdoor and bogus justification for the lawfulness of making biosimilar drugs and trading in them. How exact a copy of any tablet of an ordinary drug is another tablet of the same drug? It has the same chemical composition but uses different matter than does any other tablet of the same drug. Logically it has to be so. And so biosimilars, if they are ‘different’ will have to be different in some other ways than being not exact copies of their parent drugs, and to be different in another way than in the way of ‘non-exact copies’ as described here. Yet also a drug which claims itself to be a copy of another drug, it seems, would yet have to contain effectual ingredients of the same kind and same application – and working in the same way so as to get the same effects – as the drug it is being claimed to be an inexact copy of? Thus it has to be either a copy or else it is not. It may have constituents which differ as variations from the drug it is modelled on as it being an inexact copy – but surely the active ingredients in it have to be of the same kind and application and so give the same results, for it to be able to be called a copy of any sort?. And besides, this all is a red herring. The issue in question is the attempt at extension of a term, of the expiry date, of a patent. Should the drug creator who is also the patent holder win in a law suit; it seems that Samsung would not be able to market its bio similar drug at issue. Period
The IMS Institute for Healthcare Informatics says biosimilars could save healthcare systems in the United States and Europe’s top five markets as much as 98 billion euros (78.49 billion pounds) by 2020.
Who is this IMS? Does any reader bother to look it up? Does it carry any authority besides a grandiose name? True, that biosimilar drug copies might save their users and buyers some money; than had they bought the patentee’s variant instead – probably – but this is not the central issue – which is not stated here. The central issue is Samsung’s aiming to make profits by way of undercutting, pricewise and perhaps also attempting to undermine businesswise, the original developers of a drug. The article implies that drug firms are copying patented bio drugs in such a way which is able to avoid patent law restrictions. See previous paragraph. It is thus a form of competition – whether fair or not – who can say?
The figure of 98 billion euros to be saved by public healthcare systems, seems to be presented here so as to engage readers who might be, or become, or think they might become, public consumers of the biosimilar drugs and so to grab their interest – to get them onside and hook into their personal concerns, hopes and empathies?
The South Korean conglomerate is hoping for big things from the unit – including a revenue target of 1 trillion won ($872 million) by 2020 – amid sagging profits at its electronics business, Samsung Electronics Co Ltd (005930.KS), the world’s biggest maker of smartphones and televisions.
What ‘unit’? Samsung has great expectations of ‘big things’ by 2020 – of generating in its business 1 trillion won (Korean currency unit) = US$872 million
Success in the endeavour is seen as key for de facto Samsung Group leader Jay Y. Lee, 47, to prove himself as steward of the family-run smartphones-to-insurance empire. His father, group patriarch Lee Kun-hee, has been hospitalised since a 2014 heart attack.
A ‘human interest’ clause, centring upon a son’s bid to prove himself to be as capable as his ailing father was.
The composition patent for Humira loses its exclusivity in the United States in December 2016, and in Europe in October 2018, but Illinois-based AbbVie, which earned 61 percent of its 2015 net revenue from Humira, has been filing new patents in a bid to push back sales of biosimilars.
AbbVie is cast as villain. It is presented as if having been seeking to manipulate the patents systems so as for it to retain exclusive right to its Humira drug for longer than is normally permitted in law. It is also hinted at that the firm AbbVie’s business is unbalanced financially (61% of its income comes from one drug it owns) and so dependant too far on a single product – due to expire patent soon – Another hint to its investors perhaps?
In addition to Samsung Bioepis and Biogen, more than a dozen firms have challenged AbbVie’s strategy through patent authorities or the courts.
More than 12 interested (biosimilar drug?) firms have combined to take AbbVie to court and so challenge its strategy of trying to prolong its patent term in Humira. They perhaps see a failing alpha giant and like wolves might be lining up to destroy the alpha and to fight out amongst themselves thereafter who might become the next market leader?
“We believe that AbbVie has been attempting to obstruct market entry of competing products by applying for a large number of overlapping patents around Humira, which could affect patient access to affordable medication,” Samsung Bioepis told Reuters.
This seems to be a deliberate and detestable obfuscation. AbbVie it is said is believed to have ‘been attempting to obstruct market entry of competing products’. In fact the more believable version is that perhaps AbbVie has been attempting to obstruct market entry of the combined dozen plus companies’ (biosimilar drug makers’?) competing products? The justification for this combination of firms pressing their law suits is that if AbbVie were to succeed in its strategy to prolong its patent term, this ‘could affect patient access to affordable medication’. Does any clear-thinking person believe this is the prime motivation for the dozen plus companies to have chosen to oppose AbbVie in law? Is it not perhaps rather that the firms placing the lawsuit against AbbVie are doing so, so that they can enter the marketplace with their own (bio similar’ drug?) products? And does the combination want primarily to help the ill persons who need and who might take the drug – or is it not instead all smoke and mirrors and about making money and clawing a ways to the top of the sector?
“We believe competition should take place in the market, and not through such misuse of the patent system,” it added.
This appears to be another justification and one which is probably hypocritical. Would any clear thinking person impute uprightness to any of the dozen plus companies who in combination are bringing the suit on such grounds as they claim here? Would any clear thinking person believe that these companies themselves would not act in the exact same way and use the same strategy as AbbVie is using; were the tables turned on them?
AbbVie told Reuters it was aware of the lawsuit filed by Samsung Bioepis and Biogen.
“As we have said, we intend to defend our intellectual property,” it said.
It appears to be all about possession of property for AbbVie. Notice they are ‘defending’ their IP’, no mention of them trying to ‘extend the term of the IP’ or of any hint of doubt in them about the ethical appropriateness of their sense of their right to do so. They offer no succour to the enemy
Samsung Bioepis, which brought its first drug to market late last year, has a pipeline of 13 biosimilars, versions of existing drugs with similar efficacy at much lower prices, and is initially focussing on six of them to get out in front of the market
Samsung looks to be being cast more and more as the hero versus the villain AbbVie. It is said to be trying to ‘get out in front of the market’ – a go-getting and dynamic company – and remember the touching son/father story earlier. Samsung has in line 13 of these drugs called ‘biosimilars’ – a term that again neutralises any hint of proprietary impropriety concerning the drugs. ‘Much lower prices’ appears again to be a hook used to draw in sympathy from public audiences who might use the drugs.
The Samsung Group has a track record of moving fast. Late to enter the smartphone market, Samsung Electronics quickly rose to become the industry leader. The group is also one of the world’s most active patent filers and has over the years tried to move beyond its image as a “fast follower”.
Samsung has a ‘track record of moving fast’ – this whole paragraph is presented as a casual aside – but its big statements lean towards inferring repeatedly that Samsung is the dynamic hero in this affair. It is praised as having:
Risen to become the Industry-leader
A status as one of the world’s most active patent filers
Tried to move beyond its image
“The first drug to hit the market takes the most market share, so this is the right strategy to go with,” said Kang Yang-ku, analyst at HMC Investment & Securities.
An independent source again, this time from HMC Investment & Securities, is quoted here in another attempt which seems to aim at forming this article’s readers’ opinions favourably towards Samsung. Again who are HMC and what authority does this HMC company member hold to be able to speak categorically like this? Does any casual reader care to look them or him up? An HMC analyst says, in effect, that Samsung’s strategy for it to become placed in pole position in the market is the correct one and is sound; and by saying this the independent source seems obliquely to be endorsing Samsung, and denoting it implicitly as being a progressive company
There are potentially rich pickings for early movers; more than 10 blockbuster biological drugs with combined yearly sales of $60 billion are on track to see their U.S. and European patents expire over the next four years, according to Allied Market Research.
Compare this $60 billion with the 14 billion made last year by AbbVie in selling the single world’s most popular bio-drug. Another independent source here called, Allied Market Research, looks to be being used (again) to form the opinions of the readers of this webpage favourably towards the future of biosimilars. It mentions the ever-popular capitalist dream-myth of ‘rich-pickings for early movers’ – it looks like a glib and vacuous puff of wind; hype in fact – which announces that the chase is on with the heroic ’10 blockbuster biological drug’ firms – note ‘blockbuster’ – rooting for busting the blockage being proposed by the likes of AbbVie? These 10 ‘blockbusters’ might be pictured biting at the ankles of the patents due to expire and at those of the US and EU patentee companies who hold them? The US cavalry of ‘early movers’ are on the trail of the baddies, the patentee bio drug firms – this cavalry are already doing good to and for the general publics and at the same time hoping to turn in $60 billion whilst on their cavalry crusade. And in four years time, after the patents expire for the baddie bio drug guys, the goodie biosimilar drug guys who make and sell the bio-similars, will be cleaning up big-time, probably much more than a piffling $60 billion, and at the same time serving nobly a previously much deprived and exploited general public with their cheaper biosimilar drugs.
Biosimilars are a source of consternation for investors in firms such as AbbVie, however, as the cheaper copies threaten to undercut profits for the original drug makers.
‘Cheaper copies threaten to undercut profits of original drug makers’ – again, no allusions to property rights is mentioned as belonging to the creators of the original bio drugs – phrasing the description this way, and so bypassing saying something like ‘the present patent holders’ or ‘the creators of the drugs’ is convenient. The copies, the biosimilar-drugs, ‘are a source of consternation for investors’ at firms like AbbVie, but not for the firm itself perhaps? But of course they are! Investors are maybe being hinted at here to change horses and to back the biosimilar drug copy companies – the guys who are to make ‘rich pickings’ because they are the ‘early movers’? The fact that to deprive companies who actually create drugs of research cash and resources by poaching investors from them; logically with doubt this means that the creation of new drugs by such drug creator firms becomes harder for them to do for them and their drugs slower to succeed. This is how the marketplace, free competition and the gung-ho anything-goes under the law, capitalism, as we have it operating right now almost globally, is emphatically not in the public interest. My arguments show how it allows firms to act in their own interests exclusively, even when great public harms might be at stake and resultant from firms’ freedoms to act in ways like these.
In December Bioepis began selling a biosimilar of Amgen’s (AMGN.O) arthritis drug Enbrel in South Korea, and the drug has since launched in some European markets including Germany and Britain early this year. The European Medicines Agency on Friday also recommended the Bioepis copy of another blockbuster drug Remicade for approval in Europe.
Bioepis and Biogen; both controlled by Samsung. The split verb ‘recommended’ written in this paragraph – has been placed immediately before the words ‘the Bioepis copy of another blockbuster drug Remicade’ and so we only learn later in the sentence that the European Medicines Agency has merely ‘recommended approval’ for this copycat bio-drug. The phraseology looks to be tending to impress readers that the biosimilar drug in question itself has been recommended by EMA; and so it becomes easier for casual readers to mistake that this EMA recommendation is no more than merely approval for a drug to be marketed.
Samsung Bioepis is 91 percent-owned by Samsung Biologics, which manufactures biological drugs and is in turn mostly owned by Samsung C&T Corp (028260.KS) and Samsung Electronics.
Not wholly clearly expressed here who owns whom hereabove? Why is this explanation of ownership placed here at the very end as being as it were some ‘small print’ that is probably not going to be read with attention much. Its content is an important clarifier of the paragraph written before it, and yet this content is placed disconnected from it by being made as a new paragraph. ‘Biogen’, ‘Bioepis’ two biosimilar-drug firms owned by or controlled by Samsung? – Is this really a David versus Goliath story?
Maybe we joe p[public are the Davids, the ordinary gals and guys; and the bio drug companies are maybe the Goliaths?
($1 = 1,144.1900 won) ($1 = 0.8839 euros)
(Editing by Tony Munroe and Will Waterman)