6: Meta & Material: 303

July 7, 2011 § Leave a comment

Time is fast approaching when our/your postgraduate learner on Big Pharma shall upgrade to 404.

That is to say, right after this intro on EVERGREENING—some links here, here and here. Today, my concern is to express what its perpetrators have wrought ( or rort ) upon themselves..

Twas always the case – circa 1970s/early 1980s – that pharmaceutical patents were granted on a basis of eligible properties such as primary uses, processes (incl. intermediates), bulk forms, simple formulations and composites.

IN modern times the patent protection term was 15/16 years. We might see this period, as manufacturers of the day did, as adequate in recovering R&D costs, clinical trials and thence commercial sales. At appropriately-set patent brand form/dose/price. Criteria widely accepted as earning satisfactory revenue prior to patent lapse.

When, as had always been usual generic forms of a drug at somewhat lower prices could enter the market and compete. Unquestionably overlooked today was the fact of competition spurring innovation as well as innovation in and of itself. Pharma houses, as their practice, thereby retained their own labs and R&D.

Enter a newer business philosophy: one which amongst other changes would come to impose a means of not only extending and sustaining revenues – the object of business – but engineer/manipulate the means and markets from which profiteth such methods .

Want patent monopoly price ? continuation— answer: extend the patent term. Widely applied this became a standard 20 years. Of course, R&D and trials grew in length, too, according to Pharma, but then they have never been short of an excuse explanation or two when needed.

Besides, globalization’s rules-based trading agreements had the means of holding nation’s feet to fires, as it were. Wasn’t it TRIPs – Trade-Related Intellectual Property (rights) – that embraced coalitions of oft-unwilling smaller first world nation partners. Hence, first among unequals was always gonna be the best place to be.

Then, well, howse about a look at those properties. Bottom line, BigPharma figured, they wouldn’t have to run patents exactly when they could run the next best thing. Non-patent practices that only their new business model industry would implement to the exclusion — and do I mean exclusion – of others. Like those darn generics makers!

To properties was added an alternative— attributes. Aspects of properties does not persuade quite so well as aspects of attributes (one reason believe it or not for the addition!). And aspects allow players to borderline patent practices. Result: expand uses (e.g. a drug could be indicated, severally and individually, for say, hypertension, cardiac arrythmias, angiotensin co-enzyme inhibition(ACE = sorta diuretic). Add methods of treatment, or mechanisms of action, or dosing regime, dosing range, hey how about combinations???

Indeed, how abouts were IN. Big time. for the 1990s. Pfizer’s Global R&D director back in 2001 power-pointed his/their way with Evolution of IPR and Pharmaceutical Discovery and Development to an IPR Conference organised by the National Academy.

A big subject, I’ll have the industry most affected by this EVERGREENING revenues take the last word, though not before making its meaning crystal clear. Essentially a strategy – a patent strategy – a brand name manufacturer ‘stockpiles’ patent protection by way of separate 20-yr patents on multiple attributes of a single product. And do remember how some ingested drugs do not work as intended except after patient metabolisation. That is to say, created by the patient.

Of course, with all this multi-uses stockpiling going on, for example, and so many players and such a sizeable revenue pie to be market-shared well.. is it any wonder snarl-ups present? No, of course not. But tis expensive. Thus, drug costs balloon through aint-necessarily-so-R&D and.. and.. (blah blah). Guess whois peed off with the add-on they made!

Here’s the oppo, Greg Perry, D-G@EGA(qv link above):—

“These practices beg the question of whether they meet the intended purpose of pharmaceutical patent law. More importantly, society must ask itself how much longer it is willing to subsidise pharmaceutical companies through the high prices demanded for their products when lower-priced generic equivalents could be available.”

Last time I blogged about countries whose financial embarrassment included high levels of cost/debt due to patent brand monopoly drug prices. PIIGS.

This week there’s breaking news of how India plans foreign pharma investment curbs and more price controls. Clearly, they wish to protect their own industries and jobs and markets.. and very large patient populations.. h/t: Taylor@WorldNews…

… Proposals by Indian government advisers that the foreign direct investment (FDI) cap for existing pharma ventures should be reduced from 100% to 49%, in order to protect the local industry has been objected to by multinational drugmakers, the Times of India reports. Presently only an official approval is required for such investment, but under this India-ministerial group proposal, now before the Planning Commission, new ventures will be capped and require government approval.

Prices of around 1,500 medicines produced from 74 bulk drugs are fixed by the government, and the extension of this policy would bring nearly a third of drugs sold in India under official control.

The government is also looking at ways to put an end to drugmakers’ long-used practice of avoiding price controls by making minor adjustments to products so that they differ from the dosages specified on the official lists. [ Indian variation of evergreening.? ]

The options it is considering include restricting approval to specified dosages only, or using a provision of the Drug Pricing Control Order (DPCO) which allows the government to set prices of non-DPCO-controlled drugs if this is deemed to be in the public interest.


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