<p>Hope you enjoy taking generics and not having the option of newly developed medications. Cheap is good!</p>
<p>Did it every occur to you to actually study the patent laws affecting pharma? The patent clock starts clicking the moment the patent is filed. And that has to happen basically the moment the molecule is an idea in the chemist’s mind. Then there are all the phases. The animals studies. The early human studies. Phase 3 big clinical trials. All the intrusion and reports to the FDA along the way. The millions and millions of dollars. How long on average do you think it actually takes from the moment of visualizing the molecule to actually being able to sell a product and begin to recoup the investment? Try 10 to 20 years. Meanwhile, the patent clock ticks.</p>
<p>Branded medications have to be expensive or else no one would bother ever developing them. The shelf life is far too brief to even begin to recoup investment unless the price is high. Also, that’s why you see the ads on TV. Darn straight these companies have to market these products. They only have a brief window of opportunity to earn anything off of them after investing on average 1 billion dollars per drug.</p>
<p>Just for the sake of thinking outside the box – what do you think would happen if patents never expired? Do you not think that oddly this would increase innovation and lower the cost of prescription medications?</p>
<p>But of course for a lot of people it’s all about slapping down laws and regulations. The more the merrier.</p>
<p>But, hey, parent1986 and Dstark you will be on the side of the winners here. The industry is unequivocally leaving this country – one of the few that we were actually leading. Over a half-million high-tech well paid jobs. Gone. All that “revenue”! All those 1 percenters to be scorned and taxed. Good job!</p>
<p>The patent clock does not start ticking (at least in the US) until the filing of first non-provisional application. Most companies take advantage of extending the priority date (without triggering the clock) by 1 year by filing provisional applications. Of course, 1 year is not that much, and there are some downsides to provisional filings. Additionally, USPTO allows for extension of a patent term due to regulatory delays (in exchange for that provision, the law was created which allows generic drug makers to work on ANDA prior to patent’s term expiration without fears of being sued for infringement by the patent’s owner).
For anyone further interested in this subject matter, this is a good place to start:
[2750</a> Patent Term Extension for Delays at other Agencies under 35 U.S.C. - 2700 Patent Terms and Extensions](<a href=“http://www.uspto.gov/web/offices/pac/mpep/documents/2700_2750.htm]2750”>2750-Patent Term Extension for Delays at other Agencies under 35 U.S.C. 156)</p>
<p>“Just for the sake of thinking outside the box – what do you think would happen if patents never expired? Do you not think that oddly this would increase innovation and lower the cost of prescription medications?”</p>
<p>It is a good idea that patents have expiration dates. It cuts down on patent ■■■■■■■■ and the proverbial “dog in the manger” type of situations. The case of Polymerase Chain Reaction (PCR), a method that quickly “reads” a section of the genetic code, is a good example. Enterpreneurial researchers realized that PCR could be used in quick and accurate diagnostic tests. Roche had a monopoly on a good chunk of the PCR patent estate, but for some reasons did pretty much nothing towards development of such tests. Other companies were reluctant to dive into the development of PCR based tests because of Roche’s steep licensing fees (and in many cases, Roche simply did not even want to license their IP - maybe they were still clinging to the idea that they could dominate the world by developing their own diagnostic products). As soon as the patents began to expire, a revolution in the molecular diagnostics world happened - the number of molecular tests approved by the FDA skyrocketed. Competition can drive the molecular test prices down making them more affordable and comparable in price to other tests, and as more and more clinics and hospitals adopt these new technologies, companies are able to manufacture their products in higher volumes and at lower costs. Companies can lower their prices without harming their profits, since they are no longer on the hook for paying huge chunks of their revenue to Roche.</p>
<p>If patents never expired then companies wouldn’t sit around waiting for companies like Roche to have a patent expire before innovating. We would be in a world where innovation would be constant and with a very high bar for what counts for innovation.</p>
<p>FWIW, I have worked on products that were almost expired on the patent by the time they reached market. That is the point I’m trying to make – the finite window for marketing drives the price higher, makes investors more leery of experimental approaches, hurts innovation.</p>
<p>Sewhappy, when a patent covers one and only one narrow class of compounds, I can parially agree with what you are saying. However, US patent law treats all patents equally. I’m talking about the class of patents that cover key technologies and methods. Development of diagnostic products is much, much faster than development of a pharmaceutical product. Roche had all the resources, time and IP and still was not creating anything of value while preventing others from moving medical diagnostics from the stone age to the jet age, so to speak. Innovation is not as simple as creating a work around other companies’ IP. Sometimes, a work around is easy and simple. But other times, innovation happens when new technology is combined with old (e.g., microfluidics and DNA sequencing). On some occasions, the existing patent claims are so broad that they cover pretty much any future product in the field (when USPTO was greatly understaffed, issuance of claims that were too broad and not supported by experiments and should have never been issued in the first place happened all the time; the situation improved significantly, IMO). Additionally, unlimited patent terms would give “patent ■■■■■” companies such as intellecual Ventures who themselves do not do any research and development the means of preventing others from developing anyhing of value at reasonable costs. While theoretically a company can be forced into licensing their IP on reasonable terms by the courts, in reality it rarely happens.</p>
<p>As a biotechie, I feel your pain. Our potential products are even more complex and will require even more regulatory scruitiny than a small molecule drug, and yet our patents have same 20 yr terms, but I think it is very fair to limit monopoly to a certain term.</p>