There are several patents for genetically engineered protein now coming off patent. The FDA has to deal with regulations for the “generic” products that will result – and they are coming. Innovation also has to come from the followers, because the biologics, an example is insulin, will be made under conditions biosimilar to those of the innovator. Biosimilar is what will drive biologics, with the safety and efficacy issues resolved in the process. Since the patents will be old, the technologies have certainly changed since the issue date, so the generics will have to be innovative in applying the advances to their products – to make it cheaper, higher yield, and faster to market. Usually the innovator rests on his laurels without using the new technologies – so the generics have the opportunity to be more innovative if they want to make money too.

As for batch-to-batch variation – do you know that one of the patented hormone treatments is still purified from horse urine? Talk about batch-to-batch variation, and still FDA approved. (The patent was issued in the1950s, so it is available in a chemically purified form today, as well as the original form.) I think that variation is better controlled in the biologics. There are actually standard conditions; why do you think there have to be deposits in order to patent? Enablement requires it. After the patent term, producers have to be able to produce what the patentee enabled. With industry standards, and technical personnel who know what they are doing, follow-on biologics can be a reality. And certainly, with all the job losses in the scientific field, there are many qualified people who can set up a culture and run quality controls. There won’t be shortcuts, technology is more advanced, and quality better monitored all along the way. With all the legal layoffs, too, there should be opportunity for attorneys who actually understand the science to wade through these new “generic” innovations.

Let’s assume they use the same exact protein sequence.
Are they going to request the cell line from the brand name manufacturer or assemble their own cell line? Even if they started with the brand name cells, they must replicate exactly the growth, expression, and purification to achieve a “similar” product, it is still not the same. Unlike chemical compounds with a single unique structure and a certain level of purity, biologics are not the same, they fold differently at different temperatures, different cells modify the proteins differently and it is very difficult to get consistency batch to batch, let alone across the marketplace.

Each biologic should have to document safety, which is time consuming and costly. Without demonstrating clinical safety, there will be bad outcomes. People will be hurt or die if you enact shortcuts for biologics.

Nice … let’s just send all our manufacturing over to China, move everybody back to Europe/Asia/Africa and give the land back to the indians.

China will kill most US manufacturers on price — hand’s down. As for quality, it takes a very sophisticaed consumer and/or lots of research to differentiate quality. Could you really tell the quality of one drug (or biologic) from another?

Customer service? The best products don’t need constomer service. However, tell me, how are you going to differentiate customer service from one biologic manufacturer from another?

Location? Location is becoming meaningless these days. I don’t care if the store is 1 mile away or 3000 miles away. I go on the internet, place my order, and whatever I want shows up in a box in a couple of days.

What happens if you are a company that is great at innovation, but you suck at quality, price, customer service, and location? I guess you are out of luck then, huh? Research universities are a classic example … they produce research, but they aren’t good at much else. Royalties on patents based upon research at the university brings in a considerable amount of $$$ to universities. Do you think these universities will as excited to dump millions of dollars into research when there is no payoff?

Unlike anytime in the past, it is soooo much easier to copy somebody else’s product and bring it to market. Say some American tool company invents this nifty new tool that they are now selling in Home Depot. Within a couple months, I can have it produced in China and be selling it in Lowes for substantially less. Great for consumers who pay less and great for the workers in China …. but it sucks for the American tool company that invested $1M to develop this new tool that I copied.

Next time, after that experience, do you think that this tool company will be more inclined to bring an innovative product to market or will they wait until somebody else does and just copy what they did.

The fact that businesses can compete on quality, price, customer service, location, and a host of other factors does not mean that their $XXX,XXX investment on developing a new product will pay off. The patent system is about encouraging innovation.

One last thing, the older one gets, the more perspective they obtain. In the grand scheme of things, 20 years or even 12 years is a drop in the bucket.

Do you think that pharmaceutical companies or biotech companies that need to invest $500 million to $1 billion on a single product will find it appropriate to compete on quality, price, customer service and location? Of course not. In fact, in the pharma situation if the FDA approves Drug A generics MUST EXACTLY make Drug A or they have to go through the approval process themselves. So there would be absolutely no ability to compete on quality, because the name brand and generic MUST be identical. There would be no way for the innovator to compete on price because the copyist would not need to recoup the R&D expense, which they did not incur. They could not compete on location because it is a national and global market, geography provides no advantages. What customer service is there with a drug or biologic? None.

You seem to keep wanting to compare apples and elephants. The fact that there are industries that do not need exclusive rights does not mean every industry does not need exclusive rights.

-Gene

It’s obvious that the profit motive spurs most R&D in this country. People invest money, which they only do if they think they have a reasonable chance of making that money back, plus some profit for their troubles. I don’t think anyone can argue with this.

However, you always take the next step and say, “Greed coupled with exclusive rights is what spurs innovation.” The connection between this and the previous paragraph is what I haven’t yet seen you make. There are many ways to make money on products and exclusive rights are not necessary for most of them. Businesses make money every day by competing on things like quality, price, customer service, and location. Surely the vast majority of money made in this country is based on such competition, rather than on exploiting monopolies.

One could imagine that medical treatment and device companies could do the same. I don’t know if they could or not, since I have neither the data nor skills to do such an analysis, but why do you think they couldn’t?