Comments on: Vaccine Patent Politics and The Swine Flu

By: Gabriella Adams

Gabriella Adams — Mon, 26 Apr 2010 14:55:07 +0000

Swine flu is not as dangerous as Dengue Fever but we should still take precautions to avoid spreading and contracting this disease.

By: how to prevent flu

how to prevent flu — Tue, 04 Aug 2009 18:13:14 +0000

I think they should spend more time educating people on preventative measures while also preparing for the worse case scenario.

By: anonymous

anonymous — Thu, 07 May 2009 15:17:55 +0000

The patents for the biosimilars is like the orange book. It is HR 1427 by Waxman. Read the bill. There is very little difference between it and the current ANDA rules for small molecules. The patents are public so there is nothing confidential that is being turned over. Pharma keeps trade secrets all the time for manufacturing processes. The bill that BIO wants passed gives 12 years exclusivity regardless of any patents and 2 years for an extra indication– that would be a total of 14 years. Therefore, there would be almost no need for a patent given how long prosecution can take–how does that promote the progress?

By: far cold north

far cold north — Thu, 07 May 2009 13:40:39 +0000

Given the push to eliminate patent protectin on biologics, I do see Pharma going the trade secret route. Suppose Pharma simply ignores patents for innovative large-molecule biopharmaceutical products. For the most part, these biologics generally exhibit high molecular stereo-specific complexity, and may be quite sensitive to manufacturing process changes. A follow-on manufacturer would not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products could have serious health implications. In short, invoke state trade secret laws, and reveal NOTHING except the letter of the law to the FDA. Pharma always has many drugs in the FDA approval cycle and, as nobody is clairvoyant, it is a guessing game as to which drugs will be eventually approved. This buys time. However, most importantly, without patent preferred embodiments to guide them, the biosimilar companies will have to introduce a NEW drug, which means they will have to conduct separate clinical trials. This should give Pharma at least as much time protection as a utility patent, and who knows, maybe more. Under the current four biosimilars bills in Congress, everything revolves around the exchange of patent information. If there are no patents, then there is no exchange of information. Even if the biosimilars have samples of the final drug, complex molecules are difficult to reverse engineer and even if one were successful in duplicating it, it would have to be treated as a NEW drug. Is the FDA going to take the word of a biosimilar that their new drug is the same as one that is already in the market? What’s wrong with this scenario?

By: Gene Quinn

Gene Quinn — Mon, 04 May 2009 18:20:35 +0000

I am not sure that is exactly right. As I understand it, this bill would force innovators to turn over patent information to generics. The generics could then seek approval of bio-equivalents. This would then effectively cut into the term of patent protection. So while there is talk of exclusivity, I think this does dig into the protection already afforded to innovators. More to come.

By: anonymous

anonymous — Mon, 04 May 2009 17:40:25 +0000

I don’t think the bill limits patent protection to 5 years it gives automatic exclusivity regardless of patent protection to 5 years. If you want more than 5 years you need a patent. This is exactly the same as Hatch-Waxman for pharmaceuticals.