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Congress and the Drug Company

Is this what Congress should spend its time on?

Read the testimony on HR 5120 — a bill to help a company due to their own mistake. This is a technical and legal issue (and I’m no lawyer — please leave a comment if any of the following is in error), but medicines are patented for a period of years. The company can extend those protections in certain situations, but must follow specific procedures to do so. The company in question missed the deadline to file, but wants Congress to pass a bill restoring the patent extension after missing the deadline.

But allow the CEO of The Medicines Company to explain, as he lobbies Congress (http://judiciary.house.gov/HearingTestimony.aspx?ID=465).

The FDA approved Angiomax for the narrow initial use in coronary angioplasty on December 15, 2000. Under the Hatch-Waxman formula, we calculated that we were entitled to a restoration period of approximately 4 1/2 years. We quickly set about preparing our application for patent restoration … The current filing provision of Hatch-Waxman requires an application to be filed within 60 days of FDA’s approval of the drug in question. Unfortunately, the 60-day requirement was evidently mistaken for a two-month requirement, and our patent restoration application was filed on February 14, 2001, within a two-month window, but one day late for the actual 60-day deadline.

So, because of an inadvertent administrative error, The Medicines Company-and the patients who could be helped by Angiomax-are facing a drastic and disproportionate penalty. … others who make accidental filing mistakes in the future, may face a similar predicament.

60 days is not two months, and if you missed it, you missed it. If it’s that critical to your business, you should get the paperwork done on time. After all, it’s difficult to believe the company doesn’t have legions of lawyers at their disposal (and if they don’t know 60 days isn’t two months, I’d get new lawyers).

This is quite a bit different from a private citizen who can’t navigate the massive towers of government paperwork and misses something due to ignorance or innocent oversight. This is a company whose whole business deals with patents, the law and government — it’s their job and they’re supposed to be professionals. They well understood the rules, they just didn’t follow them.

I feel sorry for the company as the financial hit to their business could be considerable, but should Congress really give them a specific exception due to their error? If so, where does it end? Changes for the airlines when fuel goes up? Breaks for meat companies due to mad cow? Where does this end, and is this what Congress should be doing in the first place?

It’s unlikely this bill will pass by itself — more likely it will be attached as a rider to some other legislation whose passage is highly probable (who actually reads the bills anyway?). But what will the Democrats do? They’ve complained about the pro-business republicans and their business deals for a long time. Will they support the bill, or denounce it as something Congress shouldn’t be involved with in the first place?

I agree with some of the reasons the company cites (they have some valid points), but the real issue is not whether this company gets its bill through (the bill probably won’t actually do much positive or negative except for this one company), but does Congress have nothing better to do? Not taxes, fiscal problems, medicare, social security, healthcare, education, or ethics? This trumps all other issues? Is this really what the Judiciary committee should spend it’s time on?

I think not.


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