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[Wiscagent]

Supremes say: Drug Patents Don't Bar Research Use Under 35 U.S.C. 271(e)(1)

The U.S. Supreme Court ruled today, June 13,  that the pharmaceutical companies have a broad immunity from patent infringement claims when they engage in research on promising new drug candidates.  The unanimous opinion held that the Federal Circuit had erred when it drastically limited the protection of the FDA safe harbor, applying it only to the late-stage testing on human patients.

Pharmaceutical companies will have more flexibility to start experimenting with potential therapies so long as they cannot feasibly be marketed until after a competitor's patent expires. Lower courts will have to sort out just how much leeway the companies will have.  Justice Antonin Scalia wrote:

    The court agrees with the government that ''the use of patented compounds in
    preclinical studies is protected as long as there is a reasonable basis for believing
    that the experiments will produce the types of information that are relevant'' to a
    future drug application.

The case is Merck v. Integra Lifesciences, 03-1237.

[PiP]

RT, this strikes me as very funny since large pharma regularly tests their novel compounds against efficacy/toxicity of the lead compounds from competitors already!  What exactly does this ruling add to that, or am I mentioning something that was against the law until this new ruling?

[Jonathan]

The basic gist of this case is that one company was using another company's patented compound/drug for research purposes. Patents allow for a patent holder to prevent others from using their patented invention and that is the reason for the original patent lawsuit  - to prevent the 1st company from using the other company's patented invention.

The Supreme Court has now specified that it is ok for drug companies to use someone else's patented invention/compound if they stay within the rules as Richard has nicely summarized.

[Wiscagent]

PiP – I’ll be glad to share my meager understanding of this issue, but there must be others in this forum far more knowledgeable than me on this topic.

In your scenario Big Pharma Corp. is developing the drug BCP as an competition to the drug LCP, which is patented and marketed by Large Pharma Corp.  In this situation Big Pharma can buy LCP on the open market and do whatever they wish with the drug.  There shouldn’t be a patent problem because Large Pharma’s patent rights were exhausted when they sold the LCP.  I don’t think this is the issue that concerned the Court.

Alternatively, Big Pharma Corp. is developing BCP as competition to LCP.  In this scenario Big Pharma wants to synthesize LCP or another material also claimed in the LCP patent.  Perhaps Big Pharma wants to prepare a derivative or an analogue of LCP.  If 35 U.S.C. 271(e)(1) did not exist, Big Pharma would be infringing the LCP patent.  BUT 271(e)(1) does exist.  It reads in part:

    It shall not be an act of infringement to
    make, use, offer to sell, or sell ... a patented
    invention ... solely for uses reasonably
    related to the development and submission
    of information under a Federal law which
    regulates the manufacture, use, or sale of
    drugs or veterinary biological products.
   
Prior to the Supreme Court ruling, 271(e)(1) was understood to be applicable only when a drug was about to go into clinical trials required for FDA approval.  Under the recent ruling “uses reasonably related to the development and submission of information” to the FDA is extended further back in the development cycle; so pre-clinical research, such as chemical synthesis of the patented drug should be okay.

Section 271(e)(1) was written into the law because it effectively extended the enforcement life of a drug patent at the back end.  Prior to the law, the competition was unable to make and test generics (or patented variations) of the patented drug before the patent expired.  Because the FDA process is so slow, this gave the patent holder another few years of monopoly.  But don’t feel to bad for large pharma – in exchange for 271(e)(1) they got patent term extension at the front end – see USC 155 – 156.
   
As I said up front, that’s my understanding.  Personally, I like the decision.  The patentee still has protection against competition during the life of the patent, but now research into alternatives to the patented drug can be accelerated.

Now I’m asking and experts out there – Did I even come close to being correct?


Richard Tanzer

[Cibola]

Of

Prior to the Supreme Court ruling, 271(e)(1) was understood to be applicable only when a drug was about to go into clinical trials required for FDA approval.  Under the recent ruling “uses reasonably related to the development and submission of information” to the FDA is extended further back in the development cycle; so pre-clinical research, such as chemical synthesis of the patented drug should be okay.

the Supreme Court (perhaps surprising many of the amici) stated that it did not understand that the Federal Circuit made a clinical/preclinical distinction.  The Supreme Court's analysis did not make a clinical/preclinical distinction.  It did find that research on a drug for which no IND was filed might fall within 271(e)(1) and that research that did not make it to the FDA might fall within 271(e)(1).  

I would not bet the ranch on the uniform truth of the proposition:  chemical synthesis of the patented drug should be okay.

Of
Section 271(e)(1) was written into the law because it effectively extended the enforcement life of a drug patent at the back end.  Prior to the law, the competition was unable to make and test generics (or patented variations) of the patented drug before the patent expired.  Because the FDA process is so slow, this gave the patent holder another few years of monopoly.  
it is true that Congress in 1984 never contemplated the situation presented in Merck v. Integra and never contemplated whether patents on research tools would fall within the scope of 271(e)(1).  

The text of 271(e)(1) includes the word "solely," which the Supreme Court ignored.  However, by not criticizing the jury instructions in Merck v. Integra, the Supreme Court silently approved a way to re-introduce the word solely.  If Integra wins on remand (which I think has a probability greater than 50% based on the way the Supreme Court talked about the jury instructions), then the idea that the researchers get a free pass under 271(e)(1) will have to be re-thought.  Wait and see...