Tag Archives: patent

Generic and Branded Drugs

This is an interesting case that the Supreme Court will hear today.  Does a branded drug maker, faced with a potential competitor who makes generic drugs, act illegally if it pays money to the competitor in a deal that postpones the sale of the generic drug for a period of years?

The FTC says it is unlawful, while the generic and branded drug makers disagree.

So why does this matter?  Everyone knows that generic drugs are cheaper than branded drugs.  As the NY Times reported, “73 percent of consumer spending” is spent on branded drugs.  When a generic drug, which costs about 15% of the branded drug cost, enters the market, branded drug makers lose about 90% of their profits.

In FTC v. Actavis, Inc., the 11th Circuit Court of Appeals held companies holding the patent to the branded drug could make those payments to the generic drug maker.  In this case, the generic drug maker challenged the patent of the branded drug maker in court.  Both drug makers came to a settlement, whereby the generic would get some payment as long as the branded drug maker could continue to sell its branded drug exclusively for a time period.

In sum, the 11th Circuit reasoned, “absent sham litigation or fraud” when the anticompetitive effects of a patent fell within that scope, there is no antitrust claim. Further, since there was a settlement, the 11th Circuit stated that it would be hard to predict what the effect would have been.  And since the settlement was with one generic drug maker, this did not impact other generic drug makers from selling the generic version of the drug.

Now, the Supreme Court has to decide on this issue.

via Generic-Brand Name Drug Case Goes to Supreme Court – NYTimes.com.

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Can Genes Be Patented?

On Friday, the Supreme Court granted partial cert. in the Assoc. For Molecular Pathology v. Myriad Genetics, Inc., 12-398.  In other words, the Supreme Court agreed to decide only the first issue presented:

Can human genes be patented?

Myriad Genetics obtained patents for two genes, BRCA1 and BRCA2.  Mutations of these genes correlate with an increase risk of hereditary breast and ovarian cancer.  The patent claims include “every single natural variation of the genes, including those that have not yet been isolated.”

The Association for Molecular Pathology claimed the patent inhibited scientific research and prevented patients from accessing their own genes.  Further, the Association stated that because gene variation is created naturally.

Myriad claimed that the PTO has long recognized that claims to “isolated” molecules of DNA reflect human-made, patent-eligible inventions.  In fact, the PTO has issued over 40,000 patents drawn to DNA-related subject matter.

The District Court invalidated the patent on the grounds the patented genes were not “markedly different.”  The District Court held that Myriad did not “alter its essential characteristic – its nucleotide sequence that is defined by nature and central to both its biological function within the cell and its utility as a research tool in the lab.”

A divided 2-1 Federal Circuit found these genes were patentable.  On remand following the decision of Mayo, the divided panel did not change their decision.

Myriad pointed to the lead opinion’s interpretation of Mayo.  The lead opinion observed that “[w]hile Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the Supreme Court’s decision in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions matter, including isolated DNA molecules.”

The Association pointed to Judge Lourie’s and Judge Bryson’s statements regarding Mayo.  Judge Lourie stated that Mayo “clearly ought to apply equally to manifestations of nature (composition claims).”  Judge Bryson, in his dissenting opinion, interpreted Mayo’s method as asking whether the applicant made an “inventive” contribution to the product of nature.

The NY Times has an interesting article here.


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