United States: Bio/Pharma To Face Second Double Patenting Hurdle?

Term Act Seeks to Add New Bio/Pharma Litigation Hurdle

It was easy to miss last week’s introduction of a new patent reform bill on the House side entitled: “Terminating the Extension of Rights Misappropriated Act of 2019” with so much focus on the Senate’s patent subject matter eligibility hearings. The “Term Act of 2019” is described as addressing “the rising cost of prescription drugs by significantly limiting the process known as "evergreening," whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity and maintain high prices.”

Under the heading “Prevention of Double Patenting” the bill seeks to add a special presumption for Orange Book patents directed to a same drug/biological product.

The bill (here) provides:

[W]ith respect to a biological product, or a federal district court proceeding involving patents that are the subject of an action under section 271(e)(2), the patentee shall be presumed to have disclaimed the patent term each of the listed patents after the date on which the term of the first patent expires, subject to the exceptions provided for in subsection (2).

''(2) DEMONSTRATION OF DISTINCT INVENTIONS.—If a patentee demonstrates by a preponderance of the evidence that certain patents described in paragraph (1) cover patentably distinct inventions from the invention claimed in the first such patent to expire, no part of the term of any such patent shall be presumed to have been disclaimed, and all patent term extensions granted by the United States Patent and Trademark Office shall be respected, unless and to the extent the patentee expressly disclaims, in writing, the patent term for each such patent.

(emphasis added)

Thus, the Bill seeks to create a default forfeiture of patent term for a particular technology. While well intentioned, I’m not sure this type of technology-centric discrimination is consistent with U.S. obligations under Article 27 of the TRIPS Agreement. It is one thing to have a double patenting mechanism that applies to all patents, quite another to carve out presumed forfeitures of awarded patent term for certain technologies.

Likewise, the bill appears to assume Patent Office ignores double patenting of indistinct inventions, which is hardly the case. On the other hand, if the goal is to address dosage patents, or patents involving some other aspect not relating to an underlying expression/formulation, such inventions are by definition distinct from a PTO perspective. For this reason such patents typically issue from divisional, or altogether different applications. Under the proposed preponderance of the evidence standard, pointing out the PTO’s separation of such inventions would seem to end such an unnecessary debate.

Odd bill, hard to see this getting serious traction.

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