Get In Touch

Legal Articles

SUPREME COURT RULING: Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. ____ (2019)

January 22, 2019


Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. ____ (2019)

Today, the Supreme Court addressed the extent of the “on-sale” bar following the passage of the America Invents Act (“AIA”), and held that the change in language in Section 102 did not change the requirements for an invention to be considered “on sale.”

Under the pre-AIA version of Section 102(b), “[a] person shall not be entitled to a patent unless … (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States.” 

The Supreme Court had previously held in Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1998) that an invention was “on sale” within the meaning of pre-AIA Section 102 when it was “the subject of a commercial offer for sale” and “ready for patenting.”

In 2011, Congress passed the AIA, changing section 102, section (a) of which now reads: “A person shall be entitled to a patent unless—(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”

Since the AIA was passed, the patent community has questioned whether the clause “otherwise available to the public” effectively modifies the “on sale” language to imply that the “sale” must be “public” in some way.  As some scholars and practitioners have suggested, pursuant to the associated-words canon, by including the word “otherwise” in the final, catch-all clause, Congress may have implied that the preceding list of prior art (patented, published, in public use, and “on sale”) must all be “available to the public” to qualify.  Reading “public” into the “on sale” language would have had a dramatic effect on patent law, because sales that were kept non-public would not have had an invalidating effect on patents—only “public sales” (whatever those are) would have qualified for the on-sale bar.

The Supreme Court, however, held that the addition of the catch-all phrase “or otherwise available to the public” did not effectuate a change to the on-sale bar.  After tracing the history of cases and statutes addressing the on-sale bar, the Court held, “[i]n light of this settled pre-AIA precedent on the meaning of ‘on sale,’ we presume that when Congress reenacted the same language in the AIA, it adopted the earlier judicial construction of that phrase.”  The Court dismissed the argument about the potential import of the “otherwise” clause in one short paragraph, holding that the “argument places too much weight on § 102’s catchall phrase. … Given that the phrase ‘on sale’ had acquired a well-settled meaning when the AIA was enacted, we decline to read the addition of a broad catchall phrase to upset that body of precedent.”

In so holding, the Court affirmed the opinion of the United States Court of Appeals for the Federal Circuit holding that a prior private sale of a product embodying a pharmaceutical invention rendered Helsinn’s patent invalid. 

Justice Thomas wrote the unanimous opinion for the Court.

Written By