Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc.
Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc.
Opinion
The Leahy-Smith America Invents Act (AIA) bars a person from receiving a patent on an invention that was "in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention."
More than 20 years ago, this Court determined that an invention was "on sale" within the meaning of an earlier version of § 102(a) when it was "the subject of a commercial offer for sale" and "ready for patenting."
Pfaff v. Wells Electronics, Inc
.,
I
Petitioner Helsinn Healthcare S.A. (Helsinn) is a Swiss pharmaceutical company that makes Aloxi, a drug that treats chemotherapy-induced nausea and vomiting.
*631 Helsinn acquired the right to develop palonosetron, the active ingredient in Aloxi, in 1998. In early 2000, it submitted protocols for Phase III clinical trials to the Food and Drug Administration (FDA), proposing to study a 0.25 mg and a 0.75 mg dose of palonosetron. In September 2000, Helsinn announced that it was beginning Phase III clinical trials and was seeking marketing partners for its palonosetron product.
Helsinn found its marketing partner in MGI Pharma, Inc. (MGI), a Minnesota pharmaceutical company that markets and distributes drugs in the United States. Helsinn and MGI entered into two agreements: a license agreement and a supply and purchase agreement. The license agreement granted MGI the right to distribute, promote, market, and sell the 0.25 mg and 0.75 mg doses of palonosetron in the United States. In return, MGI agreed to make upfront payments to Helsinn and to pay future royalties on distribution of those doses. Under the supply and purchase agreement, MGI agreed to purchase exclusively from Helsinn any palonosetron product approved by the FDA. Helsinn in turn agreed to supply MGI however much of the approved doses it required. Both agreements included dosage information and required MGI to keep confidential any proprietary information received under the agreements.
Helsinn and MGI announced the agreements in a joint press release, and MGI also reported the agreements in its Form 8-K filing with the Securities and Exchange Commission. Although the 8-K filing included redacted copies of the agreements, neither the 8-K filing nor the press releases disclosed the specific dosage formulations covered by the agreements.
On January 30, 2003, nearly two years after Helsinn and MGI entered into the agreements, Helsinn filed a provisional patent application covering the 0.25 mg and 0.75 mg doses of palonosetron. Over the next 10 years, Helsinn filed four patent applications that claimed priority to the January 30, 2003, date of the provisional application. Helsinn filed its fourth patent application-the one relevant here-in May 2013, and it issued as
Respondents Teva Pharmaceutical Industries, Ltd., and Teva Pharmaceuticals USA, Inc. (Teva), are, respectively, an Israeli company that manufactures generic drugs and its American affiliate. In 2011, Teva sought approval from the FDA to market a generic 0.25 mg palonosetron product. Helsinn then sued Teva for infringing its patents, including the '219 patent. In defense, Teva asserted that the '219 patent was invalid because the 0.25 mg dose was "on sale" more than one year before Helsinn filed the provisional patent application covering that dose in January 2003.
The AIA precludes a person from obtaining a patent on an invention that was "on sale" before the effective filing date of the patent application:
"A person shall be entitled to a patent unless ... 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."35 U.S.C. § 102 (a)(1) (emphasis added).
See also § 102(b)(1) (exception for certain disclosures made within a year before the effective filing date). Disclosures described in § 102(a)(1) are often referred to as "prior art."
*632 The patent statute in effect before the passage of the AIA included a similar proscription, known as the "on-sale bar":
"A person shall be entitled to a patent unless-
"(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or
"(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."35 U.S.C. §§ 102 (a) - (b) (2006 ed.) (emphasis added).
The District Court determined that the "on sale" provision did not apply. It concluded that, under the AIA, an invention is not "on sale" unless the sale or offer in question made the claimed invention available to the public.
Helsinn Healthcare S
.
A
. v.
Dr
.
Reddy's Labs
.
Ltd
., ---F.Supp.3d ----, ----, ----,
The Federal Circuit reversed.
We granted certiorari to determine whether, under the AIA, an inventor's sale of an invention to a third party who is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention. 585 U.S. ----,
II
A
The United States Constitution authorizes Congress "[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." Art. 1, § 8, cl. 8. Under this grant of authority, Congress has crafted a federal patent system that encourages "the creation and disclosure of new, useful, and nonobvious advances in technology and design" by granting inventors "the exclusive right to practice the invention for a period of years."
Bonito Boats, Inc
.
v. Thunder Craft Boats, Inc
.,
To further the goal of "motivating innovation and enlightenment" while also "avoiding monopolies that unnecessarily stifle competition,"
Pfaff,
Every patent statute since 1836 has included an on-sale bar.
Pfaff,
B
Congress enacted the AIA in 2011 against the backdrop of a substantial body of law interpreting § 102's on-sale bar. In 1998, we determined that the pre-AIA on-sale bar applies "when two conditions are satisfied" more than a year before an inventor files a patent application.
Pfaff,
Although this Court has never addressed the precise question presented in this case, our precedents suggest that a sale or offer of sale need not make an invention available to the public. For instance, we held in
Pfaff
that an offer for sale could cause an inventor to lose the right to patent, without regard to whether the offer discloses each detail of the invention.
E
.
g
.,
id
., at 67,
The Federal Circuit-which has "exclusive jurisdiction" over patent appeals,
In 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
*634
the earlier judicial construction of that phrase. See
Shapiro v. United States,
Helsinn disagrees, arguing that our construction reads "otherwise" out of the statute. Citing
Paroline v. United States,
As an initial matter, neither of the cited decisions addresses the reenactment of terms that had acquired a well-settled judicial interpretation. And Helsinn's argument places too much weight on § 102's catchall phrase. Like other such phrases, "otherwise available to the public" captures material that does not fit neatly into the statute's enumerated categories but is nevertheless meant to be covered. 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.
III
Helsinn does not ask us to revisit our pre-AIA interpretation of the on-sale bar. Nor does it dispute the Federal Circuit's determination that the invention claimed in the '219 patent was "on sale" within the meaning of the pre-AIA statute. Because we determine that Congress did not alter the meaning of "on sale" when it enacted the AIA, we hold that an inventor's sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art under § 102(a). We therefore affirm the judgment of the Federal Circuit.
It is so ordered .
Reference
- Full Case Name
- HELSINN HEALTHCARE S.A., Petitioner v. TEVA PHARMACEUTICALS USA, INC., Et Al.
- Cited By
- 41 cases
- Status
- Published