From the Helsinn v. Teva case to see the patent obstacles formed by the business behavior before the application.

2019Year 1Month 22The Supreme Court of the United States ruled on whether a "previously privately concluded contract" formed an "on-sale bar", holding that before the patent application, even if the relevant product is secretly sold, the public cannot obtain the technical details of the product, which may be evidence of patent invalidity.

On-Sale Bar(sales block)

Under the Inventions Act of the United States (AIA), prior to the patent application (including before the novelty discount period) there is an act of sale or an offer of sale, indicating that "the invention has been completed (reduced to practice) "and the ability to file a patent application makes this act a prior art of the patent. ("the invention was reduced to practice and therefore was ready for patenting before the critical date", Helsinn v. Teva (Fed. Cir. 2017))

 

Critical Date(Key Date)

Critical Date(Key Date) pre-AIAS. patent application date, or AIAThe day one year before the effective application date. The Pfaff principle of sales obstruction (On-Sale Bar) is based on two main conditions:(1) the invention in the scope of the patent application before the key date (critical date) has been commercially sold, or there has been an offer of supply, and (2) the invention is ready for patentability. (Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998))

 

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.Case background

ØPetitioner (appeal):Helsinn Healthcare S. A. (Helsing Medical)

Contention is drug Aloxi used to treat chemotherapy-induced nausea and vomiting in cancer patients(The scientific name is PalonosetronPalonosetron in Chinese), the petitioner Helsinn signed a sales contract with MGI, an American pharmaceutical company, which stated the obligation of confidentiality. More than two years later (2003),Helsinn filed a U.S. provisional patent application (provisional application), and then filed four subsequent applications (US 7,947,724, US 7,947,725, US 7,960,424, US 8,598,219) claiming the priority of this provisional case within 10 years, the fourth was in 2013, the year AIA was implemented. This patent was applied in dozens of countries and regions around the world, including China, but it was not authorized in China.

2011Israeli generics giant Teva(Teva Pharmaceuticals) from FDASeeking to approve the sale of Aloxi, the Helsinn sued Teva for infringing its US patent US 8,598,219 after discovery. Teva argued that the product had already had an offer for sale (offer for sale) before the Helsinn patent application date (because it involves the effective application date/critical discount period, etc.), and that the patent was not novel (35 U.S.C. 102), so the patent was invalid.

ØDistrict Court Phase

After investigation, the local court found that the Helsinn in this caseand MGINeither party has disclosed a technical solution for the invention in question, and the non-novelty provision of 35 U.S.C. 102 does not apply, so the patent is valid.

ØCAFCStage

Judge considers invention in critical datePrevious Sales/The offer of sale indicates that the patent application has been completed and is ready to be filed, while the on-sale bar determines that the scope of the patent application in question is invalid.

ØTopic 1: critical the date hereDoes a previous offer of sale (including a sale) (even if the details of the invention are not disclosed) constitute a prior case of novelty?

Topic 2: Do "secret contracts or transactions" still hinder patent novelty?

 

See the Supreme Court of the United StatesSolution

1. third-party commercial sales that are required to be confidential may land the invention in 102(a)The specification "on-sale"」.

"A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under §102(a)."

 

The 2. Supreme Court's previous interpretation supports this opinion, the 102.Prescribed "sale"Or offer of sale "Not only do inventions that are known to the public become prior technologies.

"This Court’s precedent interpreting that provision supports the view that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art."

 

3. agree with CAFCdecision, agree with the Supreme Court pre-AIAThe previous example found that the "clandestine sale" can invalidate the subsequent patent rights.

"The Federal Circuit had made explicit what was implicit in this Court’s pre-AIA precedent, holding that “secret sales” could invalidate a patent."

 

4. if AIAAfter the 102In the same language, the judicial interpretation of the past also applies.

"the Court applies the presumption that when Congress reenacted the same “on sale” language in the AIA, it adopted the earlier judicial construction of that phrase."

 

5. LovedRear 102(a)(1)The addition of the phrase "or otherwise available to the public" is still not enough for the court to think that there is a change in the meaning of "on sale.

"The addition of the catchall phrase “or otherwise available to the public” is not enough of a change for the Court to conclude that Congress intended to alter the meaning of “on sale."

[Article Supplement] 102(a)(1)

35 U.S.C. 102 CONDITIONS FOR PATENTABILITY; NOVELTY

(a) NOVELTY; PRIOR ART.--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;

 

Conclusion

According to this U.S. Supreme Court opinion, patent law 35 U. S. C.§102(b)/102(a)(1)The "disclosure" in the one-year novelty concession clause covers "secret" sales "contracts". The Supreme Court emphasized that this is a contract involving "commercial sales", meaning that the invention has been completed and falls under the "critical date of on-sale" interpreted under 102, so the patent application for the invention must be filed within one year after the sales contract (the first case).

根据Helsinn v. TevaContent, HelsinnThe MGI contract with the pharmaceutical company specifies the content of the formula of the patented drug, which makes the court determine that the commercial marketing has been done before the patent critical date, that is, the invention has been completed, triggering the on-sale bar, which means that "whether the patent content is specified in the contract" is one of the key factors triggering the on-sale bar before the critical date. The on-sale bar includes not only the sale, but also the offer for sale (offer for sale), that is, the contract between the supplier and the distributor/wholesaler, and the court offered the on-sale bar to prevent the inventor from using commercial practices to exceed the legal term of the patent.

Therefore, the patent layout is very important, important to the need to complete the invention before the layout of the bureau, can not "sell this thing does not mean that the disclosure of the invention content" as a "application in the back" of a comfort, it is best to have completed the patent application before the sale, or in the preferential period to complete the application, and also consider the different preferential period of each country to comply with individual laws and regulations.