USPTO issued guidance to patent examiners on patent eligibility issues in light of the Federal Circuit's decisions in Sequenom and CellzDirect. According to the memorandum, neither case changes the subject matter eligibility framework concerning life sciences method claims.
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In an en banc opinion, the Federal Circuit unanimously ruled that the mere sale of manufacturing services to create embodiments of a patented product is not a "commercial sale" that triggers the on-sale bar of 35 USC 102(b) (pre-AIA). Medicines Co. v. Hospira Inc., No. 14-1469 (Fed. Cir. July 11, 2016). The Federal Circuit identified several factors to be considered in determining whether a transaction is a commercial sale or offer under Section 102(b) such as (1) whether the transaction is between a supplier and inventor; (2) whether the inventor has transferred title to the supplier; (3) whether the transaction is confidential; and (4) whether the transaction is a sale of a product at full market value or a "pre-commercial investment."
In this case, the en banc Court affirmed the lower court's determination that The Medicines Company's use of contract manufacturing services did not invalidate the patents-in-suit under the on-sale bar. The en banc Court vacated a prior panel's decision that the asserted claims were invalid under 102(b) based on transactions between the patentee and a third-party manufacturing company that was hired to make patentee's blood thinner drug. On July 11, 2016, the USPTO announced a new Post-Prosecution Pilot ("P3") program for final rejections that is available to only 1600 participants. The requirements for P3 participation are as follows: (1) outstanding final rejection (no notice of appeal, AFCP 2.0 or RCE filed); (2) filing a request for P3 participation within 2 months of mailing of final rejection; (3) filing a response to the final rejection that includes no more than 5 pages of arguments and optionally, a proposed non-broadening claim amendment; (4) filing of a statement that applicant is willing and available to participate in a conference with a panel of examiners; (5) participation in the conference including opportunity to make a 20min presentation to the panel, which may be in-person or remote, and can include exhibits or slides.
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Disclaimer: The content in this blog is solely for informational purposes and does not constitute legal advice.
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