The USPTO is seeking input on how it can leverage prior art information available on-line in related patent applications in order to “improve patent examination quality and efficiency” and reduce “applicant’s burden to...more
In Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline...more
Elm 3DS Innovations, LLC has sued the USPTO in the U.S. District Court for the Eastern District of Virginia to challenge its authority to declare that December 22-24, 2015 were “holidays” because the USPTO had experienced a...more
In Multilayer Stretch Cling Film v. Berry Plastics, the Federal Circuit provided a detailed discussion of the construction of claims that use Markush group language. The decision emphasizes the closed nature of the...more
On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more
8/10/2016
/ Abbreviated New Drug Application (ANDA) ,
AbbVie ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents
To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more
3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more
8/1/2016
/ 3D Printing ,
Bilski ,
CLS Bank v Alice Corp ,
Contributory Infringement ,
Food and Drug Administration (FDA) ,
Induced Infringement ,
Intellectual Property Protection ,
Manufacturers ,
Medical Devices ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Professional Conferences ,
USPTO
In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more
7/22/2016
/ Amicus Briefs ,
CAFC ,
En Banc Review ,
Hospira ,
Manufacturers ,
On-Sale Bar ,
Orange Book ,
Outsourcing ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Remand ,
Uniform Commercial Code (UCC)
On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more
7/18/2016
/ CLS Bank v Alice Corp ,
Examiners ,
Guidance Update ,
Life Sciences ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Section 101 ,
Sequenom ,
USPTO
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more
7/15/2016
/ Actual Damages ,
Biosimilars ,
Confidentiality Agreements ,
Direct Infringement ,
Hospira ,
Induced Infringement ,
Injunctive Relief ,
Janssen Pharmaceuticals ,
On-Sale Bar ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Treble Damages
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more
The USPTO has launched a new after final program available starting July 11, 2016. The Post-Prosecution Pilot Program (P3) combines features of the After Final Consideration Pilot 2.0 (AFCP 2.0) and Pre-Appeal Brief...more
The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S....more
7/8/2016
/ CAFC ,
CLS Bank v Alice Corp ,
Examiners ,
Mayo v. Prometheus ,
Method Claims ,
New Guidance ,
Patent-Eligible Subject Matter ,
Remand ,
Section 101 ,
USPTO ,
Vacated
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more
7/8/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz v Amgen
In Trustees of the University of Pennsylvania v. Eli Lilly and Co., the U.S. District Court for the Eastern District of Pennsylvania refused to correct improper multiple dependent claims and instead held them invalid under 35...more
“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more
The U.S. Supreme Court has denied certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc. (No. 15-1182), declining to review the Federal Circuit’s June 12, 2015, decision that certain methods of detecting paternally...more
The Federal Circuit decided not to disturb the “longstanding administrative construction” of 35 USC § 120 that permits the filing of a continuation application on the same day its parent application grants as a patent. The...more
On June 20, 2016, instead of deciding whether to grant certiorari in the biosimilar patent dance dispute between Amgen and Sandoz, the Supreme Court invited the Solicitor General “to file a brief in this case expressing the...more
6/21/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General
As we wait for the Supreme Court decision in Cuozzo Speed Technologies, LLC v. Lee, where the Court has been asked to decide whether the USPTO Patent Trial and Appeal Board (PTAB) should apply the “broadest reasonable...more
In Halo Electronics, Inc. v. Pulse Electronics, Inc., the Supreme Court rejected the Federal Circuit’s two-part Seagate test for awarding enhanced damages under 35 USC § 284, finding that both the substantive requirement for...more
6/15/2016
/ 35 U.S.C. § 284 ,
Enhanced Damages ,
Halo v Pulse ,
Judicial Discretion ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preponderance of the Evidence ,
SCOTUS ,
Seagate ,
Willful Infringement
The USPTO Patent Trial and Appeal Board has instituted Post Grant Review (PGR) proceedings against a patent directed to a process for treating contaminated media. The petition for PGR challenged that patent on written...more
In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more
5/31/2016
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Confidentiality Agreements ,
Generic Drugs ,
Joint Venture ,
Merck ,
Non-Compete Agreements ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Patents ,
Reversal ,
Watson Pharmaceuticals
In Intendis GmbH v. Glenmark Pharmaceuticals Inc., USA, the Federal Circuit affirmed the district court decision that found infringement under the doctrine of equivalents. This case shows that the doctrine of equivalents...more
5/24/2016
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
De Novo Standard of Review ,
Doctrine of Equivalents ,
Estoppel ,
FDA Approval ,
Generic Drugs ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Prior Art
When I first wrote about the new natural products Subject Matter Eligibility Examples issued by the USPTO on May 4, 2016, I noted a puzzling difference between the treatment of a claim reciting a vaccine coated on a...more