An issue for many tech entrepreneurs is whether they should spend the resources (money and time) on getting a patent. Let me address the issues here why you should or should not get a patent. Before we even get to the issues, let’s define what is eligible for a patent: to get a patent you …
Author Archives: Andrew Berks
You Have A Book Deal Offer — Now What?
My clients have learned from their mistakes and currently understand the importance of having the advice of a qualified attorney prior to signing with a publisher. Because these mistakes or pitfalls often come with a hefty price tag down the line, in this article we share with our reader’s important negotiation points that are commonly …
Immunogen Antibody Conjugate Patent Survives IPR
Immunogen’s US Patent 8,337,856, which claims antibody-toxin immunogates for the treatment of cancer, survives an IPR challenge in a final written decision by the PTAB. In an unpredictable art, the Board finds that general statements in the prior art giving hints of future research were insufficient to provide a reasonable expectation of success.
Crowd Funding Boost? Crowd Funding Patent Invalidated by Kickstarter
US Patent 7,885,887, claiming crowd funding, is invalid under §101. “The ‘887 Patent claims only the abstract and time-honored concept of patronage, and even the addition of an element of computer use is insufficient to render it valid under Section 101 of the Patent Act, 35 U.S.C. § 101.” Kickstarter’s motion for summary judgment is granted
Apotex loses IPR on Prodrug Obviousness (Institution Denied)
Petitioner Apotex asserted that claims directed to fosaprepitant were obvious, but the PTAB finds that there was no valid lead compound, so the patent is not obvious.
Means-Plus-Function Software Claims Must Have an Underlying Algorithm
EON’s patent with means-plus-function claiming describing complex computer functionality is indefinite because there are no algorithms to provide structure to the claims. When a patentee invokes means-plus-function claiming to recite a software function, it accedes to the reciprocal obligation of disclosing a sufficient algorithm as the corresponding structure.
Apotex Bid to Steal Mylan Exclusivity on Benicar
In this Hatch-Waxman action, Apotex is attempting to trigger a forfeiture event, that if successful, will cause Mylan to forfeit its 180-day exclusivity for a generic copy of Benicar®, olmesartan medoximil, that Mylan is otherwise eligible to receive.
ATELVIA® Patents Obvious at District Court
The court therefore found clear and convincing evidence that a person of ordinary skill at the time of the invention (in 2005) would have been motivated to use EDTA in the claimed amounts with a reasonable expectation of success.
In this Hatch-Waxman case, Bristol-Myers Squibb, owner of the drug entecavir (sold as Baraclude®, indicated for hepatitis B (HBV) infection), sued Teva Pharmaceuticals for patent infringement. Teva responded that the patent (the only patent at issue was US5206244, priority date 10/18/1990), which claims the chemical structure of entecavir, was obvious. The district court found in …
Megestrol Nanoparticle Formulation Claims – Not Inherently Obvious (at least not yet)
in an obviousness analysis, an inherency argument has a heightened standard that must be the natural result flowing from the operation as disclosed in prior art references.
Means-plus-function claims – indefinite because of insufficient structure in the specification
Contact the author: Andrew Berks Robert Bosch, LLC v. Snap-On, Inc., No. 2014-1040 (Fed. Cir. 10/14/2014). The Federal Circuit panel, (Prost, Taranto, and Hughes) outlines a two-step framework for determining if a claim invokes 35 U.S.C. § 112(f) (formerly (formerly 112 ¶ 6). The panel concludes the challenged claim invoked 35 U.S.C. § 112(f), i.e., the claim is …
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Abbvie v. Janssen: Another nail in the coffin of functional claiming
Contact the author: Andrew Berks AbbVie Deutschland GmbH v. Janssen Biotech, Inc., No. 2013-1338 (Fed. Cir. 7/1/2014) This is a significant decision that extends the Federal Circuit’s holdings on written description from Ariad Pharms., Inc. v. Eli Lilly Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc), and has important lessons for patent applicants seeking to …
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Nautilus v. Biosig – The Supreme Court Clarifies the Clarity Requirement
Contact the author: Andrew Berks Nautilus, Inc. v. Biosig Instr.. Inc., No. 13-369 (S. Ct. 6/2/2014) Opinion by Ginsburg. The definiteness requirement, 35 U.S.C. §112(b) (AIA, effective 9/12/2012; previously §112 second para.) requires that a patent “specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or …
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Gilead v. Natco – Gilead’s patent invalid for obviousness-type double patenting
The panel concludes that looking to the earliest patent expiration for patents that are obvious variants “best fits and serves the purpose of the doctrine of double patenting.”
Zydus Not Infringing Lansoprazole ODT Particle Size Claim
Contact the author: Andrew Berks Takeda Pharm. Co. Ltd. v. Zydus Pharms. USA, Inc., No. 2013-1406 (Fed. Cir. 2/20/2014) This Hatch-Waxman case pertains to particle size claims for the brand name drug Prevacid® SoluTab™. The product is an orally dissolving tablet (ODT) containing lansoprzaole. Only claim 1 of US6328994 is in dispute, which reads, in relevant …
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PTAB Obviousness Finding Reversed in Institut Pasteur GIIE Endonuclease Patents
Contact the author: Andrew Berks Inst. Pasteur v. Focarino, No. 2012-1485 (Fed. Cir. 12/30/2013) Three patents were at issue, US6610545, US6833252, and US7309605, all based on an application originally filed 5/6/1992 and expired on 5/6/2012. The patents disclose group I intron encoded (GIIE) endonucleases. GIIE endonucleases are valuable research tools that are highly specific in selecting …
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Wyeth’s expansive claim construction results in finding of non-enablement
Contact the author: Andrew Berks Patents on rapamycin for restenosis held invalid for lack of enablement. Wyeth v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013). Wyeth sued defendants for patent infringement. Defendants counterclaimed that the patents were invalid as not enabled and for lack of written description. The specification disclosed only one rapamycin species (sirolimus). The alleged …
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Sloppy Claim Drafting Invalidates Teva Copaxone Claims
Teva Pharms. USA, Inc. v. Sandoz, Inc.,, No. 2012-1567 (Fed. Cir. 7/26/2013) (no reporter cite) (Rader, Moore, and Benson (sitting by designation from the District of Utah). Opinion by Moore. Teva sued Mylan and Sandoz for patent infringement of nine patents covering copolymer-1, marketed by Teva as “Copaxone®” for the treatment of multiple sclerosis. Copolymer-1 …
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Wellman, Inc. v. Eastman Chemical Co. – A Trade Secret Does Not Excuse Best Mode
Wellman lost a patent infringement claim on the grounds that it failed to disclose a specific preferred formulation known at the time the patent was filed, and also because it attempted to hold back part of the invention as a trade secret. Wellman, Inc. v. Eastman Chemical Co., No. 2010-1249 (Fed. Cir. 4/29/2011). Wellman had …
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Stanford v. Roche – When is an assignment not an assignment?
This case was a dispute over conflicting assignments by an inventor to Stanford and a private lab where he did supporting work. When infringement litigation erupted between the parties, the defendant asserted it was a co-owner so the plaintiff had no standing to sue. The underlying research was federally funded, and Stanford asserted that the …
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Billups-Rothenberg – Another Biotech Patent Invalid for Lack of Written Description
In Billups-Rothenberg, Inc. v. Assoc’d Regional Univ. Pathologists, Inc., No. 2010-1401 (Fed. Cir. 4/29/2011), U.S. Patent Nos. 5,674,681 (the ’681 patent) and 6,355,425 (the ’425 patent) describe genetic tests for Type I hereditary hemochromatosis, an iron disorder characterized by excessive iron absorption by the body. The defective gene in hemochromatosis is the High Fe (“HFE”) gene. The …
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New Dependent Claim is Proper Basis for Reissue Patent
The reissue procedure is prescribed by 35 U.S.C. § 251, which permits a patentee to seek a review of a granted patent on the grounds that the patent is inadvertently defective due to an error in conduct which was made in the preparation and/or prosecution. The patent must be “wholly or partly inoperative or invalid by …
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Ariad v. Lilly: Federal Circuit Upholds Separate Written Description and Enablement
In an en banc decision, the majority opinion of the Federal Circuit affirmed, in Ariad Pharms., Inc. v. Eli Lilly Co., that there are separate written description and enablement requirements in 35 U.S.C. § 112 first paragraph, and that the requirement applies to original claims as well as amended claims. (598 F.3d 1336 (No. 2008-1248) …
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Claim to breach of “have made” rights a federal question if enforcement is a question of patent infringement
In ABB Inc. v. Cooper Indus. LLC, No. 2010-1227 (Fed. Cir. 2/17/2010), ABB took a license to a group of Cooper patents pertaining to a vegetable oil-based dialectric fluid called “Biotemp.” The license purported to contain a “have made” provision prohibiting 3rd parties from manufacturing the claimed material. ABB then outsourced manufacturing to Dow Chemical. Cooper …
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Centocor human antibody claims invalidated for lack of written description
Centocor Ortho Biotech Inc. v. Abbott Labs., No. 2010-1144 (Fed. Cir. 2/23/2011) (opinion by Prost). Centocor sued Abbott for patent infringement alleging that Abbott’s Humira® antibody infringes US Patent No. 7,070,775. The jury rejected Abbott’s defense that the asserted claims were invalid, and found Abbott liable for willful infringement and awarded Centocor $1.67 B. Abbott moved for …
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Obviousness in view of references considered in examination – Tokai Corp. v. Easton Enterprises, Inc.
Tokai owned three patents at issue, pertaining to lighters with an elongated rod, useful for lighting barbecue grills. Easton makes competitive products. Tokai sued Easton for patent infringement. The diputed feature was a safety device requiring the user to depress a button while pulling the trigger. Tokai Corp. v. Easton Enterprises, Inc., No. 2010-1057 (Fed. …
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Defective Chain of Priority Results in Holding of Anticipation
Encyclopaedia Britannica v. Alpine Electronics of America, No. 2009-1544 (Fed. Cir. 6/18/2010). Encylopedia Britannica (EB) owns the ‘018 and ‘437 patents, pertaining to multimedia database search system for retrieving textual and graphical information. EB sued defendants Alpine Electronics and several others alleging infringement of these two patents. The defendants argued that the patents were invalid …
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Prosecution Laches as Defense to Infringement — Cancer Res. Tech. Ltd. v. Barr Labs., Inc.
Prosecution laches is an equitable defense to a charge of patent infringement, that “may render a patent unenforceable when it has issued only after an unreasonable and unexplained delay in prosecution” that constitutes an egregious misuse of the statutory patent system.
Obviousness in prodrugs — Daiichi Sankyo Co. v. Mylan
Proof of obviousness based on structural similarity requires clear and convincing evidence that a medicinal chemist of ordinary skill would have been motivated to select and then to modify a prior art compound (e.g., a lead compound) to arrive at a claimed compound with a reasonable expectation that the new compound would have similar or improved properties compared with the old.
Donepezil: Teva has standing in declaratory judgement action that it doesn’t infringe listed patents
Teva Pharms. USA Inc. v. Eisai Co., Ltd., No. 2009-1593 (Fed. Cir. 10/6/2010). Ranbaxy was first-filer (pre-MMA) for donepezil of an ANDA with a “paragraph IV” certification, and Teva was a subsequent filer with a paragraph IV certification. Teva obtained tentative approval for its ANDA, but was prevented from marketing by Ranbaxy’s first-filing. Teva sued …
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Adams Respiratory Therapeutics, Inc. v. Perrigo Co.
No. 2010-1246 (Fed. Cir. 8/5/2010) (Linn, Moore, Friedman, opinion by Moore).This case highlights several important issues in an ANDA litigation. Background Adams owns the ‘252 patent for controlled release guaifenesin. Adams markets Mucinex® which is the preferred embodiment of the ‘252 patent. Slip op. at 3. Perrigo filed an ANDA seeking to market 600 mg …
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Obviousness upheld: Purdue Pharma Products L.P. v. Par Pharmaceutical, Inc.
No. 2009-1553 (Fed. Cir. 6/3/2010) (non precedential). Par filed an ANDA for once daily tramadol, with PIV cert’s against two patents. Purdue sued, and Par counterclaimed that the patents were invalid under 35 U.S.C. § 112 for lack of enablement and written description, invalid under § 103 for obviousness, and unenforceable due to inequitable conduct. …
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Inequitable Conduct: Leviton Manufacturing Co., Inc. v. Universal Security Instruments, Inc.
No. 2009-1421 (Fed. Cir. 5/28/2010). Leviton filed several patent applications (that matured to granted patents) in 1999 and 2003 (“Germain application”) with nearly identical and in some cases identical claims. The 1999 and Germain application families were unrelated by priority and had no overlap of inventorship. Leviton failed to disclose the 1999 application during prosecution …
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Vizio, Inc. v. ITC
No. 2009-1386 (Fed. Cir. 5/26/2010). Funai owns the ‘974 patent that improves “channel latency,” a delay in digital TV decoders while data is received. Funai brought an action at the ITC alleging that defendants imported infringing TV’s. The ITC concluded that certain claims of the ‘974 patent were valid and enforceable, and infringed by defendants. …
Aspex Eyewear Inc. v. Clariti Eyewear, Inc.
In Aspex Eyewear Inc. v. Clariti Eyewear, Inc., No. 2009-1147 (Fed. Cir. 5/24/2010), Aspex sent Clariti several letters in 2003 alleging infringement of Aspex patents pertaining to eyewear. The last letter from Clariti was sent in June, 2003. Aspex then had no further contact with Clariti until August, 2006, when Aspex again renewed its allegations …
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Federal Circuit News
Judge Michel (retiring May 31, 2010) posted his state of the court address, which is very interesting. Anyone interested in IP law should read these comments. Judge Michel will fully retire (i.e., not go on senior status) and work for “stronger Congressional support for all the Federal courts and other institutions such as the Patent and Trademark …
Orion IP, LLC. v. Hyundai Motor Co.
U.S. Patent No. 5,367,627 is drawn to a computerized method for selecting parts, for example in an auto shop for selecting parts for repairs. Orion IP, LLC v. Hyundai Motor Co., No. 2009-1130 (Fed. Cir. 5/17/2010). The patentee alleged that Hyundai and other plaintiffs infringed the claimed method in their online sales systems. A jury …
Standing to sue: Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp.
In Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp., No. 2009-1447 (Fed. Cir. 5/14/2010) the issue was whether a patent licensor had standing to sue. The Mann Foundation (AMF) licensed US 5609616 and US5938691, both pertaining to cochlear implants for the treatment of hearing loss, to a firm called Advanced Bionics (AB) in …
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Federal Circuit Issues Two § 156 Decisions
On Monday, May 10, 2010, the Federal Circuit issued two decisions dealing with 35 U.S.C. § 156 (patent term extension to compensate for regulatory delays). In Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., No. 2009-1362 (Fed. Cir. 5/10/2010) (Judges Newman, Rader, Linn; opinion by Newman). Daiichi Pharmaceuticals owns U.S. 5,053,404, and obtained a patent term …
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