Posts Tagged: "written description"

Supreme Court’s Denial of Juno Therapeutics is Another Blow to the Life Science Patent Industry

On November 7, the U.S. Supreme Court issued an order list showing that it had denied the petition for writ of certiorari filed in Juno Therapeutics, Inc. v. Kite Pharma, Inc. In denying the petition, the Court refused yet again to clarify the Federal Circuit’s questionable interpretation of U.S. patent code, this time within the context of the written description requirement of 35 U.S.C. § 112, and leaves in place an appellate court ruling that many believe will be very damaging to the United States’ life sciences innovation sector.

Amicus Filings in Biogen v. Mylan Urge SCOTUS to Eliminate Uncertainty in Drafting Patents to Satisfy Written Description Requirement

Last week, the U.S. Supreme Court received several amicus briefs filed in support of the petition for writ of certiorari filed in Biogen International GmbH v. Mylan Pharmaceuticals Inc. If cert is granted, this case will ask the nation’s highest court to clarify the written description requirement under 35 U.S.C. § 112. The appeal follows a contentious decision this March from the U.S. Court of Appeals for the Federal Circuit to deny panel rehearing and rehearing en banc of an earlier ruling affirming the Northern District of West Virginia’s invalidation of Biogen’s patent claims covering a method of treating multiple sclerosis (MS) under Section 112.

CAFC Reverses January Decision Affirming Sufficient Written Description for Negative Claim Limitation Over Judge Linn’s Dissent

Earlier today, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. granting a petition for rehearing from appellant HEC Pharm Co., Ltd. In granting HEC’s petition, the panel majority of Chief Judge Kimberly Moore, who authored the decision, and Circuit Judge Todd Hughes vacated a previous January ruling by the Federal Circuit, which had affirmed the District of Delaware’s final judgment that Novartis patent claims covering its Gilenya treatment for multiple sclerosis were not invalid for failing to satisfy the written description requirement under 35 U.S.C. § 112. Senior Circuit Judge Richard Linn authored a dissent arguing that the panel majority had improperly adopted a heightened written description standard and failed to take into account expert testimony from Novartis regarding a negative claim limitation that the district court found was supported by ample evidence.

Juno Petition Asks SCOTUS to Clarify Written Description Standard

Juno Therapeutics last week petitioned the U.S. Supreme Court, asking it to review an August 2021 decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) that reversed a jury verdict for Juno and Sloan Kettering Institute for Cancer Research, wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence.

CAFC Vacates Section 112 Indefiniteness Ruling, Sending St. Jude Medical Back to Court

On April 11, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Niazi Licensing Corp. v. St. Jude Medical S.C., Inc. in which the court affirmed most of a ruling from the District of Minnesota, including sanctions against Niazi for improper use of expert testimony, as well as a finding of no induced infringement by St. Jude on one of Niazi’s asserted patent claims. However, the Federal Circuit’s decision reversed the Minnesota district court’s ruling invalidating most patent claims asserted by Niazi for indefiniteness under Section 112. The CAFC found that Niazi’s asserted claims were not invalid simply for including descriptive words or terms of degree, as long as the intrinsic record and extrinsic evidence enable a skilled artisan to identify the boundaries of a claim’s scope.

Stinging CAFC Dissent from Denial of Biogen Rehearing Petition Accuses Majority of Muddying Written Description

The U.S. Court of Appeals for the Federal Circuit today denied rehearing and rehearing en banc to Biogen International, which had petitioned the court following a November decision  affirming a district court ruling that Biogen’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Three judges split from the majority, with Judges Lourie, Moore and Newman dissenting on the denial of en banc rehearing. Judge O’Malley had dissented from the November panel decision, but she retired on March 11, 2022, and only participated in the decision on panel rehearing.

CAFC Affirms PTAB Ruling that Ballistic Parachute System Patent Claims Are Obvious

On March 10, the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB’s) obviousness determination and its denial of patent owner Hoyt Fleming’s motion to amend the asserted claims of the U.S. Patent No. RE47,474. Cirrus Design Corp. petitioned for inter partes review of multiple claims, including claims 135-139, of the ’474 patent. During the proceeding, Fleming moved to amend, seeking to replace the asserted claims with proposed substitute claims. The Board concluded that claims 137-139 were unpatentable as obvious over the combination of Cirrus Design’s Pilot Operation Handbook for the SR22, Revision A7, (Oct. 10, 2003) (POH) and U.S. Patent No. 6,460,810 (James). The Board further found that Fleming’s proposed amended claims did not meet the statutory and regulatory requirements for patentability because they lacked written description support and thus constituted new matter. On appeal, Fleming argued the Board erred in determining that the asserted claims are unpatentable and in denying his motion to amend.

In Dissent to CAFC Ruling for Novartis on Written Description, Chief Judge Argues ‘Silence is not Disclosure’

The U.S. Court of Appeals for the Federal Circuit (CAFC) yesterday affirmed a district court’s ruling that Novartis’ U.S. Patent No. 9,187,405 is not invalid and that HEC Pharm Co., Ltd. and HEC Pharm USA Inc.’s Abbreviated New Drug Application (ANDA) infringed the patent. The CAFC found no clear error in the district court’s finding that the patent’s claims did not fail the written description requirement under 35 U.S.C. § 112(a). Chief Judge Moore dissented, arguing that the district court’s analysis was inconsistent with the CAFC’s established precedent. The ‘405 patent covers methods of treating relapsing remitting multiple sclerosis (RRMS) with fingolimod (an immunomodulating medication) or a fingolimod salt “at a daily dosage of 0.5 mg without an immediately preceding loading dose.”

O’Malley Dissents from ‘Concerning’ CAFC Ruling that Biogen’s MS Drug Patent is Invalid

The U.S. Court of Appeals for the Federal Circuit (CAFC) earlier today affirmed a district court ruling that Biogen International’s patent for a method of treating multiple sclerosis (MS) was invalid for lack of written description. Judge O’Malley dissented, arguing that the district court clearly erred in its finding that Biogen was judicially estopped from drawing a distinction between clinical and therapeutic effect, and that the entire analysis “might well change” if the case was remanded “for reconsideration of the record with the understanding that the patent is not about clinical efficacy” but therapeutic effect.

CAFC Reverses Massive Jury Verdict for Juno and Sloan Kettering

The U.S. Court of Appeals for the Federal Circuit (CAFC) today reversed a jury verdict for Juno Therapeutics and Sloan Kettering Institute for Cancer Research (Juno), wiping out a $1.2 billion judgment for the entities. The CAFC found that the jury’s verdict with respect to written description was not supported by substantial evidence. The case relates to U.S. Patent No. 7,446,190, owned by Sloan Kettering, which is titled “Nucleic Acids Encoding Chimeric T Cell Receptors.” The patent generally covers cancer immunotherapy technology. Juno sued Kite Pharma, Inc. for infringement of the ‘190 patent through the sale of its YESCARTA product. Kite countersued, seeking declaratory judgments of noninfringement and invalidity. The jury ultimately found in Juno’s favor and, in post-trial briefs, Kite moved for judgment as a matter of law (JMOL) on several grounds, including that the claims were not supported by sufficient written description. The district court denied JMOL and Kite appealed.

‘AISITAs’ and Written Description Requirements: Considerations and Guidance for AI Patent Applications

Artificial intelligence (AI) is everywhere, touching nearly every aspect of our daily lives, including how we work, communicate, shop, travel and more. The term “AI” is generally understood to encompass computerized systems that perform tasks ordinarily perceived as requiring some form of human intelligence. Many AI-based systems are able to recognize trends, patterns and connections, test hypotheses using available data sets, and continuously improve decision trees based on user input. As such, AI has been shown to have near endless applications, driving a surge of inventions and related patent application filings.

Written Description in the Life Sciences: The Devil is in the Details

There is a quid pro quo under the U.S. patent laws. In exchange for disclosing her invention, an inventor receives a limited monopoly. Recent developments, however, have made it harder for those in the biotechnology industry to obtain the benefit of this bargain. The written description requirement mandates that a patent specification convey to one of skill in the art that the inventors had possession of their invention as of the day they filed their patent application. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Over the last decade, three areas have proven troublesome in the life sciences.

Thought Experiment: Is Our Patent System Ready for a Potential Future of Brain Interfacing?

Currently, brain recording and/or brain stimulation is used almost entirely for medical or research purposes. Invasive surgery is generally required to read neural signals with high temporal and spatial resolution. High resolution of neural signals enables researchers to decode a brain’s underlying intentions, sensations, reactions, etc. rather reliably, if only in constrained environments. With regard to stimulation, researchers have demonstrated the ability to trigger different types of effects. For example, stimulating the reticular formation can cause a subject to become awake; stimulating the amygdala can evoke fear; stimulating the motor cortex can trigger movement; stimulating the visual cortex can cause a subject to see light flashes. However, the state of the art is neither able to decode complex and unrestrained thoughts nor cause a subject to have a particular “target” complex thought. At least not yet.

Implications of Filing Subsequent Patent Applications in the United States (Part III)

In Part I, the authors reviewed the law behind subsequent patent applications. In Part II, we reviewed the different types of subsequent applications. Part III will discuss some of the implications of these. When an applicant seeks to add new claims pursuant to a continuation or divisional application, U.S. Patent Law explicitly requires that the original specification provide adequate support for the new claims by the original specification satisfying the Section 112(a) written description and enablement requirements for the new claims. 35 U.S.C. § 120. The same is also true for continuation-in-part (CIP) applications claiming overlapping subject matter but not for claims comprising “new matter” because the new matter claimed must find support in additional disclosure, i.e., in material added to the CIP application itself.

Federal Circuit Remands District Court Decision for Erroneous Claim Construction

On August 27, the United States Court of Appeals for the Federal Circuit (CAFC) reversed and remanded a decision of the U.S. District Court for the District of Delaware in Baxalta Inc. v. Genentech, Inc. The CAFC reversed the district court’s claim construction of the terms “antibody” and “antibody fragment” in Baxalta’s patent claims and remanded for proceedings consistent with the correct constructions.