Posts Tagged: "Guest Contributor"

Patents allow you to protect your inventions, license the use of the inventions of others, and introduce additional revenue streams to your business. Patents also require investments of time and money to maximize their usefulness. By focusing your investment and efforts on optimizing the usability of patents of value, you can improve the validation that your applications read on markets of interest, and that further your portfolio goals, help tune a patent portfolio by developing indication of use (IoU) of some applications regarding products of interest, and early cost savings by avoiding applications with challenges or concerns, use applications as soon as they are granted and improve utilization of filed inventions by identifying continuation opportunities… There are many ways that patent strengthening can improve a portfolio. By focusing on optimizing the quality of patents of value you can achieve maximum ROI from their use, and you can minimize the cost by avoiding lower-value applications as well as their future maintenance.

In justifying the constitutionality of the inter partes review (“IPR”) statute enacted by the America Invents Act (“AIA”), a common refrain persistently asserted is that patent rights emanate solely from federal statute and are therefore public rights, derived from a “federal regulatory scheme.” Another reprise is the remedial tenor of the IPR statute: Congress merely authorized a “narrow” post-issuance means for the agency to “correct its own errors.” My paper shows that both contentions above are without merit; that the exclusive patent right emanates from the inventor – not from Congress – and therefore the right adjudicated in IPRs is a “private right”; and that the notion of post-issuance “error correction” is fiction, as it overlooks the irreversible and uncorrectable exchange of rights upon patent issuance.

I was just thinking how often someone teaching intellectual property law leads the attack on the patent system when “Racing for academic glory and patents: Lessons from CRISPR” appeared. It sounds a dire warning that “overly broad patents must be reined in” as the passage of the Bayh-Dole Act “invoking patents as a mechanism for promoting commercialization of federally funded research” set off an “often socially wasteful race…for glory in academic research and in the patent sphere.” What’s particularly striking is that neither the paper nor the articles hyping it provide any evidence the CRISPR patents are restricting research or blocking commercial development. Indeed, most signs point in the opposite direction… Doesn’t a finding by NIH that there’s no evidence of any problems with how universities are licensing their CRISPR patents deserve to be mentioned? It seems like a pretty important point.

In a recent trademark opposition, the Opposition Board of the Japan Patent Office (JPO) dismissed an opposition by Mattel, Inc. – maker of the world-famous Barbie doll – who claimed “Salon BARBIES” is likely to cause confusion or association with famous Barbie doll when used on restaurant and fan club services.

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including Dr. Reddy’s, Zydus, Cipla, and Lotus Pharmaceutical.  Those ANDAs have triggered corresponding Hatch-Waxman lawsuits from Celgene.  Among the asserted patents, most of them expire by 2022, with the exception of two polymorph patents that could extend Revlimid® monopoly until 2027.  The lawsuits are in their early stages, but an upcoming Markman hearing in the case against Dr. Reddy’s is shaping up to be critical to whether Celgene can protect is Revlimid® monopoly past 2022.

In what appears to be a clear departure from the past, in Amgen, the Federal Circuit has rejected the test, basing its rejection on the ground that it effectively eliminates the written description requirement.  Amgen at 15, 16.  According to the Court, where a functional genus claim to antibodies to a newly characterized antigen is concerned, the underlying science is not so advanced as to establish that “make and use” is equivalent to the required description of the claimed antibodies.  Id. at 16.  Drawing such equivalence, the Court said would amount to declaring a contested scientific proposition to be so settled as to be entitled to judicial notice, which the Court was not prepared to do.  Id.

When an individual or company challenges the validity of a patent, “the burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.” In other words, the challenger bears the burden of demonstrating that the patent is invalid—the individual or company holding the patent need not show that the patent is valid. However, the text of the statute is silent on the precise nature of the challenger’s burden.

For the last 20 years, manufacturers have used 3D printing to build prototypes, but it was only recently that this industrial technology entered the mainstream.  The 3D printing of products can enable faster time-to-market, save money, mitigate risk and allow manufacturers to customize a component to suit customer needs. 3D printing can produce individual, specifically tailored parts on demand. Boeing printed an entire plane cabin in 2013 and Ford can manufacture vehicle parts in four days that would have taken four months using traditional methods.

The first design patent case to go to trial since Apple v. Samsung has given design patent owners hope that a ‘total profit’ award is still achievable… Patent owners are keeping a close eye on how juries respond to the new legal framework, and will be carefully attuned to appeals from these cases as the Federal Circuit addresses the standards that apply to design patent damages cases going forward. If patent owners continue to get total profits for design patent infringement, even after Samsung v. Apple, companies are likely to increase their efforts in obtaining design patents, particularly given the current climate facing utility patents.

Specifically, the petition presents the question: is patent ineligibility under 35 U.S.C. § 101, which Congress did not codify in 35 U.S.C. § 282(b), not a cognizable defense in a patent litigation? The question presented parallels that of the one recently decided by the Supreme Court in SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, 137 S. Ct. 954 (2017). In SCA Hygiene, the Supreme Court examined 35 U.S.C. § 282(b), which enumerates the defenses that may be raised in a patent litigation, and held that laches, which is not recited in § 282(b), is not a defense to patent damages within the statute of limitations set forth in 35 U.S.C. § 286. RPost’s petition asks the Court to again examine § 282(b) in order to determine whether patent ineligibility under 35 U.S.C. § 101, which, like laches, is not recited in § 282(b), is similarly not a defense that may be raised in a patent litigation.

The PTO reports a case as affirmed if all claims are rejected for at least one issue on appeal and reversed if all claims are reversed for at least one ground of rejection. A case is only reported affirmed-in-part by the PTO’s statistics if at least one claim remains standing, regardless of which legal issue ((§101, §103, §112, etc.) the claim was originally rejected. Since a large portion of PTAB ex parte appeals involve rejections over more than one ground of rejection (between 35%-45% according to this statistical estimate), this reporting process masks what the PTAB is deciding on each legal issue presented to it. Because the USPTO data does not report the outcome of each legal issue in multiple issue cases, it is impossible to collect statistically meaningful data on outcomes of specific legal issues from the data set from the FOIA website.

Do you sometimes feel unsure of yourself when speaking to a client or making a presentation?   Anyone who answered no is not being honest.   We all feel insecure at certain times; that is human.   It is impossible to know everything or anticipate every possible question.  You can be more effective with clients and colleagues if you follow a few simple rules when dealing with situations where you are not 100% certain.

Once your patent has been awarded you may still need additional capital to turn that patent into a business. Fortunately it is not as difficult to find investors as you may think. Equity crowdfunding is on the path to surpass venture capital as the preferred way for start-ups and small businesses to raise capital. In a nutshell, equity crowdfunding is the sale of equity (or debt) in your business directly to investors using an online platform instead of a stock brokerage firm.  It is also less expensive than hiring one. Although direct to investor funding over the internet has been around since the late 1990s, it came of age with the JOBS Act in 2012.   

In the case, Amgen v. Sanofi, the Court vacated an injunction Amgen obtained against a competing drug to its new PCSK9-inhibitor.  The Court’s decision turned on a finding that the jury was improperly instructed on the criteria for invalidating a patent directed to an antibody for lack of written description.  Thus, will the precedent recently established in Amgen’s PCSK9 case doom the validity of its patents covering Enbrel®?  There are likely two ways that the decision in Amgen v. Sanofi made a validity challenge to Enbrel®’s patents easier.

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the use of a claimed invention in connection with carrying out clinical trials will constitute an invalidating public use. Patent applications are typically filed early on in the process of developing and commercializing a pharmaceutical drug product. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar. The circumstances under which clinical trials involving administration of a drug product that occur prior to the critical date may constitute an invalidating public use is a murky area of the law and courts’ decisions in this area are highly dependent on the facts of the case before them.